Devices for preventing percutaneous exposure injuries caused by needles in healthcare personnel

  • Review
  • Intervention

Authors


Abstract

Background

Needlestick injuries from devices used for blood collection or for injections expose healthcare workers to the risk of blood borne infections such as hepatitis B and C, and human immunodeficiency virus (HIV). Safety features such as shields or retractable needles can possibly contribute to the prevention of these injuries and it is important to evaluate their effectiveness.

Objectives

To determine the benefits and harms of safety medical devices aiming to prevent percutaneous exposure injuries caused by needles in healthcare personnel versus no intervention or alternative interventions.

Search methods

We searched CENTRAL, MEDLINE, EMBASE, NHSEED, Science Citation Index Expanded, CINAHL, Nioshtic, CISdoc and PsycINFO (until January 2014) and LILACS (until January 2012).

Selection criteria

We included randomised controlled trials (RCT), controlled before and after studies (CBA) and interrupted time-series (ITS) designs on the effect of safety engineered medical devices on needlestick injuries in healthcare staff.

Data collection and analysis

Two authors independently assessed study eligibility and risk of bias and extracted data. We synthesized study results with a fixed-effect or random-effects model meta-analysis where appropriate.

Main results

We included four RCTs with 1136 participants, two cluster-RCTs with 795 participants and 73,454 patient days, four CBAs with approximately 22,000 participants and seven ITS with an average of seven data points. These studies evaluated safe modifications of blood collection systems, intravenous (IV) systems, injection systems, multiple devices and sharps containers. The needlestick injury (NSI) rate in the control groups was estimated at about one to five NSIs per 1000 person-years. There was only one study from a low- or middle-income country. The risk of bias was high in most studies.

In one ITS study that evaluated safe blood collection systems, NSIs decreased immediately after the introduction (effect size (ES) -6.9, 95% confidence interval (CI) -9.5 to -4.2) and there was no clear evidence of an additional benefit over time (ES -1.2, 95% CI -2.5 to 0.1). Another ITS study used an outdated recapping shield.

There was very low quality evidence that NSIs were reduced with the introduction of safe IV devices in two out of four studies but the other two studies showed no clear evidence of a trend towards a reduction. However, there was moderate quality evidence in four other studies that these devices increased the number of blood splashes where the safety system had to be engaged actively (relative risk (RR) 1.6, 95% CI 1.08 to 2.36).

There was no clear evidence that the introduction of safe injection devices changed the NSI rate in two studies.

The introduction of multiple safety devices showed a decrease in NSI in one study but not in another. The introduction of safety containers showed a decrease in NSI in one study but inconsistent results in two other studies.

There was no evidence in the included studies about which type of device was better, for example shielding or retraction of the needle.

Authors' conclusions

For safe blood collection systems, we found very low quality evidence in one study that these decrease needlestick injuries (NSIs). For intravenous systems, we found very low quality evidence that they result in a decrease of NSI compared with usual devices but moderate quality evidence that they increase contamination with blood. For other safe injection needles, the introduction of multiple safety devices or the introduction of sharps containers the evidence was inconsistent or there was no clear evidence of a benefit. All studies had a considerable risk of bias and the lack of evidence of a beneficial effect could be due both to confounding and bias. This does not mean that these devices are not effective.

Cluster-randomised controlled studies are needed to compare the various types of safety engineered devices for their effectiveness and cost-effectiveness, especially in low- and middle-income countries.

Résumé scientifique

Les dispositifs pour la prévention des blessures liées à l'exposition percutanée et causées par les aiguilles chez le personnel médical

Contexte

Les blessures par piqûre d'aiguille de dispositifs utilisés pour le prélèvement sanguin ou pour les injections exposent le personnel médical au risque de contamination par voie sanguine, telle que l'hépatite B et C, ainsi que le virus de l'immunodéficience humaine (VIH). Les dispositifs de protection, tels que les manchons de protection pour aiguille ou les aiguilles rétractables, pourraient permettre de prévenir ces blessures et il est important d'évaluer leur efficacité.

Objectifs

Déterminer les effets bénéfiques et délétères des dispositifs médicaux protecteurs visant à prévenir des blessures liées à l'exposition percutanée causée par les aiguilles chez le personnel médical par rapport à l'absence d'intervention ou à d'autres interventions.

Stratégie de recherche documentaire

Nous avons effectué des recherches dans CENTRAL, MEDLINE, EMBASE, NHSEED, Science Citation Index Expanded, CINAHL, Nioshtic, CISdoc et PsycINFO (jusqu'en janvier 2014) et LILACS (jusqu'en janvier 2012).

Critères de sélection

Nous avons inclus les essais contrôlés randomisés (ECR), les études contrôlées avant et après (CAA) et les séries chronologiques interrompues (SCI) évaluant l'effet des dispositifs médicaux protecteurs contre les blessures par piqûre d'aiguille chez le personnel médical.

Recueil et analyse des données

Deux auteurs ont indépendamment évalué l'éligibilité et le risque de biais et extrait les données. Nous avons synthétisé les résultats des études avec une méta-analyse de modèle à effets fixes ou à effets aléatoires lorsque cela était approprié.

Résultats principaux

Nous avons inclus quatre ECR totalisant 1 136 participants, deux ECR en grappes portant sur 795 participants et 73 454 jours-patients, quatre études CAA présentaient environ 22 000 participants et 7 SCI avec une moyenne de sept points de données. Ces études ont évalué les modifications sécuritaires des systèmes de collecte de sang, des systèmes par voie intraveineuse (VI), des systèmes d'injection, des multiples dispositifs et des contenants pour objets tranchants. Le taux de blessures par piqûre d'aiguille (BPA) dans les groupes témoins était estimé d'une à cinq BPA pour 1000 personnes par année. Il y avait une seule étude d'un pays à revenu faible ou moyen. Le risque de biais était élevé dans la plupart des études.

Dans une étude SCI qui évaluait les systèmes sûrs de prélèvement sanguin, les BPA réduisaient immédiatement après l'introduction de ces systèmes (ampleur de l'effet (AE) -6,9, intervalle de confiance à 95 % (IC) de -9,5 à -4,2) et il n'y avait aucune preuve probante d'un bénéfice supplémentaire au fil du temps (AE -1,2, IC à 95 % -2,5 à 0,1). Une autre étude SCI utilisait un capuchon de protection obsolète.

Dans deux études sur quatre, des preuves de très faible qualité indiquaient que les BPA diminuaient suite à l'introduction de dispositifs intraveineux sûrs, mais les deux autres études ne montraient aucune preuve probante d'une tendance à la baisse. Cependant, des preuves de qualité modérée dans quatre autres études indiquaient que ces dispositifs augmentaient le nombre d'éclaboussure de sang lorsque le système de protection devait être allumé en continu (risque relatif (RR) 1,6, IC à 95 % 1,08 à 2,36).

Dans deux études, il n'y avait aucune preuve probante que l'introduction de dispositifs d'injection sûrs modifiait les taux de BPA.

L'introduction de multiples dispositifs de protection montrait une diminution des BPA dans seulement une étude. L'introduction de contenants protecteurs montrait une diminution de BPA dans une étude, mais deux études indiquaient des résultats incohérents.

Il n'y avait aucune preuve dans les études incluses sur le type de dispositif le plus efficace, par exemple les manchons de protection pour aiguille ou les aiguilles rétractables.

Conclusions des auteurs

Dans une étude, des preuves de très faible qualité indiquaient que les systèmes sûrs de collectes du sang réduisaient les blessures par piqûre d'aiguille (BPA). Des preuves de très faible qualité indiquaient que les systèmes par voie intraveineuse entraînaient une diminution de BPA par rapport aux dispositifs ordinaires, mais des preuves de qualité modérée indiquaient qu'ils augmentaient la contamination avec le sang. Les preuves étaient incohérentes ou il n'y avait aucune preuve probante d'un bénéfice concernant les autres aiguilles d'injection sûres, l'introduction de multiples dispositifs de protection ou l'introduction de contenants pour objets tranchants. Toutes les études présentaient un risque considérable de biais et le manque de preuves d'un effet bénéfique pourrait être dû à la fois à des confusions et à des biais. Cela ne signifie pas que ces dispositifs ne sont pas efficaces.

Des études randomisées par grappes sont nécessaires pour comparer les différents types de dispositifs de protection selon leur efficacité et leur rapport coût-efficacité, en particulier dans les pays à faibles et moyens revenus.

摘要

預防醫療人員因針刺意外導致經皮暴露傷害的裝置

背景

因為採血或注射裝置所造成的針刺意外,使醫療人員暴露於發生血液傳播感染症 (blood borne infection) 的風險,例如B 型肝炎、C 型肝炎和人類免疫不全病毒 (human immunodeficiency virus, HIV)。配備安全性能例如護罩或回縮式針頭,或許有助於預防這些針刺意外,因此評估這些功能的有效性非常重要。

目的

相較於無介入或其他介入法,判斷使用安全性醫療裝置,對預防醫療人員因針刺意外導致受傷的利弊得失。

搜尋策略

我們搜尋CENTRAL、MEDLINE、EMBASE、NHSEED、Science Citation Index Expanded、 CINAHL、Nioshtic、CISdoc、 PsycINFO (截至2014年1月為止) 和LILACS (截至2012年1月為止)。

選擇標準

本次文獻回顧納入隨機對照試驗 (randomised controlled trial, RCT)、前後對照試驗 (controlled before and after study, CBA) 與 間斷時間序列 (interrupted time-series, ITS) 設計,研究安全性設計醫療裝置對醫療人員針刺意外的影響。

資料收集與分析

由2位作者獨立評估試驗是否符合納入條件、試驗的偏差風險,並進行資料萃取。我們視情況採用固定效果 (fixed-effect) 或隨機效果 (random-effect) 模式後設分析 (meta-analysis),綜合試驗結果。

主要結果

本次文獻回顧納入4篇RCT (含1136名受試者)、2篇叢集隨機對照試驗 (cluster-RCT) (含795名受試者和73,454患者日 [patient days])、4篇CBA (約含22,000名受試者) 和7篇ITS (平均7個資料收集點 [data point])。上述試驗評估採血系統、靜脈注射 (IV) 系統、注射系統、多重安全裝置與針頭收集容器的安全改良設備。根據估計,對照組的針刺意外 (needlestick injury, NSI) 發生率約為每 1000 人年 (person-years) 1至5次 NSI。只有1篇試驗在低、中收入國家進行,大部分試驗的偏差風險偏高。

一項評估安全採血系統的ITS試驗顯示,開始使用安全系統後NSI發生率立即降低 (效應量 [effect size, SE]為-6.9,95%信賴區間 [confidence interval, CI] 為2.5至0.1) ,另一項ITS試驗則使用舊型回套針頭護罩 (recapping shield)。

4篇試驗中有2篇試驗「引進安全IV裝置可降低NSI」的證據品質非常低,但其他2篇試驗則無明確證據證明使用安全裝置可降低NSI。不過有4篇其他試驗關於「安全裝置會增加血液潑濺發生次數」的證據品質中等,這些試驗使用的安全系統必須由使用者主動啟動 (相對風險 [relative risk, RR] 為1.6,95% CI為1.08至2.36)。

有2篇試驗並未發現明確證據,顯示採用安全注射裝置會影響NSI的發生率。

有1篇試驗指出,採用多重安全裝置可降低NSI的發生,但另一篇試驗並未得到相同結果。有1篇試驗顯示,使用安全收集容器可降低NIS,但與其他2篇試驗的結果並不一致。

本次文獻回顧所納入的試驗,並未發現哪一種類型的裝置效果較佳,例如護罩或回縮針頭。

作者結論

關於安全採血系統,有1篇試驗指出安全採血系統可降低針刺意外 (NSI),但證據品質極低。關於靜脈注射系統,有試驗指出相較於一般裝置,靜脈注射系統可減少NSI發生,但證據品質極低;不過「靜脈注射系統會增加血液污染」的證據品質中等。至於其他類型的安全注射針頭、多重安全裝置或針頭收集容器的使用成效,不但試驗所得結果不一致,而且亦無明確的有利證據。所有試驗均具有相當大的偏差風險,而且可能因為混淆與偏差的影響,以致未能證明使用這些裝置具有效益。但並不表示這些裝置無效。

必須藉助叢集隨機對照試驗,比較各類型安全啟動裝置的效果和成本效益,尤其是低、中收入的國家。

譯註


翻譯者:臺北醫學大學實證醫學研究中心
本翻譯計畫由衛生福利部補助經費,臺北醫學大學實證醫學研究中心、台灣實證醫學學會及東亞考科藍聯盟(EACA)統籌執行。

Plain language summary

Devices with safety features for preventing needle stick injuries in healthcare staff

Background

Needlestick injuries (NSIs) from devices used for blood collection or for injections expose healthcare workers to the risk of serious infections such as hepatitis or human immunodeficiency virus (HIV). Safety features such as shields or retractable needles can help prevent these injuries. We wanted to find out how effective these devices are. We searched for studies in multiple databases until January 2012 for randomised (RCTs) and non-randomised studies (NRS).

Studies included in this review

We included eight RCTs and 11 NRS. These studies evaluated the safety of blood collection systems, intravenous (IV) systems, injection systems, multiple devices and sharps containers. We estimated that the NSI rate in the control groups was one to five NSIs per 1000 person-years. The risk of bias was high in most studies.

What does the research say?

In one NRS study that evaluated safe blood collection systems, NSIs decreased right after the systems were put into use but there was no further decrease over time.

There was very low quality evidence that NSIs reduced significantly using safe IV devices. However, there was moderate quality evidence in four other studies that these devices increased the number of blood splashes where the user had to switch on the safety system.

There was no clear evidence that safe injection devices reduced the NSI rate in two studies.

Using many safety devices showed a decrease in NSI in one study but not in another. Using safety containers showed a decrease in NSI in one study but inconsistent results in two studies.

There was no evidence in the included studies about which type of device was better. So, for example, we do not know if it is safer to shield or retract a needle.

What is the bottom line?

We concluded that there is only very low quality, inconsistent evidence that most safety devices prevent needlestick injuries (NSIs). The risk of blood contamination is greater with devices that have to be actively switched on. The lack of a clear beneficial effect could be due to the high risk of bias in the studies. This does not mean that these devices are not effective.

Cluster-randomised studies are needed to compare the various types of safety devices for their effectiveness and cost-effectiveness, especially in low- and middle-income countries.

Résumé simplifié

Les dispositifs de protection pour prévenir les blessures par piqûre d'aiguille chez le personnel médical

Contexte

Les blessures par piqûre d'aiguille (BPA), provenant de dispositifs utilisés pour le prélèvement sanguin ou pour les injections, exposent le personnel médical à des risques d'infections graves, telles que l'hépatite ou le virus de l'immunodéficience humaine (VIH). Les dispositifs de protection, tels que les manchons de protection pour aiguille ou les aiguilles rétractables, peuvent permettre de prévenir ces blessures. Nous avons voulu déterminer l'efficacité de ces dispositifs. Nous avons recherché des études d'essais randomisés (ECR) et non randomisés (ENR) dans plusieurs bases de données jusqu'en janvier 2012.

Études incluses dans cette revue

Nous avons inclus 8 ECR et 11 ENR. Ces études évaluaient la sécurité des systèmes de collecte de sang, des systèmes par voie intraveineuse (VI), des systèmes d'injection, des dispositifs multiples et des contenants pour objets tranchants. Nous avons estimé que le taux de BPA dans les groupes témoins était de une à cinq BPA pour 1000 personnes par année. Le risque de biais était élevé dans la plupart des études.

Que dit la recherche?

Dans une étude d'ENR qui évaluait les systèmes sûrs de collecte du sang, les BPA ont diminuées immédiatement après l'introduction de ces systèmes, mais il n'y avait aucune baisse supplémentaire au fil du temps.

Des preuves de très faible qualité indiquaient que les BPA réduisaient significativement en utilisant les dispositifs intraveineux sûrs. Cependant, des preuves de qualité modérée dans quatre autres études indiquaient que ces dispositifs augmentaient le nombre d'éclaboussures de sang lorsque l'utilisateur devait mettre le système de protection en marche.

Dans deux études, aucune preuve probante n'indiquait que les dispositifs sûrs d'injection réduisaient le taux de BPA.

L'utilisation de plusieurs dispositifs de protection montrait une diminution des BPA dans une étude, mais pas dans l'autre. L'utilisation de contenants protecteurs montrait une diminution de BPA dans une étude, mais deux études indiquaient des résultats incohérents.

Il n'y avait aucune preuve dans les études incluses sur le type de dispositif le plus efficace. Nous ne savons donc pas si, par exemple, les manchons de protection pour aiguille sont plus sûrs que les aiguilles rétractables.

Quelles conclusions peut-on en tirer ?

Nous avons conclu qu'il existe uniquement des preuves de très faible qualité et contradictoires indiquant que la plupart des dispositifs de protection préviennent les blessures par piqûre d'aiguille (BPA). Le risque de contamination du sang est plus important avec des appareils qui doivent être allumés en continu. Le manque d'effet bénéfique probant pourrait être dû au risque de biais élevé dans les études. Cela ne signifie pas que ces dispositifs ne sont pas efficaces.

Des études randomisées par grappes sont nécessaires pour comparer les différents types de dispositifs de protection selon leur efficacité et leur rapport coût-efficacité, en particulier dans les pays à faibles et moyens revenus.

Notes de traduction

Traduit par: French Cochrane Centre 22nd June, 2014
Traduction financée par: Financeurs pour le Canada : Instituts de Recherche en Santé du Canada, Ministère de la Santé et des Services Sociaux du Québec, Fonds de recherche du Québec-Santé et Institut National d'Excellence en Santé et en Services Sociaux; pour la France : Ministère en charge de la Santé

淺顯易懂的口語結論

使用具安全功能的裝置預防醫療人員發生針刺意外

背景

因為抽血或注射所導致的針刺意外 (needlestick injury, NSI),會使醫療人員暴露於嚴重感染症的風險之下,例如肝炎或人類免疫不全病毒 (human immunodeficiency virus, HIV)。具備安全性能的裝置例如護罩或回縮式針頭,有助於預防針刺意外。本次文獻回顧希望瞭解這些裝置的針刺意外預防效果。我們搜尋截至2012年1月為止的多個資料庫,找尋隨機 (RCT) 和非隨機 (non-randomised study, NRS) 試驗。

本次文獻回顧納入的試驗

本次文獻回顧納入8篇RCT和11篇NRS。這些試驗評估採血系統、靜脈注射 (IV) 系統、注射系統、多重安全裝置和針頭收集容器的安全性。我們估計對照組的NSI發生率為每1000人年1至5次NSI,大部分試驗具有高偏差風險。

研究結果如何?

有1篇評估安全採血系統的NRS試驗指出,使用該系統後NSI的發生率立即降低,但並未隨時間進一步降低。

「使用安全IV裝置可顯著降低NSI」的證據品質極低;不過有4篇試驗的證據品質中等,指出安全裝置會增加發生血液潑濺的次數,這些試驗採用必須由使用者開啟安全系統的裝置。

有2篇試驗並未發現明確證據,顯示安全注射裝置可降低NSI發生率。

有1篇試驗指出使用多台安全裝置可降低NSI,但另1篇試驗並未得到相同結果。有1篇試驗證實使用安全收集容器可降低NSI,但與其他2篇試驗所得結果不一致。

此次文獻回顧納入的試驗,並未發現哪一類型的安全裝置效果較佳。因此,舉例來說,我們不知道護罩和回縮式針頭哪一種比較安全。

有何結論?

我們認為對於大部分安全裝置的針刺意外 (NSI) 預防效果,不但證據品質極低而且也不一致。必須由使用者主動開啟開關的裝置,發生血液污染的風險較高。因為試驗的偏差風險偏高,所以並未發現安全裝置確實具有效益,但並不表示這些裝置效果不彰。

必須藉助叢集隨機對照試驗,比較各類型安全裝置的效果和成本效益,尤其是低、中收入的國家。

譯註


翻譯者:臺北醫學大學實證醫學研究中心
本翻譯計畫由衛生福利部補助經費,臺北醫學大學實證醫學研究中心、台灣實證醫學學會及東亞考科藍聯盟(EACA)統籌執行。

Background

Healthcare workers (HCWs) are exposed to several occupational hazards, including biological agents. Percutaneous injury and occupational exposure to blood and body fluids increase the risk of exposure of HCWs to blood borne pathogens such as hepatitis B (HBV), hepatitis C (HCV) and human immunodeficiency virus (HIV). These infections can lead to chronic and fatal diseases. In the United States (US), the annual number of percutaneous injuries among hospital-based HCWs was estimated to be 384,325 in 1997 to 1998 (Panlilio 2004). The World Health Organization (WHO) estimates that 16,000 HCV, 66,000 HBV and 1000 HIV infections may have occurred worldwide among HCWs in the year 2000 due to their occupational exposure to blood and body fluids (Pruss-Ustun 2005).

Description of the condition

A HCW's risk for acquiring infectious diseases at work is influenced by a variety of environmental and social factors. The population prevalence of specific diseases, percentage HBV vaccination coverage in the population, availability of medical supplies, adherence to standard precautions, accessibility and availability of post-exposure prophylaxis, among others are important components influencing the risk of HCWs becoming infected by blood borne diseases. For HBV, the risk varies greatly based on the immunization coverage among health workers and the served population. For example, in 1990 the HBV infection rate among unvaccinated US healthcare personnel was three to five times greater than in the US general population (MacCannell 2010). This number decreased significantly due to the introduction of routine HBV immunization and comprehensive occupational health and safety policies. The prevalence of HBV among HCWs is now five times less than in the US general population (MacCannell 2010).

Occupational transmission of infectious diseases has a significant impact on the health of the workers and also on the healthcare system as a whole. The transmission of occupational blood borne infectious diseases leads to increased absenteeism and morbidity, and in some cases to higher mortality rates, among HCWs. These outcomes affect the delivery, provision, quality and safety of care. HCWs may suffer from psychological stress due to the risk of acquiring an infectious disease, which affects both their work and personal life (Fisman 2002; Sohn 2006). There is also the financial burden associated with occupational exposure to blood borne diseases, which includes costs related to blood tests, treatment, outpatient visits, and lost working hours (Jagger 1990; Leigh 2007).

Description of the intervention

Exposure to blood or body fluids is also called percutaneous exposure and happens most often when HCWs are injured with sharp needles or instruments, or when blood or body fluids are splashed during medical interventions or accidents. These incidents are called sharps or needlestick injuries, or percutaneous exposure incidents. The actual causes of a needlestick injury are multifactorial and include elements such as types of devices and procedures, lack of access to or availability of personal protective equipment for the HCWs, suboptimal use of personal protective equipment, lack of training and education on infection control and occupational health principles, improper management of needles, poor organisational climate, high workload and fatigue, working alternate shifts, high mental pressure and subjective perception of risk (Akduman 1999; Ansa 2002; Clarke 2002; Doebbeling 2003; Fisman 2007; Ilhan 2006; Ngatu 2011; Oh 2005; Orji 2002; Roberts 1999; Smith 2006; Smith 2006b; Wallis 2007). Most of these causes can be addressed by specific interventions.

Several epidemiological studies have demonstrated that some needlestick injuries are associated with specific actions and medical equipment, such as recapping and sharp devices respectively (De Carli 2003). The practice of recapping needles is a major factor contributing to needlestick injuries (Ngatu 2011) and specific devices have also been associated with an increased risk of percutaneous injuries. According to MacCannell 2010, needlestick injuries occurred more frequently with hollow-bore needles compared to solid sharps (54% versus 40%). Up to 25% of reported hollow-bore needlestick injuries among nurses and physicians could have been prevented by the use of safer devices (MacCannell 2010). Almost two-thirds of all reported injuries occurred with devices without safety features (MacCannell 2010). Engineered medical devices such as retractable needles can reduce and eliminate the exposure to blood and body fluids.

How the intervention might work

There are several possibilities to prevent infection from needlestick injuries. For hepatitis B, vaccination has been successful (Chen 2005). Vaccination is not yet possible for HCV or HIV (Mast 2004). Therefore, exposure elimination and reduction remain the main preventive strategies.

Many hospitals are now using safety medical devices as an intervention to reduce the risk of needlestick injuries. These devices eliminate or encapsulate the needles. For example, needleless intravenous systems are defined as systems that administer medications through an intravenous access device without using needle connections. Some studies have noted a decrease in the risk of needlestick injuries following the introduction of safety medical devices such as a needle free system for intravenous therapy (Mendelson 1998), meanwhile other studies have found inconclusive findings for such systems (L'Ecuyer 1996 2wva).

Why it is important to do this review

There are several strategies available to abate needlestick injuries among HCWs workers, and these are widely used. Therefore, it is important to know if these preventive interventions are effective. Retrospective studies indicate that percutaneous exposure incidents would be reduced by more than 50% by behavioural interventions, either through education or adoption of new techniques (Bryce 1999; Castella 2003). The use of safety devices would probably also have a significant effect (Bryce 1999; Castella 2003; Jagger 1988; Waclawski 2004). There have been several reviews on the effectiveness of interventions (Hanrahan 1997; Hutin 2003; Rogers 2000; Trim 2004; Tuma 2006) but none have used the systematic Cochrane methodology. This review excluded studies where sharp suture needles were substituted with blunted ones as another Cochrane review (Parantainen 2011) has already addressed the effect of this intervention. Extra gloves or special types of gloves could theoretically be considered a device to prevent needle stick injuries while handling needles, but we excluded these studies because there is another Cochrane Review in preparation on the effect of extra gloves to prevent needlestick injuries (Parantainen 2012).

Objectives

To determine the benefits and harms of safety medical devices aiming to prevent percutaneous exposure injuries caused by needles in healthcare personnel versus no intervention or alternative interventions.

Methods

Criteria for considering studies for this review

Types of studies

We included all randomised controlled trials (RCT), cluster-randomised trials (c-RCT), interrupted time-series (ITS) and controlled before and after studies (CBA) irrespective of language of publication, publication status, or blinding.

We expected that the availability of RCTs would be limited for this topic. Interventions for prevention are often very different from clinical interventions. Many interventions are not implemented at the individual level. For example, new equipment is used by a group of workers or safety engineering controls are applied to the whole department simultaneously. This approach makes individual randomisation impossible. In principle, this can be partly overcome by randomisation at the department level as in a c-RCT design. However, as the level of aggregation increases, the more difficult this is to perform due to the level of recruitment required. Therefore, we included the following non-randomised study designs in our review: CBA studies with a concurrent control group, and ITS. CBA studies are also called prospective cohort studies. They are easier to perform, taking into account that the intervention is assigned at the group level, and still have reasonable validity.

ITS designs are often based on routinely collected administrative data from insurance or governmental sources, collected for injury outcomes. In many cases the data are collected independently from interventions and over long periods of time, offering reasonable validity. If there are at least three data points before and three data points after the intervention, we included these study designs as ITS (EPOC 2006). Both ITS with and without a control group were eligible for inclusion.

Types of participants

We included studies where participants were HCWs, including dentists, which means all persons that are professionally involved in providing health care to patients. The majority of study participants had to fulfil this criterion.

Types of interventions

Inclusion criteria

We included studies examining any medical devices that aim to prevent percutaneous exposure injuries and thus could reduce the risk of exposure to blood or bodily fluids.

We categorised the interventions based on the type of device in the following way.

- Safety engineered devices for blood collection.

- Safety engineered devices for Injecting fluids.

- Containers for collecting sharps.

Because these categories did not cover all studies that we found, we added two categories.

- The use of multiple safety devices in an intervention programme.

- Intravenous systems.

Exclusion criteria

We excluded studies where sharp suture needles were substituted with blunted ones. Another Cochrane review (Parantainen 2011) has addressed the effect of this intervention. We also excluded studies on devices that eliminate the use of suture needles or that encapsulate suture needles during surgery because the risk of a needlestick injury is different with suture needles in surgery. Extra gloves or special types of gloves could theoretically be considered a device to prevent needlestick injuries while handling needles, but we excluded these studies because there is another Cochrane review in preparation on the effect of gloves to prevent needlestick injuries (Parantainen 2012).

Types of outcome measures

Primary outcomes

Our primary outcome measure was exposure of HCWs to potentially contaminated blood or bodily fluids. Exposure can be reported as self-reported needlestick injury, sharps injury, blood stains inside the gloves, or glove perforations. We considered all reports of such exposure as valid measures of the outcome, such as self-reports, reports by the employer, or observations of blood stains.

Secondary outcomes

We considered ease of use of the devices (including user satisfaction) and information related to the cost of the intervention as secondary outcomes.

Search methods for identification of studies

Electronic searches

First, we applied search terms for percutaneous exposure incidents. We then combined these terms for percutaneous exposure incidents with the recommended search strings for randomised trials and for non-randomised studies. We used the Robinson 2002 search strategy for randomised clinical trials and controlled clinical studies. For finding non-randomised studies, we used the sensitive search strategy for occupational health intervention studies (Verbeek 2005).

We used the strategy to search CENTRAL, MEDLINE, EMBASE, NHSEED, Science Citation Index Expanded, CINAHL, OSH-update, and PsycINFO from the earliest record to 27 January 2014. We also searched LILACS but only until 2012. We felt that the yield did not outweigh the efforts and decided to stop searching LILACS. In addition, we searched the databases of WHO, the UK National Health Service (NHS) and www.med.virginia.edu/epinet (Royle 2003).

We present the search strategies for the databases listed above in Appendix 1.

In an update of the basic search that is common with Parantainen 2011 and Parantainen 2012, we used recap* and device* as additional search terms combined by OR and with the other terms (Appendix 2).

Searching other resources

We screened the reference lists of all relevant studies for additional studies.

Data collection and analysis

Selection of studies

Using the inclusion and exclusion criteria, the authors (M-CL, JV, AP, MP) worked individually and independently to screen the titles and abstracts of the references that were identified by the search strategy as potential studies. Pairs of authors went through the same references to increase the reliability of the results. We obtained the full texts of those references that appeared to meet the inclusion criteria. We did not blind ourselves regarding the trial author details because we felt that it would not increase validity. We solved disagreements between pairs by discussion. A pair consulted a third author if disagreement persisted.

Data extraction and management

Review authors worked in pairs (AP and JV, M-CL and MP) but independently to extract the data onto a form. The form included the essential study characteristics about the participants, interventions, outcomes and results. We also noted any adverse events and the sponsorship of the study. Two pairs of authors (AP and JV, M-CL and MP) independently assessed the risk of bias of the studies. The pairs used a consensus method if disagreements occurred. The pairs consulted a third author if disagreement persisted. Again, we did not mask trial names because we believed that it would not increase validity.

Assessment of risk of bias in included studies

For the assessment of risk of bias in RCTs we used the risk of bias tool in RevMan 2011. For CBA studies, we used a validated instrument (Downs 1998). The instrument has been shown to have good reliability, internal consistency and validity. We used the score on internal validity to judge the risk of bias of the included studies. We scored all items as 1 when the criterion was fulfilled and 0 if this was unclear or not the case.

We used the score on the checklist to discern trials with a low risk of bias from trials with a high risk of bias. We labelled trials as having a high risk of bias when the score was less than 50% of the total attainable score. We reported the most pertinent items in the risk of bias tables in the 'Characteristics of included studies' table.

For ITS studies we used the risk of bias criteria as presented by Ramsay 2003.

Measures of treatment effect

For RCTs and CBA studies with dichotomous outcomes, we used relative risks or risk ratios (RR) as the measure of the treatment effect. We did not use odds ratios because the incidence of most outcomes was higher than 10% and then odds ratios give an inflated impression of the relative risk.

In studies where needlestick injuries or glove perforations were reported more than once for an individual we used rates and rate ratios as the treatment effect. We calculated the log rate ratio and the standard error and used these data as the input for RevMan.

For ITS studies, we extracted and re-analysed the data from the original papers according to the recommended methods for analysis of ITS designs for inclusion in systematic reviews (Ramsay 2003). These methods utilise a segmented time-series regression analysis to estimate the effect of an intervention while taking into account secular time trends and any autocorrelation between individual observations. For each study, we fitted a first order autoregressive time-series model to the data using a modification of the parameterization of Ramsay 2003. Details of the mode specification are as follows:

Y = ß0 + ß1 time + ß2 (time - p) I (time > p) + ß3 I (time > p) + E, E ˜ N (0, s2).

For time = 1,...,T, where p is the time of the start of the intervention, I (time ≥ p) is a function which takes the value 1 if time is p or later and zero otherwise, and where the errors E are assumed to follow a first order autoregressive process (AR1) and the errors E are normally distributed with mean zero and variance s2. The ß parameters have the following interpretation:
ß1 is the pre-intervention slope;
ß2 is the difference between post- and pre-intervention slopes;
ß3 is the change in level at the beginning of the intervention period, meaning that it is the difference between the observed level at the first intervention time point and that predicted by the pre-intervention time trend.

We used the change in slope and the change in level as two different measures of treatment effect for ITS studies.

Unit of analysis issues

For studies that employed a cluster-randomised design but did not make an allowance for the design effect, we intended to calculate the design effect. If no intra-cluster coefficients were reported, although they are needed to calculate the design effect, we would have assumed a fairly large intra-cluster coefficient of 0.05 to enable the calculation of design effect. We intended to use the methods that are recommended in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011) for the calculations. However, the two studies that used a cluster-randomised design either did not provide data on the size of the clusters (L'Ecuyer 1996 2wva) or had a loss to follow up of 50% (van der Molen 2011), which made the cluster calculations questionable. Therefore, we did not perform these calculations.

For studies with multiple study arms that belonged to the same comparison, we divided the number of events and participants in the control group equally over the study arms to prevent double counting of study participants in the meta-analysis (Asai 2002 active; Asai 2002 passive).

Dealing with missing data

We contacted the authors for additional information if the data needed for meta-analysis were missing (Hotaling 2009; Sossai 2010). If data were presented in figures only and the authors could not be reached, we extracted data from the figures presented in the article (Goldwater 1989). If data such as standard deviations had been missing and they could be calculated from other data present in the article, such as P values, we would have done so according to the recommendations in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011), but there were no studies where this was necessary.

Assessment of heterogeneity

Clinical homogeneity among studies was defined based on the similarity of populations, interventions, and outcomes measured at the same follow-up point. We regarded all healthcare professionals as sufficiently similar to assume a similar preventive effect from the use of similar devices. We categorised safe devices as indicated under types of interventions and assumed that different devices would lead to different effects. We added two extra categories: intravenous (IV) systems and the introduction of multiple safe devices at the same time.

We divided outcomes into a category of needlestick injuries and a category of blood or bodily fluid splashes. We deemed the devices contained within these categories to be conceptually similar and sufficiently homogeneous to be combined in a meta-analysis. Thus, we had two different outcome measures: needlestick injuries and blood splashes. Even though the denominator of the needlestick injury rates differed from patients to devices to workers we felt that they were sufficiently similar to be combined.

We did not combine various study designs as we assumed that there were large differences in risk of bias between the different study types. We have presented the results per comparison separately for each design type.

We assessed statistical heterogeneity by means of the I2 statistic. We used the values of < 40%, between 30% and 60%, between 50% and 90%, and over 75% as indicating not important, moderate, substantial, and considerable heterogeneity respectively, as proposed in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011).

Assessment of reporting biases

We aimed to assess publication bias with a funnel plot if more than five studies were available in a single comparison.

Data synthesis

We pooled studies that contained sufficient data and that we judged to be clinically and statistically homogeneous with RevMan 5 software (RevMan 2011).

When studies were statistically heterogeneous we used a random-effects model; otherwise we used a fixed-effect model.

For ITS, we first standardised the data by dividing the outcome and standard error by the pre-intervention standard deviation resulting in an effect size, as recommended by Ramsay 2001. Then, we entered the results into RevMan as the change in level and in slope as two different outcomes using the general inverse variance method.

Finally, we used the GRADE approach to assess the quality of the evidence per comparison and per outcome as described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). For comparisons that only included RCTs, we started at high quality evidence. Then, we reduced the quality of the evidence by one or more levels if there were one or more limitations in the following domains: risk of bias, consistency, directness of the evidence, precision of the pooled estimate, and the possibility of publication bias. When the comparison included non-randomised studies we started off at the low quality level and downgraded further if there were limitations, or we would have upgraded the quality if there were reasons to do so. We intended to use the programme GRADEpro 2008 to generate summary of findings tables for the two most important comparisons and outcomes, but this was not possible because we found a range of study designs which could not be combined statistically. Instead, we presented the quality of evidence and our considerations per comparison in an additional table.

Subgroup analysis and investigation of heterogeneity

We intended to re-analyse the results for studies with a high baseline or control group exposure rate, and for studies from low- and middle-income countries, but this was not possible due to the few studies that we found and the lack of studies from low- and middle-income countries.

Sensitivity analysis

We intended to re-analyse the results including only studies with a low risk of bias in order to find out if risk of bias led to changes in the findings but there weren't enough studies to do so.

Results

Description of studies

Results of the search

With the initial search strategy described in Appendix 1 and after removal of duplicates we had a total of 11,239 references. Based on titles and abstracts, we selected 322 references for full-text reading. Of these, we excluded those that did not fulfil our inclusion criteria or that were duplicate publications. In cases where the article did not provide enough data we contacted the authors and asked them to send the missing information. If we did not receive sufficient information to judge if the study should be included, we excluded the study. This resulted in 84 studies on needlestick injury prevention. Of these, 14 studies fulfilled the inclusion criteria for this review. We updated the search by adding the strategy described in Appendix 2 in January 2012. This resulted in 167 additional references from which we selected seven for full-text reading. Of these full-text studies, there were three additional studies that fulfilled our inclusion criteria. Another update of the whole search (Appendix 1 combined with Appendix 2) in January 2014 yielded another 292 references of which three could be potentially included but are awaiting classification. Two of the three are pending more information from the authors (Perry 2012; Phillips 2012) and one is pending translation from Italian (Ferrario 2012). Altogether, this process led to 17 studies which fulfilled our inclusion criteria.

Included studies

Interventions

We included a total of 17 studies, which included two studies with two intervention arms (Asai 2002 active; Asai 2002 passive; Prunet 2008 active; Prunet 2008 passive) and one study with three intervention arms (L'Ecuyer 1996 2wva; L'Ecuyer 1996 mbc; L'Ecuyer 1996 pbc), corresponding to 21 different comparisons of safety medical devices. We elaborated on the details of the devices in Table 1. Based on the information in the articles, we checked on the Internet if the devices were still for sale and if they still resembled the original description given in the article. Even though we could not be sure that the devices currently sold were exactly similar to those in the articles, we are confident that the main safety features are still the same.

Table 1. Content of the interventions
Study nameDevice Commercial NamesDevice CategorySafety Device type

passive/

active

For sale?
Asai 1999 activeInsyte AutoGuard intravenous cannulaSafe IV system (insertion)button for actively retracting the needleactiveYes
Asai 2002 activeInsyte Autoguard intravenous cannulaSafe IV system (insertion)button for actively retracting the needleactiveYes
Asai 2002 passiveProtective AcuvanceSafe IV system (insertion)automated retraction of needlepassiveYes
Azar-Cavanagh 2007Unnamed intravenous catheter styletSafe IV system (insertion)retractable protection shieldactive??
Cote 2003Angiocath Autoguard IV cathetersSafe IV system (insertion)button for actively retracting the needleactiveYes
Edmond 1988Winfield sharpsguardSharps containerbedside sharps containern.a.No
Goldwater 1989Needle guard Biosafe New ZealandBlood collectionshield on cap prevents injury while recappingn.a.No
Grimmond 2010Daniels sharpsmartSharps containerbedside sharps containern.a.Yes
L'Ecuyer 1996 2wva2-way valve Safsite Braun medicalSafe IV system (insertion and needleless)two valve system with plastic sharp that remains in the devicepassiveYes
L'Ecuyer 1996 mbcLifeshield metal blunt cannulaSafe IV system (needleless iv system)metal blunt cannulapassiveYes
L'Ecuyer 1996 pbcInterlink PBC plastic cannulaSafe IV system (insertion and needleless)plastic sharp covered by blunt plastic cannulapassiveYes
Mendelson 19981-valve Safsite Braun medicalSafe IV system (needleless)valve of IV system incompatible with needlepassiveYes
Prunet 2008 activeInsyte Autoguard intravenous cannulaSafe IV system (insertion)button for actively retracting the needleactiveYes
Prunet 2008 passiveIntrocan Safety IV system (Braun)Safe IV system (insertion)automatic shield on needle tip at withdrawingpassiveYes
Reddy 2001'safety syringes and needleless IV'Multiple safe devicesnot explained??
Richard 2001'sharps containers'Sharps containerfirst in treatment rooms later bedside placements??
Rogues 2004SafetyLock BD, resheathable winged steel needleBlood collectionafter pushing (two handed) needle retracts into sheathactiveYes
Sossai 2010Introcan safety IV system (Braun)Safe IV system (insertion)automatic shield on needle tip at withdrawingpassiveYes
Valls 2007Eclipse BD; Saf-T- E-Z Set, BD; Surshield, Terumo; Preserts BD; Provent plus, Smiths; Genie BD; Surgilance Terumo; Blunt administration needles BDMultiple systemsn.a.active and passiveYes
van der Molen 2011Eclipse BDInjection systemafter injection needle covered with shieldactiveYes
Zakrzweska 2001Safety Plus Septodont (Dental injections)Injection systemProtective sheaths can be temporarily or definitely protect the needleactiveYes

The types of devices used in the various studies were:

Safety engineered devices can be divided into two broad categories, passive and active devices. Passive devices have a safety function that is automatically activated without the user's interference. This type of safety device is supposed to offer better protection because the human factor is excluded. Active devices require one- or two-handed activation by a health worker after use.

Four studies used a similar type of safe active IV system (Autoguard IV) (Asai 1999 active; Asai 2002 active; Cote 2003; Prunet 2008 active). The safety mechanism of this device is activated by pushing a button which retracts the needle. Two studies included a passive and an active system (Asai 2002 active; Asai 2002 passive; Prunet 2008 active; Prunet 2008 passive). In addition to the Autoguard IV, Asai 2002 passive and Prunet 2008 passive included a passive device. Asai 2002 passive included the Protective Acuvance, which consists of two needles (one inside the other) where the tip of the needle is automatically changed to a blunt needle upon withdrawing. Prunet 2008 passive used the Introcan safety, which automatically shields the needle tip upon withdrawing. The Introcan safety IV system was also used by Sossai 2010.

A needleless system refers to a device that does not use needles for the collection of body fluids or administration of medication or fluid after initial IV access is established (Mendelson 1998). L'Ecuyer 1996 2wva; L'Ecuyer 1996 mbc; L'Ecuyer 1996 pbc used three needleless IV systems. One, the safety needleless IV tubing system (blunt metal cannula), was replaced after four months by a blunt plastic cannula due to dissatisfaction of employees with the device. Mendelson 1998 evaluated a needleless IV system which is incompatible with a needle. All other studies had either a combination of the needleless system and insertion or evaluated the effects of safe insertion only.

In the two studies involving multiple safety devices, one study included safety syringes and needleless IV systems (Reddy 2001). The second study included safety vacuum phlebotomy systems, blood-gas syringes with a needle sheath, lancets with retractable single-use puncture sticks, safe IV catheters (passive and active), and safe injection devices (Valls 2007).

In the studies on safe disposal boxes, Edmond 1988 included a bedside needle disposal; Grimmond 2010 assessed a sharps container with enhanced safety features such as automatic lock-out when full; and Richard 2001 introduced small containers in all patient areas combined with an educational program.

In studies focusing on safe blood collection, Rogues 2004 introduced two devices: re-sheathable winged steel needles and Vacutainer blood-collecting tubes with recapping sheaths. Goldwater 1989 used a shield on the needle cap to prevent the needle from injuring the worker.

Representing safe injection devices, van der Molen 2011 included an injection needle with a safety feature shielding the needle after the injection, and Zakrzewska 2001 included one type of safety syringe for dentistry. The injection devices had an active safety mechanism that had to be activated by the workers.

A total of 12 studies reported introducing the safety devices together with training sessions (Azar-Cavanagh 2007; Edmond 1988; Goldwater 1989; L'Ecuyer 1996 mbc; L'Ecuyer 1996 pbc; L'Ecuyer 1996 2wva; Mendelson 1998; Prunet 2008 active; Prunet 2008 passive; Richard 2001; Rogues 2004; Sossai 2010; Valls 2007; van der Molen 2011; Zakrzewska 2001). Goldwater 1989 briefly stated that staff completed an educational program. Two studies did not report on the integration of training or education as part of the study (Grimmond 2010; Reddy 2001).

Types of study designs

Study designs used to assess the effect of the intervention were:

Participants

There were slight differences across studies in terms of selected participants for the study. In six studies, researchers referred to the broad term of healthcare personnel or hospital workers as participants (Edmond 1988; Grimmond 2010; Richard 2001; Rogues 2004; Sossai 2010; van der Molen 2011). Reddy 2001 included health personnel with the exception of physicians. Two studies included healthcare workers explicitly at risk of blood borne pathogen exposure from contaminated needles, referred to as house staff, physicians, medical students, nurses, nursing assistants, emergency medical technicians and environmental service workers (Azar-Cavanagh 2007; Mendelson 1998). Two studies included anaesthesiologists (Cote 2003; Prunet 2008 active; Prunet 2008 passive). Two studies included nursing personnel only as participants (L'Ecuyer 1996 2wva; Valls 2007;). One study included only laboratory staff (Goldwater 1989). In two studies researchers and assistants were the persons handling the needles (Asai 1999 active; Asai 1999 active; Asai 2002 active). Dental clinic staff were the target group in one study (Zakrzewska 2001).

In the RCTs the number of participants varied from 50 each in the intervention and control groups (Asai 1999 active; Asai 2002 active; Asai 2002 passive) to about 253 in each of the two intervention groups and control group (Prunet 2008 active; Prunet 2008 passive) and about 165 in each group in Cote 2003.

In the c-RCTs, van der Molen 2011 reported on eight wards in each of the two intervention groups and the control group, representing approximately 265 workers in each of the these three groups during the initial phase. The authors adjusted for the cluster effect by means of a GEE-analysis. L'Ecuyer 1996 2wva reported 19,436 patient-days for the plastic two-way valves, 3840 patient-days for the metal blunt cannula (L'Ecuyer 1996 mbc) and 15,737 patient-days for the plastic blunt needle (L'Ecuyer 1996 pbc). However, the study did not mention the number of wards that were randomised.

In the CBA studies, Grimmond 2010 recruited 14 hospitals in both the control and the intervention groups, approximating overall 19,880 full-time equivalents (FTE) during the two-year study period. Valls 2007 recruited seven wards for the intervention group and five wards for the control group from a hospital with 1000 workers. Zakrzewska had approximately 300 workers in both the intervention and control groups. Mendelson 1998 reported on eight medical units in both the intervention and control groups, corresponding to approximately 220 workers per group.

In the ITS studies, Azar-Cavanagh 2007 reported on 11,161 healthcare workers for the pre-intervention period (18 months) and 12,851 healthcare workers for the post-intervention period (18 months). Reddy 2001 reported on 3011 FTE for the pre-intervention period (three years) and 3992 FTE for the post-intervention period (three years). Rogues 2004 reported on 8500 FTE (2000 nurses) per year for the pre-intervention period (four years) and post-intervention period (three years). Edmond 1988 followed 278 nurses for the pre-intervention period (eight months) but provided no information to determine if this number remained the same for the intervention period (four months). Richard 2001 did not report the number of participants in the one participating hospital during the seven-year study period. Goldwater 1989 reported 127,000 venipunctures for the pre-intervention period (six months), and 483,000 venipunctures with the device and 232,348 without the device during the intervention period (33 months). Sossai 2010 reported that the number of employees at the hospital fluctuated between 4447 and 4636 throughout the study period (two years pre-intervention and three years post-intervention).

The average number of data points in the seven ITS studies was seven and ranged from six to 39.

Outcomes

Sixteen studies included self-reported percutaneous injuries as their main outcome (Asai 1999 active; Asai 2002 active; Asai 2002 passive; Azar-Cavanagh 2007; Cote 2003; Edmond 1988; Goldwater 1989; Grimmond 2010; L'Ecuyer 1996 2wva; L'Ecuyer 1996 mbc; L'Ecuyer 1996 pbc; Mendelson 1998; Reddy 2001; Richard 2001; Rogues 2004; Sossai 2010; Valls 2007; van der Molen 2011; Zakrzewska 2001). In one study (Prunet 2008 active; Prunet 2008 passive) the main outcomes were both blood splashes and needlestick injuries. In three studies researchers reported only blood splashes (Asai 1999 active; Asai 2002 passive; Cote 2003; Prunet 2008 active; Prunet 2008 passive). Three studies did not report percutaneous injuries as their main outcome as no injury was reported during the study (Asai 1999 active; Asai 2002 passive; Prunet 2008 active; Prunet 2008 passive). Cote 2003 reported that the study was underpowered to assess the difference in needlestick injuries between the groups.

The denominators for the self-reported needlestick injuries (NSIs) included: the number of procedures (Goldwater 1989; Rogues 2004), medical devices (Prunet 2008 active; Prunet 2008 passive; Sossai 2010), FTE (Grimmond 2010; Reddy 2001), health workers (Azar-Cavanagh 2007; Edmond 1988; van der Molen 2011), patient-days and productive hours worked (L'Ecuyer 1996 2wva; L'Ecuyer 1996 mbc; L'Ecuyer 1996 pbc), study weeks (Mendelson 1998), hours worked (Zakrzewska 2001), patients-days and patients (Valls 2007). Richard 2001 reported the number of percutaneous injuries and the proportion of injuries due to improper disposal of sharps, which was defined by the authors as an NSI to worker assisting with a procedure, or NSI located on the non-dominant hand while removing the needle. The denominators for the blood splashes were patients (Asai 1999 active; Asai 2002 active; Asai 2002 passive; Prunet 2008 active; Prunet 2008 passive) and number of procedures (Cote 2003).

Researchers reported the ease of use of the devices in four studies (Asai 1999 active; Asai 2002 active; Asai 2002 passive; Mendelson 1998; Prunet 2008 active; Prunet 2008 passive). Two studies included a cost analysis of the intervention (Valls 2007; Zakrzewska 2001).

To be able to estimate the absolute effect of an intervention it was important to know what the control group injury rate or the baseline rate was. The NSI rate varied from 5.0 percutaneous injuries (PIs) per 1000 person-years for Azar-Cavanagh 2007 to 1.03 per 1000 FTE-years for Reddy 2001. Rogues 2004 reported a rate of 17.0 phlebotomy related PIs per 100,000 devices purchased. Sossai 2010 had a baseline rate of 9.67 per 100,000 catheters used per year. Goldwater 1989 reported a rate of about 49 per 100,000 venipuncture-years.

Geographical location

The studies originated from nine different countries. Seven studies were from the US (Azar-Cavanagh 2007; Cote 2003; Edmond 1988; Grimmond 2010; L'Ecuyer 1996 2wva; L'Ecuyer 1996 mbc; L'Ecuyer 1996 pbc; Mendelson 1998; Reddy 2001), two from Japan (Asai 1999 active; Asai 2002 active; Asai 2002 passive), two from France (Prunet 2008 active; Prunet 2008 passive; Rogues 2004), and one each from the following countries: New Zealand (Goldwater 1989), India (Richard 2001), Italy (Sossai 2010), Spain (Valls 2007), the Netherlands (van der Molen 2011) and UK (Zakrzewska 2001).

Year of study

Most studies (n = 12) had been published after the year 2000 (Asai 2002 active; Asai 2002 passive; Azar-Cavanagh 2007; Cote 2003; Grimmond 2010; Prunet 2008 active; Prunet 2008 passive; Reddy 2001; Richard 2001; Rogues 2004; Sossai 2010; Valls 2007; van der Molen 2011; Zakrzewska 2001), whereas three studies had been published in the 1990s (Asai 1999 active; L'Ecuyer 1996 2wva; L'Ecuyer 1996 mbc; L'Ecuyer 1996 pbc; Mendelson 1998) and two studies in the 1980s (Edmond 1988; Goldwater 1989).

Excluded studies

The table Characteristics of excluded studies lists the reasons for exclusion of 17 studies. We excluded a total of 16 studies due to study design (one was a commentary paper, seven articles reported surveillance data, three were not original research, three did not have comparison groups, and one had insufficient data points for an ITS study). We also excluded one study because the outcome did not include needlestick injuries nor blood splashes.

Risk of bias in included studies

Risk of bias varied considerably across studies (Figure 1; Figure 2).

Figure 1.

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Figure 2.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Allocation

Adequate sequence generation

One of the four RCTs had a low risk of bias for sequence generation because the researchers used a ballot box to randomise patients (Prunet 2008 active; Prunet 2008 passive). One RCT used randomisation by week (Cote 2003) and was classified as having a high risk due to the predictability of the randomisation. Two of the four RCTs had an unclear risk of bias because specific information on the method used for randomisation was missing (Asai 1999 active; Asai 2002 active; Asai 2002 passive).

Neither of the two c-RCTs provided sufficient information about their randomisation process and therefore we judged them to have an unclear risk of bias (L'Ecuyer 1996 2wva; L'Ecuyer 1996 mbc; L'Ecuyer 1996 pbc; van der Molen 2011).

Allocation concealment

Two of the four RCTs had a low risk of bias for allocation concealment because the researchers used sealed opaque envelopes or a single-blinded envelope (Asai 2002 active; Asai 2002 passive; Prunet 2008 active; Prunet 2008 passive). Two RCTs and two c-RCTs (Asai 1999 active; Cote 2003; L'Ecuyer 1996 2wva; L'Ecuyer 1996 mbc; L'Ecuyer 1996 pbc; van der Molen 2011) had an unclear risk of bias. No information about allocation concealment was available for these four studies.

Blinding

Among the RCTs, Asai 1999 active and Asai 2002 passive reported that the presence or absence of blood on the tray was assessed by blinded researchers. We judged these two studies to have a low risk bias. Cote 2003; and Prunet 2008 active; Prunet 2008 passive also reported the presence or absence of blood spills but they did not report if the outcome assessors were blinded. These two studies had unclear risk of bias. The remaining 13 studies had an unclear risk as no information was available on blinding.

Two studies reported that healthcare workers were unaware of the study (Edmond 1988; Grimmond 2010). In these two studies it is unlikely that the staff changed their work practices or behaviours towards reporting NSIs due to the acknowledgment of the study. However, health workers would be aware of the change in the type of devices used. These two studies had an unclear risk of bias.

Incomplete outcome data

Among the four RCTs and two c-RCTs, five studies had a low risk for incomplete outcome data because they reported all outcome data for all participants (Asai 1999 active; Asai 2002 active; Cote 2003; L'Ecuyer 1996 2wva; van der Molen 2011). Outcome information was unclear for the remaining RCT (Prunet 2008 active).

Among the four CBA studies, three studies had a low risk of bias (Grimmond 2010; Mendelson 1998; Zakrzewska 2001). Outcome information was unclear for one CBA study (Valls 2007).

Selective reporting

Among the four RCTs and two c-RCTs, five studies reported all outcomes as described in the method section (Asai 1999 active; Asai 2002 active; Asai 2002 passive; Cote 2003; Prunet 2008 active; Prunet 2008 passive; van der Molen 2011). We judged L'Ecuyer 1996 2wva to have an unclear risk as information that we expected based on the described methods appeared to be missing in the results section.

Among the four CBA studies, two studies reported all outcomes as described in the methods sections (Grimmond 2010; Mendelson 1998). Valls 2007 was at high risk of selective reporting because the authors did not fully report outcomes in the results section and they did not consistently report the denominator used for their analyses. Zakrzewska 2001 had an unclear risk of reporting bias because outcome measures were not specifically mentioned in the methods section.

Similar recruitment of groups

Among the four RCTs and two c-RCTs, Prunet 2008 passive and van der Molen 2011 had a low risk of bias. Three studies had an unclear risk due to the lack of information related to recruitment of groups (Asai 1999 active; Asai 2002 active; Cote 2003). One study was at high risk due to a difference in the recruitment process for the intervention and control groups (L'Ecuyer 1996 2wva; L'Ecuyer 1996 mbc; L'Ecuyer 1996 pbc).

Among the four CBA studies, two studies had low risk of bias (Grimmond 2010; Mendelson 1998). The studies reported either a small difference in staff full-time equivalents (FTE) (< 1%), or were completed within a relatively short period of time (for example six months). One study had an unclear risk due to the lack of information related to the recruitment of groups (Zakrzewska 2001). One study was at high risk due to researchers' self-assigned control and intervention hospital wards (Valls 2007).

Adjustment for baseline differences

For an RCT, any baseline difference should be due to chance if the randomisation process was appropriately completed. Asai 1999 active; Asai 2002 active; Asai 2002 passive; Cote 2003 and L'Ecuyer 1996 2wva; L'Ecuyer 1996 mbc; L'Ecuyer 1996 pbc had unclear risk as they provided no information about the participants in the intervention and control groups. We judged Prunet 2008 active; Prunet 2008 passive and van der Molen 2011 to have a low risk of bias as they had adequately adjusted for baseline differences.

Among the four CBAs, three studies had an unclear risk as they reported no information regarding the adjustment for baseline difference (Grimmond 2010; Mendelson 1998; Valls 2007). We judged Zakrzewska 2001 to have a low risk because both groups were similar.

ITS study design

Among the seven ITS studies (Table 2), only one study fulfilled the criterion that the intervention was independent of other changes (Rogues 2004). None of the studies reported a repeated measures analysis nor tested for trend, but this was overcome by our re-analysis of the data. None of the studies reported testing for trend. Five studies (Azar-Cavanagh 2007; Edmond 1988; Goldwater 1989; Reddy 2001; Rogues 2004) used a data collection method which was sustained throughout the study and thus was unlikely to have affected the data collection. None of the studies reported information to help determine if blind outcome assessment was used. For the criterion of the completeness of the data set, three studies reported outcomes data adequately (Azar-Cavanagh 2007; Goldwater 1989; Sossai 2010). We assessed the outcome measures as reliable for five studies that used a consistent reporting system for NSI throughout the study period (Azar-Cavanagh 2007; Edmond 1988; Reddy 2001; Rogues 2004; Sossai 2010). One ITS study had an additional risk of bias due to participating health workers having access to conventional needles during the intervention period (Reddy 2001).

Table 2. Risk of bias in ITS studies
StudyIntervention independent of other changesSufficient data pointsTest for trendIntervention not affect data collectionBlinded outcome assessmentComplete data setReliable outcome measureTotal score
Goldwater 1989

Not done (0)

Comment: staff turnover during study period. Staff preference for the use of the intervention devices varied across study periods.

Not done (0)

Comment: no repeated measures analysis used

Not done (0)

Done (1)

Data collection seems to remained the same pre and post-intervention.

Not clear (0)

Authors do not provide information on blinding.

Done (1)

Not clear (0):

Comment: no system for NSI seems to have been in placed during the study period. Uncertain about the consistency of the reporting during the study period.

2
Rogues 2004

Done (1)

Quote: "Conventional phlebotomy non-safety devices were removed from all departments, and the new products were in place on implementation"

Comment: only one device seems to have been introduced during intervention but authors do not specify if additional changes occurred during the study.

Not done (0)

Comment: data not available for the estimated number of phlebotomies performed for 1993 and 1994.

Not done (0)

Quote: we used chi square test to compare pre and post intervention data.

Comment: no formal test for trend reported

Done (1)

Comment: the method of data collection remains the same throughout the study. It does not appears to be influenced by the intervention.

Not clear (0)

Comment

No information is available on blinding.

Not done (0)

Comment: data not available for the estimated number of phlebotomies performed for 1993 and 1994.

Done (1)

Comment: hospital has a sharp injury surveillance system prior and after intervention. Althought not ideal as possibility of underreporting but appropriate for the study outcome.

3
Reddy 2001

Not done (0)

Quote: one of the confounder present throughout the post intervention phase was the availability of traditional needles devices.

Comment:

intervention occurs simultaneously with the availability of non-safety device.

Not done (0)

comment:

3 data points before and after but no repeated measures analysis use

Not done (0)

A Chi2 test for trend was also performed- not adequate as it does not take into account the time trend

Done (1)

Comment: the method of data collection remains the same throughout the study. It does not appears to be influenced by the intervention.

Not clear (0)

Comment:

no information available on blinding

Not done (0)

Comment: physicians were excluded from analysis as no information on FTE.

Done (1)

Comment: hospital had a sharp injury surveillance system prior and after intervention. Althought no ideal as possibility of underreporting but appropriate for the study outcome.

2
Azar-Cavanagh 2007

Done (1)

Comment: safety devices seem to have systematically replaced the conventional devices. Authors do not specify if additional changes occurred during the study.

Not Done (0)

comment:

3 data points before and after but no repeated measures analysis used

Not done (0)

Done (1)

Comment: the method of data collection remains the same throughout the study. It does not appears to be influenced by the intervention.

Not clear (0)

Comment: authors do not specify if data analysts were blinded to the study. Healthcare workers could not have been blinded to the introduction of the new devices.

Done (1)

Comment: data is available for all health workers.

Done (1)

Coment:

4
Sosai 2010

Not done (0)

Comment: authors indicated that some conventional devices were still used during the intervention period despite study which aimed to replace all conventional devices by new safety devices.

Not done (0)

comment:

3 data points before and after but no repeated measures analysis used

Not done (0)

Not done (0)

Quote: "after launching the sharps awareness campaign in 2003, # of injuries increased possibility because of sharps awareness campaign"

Comment: intervention seems to have affected reporting of NSI.

Not clear (0)

Comment: information on blinding is not reported.

Done (1)

Comment: all hospital employees were included in the study.

Done (1)

Comment: used the incident reporting system throughout the study which appears to be adequate measure for NSI.

2
Edmond 1988

Not clear (0)

Comment:

no information if additional changes were introduced during the same period at the hospital.

Not done (0)

comment:

3 data points before and after but no repeated measures analysis used.

Not done (0)

Done (1)

Comment: intervention does not appears to have affected method of data collection.

Not clear (0)

Quote: "the subjects were unaware of the nature of the study".

Comment: the reporting of the NSI was not likely to be affected by the staff knowing of the study. However, health workers would be aware of the change in the type of devices used.

Not clear (0)

Comment: information about the number of nurses for pre-intervention but not for post-intervention. For NSI, the number of staff per year is not available.

Done (1)

Comment: authors used employee health records for pre and post intervention. For NSI, this system appears reliable for the outcome of interest.

2
Richard 2001

Not clear (0)

Comment:

no information if additional changes were introduced during the same period at the hospital.

Not done (0)

comment:

3 data points before and after but the authors do not report using repeated measures analysis.

Not done (0)

Not done (0)

Quote: the increase in total injuries reported in 1998 followed a better reporting stimulated by the second educational program.

Comment: the reporting system started in 1993, it is possible that as more people became aware of the surveillance system, there was an increase in reporting.

Not clear (0)

Comment:

No information is available on blinding

Not clear (0)

Comment: no information on the actual number of healthcare workers included during pre and post intervention.

Not clear (0)

Comment: it is unclear if the reporting system was used consistently throughout the years especially as it was launched during the early phase of the study.

0

Other potential sources of bias

In two RCTs (Asai 1999 active; Asai 2002 active; Asai 2002 passive) the authors reported that the industry supplied the medical safety devices, which could have potentially introduced bias. Therefore we judged these studies to have a high risk of bias. In one study, health workers had access to conventional needles during the intervention period (L'Ecuyer 1996 2wva; L'Ecuyer 1996 mbc; L'Ecuyer 1996 pbc). Injuries during this period were attributed to the new devices even if they were caused by the conventional devices. In one study, the low response rate of the questionnaire was identified as a potential source of bias (van der Molen 2011).

Among the four CBA studies, Zakrzewska 2001 reported that the industry supplied the medical safety devices, which could potentially have introduced bias. We judged this study to have a high risk of bias. In another study, the surveillance system for NSIs differed between the pre- and post-intervention phases (Valls 2007). This difference may have lead to bias because a more active case finding system was used during the intervention period. Finally, one study introduced another device parallel to the main intervention (Zakrzewska 2001). We considered all of the above instances to be evidence of other potential sources of bias.

The measurement of NSIs was a source of bias in all studies that used this outcome. NSIs can only be based on self-report because there are no other ways of ascertaining that an injury has occurred. Like any occupational injury, the reporting of NSIs increases when workers are more aware of the problem, for example due to an awareness campaign. Any intervention has the same effect as an awareness campaign and will thus raise the number of reported injuries. This will probably lead to an underestimation of the true intervention effect.

Effects of interventions

1. Safe blood collection systems versus regular systems

ITS
Outcome: needlestick injuries (NSIs)

The two included ITS studies evaluated very different interventions. Therefore, we did not combine the studies in a meta-analysis. One study evaluated a shield on the needle cap that should prevent the needle from injuring the worker when the cap is put back on the needle (Goldwater 1989). There was a non-significant trend towards a decrease of injuries in this study (Analysis 1.1). The other used a needle sheath (Rogues 2004). In this study the level of injuries decreased substantially (effect size (ES) -6.88, 95% CI -9.53 to -4.23) but the trend over time showed a non-significant decrease (Analysis 1.2).

2. Safe intravenous systems versus regular systems

RCT
Outcome: needlestick injuries (NSIs)

One trial evaluated the effect of three different safe IV systems to prevent NSI, which resulted in a non-significant reduction of reported NSIs with a RR of 0.62 (95% CI 0.27 to 1.41) (Analysis 2.1) (L'Ecuyer 1996 mbc; L'Ecuyer 1996 2wva; L'Ecuyer 1996 pbc).

Outcome: incidence of blood contamination

Six trials with 1489 participants studied if safe IV systems resulted in a change in blood contamination compared to the usual systems. There was a statistically non-significant increased risk of blood contamination with the safe systems with a RR of 1.38 (95% CI 1.00 to 1.92). Active systems, which had to be activated by health workers, displayed a statistically significant increase in blood splashes (RR 1.60, 95% CI 1.08 to 2.36). Passive systems, which don't have to be activated, displayed a similar incidence in blood splashes in both the intervention and control groups (RR 0.94, 95% CI 0.50 to 1.75) (Analysis 2.2).

CBA
Outcome: needlestick injuries (NSIs)

One CBA study (Mendelson 1998) evaluated the effect of safe IV systems to prevent NSI, which resulted in a non-significant reduction of reported NSIs with a RR of 0.06 (95% CI 0.0 to 1.09) (Analysis 3.1).

ITS
Outcome: needlestick injuries (NSIs)

In two ITS studies (Azar-Cavanagh 2007; Sossai 2010) the results were statistically very heterogenous (I2 = 79% for level and I2 = 99% for trend) and therefore we did not combine them in a meta-analysis. The level in both studies decreased with a big effect size (Analysis 4.1). The trend over time decreased substantially in one study but not in the other (Analysis 4.2).

3. Safe injection systems versus regular systems

RCT

One RCT (van der Molen 2011) evaluated the effect of a workshop on NSI combined with the introduction of safety engineered injection needles in seven wards (n = 267) compared to a non-intervention control group (eight wards, n= 266) and to a workshop on the prevention of NSIs only control group in eight wards (n = 263). NSIs were measured by questionnaires and by the hospital reporting system.

At six-months follow-up, there was a statistically non-significant decrease in NSI based on the questionnaires (RR 0.49, 95% CI 0.16 to 1.56), but based on the hospital records there was a statistically non-significant increase in NSI (RR 1.20, 95% CI 0.42 to 3.39) (Analysis 5.1; Analysis 5.3).

At 12-months follow-up, based on the questionnaire results there was a statistically significant reduction of NSI with RR of 0.20 (95% CI 0.04 to 0.96), but based on the hospital recording system there was a statistically non-significant reduction of NSI with RR 0.72 (95% CI 0.28 to 1.81) (Analysis 5.2; Analysis 5.4).

CBA

In one study among dentists (Zakrzewska 2001) the risk of NSI with safe syringes compared to traditional ones was less but this was not significant (RR 0.34, 95% CI 0.04 to 3.28) (Analysis 6.1).

4. Multiple safe devices versus regular devices

CBA
Outcome: needle stick injuries (NSIs)

One study that compared hospital level injury rates (Valls 2007) found a decrease in NSI in the hospitals that introduced safety devices compared to those that did not (RR 0.11, 95% CI 0.01 to 0.81) (Analysis 7.1).

ITS
Outcome: needle stick injuries (NSIs)

In one ITS study (Reddy 2001), there was a statistically non-significant increase in the level of injuries following the introduction of the safety syringes and needleless IV system (ES 0.43, 95% CI -0.30 to 1.16) (Analysis 8.1). The ES for the change in long-term time trend showed an increase in the number of reported NSIs (ES 0.56, 95% CI 0.23 to 0.89) (Analysis 8.2).

5. Sharps containers versus no containers

CBA
Outcome: needlestick injuries (NSIs)

In one CBA study (Grimmond 2010), the NSI rate decreased following the introduction of sharps containers compared to departments where these were not introduced, with a RR of 0.88 (95% CI 0.78 to 0.99) (Analysis 9.1). This reduction was statistically significant when only container-related NSIs were counted with a RR of 0.22 (95% CI 0.11 to 0.41) (Analysis 9.2).

ITS

Two ITS studies (Edmond 1988; Richard 2001) showed an increased level of NSI immediately after the introduction of sharps containers and a contradictory effect in the long-term trend which prevented the synthesis of these studies in a meta-analysis (Analysis 10.1; Analysis 10.2.).

Secondary outcomes

1. Cost

A total of three studies reported information regarding the cost of the intervention. Valls 2007 reported that the direct cost of the use of safety devices was an additional USD 19,417 (USD 0.75 per patient) for the emergency department and USD 16,336 (USD 0.56 per patient-day) for the hospital wards compared to the pre-intervention period. Zakrzewska 2001 reported that the price of the safety syringes was comparable to the non-disposable syringes, approximately USD 0.33 per item. Mendelson 1998 reported that the estimated incremental hospital-wide cost was USD 82,822 (in 1991) but the cost of injury prevented was USD 1593.

2. Ease of use

Asai 1999 active reported no difference between the safety and the conventional devices in terms of ease of insertion. However, the authors reported statistically higher ease of handling the device for the safety device compared to the conventional one. Asai 1999 active; Asai 2002 active; Asai 2002 passive reported that the Autoguard IV was judged to be significantly easier to insert and handle compared to the other safety device and the conventional catheter needle. Mendelson 1998 reported that 94% of the individuals who completed the survey (approximately 52% response rate) were comfortable using the safe IV system after five or less trials. Prunet 2008 active; Prunet 2008 passive reported that the Insyte Autoguard device was significantly more difficult to insert in comparison to non-safety devices and the passive devices. With both safety devices the needle was significantly more difficult to withdraw in comparison to the conventional catheter.

Grading of the evidence

We graded the quality of the evidence per intervention-outcome combination (Table 3). Because we based our conclusions upon results obtained with a range of study designs, we could not use the GRADE programme. We present our considerations in Table 3. For all but one combination we assessed the quality of the evidence as very low because of serious limitations in the study design and the inconsistency of the results. Starting with a low level of quality because of the non-randomised studies included, the level goes down to very low quality. Only for the combination of safe IV systems and blood contamination, we assessed the quality of evidence as moderate because all included studies were RCTs and they did not have limitations in their design or in the other qualifiers.

Table 3. Grading of the evidence
Comparison and outcomeRisk of biasConsistencyDirectnessPrecisionPublication biasQuality of evidence

Safe versus traditional blood collection systems;

needle stick injuries

high RoB in 2 ITS studies: serious limitationconsistentdirect

moderate

to large effect

impossible

to determine

very low

Safe versus traditional IV systems;

blood contamination

3 RCTs low RoB, 1 RCT high RoB: no limitationconsistent I2 = 18%directwide CIimpossible to determinemoderate

Safe versus traditional IV systems;

needle stick injuries

1 RCT and 1 CBA high RoB, 1 ITS low RoB, 1 ITS high RoB: serious limitationconsistent; all show a decreasedirectwide CIimpossible to determinevery low

Safe versus traditional injection systems;

needle stick injuries

1 RCT high RoB, 1 CBA high RoB: serious limitationconsistent both show a decreaseindirect; hospital and dentistswide CIimpossible to determinevery low

Multiple safe versus traditional devices;

needle stick injuries

1 CBA high RoB, 1 ITS high RoBinconsistentdirectwide CIimpossible to determinevery low

Sharps containers versus no containers;

needle stick injuries

1 CBA and 2 ITS high RoBinconsistentdirectwide CIimpossible to determinevery low

Sensitivity analysis

We re-analysed the results comparing safe IV systems for blood contamination leaving out the one study with a high risk of bias (Cote 2003), but that did not substantially change the results.

Publication bias

We did not have enough studies in any one comparison to assess the effect of publication bias with a funnel plot or a statistical test. However, because we also found small studies with negative results, we don't think that publication bias has played a significant role in the results of this review.

Subgroup analysis and exploration of heterogeneity

We intended to do a subgroup analysis based on the control group or baseline exposure rate. Since the exposures were measured in various ways and we had only few studies in each comparison we refrained from doing so. In some comparisons, such as multiple safe devices and sharps containers, the results were inconsistent and we could not see any other reasons than the high risk of bias in the non-randomised studies. We also intended to re-analyse the results according to the origin of the study as one could expect low- and middle-income countries to have a higher infectious disease prevalence (UNAIDS 2009). However, we included only one study (Richard 2001) from a low- or middle-income country (India) that did not show a preventive effect from introducing safety containers.

Discussion

Summary of main results

The introduction of a safe blood collection system with re-sheathable winged steel needles resulted in a lower NSI rate in two interrupted time-series (ITS) studies.

There was evidence of a reduction of NSIs with the introduction of safe IV devices in one randomised controlled trial (RCT). According to four RCTs, active safe IV devices requiring activation by health workers significantly increase blood splashes. In two RCTs, passive safe IV systems produced a similar number of blood splashes to conventional systems. Blood splashes were reported to occur either on equipment, clothing, a tray, staff or patients but none were reported as mucocutaneous exposure to eyes or nose or contact with skin cuts.

The introduction of safe injection devices did not significantly reduce the NSI rate in one RCT and one controlled before and after (CBA) study. The introduction of multiple safety devices showed an effect in one CBA study but not in an ITS study.

The introduction of safety containers similarly showed a reduction in one CBA study but not in the two ITS studies. There was no evidence in the included studies regarding which type of device was better, either shielding of the needle or retraction of the needle.

The evidence mainly consists of non-randomised studies and we rated it as being very low quality. Where it was based on RCTs we judged the quality to be moderate.

Overall completeness and applicability of evidence

The studies included in this review cover a time period from 1988 to 2010. With the exception of one study, completed in India, the remaining studies were from high-income countries. Studies covered a wide range of devices used for blood collection or injections. Some studies either had a discontinued safety device or the conventional device, in this case the standard needled intravenous system, which have been widely discontinued and have been replaced by safety devices such as a needleless IV system. We included studies examining safety devices regardless of whether they were presently in use or not, as long as they met our original inclusion criteria.

Since we included randomised and non-randomised studies, we have reduced the possibility of missing any lower quality evidence for more complex interventions at a higher aggregated level. By including ITS studies we were able to detect both short-term and long-term effects on trends of injury rates.

Most studies could be named pragmatic trials because they were either carried out by the healthcare staff who were themselves at risk or they were based on routinely gathered data, such as needlestick injury reports. This increased the applicability of the evidence but probably at the same time has decreased the quality of the studies. Most studies cover healthcare staff that are exposed to the risk of needlestick injuries, and as such the evidence is directly applicable to nurses, physicians and laboratory staff. There were two RCT studies in which researchers and assistants completed the procedures. Their findings may not apply to the general population of healthcare workers. However, they completed the procedures in ordinary healthcare conditions and we assumed that they formed a part of the healthcare staff.

Among health workers there is a wide variation of skills, experience and working conditions that leads to a wide variation in needlestick injury risk. For example, phlebotomists spend nearly all of their working hours drawing blood, and by repetition and practice will be more adept at this procedure than the average physician; although their occupational exposure to needlestick injuries will also be higher due to the nature of their work. This variation can almost certainly lead to a difference in the rate of percutaneous exposure injuries. However, there was not enough variation in the included studies to assess this.

Quality of the evidence

The quality of the included studies was low, with most studies not being randomised. In addition, we judged many of these studies to have a high risk of bias. The fact that we did find RCTs shows that rigorously controlled research methods can be used to evaluate the introduction of safety devices, especially in a cluster-randomised design where hospital departments are randomised to the introduction of safety devices. Most studies had low quality in terms of methodology, which may have resulted from the lack of involvement by research institutions.

With the exception of three studies, all studies reported needlestick injuries as their outcome. This outcome is problematic because these injuries are known to be under-reported and are likely to increase with raised awareness, for example through an intervention study (Ratner 1994). This might explain the lack of effect in many studies, especially in the ITS studies. Nowadays, where the use of gloves with procedures that involve blood has increased, it would also be possible to use glove perforations as an outcome measure, which is less subject to reporting bias. Another problem with the outcome is that the denominator varies across studies, with person-years in some studies and 100,000 devices in others. We judged these all to be similar enough to be combined across studies because all these denominators reflect the hazard of needlestick injuries in a similar way, both in the intervention and the control group. There is most likely no single valid denominator for different purposes. It has been argued that for comparing hospitals the best denominator would be patient-days, because of the accuracy and availability of the figures (Chen 2005).

Potential biases in the review process

We did not exclude articles in languages other than English, but we found very few. Therefore, we are confident that there is no language bias in our review. We carried out all selection and data-extraction processes in duplicate and involved a third assessor if we could not reach consensus easily.

The inclusion of non-randomised studies further decreased the likelihood that we excluded important evidence. Because we analysed the non-randomised studies separately, we believe that this has not introduced bias.

It was difficult to ascertain the validity of the outcome measures. Given the consistency of the results and the fact that the outcome was measured similarly in the intervention and control groups, we feel that this did not introduce bias. However, in some studies healthcare workers still had access to the conventional devices during the intervention period. Needlestick injuries caused by the conventional devices may have been mis-classified under safety device, decreasing the effect of the intervention. The rate of needlestick injuries is a problematic outcome as attention to the problem has the potential to increase the rate of reporting thus nullifying the effect of the intervention. It could be that non-significant results are due to this effect.

Agreements and disagreements with other studies or reviews

Several reviews have been published on prevention of percutaneous exposure injuries in the past years. Compared to earlier reviews (Hutin 2003; Rogers 2000), the number of studies has increased. Tuma 2006 reviewed the effect of safety engineered devices on percutaneous injuries, and reported that all 17 included studies reported a substantial decrease in injury rates. However, only five of these studies used a control group and the authors did not use meta-analysis to combine results.

Authors' conclusions

Implications for practice

We found very low quality evidence that safety features in blood collection systems and intravenous access systems can lower needlestick injuries compared to systems without safety features. The extent of the effect and which features are best remain unclear. Safety features on intravenous devices that have to be actively set in motion increase the risk of blood contamination. Studies did not show evidence of a decrease in needlestick injuries due to safe injection needles, the introduction of multiple safety devices or the introduction of sharps containers. The lack of evidence of a benefit could be due to confounding and bias in the included studies.

Implications for research

Even though safety medical devices technically reduce the risk of a needlestick injury, the risk will not be eliminated completely. The term safety medical devices or safety engineered devices, commonly used for devices that include built-in safety features, could be misleading as it may lead users to believe that these devices are safer than conventional devices or share similar quality in terms of safety. However, there is no specific requirement in terms of effectiveness to reduce needlestick injuries to be referred to as safety engineered devices. Limitation of the name 'safe device' to devices that comply with minimum quality requirements would be helpful in practice. In the US, it has been estimated that there are over 300 sharps safety devices for injection and blood drawing, among other procedures (Jagger 2013). Comparisons of various types of safety engineered devices would be able to show which device works best. Since there are considerable costs related to safety engineering, research is also needed on what are the most cost-effective devices.

Studies that have a no-intervention control group should consider integrating a pre-intervention period in which an awareness campaign or training sessions, or both, are available to healthcare workers about needlestick injuries and reporting procedures. Without such a time period, an intervention may show no effect or an increase in needlestick injuries due to the increase in reporting but not in the actual number of needlestick injuries.

Given the strong emphasis through regulation on their use in practice, studies comparing safety engineered devices versus no safety devices are not feasible in Europe and North America. However, studies should focus on evaluating the most effective type of device. A large cluster-randomised trial focused on needlestick injury reporting in both the intervention and the control group would be the preferred research design. Because needlestick injuries are not very frequent, a large sample size is needed, with at least several large hospitals or groups of healthcare workers involved. There is also a need for similar trials in low- and middle-income countries with a high prevalence of HIV or hepatitis C to evaluate low-cost safety devices against the current use of conventional devices.

Surveillance systems for needlestick injury could also contribute to the evidence base by collecting information on names of devices to identify more precisely which particular devices are associated with injuries.

Acknowledgements

We thank Annika Saarto (previously Parantainen) for her groundwork as the initial first author of this protocol. We thank Minna Anthoni and Ulla-Maija Hellgren who participated in the writing of an early version of the first protocol. We extend our gratitude to Ms Leena Isotalo, the Trials Search Coordinator of the Cochrane Occupational Safety and Health Review Group, for designing the systematic search strategies and for running them in all the chosen electronic reference databases. We would also like to thank Dimitrinka Nikolova and Christian Gluud from the Hepato-Biliary Group for their comments on an early version of our protocol and Jani Ruotsalainen from the Occupational Safety and Health Group and Janet Wale from the Bone, Joint and Muscle Trauma Group for copy editing the text.

Data and analyses

Download statistical data

Comparison 1. Safe blood collection systems versus regular systems ITS
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Number of reported sharps injuries, level2 Effect Size (Random, 95% CI)Totals not selected
1.1 Cap shield1 Effect Size (Random, 95% CI)0.0 [0.0, 0.0]
1.2 Needle sheath1 Effect Size (Random, 95% CI)0.0 [0.0, 0.0]
2 Number of reported sharps injuries, slope2 Effect Size (Fixed, 95% CI)Totals not selected
2.1 Cap shield1 Effect Size (Fixed, 95% CI)0.0 [0.0, 0.0]
2.2 Needle sheath1 Effect Size (Fixed, 95% CI)0.0 [0.0, 0.0]
Analysis 1.1.

Comparison 1 Safe blood collection systems versus regular systems ITS, Outcome 1 Number of reported sharps injuries, level.

Analysis 1.2.

Comparison 1 Safe blood collection systems versus regular systems ITS, Outcome 2 Number of reported sharps injuries, slope.

Comparison 2. Safe intravenous systems versus regular systems RCT
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Needlestick injuries3 Rate Ratio (Fixed, 95% CI)0.62 [0.27, 1.41]
2 Incidences of blood contamination61489Risk Ratio (M-H, Fixed, 95% CI)1.38 [1.00, 1.92]
2.1 Active systems4961Risk Ratio (M-H, Fixed, 95% CI)1.60 [1.08, 2.36]
2.2 Passive systems2528Risk Ratio (M-H, Fixed, 95% CI)0.94 [0.50, 1.75]
Analysis 2.1.

Comparison 2 Safe intravenous systems versus regular systems RCT, Outcome 1 Needlestick injuries.

Analysis 2.2.

Comparison 2 Safe intravenous systems versus regular systems RCT, Outcome 2 Incidences of blood contamination.

Comparison 3. Safe intravenous systems versus regular systems CBA
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Number of needlestick injuries1 Rate Ratio (Fixed, 95% CI)0.06 [0.00, 1.09]
Analysis 3.1.

Comparison 3 Safe intravenous systems versus regular systems CBA, Outcome 1 Number of needlestick injuries.

Comparison 4. Safe intravenous systems versus regular systems ITS
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Number of reported sharps injuries, level2 Effect Size (Random, 95% CI)Totals not selected
2 Number of reported sharps injuries, slope2 Effect Size (Random, 95% CI)Totals not selected
Analysis 4.1.

Comparison 4 Safe intravenous systems versus regular systems ITS, Outcome 1 Number of reported sharps injuries, level.

Analysis 4.2.

Comparison 4 Safe intravenous systems versus regular systems ITS, Outcome 2 Number of reported sharps injuries, slope.

Comparison 5. Safe injection systems versus regular systems RCT
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Questionnaire reported Needlestick injuries 6 mo follow up1154Risk Ratio (M-H, Fixed, 95% CI)0.42 [0.14, 1.25]
2 Questionnaire reported Needlestick injuries 12 mo follow up1144Odds Ratio (M-H, Fixed, 95% CI)0.20 [0.04, 0.96]
3 Hospital reported Needlestick injuries 6 mo follow up1533Odds Ratio (M-H, Fixed, 95% CI)1.20 [0.51, 2.84]
4 Hospital reported Needlestick injuries 12 mo follow up1533Odds Ratio (M-H, Fixed, 95% CI)0.72 [0.28, 1.81]
Analysis 5.1.

Comparison 5 Safe injection systems versus regular systems RCT, Outcome 1 Questionnaire reported Needlestick injuries 6 mo follow up.

Analysis 5.2.

Comparison 5 Safe injection systems versus regular systems RCT, Outcome 2 Questionnaire reported Needlestick injuries 12 mo follow up.

Analysis 5.3.

Comparison 5 Safe injection systems versus regular systems RCT, Outcome 3 Hospital reported Needlestick injuries 6 mo follow up.

Analysis 5.4.

Comparison 5 Safe injection systems versus regular systems RCT, Outcome 4 Hospital reported Needlestick injuries 12 mo follow up.

Comparison 6. Safe injection systems versus regular systems CBA
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Needlestick injury rate1 Rate Ratio (Fixed, 95% CI)Totals not selected
Analysis 6.1.

Comparison 6 Safe injection systems versus regular systems CBA, Outcome 1 Needlestick injury rate.

Comparison 7. Multiple safe devices versus regular devices CBA
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Needle stick injuries1 Rate Ratio (Fixed, 95% CI)Totals not selected
Analysis 7.1.

Comparison 7 Multiple safe devices versus regular devices CBA, Outcome 1 Needle stick injuries.

Comparison 8. Multiple safe devices versus regular devices ITS
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Number of reported sharps injuries, level1 Effect Size (Fixed, 95% CI)0.43 [-0.30, 1.16]
2 Number of reported sharps injuries, slope1 Effect Size (Random, 95% CI)Totals not selected
Analysis 8.1.

Comparison 8 Multiple safe devices versus regular devices ITS, Outcome 1 Number of reported sharps injuries, level.

Analysis 8.2.

Comparison 8 Multiple safe devices versus regular devices ITS, Outcome 2 Number of reported sharps injuries, slope.

Comparison 9. Sharps containers versus no containers CBA
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Number of needlestick injuries1 Rate Ratio (Fixed, 95% CI)Totals not selected
2 Number of container related needlestick injuries1 Rate Ratio (Fixed, 95% CI)0.22 [0.11, 0.41]
Analysis 9.1.

Comparison 9 Sharps containers versus no containers CBA, Outcome 1 Number of needlestick injuries.

Analysis 9.2.

Comparison 9 Sharps containers versus no containers CBA, Outcome 2 Number of container related needlestick injuries.

Comparison 10. Sharps containers versus no containers ITS
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Number of reported sharps injuries, level2 Effect Size (Random, 95% CI)2.49 [0.49, 4.48]
2 Number of reported sharps injuries, slope2 Effect Size (Random, 95% CI)Totals not selected
Analysis 10.1.

Comparison 10 Sharps containers versus no containers ITS, Outcome 1 Number of reported sharps injuries, level.

Analysis 10.2.

Comparison 10 Sharps containers versus no containers ITS, Outcome 2 Number of reported sharps injuries, slope.

Appendices

Appendix 1. General search strategy, needle stick injury prevention interventions

DatabasePeriod of searchSearch strategy
The Cochrane Hepato-Biliary Group Controlled Trials Register1996 to 7 Oct 2010('health care worker*' or 'health personnel' or 'HCWs' ) and ( 'virus disease*' or 'virus*' or 'viral infect*')
EMBASE1974 to 17 Sept 2010

#6 #5 AND [humans]/lim AND [embase]/lim

#5 #3 AND #4

#4 [randomized controlled trial]/lim OR [controlled clinical trial]/lim OR random* OR 'double blind' OR 'single blind' OR (singl* OR doubl* OR trebl* OR tripl* AND (blind* OR mask*)) OR 'single blind procedure'/exp OR 'double blind procedure'/exp OR 'triple blind procedure'/exp OR placebo* OR 'controlled study'/exp OR 'cross sectional study'/exp OR 'crossover procedure'/exp OR 'latin square design'/exp OR 'follow up'/exp OR 'comparative study'/exp OR 'evaluation studies'/exp OR 'evaluation study' OR prospectiv* OR volunteer*

#3 #1 AND #2

#2 'health care personnel'/exp OR 'health care personnel' OR 'health care worker'/exp OR 'health care worker' OR 'health care workers' OR 'health care facilities and services'/exp OR 'medical profession'/exp OR 'nursing as a profession'/exp OR ('virus transmission'/exp AND 'patient'/exp AND professional)

#1 'needlestick injury'/exp OR needlestick* OR 'needle stick'/exp OR 'sharp injury' OR 'sharp injuries' OR 'sharp medical' OR 'sharp instrument' OR 'sharp needle' OR 'sharp needles' OR sharps OR 'percutaneous exposure' OR 'percutaneous injury' OR 'percutaneous injuries' OR 'percutaneous trauma' OR 'stick injury' OR 'stick injuries' OR 'stab wound'/exp OR 'face injury'/de OR 'eye injury'/de OR 'arm injury'/de OR 'hand injury'/de OR 'needle'/exp OR (splash* AND ('blood'/exp OR blood OR secretion* OR fluid* OR 'body fluid'/exp OR 'body fluids'/exp))

Wiley InterScience
Cochrane Library Databases:
CENTRAL and NHSEED
1993 to 7 Oct 2010

#3 #1 AND #2

#2 EXP Needlestick Injuries (MeSH) OR needlestick* OR "needle stick OR "needle sticks" OR "percutaneous exposure" OR "percutaneous exposures" OR "percutaneous injury" OR "percutaneous injuries2 OR "stick injury" OR "stick injuries" OR Wounds, Stab (MeSH) OR Wounds, Penetrating (MeSH) OR Facial injuries (MeSH) OR EXP Eye Injuries, Penetrating (MeSH) OR Forearm Injuries (MeSH) OR EXP Hand Injuries (MeSH) OR [splash* AND blood OR secretion* OR fluid* OR EXP Body Fluids (MeSH)  OR EXP Bodily Secretions (MeSH)]

#1 EXP Health Occupations (MeSH) OR EXP Health Personnel (MeSH) OR EXP Health Facilities (MeSH)  OR "health care worker"  OR "health care workers"  OR Disease Transmission, patient-to-Professional (MeSH)

Science Citation Index Expanded1986 to 5 October 2010

#4 #1 AND #2 AND #3

#3 TS=(random* OR control* OR trial OR trials OR "single blind" OR "double blind" OR "triple blind" OR "latin square" OR placebo* OR comparative OR "follow up" OR prospectiv* OR "cross over" OR volunteer*)

#2 TS=(needlestick* OR "needle stick" OR "needle sticks" OR "stick injury" OR "stick injuries"  OR "wound stab" OR "stab wound"  OR "penetrating wound" OR "penetrating wounds") OR TS=(sharp* AND ( injury OR injuries OR medical OR instrument*))  OR TS=(percutaneous AND (exposure OR exposures OR injury OR injuries)) OR TS=(injur* AND (facial OR eye OR eyes OR arm OR hand OR finger OR fingers)) OR TS=(splash* AND (blood OR secretion* OR fluid OR fluids)) OR TS="blood borne infection"

#1 TS=("health care worker"  OR "health care workers" OR "health occupations" OR "health personnel"  OR physician* OR nurse* OR hospital* OR clinic OR clinics)

CINAHL1982 to 30 Sept 2010

#5 #3 AND #4

#4 "randomized controlled trial" or "clinical trials" or "clinical trial" or "random allocation" or "double blind". or "single blind" or ((singl* or doubl* or trebl* or tripl*) and (blind* or mask*)) or "latin square" or placebo# or random* or "research design" or "comparative study" or "comparative studies" or "evaluation study" or "evaluation studies" or "follow up study" or "follow up studies" or "prospective study" or "prospective studies" or "cross over study" or "cross over studies" or control* or prospective* or volunteer or (MH "Clinical Trials+") or (MH "Nonrandomized Trials") or (MH "Crossover Design")

#3 #1 AND #2

#2 TX "needlestick injury" or needlestick# or "needle stick" or "needle sticks" or "sharp injury" or "sharp injuries" or "sharp medical device" or "sharp medical devices" or "sharp instrument" or "sharp instruments" or "sharp needle" or "sharp needles" or "percutaneous exposure" or "percutaneous exposures" or "percutaneous injury" or "percutaneous injuries" or "stick injury" or "stick injuries" or "wounds, stab" or "wounds, penetrating" or "facial injuries" or "eye injuries, penetrating" or "arm injuries" or "forearm injuries" or "hand injuries" or "finger injuries" or (splash# and (blood or secretion# or fluid#)) or ("occupational exposure" and ("body fluid" or  "body fluids" or blood))

#1 (MH "Health Occupations") OR health occupations   or (MH "Health Personnel+")  or (MH "Health Facilities+") OR health facilities  or TX "health care worker"  or TX "health care workers"  or (MH "Personnel, Health Facility+") or (MH "Occupational Health Services+")  or (MH "Occupational Hazards+")  or (MH "Occupational Exposure")  or TX "health care personnel"   or  (MH "Health Personnel+") or (MH "HIV Infections+")

OSH UPDATE (NIOSHTIC-2 and CISDOC)NIOSHTIC-2: 1900 to 7 Oct 2010
CISDOC: 1987 to 7 Oct 2010

#15 #13 AND #14

#14 PY{2007} OR PY{2008} OR PY{2009}

#13 #7 AND #12

#12 #8 OR #11

#11 #9 AND #10

#10 GW{blind* OR mask*}

#9 GW{singl* OR doubl* OR tripl* OR trebl*}

#8 GW{random* OR control* OR trial OR trials OR comparativ* OR evaluation* OR "latin square" OR placebo OR "follow up" OR prospectiv* OR "cross over" OR volunteer*}

#7 #1 AND #6 

#6 #2 OR #5

#5 #3 AND #4

#4 GW{splash*}

#3 GW{blood OR fluid* OR secretion*}

#2 GW{"sharp medical" OR "sharp instrument" OR "sharp instruments" OR needlestick* OR "needle stick" OR "needle sticks" OR "sharp injury" OR "sharp injuries" OR "stab wound" OR "stab wounds" OR "wound penetrating" OR "stick injury" OR "stick injuries" OR "percutaneous injury" OR "percutaneous injuries" OR "percutaneous exposure" OR "percutaneous exposures" OR "sharp needle" OR "sharp needles"}

#1 GW{nurse OR nurses OR physician OR physicians OR hospital* OR "health occupation" OR "health occupations" OR "health personnel" OR "health care personnel" OR "health care worker" OR "health care workers" OR "health worker" OR "health workers"}

MEDLINE in PubMedfrom 1950 to 17 Sept 2010

#5 Search #1 AND #2 AND (#3 OR #4)

#4 Search effect*[tw] OR control[tw] OR controls*[tw] OR controla*[tw] OR controle*[tw] OR controli*[tw] OR controll*[tw] OR control'*[tw] OR evaluation*[tw] OR program*[tw]

#3 ("Randomized Controlled Trial"[pt] OR "Controlled Clinical Trial"[pt] OR "Randomized Controlled Trials as Topic"[mh] OR "Random Allocation"[mh] OR "Double-Blind Method"[mh] OR "Single-Blind Method"[mh] OR "Clinical Trial"[pt] OR "Clinical Trials as Topic"[mh] OR "clinical trial"[tw] OR ((singl*[tw] OR doubl*[tw] OR trebl*[tw] OR tripl*[tw]) AND (mask*[tw] OR blind*[tw])) OR "latin square"[tw] OR Placebos[mh] OR placebo*[tw] OR random*[tw] OR "Research Design"[mh:noexp] OR "Comparative Study"[pt] OR "Evaluation Studies as Topic"[mh] OR "Follow-up Studies"[mh] OR "Prospective Studies"[mh] OR "Cross-over Studies"[mh] OR control[tw] OR controls*[tw] OR controla*[tw] OR controle*[tw] OR controli*[tw] OR controll*[tw] OR control'*[tw] OR prospectiv*[tw] OR volunteer*[tw]) NOT (Animals[mh] NOT Humans[mh)

#2 "Needlestick injuries"[mh] OR needlestick*[tw] OR "needle stick"[tw] or "needle sticks"[tw] OR "sharp injury"[tw] OR "sharp injuries"[tw] OR sharps[tw] OR "sharp medical device"[tw] OR "sharp medical devices"[tw] OR "sharp instrument"[tw] OR "sharp instruments"[tw] OR "sharp medical instrument"[tw] OR "sharp medical instruments"[tw] OR "sharp needle"[tw] OR "sharp needles"[tw] OR "percutaneous exposure"[tw] OR "percutaneous exposures"[tw] OR "percutaneous injury"[tw] OR "percutaneous injuries"[tw] OR "stick injury"[tw] OR "stick injuries"[tw] OR "Wounds, Stab"[mh:noexp] OR "Wounds, Penetrating"[mh:noexp] OR "Facial injuries"[mh:noexp] OR "Eye Injuries, Penetrating"[mh] OR "Arm Injuries"[mh:noexp] OR "Forearm Injuries"[mh:noexp] OR "Hand Injuries"[mh] OR (splash* AND (blood[tw] or secretion*[tw] OR fluid*[tw] OR "Body Fluids"[mh]))

#1 "Health Occupations"[mh] OR "Health Personnel"[mh] OR "Health Facilities"[mh] OR "health care worker"[tw] OR "health care workers"[tw] OR "Infectious Disease Transmission, Patient-to-Professional"[mh]

PsycINFO (OvidSP)1967 to 6 Oct 2010

#5 limit 4 to all journals

#4 #1 AND #2 AND #3

#3 random* OR control* OR trial OR trials OR comparativ* OR evaluation* OR ((singl* OR doubl* OR tripl* OR trebl*) AND (blind* OR mask*)) OR "latin square" OR placebo* OR "follow up" OR prospectiv* OR "cross over" OR volunteer*   

#2 (splash* AND (blood OR secretion* OR fluid OR fluids)) OR ("eye injuries" AND penetrating) OR (wound* AND (stab OR penetrating)) OR "percutaneous exposure" OR "percutaneous exposures" OR "percutaneous injury" OR "percutaneous injuries" OR "stick injury" OR "stick injuries" OR "sharp injury" OR "sharp injuries" OR "sharp medical" OR "sharp instrument" OR "sharp instruments" OR "sharp needle" OR "sharp needles" OR needlestick* OR "needle stick" OR "needle sticks"

#1 (nursing or nurse or nurses or physician or physicians or "health care personnel" or "health personnel" or "health care worker" or "health care workers" or "Clinicians*" or "Dentist*" or "Health-Personnel" or "Medical Personnel" or "Military-Medical-Personnel" or "Nurses*" or "Physician*" or "Psychiatric-Hospital-Staff*" or "medical students" or "hospitals" or "occupational exposure" or "occupational exposures").mp. [mp=title, abstract, heading word, table of contents, key concepts]

LILACS "Health Occupations" or "Health Personnel" OR "Health Facilities" OR "health care worker" OR "health care workers" OR "Disease Transmission, Patient-to-Professional" OR "INJURIES" or "WOUNDS AND INJURIES/PC" or "accidents, OCCUPATIONAL" or "injuries, poisonings, and OCCUPATIONAL diseases" or "OCCUPATIONAL exposure" or "OCCUPATIONAL health policy" or "OCCUPATIONAL risks" OR "INJURIES" or "WOUNDS AND INJURIES/PC" or "accidents, OCCUPATIONAL" or "injuries, poisonings, and OCCUPATIONAL diseases" or "OCCUPATIONAL exposure" or "OCCUPATIONAL health policy" or "OCCUPATIONAL risks" [Descritor de assunto] and "CLINICAL TRIAL" OR "CLINICAL TRIAL, PHASE I" OR "CLINICAL TRIAL, PHASE II" OR "CLINICAL TRIAL, PHASE III" OR "CLINICAL TRIAL, PHASE IV" OR "COMPARATIVE STUDY" OR "CONTROLLED CLINICAL TRIAL" OR "EVALUATION STUDIES" OR "META-ANALYSIS" OR "MULTICENTER STUDY" OR "RANDOMIZED CONTROLLED TRIAL" OR "REVIEW" [Tipo de publicação] and not "ANIMALS" or "HUMANS" [Palavras]

Appendix 2. Updated search strategy, recapping prevention

We added the following search words to the general search strategy to restrict the interventions to prevention of recapping interventions:

(recap* OR device*)

What's new

DateEventDescription
7 February 2012AmendedThe original version of this protocol was published with the title: "Prevention of percutaneous injuries with risk of hepatitis B, hepatitis C, or other viral infections for health-care workers". However, it turned out that the scope was far too wide and would result in an unmanageable number of studies for one review. Therefore the decision was taken to split the protocol into four new ones. The other three new titles are: "Blunt versus sharp suture needles for preventing percutaneous exposure incidents in surgical staff", "Education and training for preventing percutaneous exposure injuries in health care personnel" and "Extra gloves or special types of gloves versus a single pair of gloves for preventing percutaneous exposure injuries in healthcare personnel".

Contributions of authors

Conceiving and designing the review: JV and ML

Co-ordinating the review: JV

Data extraction: JV, MC, AP, MP

Data analyses: JV, MC

Data interpretation: JV, MC

Writing of the review: MC, JV

Declarations of interest

None known.

Sources of support

Internal sources

  • Finnish Institute of Occupational Health, Finland.

    Provided salaries and office facilities and resources for Annika Parantainen and Jos Verbeek

  • Pan American Health Organization, USA.

    Provided salaries and office facilities and resources as well as support to attend Cochrane Collaboration training sessions for Manisha Pahwa and Marie-Claude Lavoie

External sources

  • No sources of support supplied

Differences between protocol and review

The protocol stated that the interventions will be categorized based on the type of device: 1) safety engineered devices for blood collection; 2) safety engineered devices for Injecting fluids; and 3) containers for collecting sharps. During the review process, we added two more categories, intravenous systems and multiple safety devices, as two studies included more than one type of device as part of their intervention.

Notes

The protocol for this review was first published as "Prevention of percutaneous injuries with risk of hepatitis B, hepatitis C, or other viral infections for healthcare workers" (Parantainen 2008). Our initial idea was to include all interventions used to prevent needlestick injuries. However, after the publication of the protocol it became apparent that very many studies would be eligible for inclusion. The decision was therefore made to split the protocol up into four new protocols. The protocols in addition to the present protocol are titled: "Blunt versus sharp suture needles for preventing percutaneous exposure incidents in surgical staff", "Education and training for preventing percutaneous exposure injuries in healthcare personnel" and "Extra gloves versus a single pair of gloves for preventing percutaneous exposure injuries in healthcare personnel".

The original protocol was hosted by the Hepato-Biliary Group but due to the heavy involvement of Jos Verbeek and the Occupational Safety and Health Group the new titles were registered under their aegis.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Asai 1999 active

MethodsStudy design: Randomised Controlled Trial. Object of randomisation: patients
ParticipantsJapan. Researchers and their assistants performing intravenous infusion on patients scheduled for elective surgery. Number studied: 100 patients. Intervention group n=50. Control group n=50
InterventionsUse of Insyte AutoGuard intravenous cannula where the needle can be retracted into a safety barrel by actively pushing a button. The control group used conventional Insyte intravenous cannula
OutcomesOutcome: (1) Number of needlestick injuries per total number of procedures; (2) blood contamination from either the inserted cannula or needle on researcher, assistant, patient or equipment; (3) blood stains on the collection tray. Measurement: (1) self-reporting of needlestick injuries; (2) number of incidents of blood contamination by visual assessment; (3) number of blood stains with a maximum score of 10 if there were more than 10 stains
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationUnclear risk"the patient was allocated to one of the two groups by blocked randomisation (blocks of 10). " No additional information is available on the blocked randomisation
Allocation concealmentUnclear riskInformation about allocation concealment is not available in the article
Blinding
All outcomes
Low risk

"The presence or absence of blood on the tray was assessed by a blinded researcher"

Healthcare workers could not have been blinded as they were using the devices but it is unlikely that this introduces bias

Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data
Free of selective reportingLow riskAuthors reported the outcomes mentioned in the method section. Information is available for the two groups for the number of attempts at insertion, ease of insertion, ease of handling needle, blood contamination, and needlestick injuries
Similar recruitment of groupsUnclear risk

Patient characteristics were similar in terms of sex, age, weight and height

No information available on the characteristics of the researchers and assistants such as years of experience, professions, difference between the intervention and control groups in terms of staff

Adjustment for baseline differencesUnclear riskNo information related to adjustment for baseline differences is reported
Free of other biasHigh risk

"We thank Japan Becton for supplying the Insyte and Autoguard cannulae."

The involvement of a medical devices manufacturing company may have potentially introduced information bias

Asai 2002 active

MethodsStudy design: Randomised Controlled Trial with two intervention arms and one control arm. Object of randomisation: patients
ParticipantsJapan. Researchers and assistants performing intravenous (N=150) and intra-arterial cannulations (N=150) in elective surgery. Number studied: 300 patients. Intervention group one n=100 (Insyte Autoguard cannula with a button for actively retracting the needle. Control group n=100 (divided over the two intervention arms)
InterventionsIntervention arm one: Use of safeguarded needles (Insyte Autoguard) in intravenous cannulations. The control group used conventional Insyte catheter needles
OutcomesOutcome: Needlestick injuries (none detected), median number of blood contamination from inserted catheter or needles on staff, patients, equipment or tray
NotesWe combined the results of the intravenous and intra-arterial cannulation when the same devices were used
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationUnclear risk"In each part of the study, patients were randomly allocated intro three groups. Block randomisation (in block of 15) was used for the allocation. No additional information available on randomisation process
Allocation concealmentLow risk

"cards indicating allocations were placed in a serially numbered, sealed opaque envelope?"

Adequate allocation concealment

Blinding
All outcomes
Low risk

"The presence or absence of blood on a tray was assessed by a researcher who was blinded to the allocation"

Healthcare workers could not have been blinded as they were using the devices but bias seems unlikely here

Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data
Free of selective reportingLow riskAuthors reported the outcomes mentioned in the method section: information is available for the three groups for the ease of insertion, information on the backflow, ease of handling needle, blood contamination, needlestick injuries and problems at insertion
Similar recruitment of groupsUnclear risk

Patients characteristics were similar in terms of the age, weight and height. There were differences between groups for sex

No information available on the characteristics of the researchers and assistants such as years of experience, professions, difference between the intervention and control groups in terms of the staff

Adjustment for baseline differencesUnclear riskNo information related to adjustment for baseline differences is reported
Free of other biasHigh risk

"We thank Japan Becton for supplying Insyte and Insyte Autoguards and Johnson & Johnson Medical for supplying protective acuvance needles."

The involvement of a medical devices manufacturing company may have potentially introduced information bias

Asai 2002 passive

MethodsStudy design: Randomised Controlled Trial with two intervention arms and one control arm. Object of randomisation: patients
ParticipantsJapan. Researchers and assistants performing intravenous (N=150) and intra-arterial cannulations (N=150) in elective surgery. Number studied: 300 patients. Intervention group two n=100 (Protective Acuvance) cannula with a passive mechanism that retracts the needle, Control group n=100 (divided over the two intervention arms)
InterventionsIntervention arm two: Use of safeguarded needles (Protective Acuvance) in intravenous and intra-arterial cannulations. The control group used conventional Insyte catheter needles
OutcomesOutcome: Needlestick injuries (none detected), median number of blood contamination from inserted catheter or needles on staff, patients, equipment or tray, and median number of blood stains on tray
NotesWe combined the results of the intravenous and intra-arterial cannulation when the same devices were used
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationUnclear risk"In each part of the study, patients were randomly allocated intro three groups. Block randomisation (in block of 15) was used for the allocation and cards indicating allocations we placed in a serially numbered, sealed opaque envelope"
Allocation concealmentLow risk"cards indicating allocations were placed in a serially numbered, sealed opaque envelope"
Blinding
All outcomes
Low risk

"The presence or absence of blood on a tray was assessed by a researcher who was blinded to the allocation"

Healthcare workers could not been blinded as they were using the devices but bias is unlikely here

Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data
Free of selective reportingLow riskAuthors reported on outcomes mentioned in the method section:information is available for the three groups for the ease of insertion, information on the backflow, ease of handling needle, blood contamination, needlestick injuries and problem at insertion
Similar recruitment of groupsUnclear risk

Patients characteristics were similar in terms of the age, weight and height. There were differences in between groups for sex

No information available on the characteristics of the researchers and assistants such as years of experience, professions, difference between the intervention and control groups in terms of the staff

Adjustment for baseline differencesUnclear riskNo information related to adjustment for baseline differences is reported
Free of other biasHigh risk

"We thank Japan Becton for supplying Insyte and Insyte Autoguards and Johnson & Johnson Medical fro supplying protective acuvance needles."

The involvement of a medical devices manufacturing company may have potentially introduced information bias

Azar-Cavanagh 2007

MethodsStudy design: Interrupted Time-Series Study
Participants

USA. Healthcare workers handling needles and thus with potential exposure to bloodborne pathogens

Number studied: 11,161 healthcare workers for the pre-intervention period (18 months) and 12,851 healthcare workers for the post-intervention period (18 months)

InterventionsIntroduction of an intravenous catheter stylet with a safety engineered feature (a retractable protection shield). The mechanism has to be activated by the worker. Suture needles were not replaced by safety engineered needles and were thus used as control group
OutcomesOutcome: Number of percutaneous injuries per 1000 healthcare workers
NotesPre-intervention rate (PI per 1000 health workers) IV catheter needle (2.5; 2.3, 2.5 for each six-month period respectively)
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationUnclear riskna
Allocation concealmentUnclear riskna
Blinding
All outcomes
Unclear riskna
Incomplete outcome data addressed
All outcomes
Unclear riskna
Free of selective reportingUnclear riskna
Similar recruitment of groupsUnclear riskna
Adjustment for baseline differencesUnclear riskna
Free of other biasUnclear riskna

Cote 2003

MethodsStudy design: Randomised Controlled Trial. Object of randomisation: patients by calendar week
ParticipantsUSA. Staff of the operating theatre. Participation by attending anaesthesiologists was voluntary. Number randomised: 330 patients receiving IV catheter insertions. Intervention group n=211. Control group n=119
InterventionsThe intervention group used Angiocath Autoguard IV catheters with retractable needles where retraction has to be activated with a button. The control group used traditional JELCO IV catheters
OutcomesOutcome: number of spills and splatters of blood on linen, table, floor, skin or clothing per total number of procedures. Measurement: visual observations by the operating staff
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationHigh risk"Assignment of catheter type was randomised by week"
Allocation concealmentUnclear riskResearchers do not provide information on allocation concealment
Blinding
All outcomes
Unclear riskNo information available
Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data. Data available includes all participants (n=330)
Free of selective reportingLow riskPre-specified outcomes were reported accordingly
Similar recruitment of groupsUnclear riskThe intervention and control groups were recruited from the same hospital. The study was completed over 20 days, 11 days for intervention and 9 days for the control. It is unclear if patients recruited to the study differed based on the week the person was selected to participate into the study
Adjustment for baseline differencesUnclear riskNo information on the adjustment for baseline difference reported
Free of other biasLow riskThe study appears to be free of other types of bias

Edmond 1988

MethodsStudy design: Interrupted Time-Series Study
ParticipantsUSA. Registered nurses on medical and surgical wards, emergency department, intensive care unit and in the operating room performing tasks which require handling of needles. Number studied: 278 registered nurses with outcomes reported over 12 months
InterventionsIntroduction of bedside needle disposal units. In the pre-intervention period the disposal units were located in medication rooms and on medication carts
OutcomesOutcome: Number of reported needlestick per total number of healthcare personnel. Secondary outcome: recapping rate
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationUnclear riskna
Allocation concealmentUnclear riskna
Blinding
All outcomes
Unclear riskna
Incomplete outcome data addressed
All outcomes
Unclear riskna
Free of selective reportingUnclear riskna
Similar recruitment of groupsUnclear riskna
Adjustment for baseline differencesUnclear riskna
Free of other biasUnclear riskna

Goldwater 1989

MethodsStudy design: Interrupted Time-Series Study surrounding two interventions
ParticipantsNew Zealand. Laboratory staff performing venipunctures. Number studied: 644,000 venipunctures during a four-year period
Interventions1. Adaption of Centers for Disease Control (CDC) guidelines on non-recapping of needles. 2. Introduction of recapping injury prevention device Needle Guard and training on its use. In this review we only used the part on the introduction of the injury prevention device Needle Guard. The needle guard consists of a shield at the bottom of the protective cap that covers the needle. The shield should prevent a needle stick injury while the cap is placed beside the needle. Passive device because no worker intervention required
OutcomesOutcome: Number of needlestick injuries per total number of venipunctures performed
Notes

Not recapping prevention but prevention of PEI while recapping

During pre-intervention, baseline rate estimated at 0.63 NSI per 1000 venipuncture-years

Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationUnclear riskna
Allocation concealmentUnclear riskna
Blinding
All outcomes
Unclear riskna
Incomplete outcome data addressed
All outcomes
Unclear riskna
Free of selective reportingUnclear riskna
Similar recruitment of groupsUnclear riskna
Adjustment for baseline differencesUnclear riskna
Free of other biasUnclear riskna

Grimmond 2010

MethodsStudy design: Controlled Before and After Study
ParticipantsUSA. Staff from non-profit hospitals. Demographics and working experience of staff not reported. Number studied: 14 hospitals (control) and 14 hospitals (interventions). Approximating overall 19,880 FTE during the two-year study period
Interventions1. Engineered safety features of a sharps container
OutcomesOutcome: sharp injury (a) during procedure; b) after procedure but before disposal; c) container-associated (CASI); d) inappropriate disposal. We used the total number and the container-related injuries to calculate intervention effects
NotesWe calculated the RR of needlestick injury after the introduction of containers and the SE. These were put into RevMan data tables. We did not adjust for baseline difference nor for a clustering effect
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationHigh riskNot RCT
Allocation concealmentHigh riskNot RCT
Blinding
All outcomes
Unclear risk

No information on blinding

"Staff who suffered sharp injuries were not aware of the study at the time of their injury report". However, health workers would be aware of the change in the type of devices used

Incomplete outcome data addressed
All outcomes
Low riskAuthors reported that data on the outcome was obtained for the pre- and post-intervention periods for the 14 participating hospitals. Authors do not include hospital-level information
Free of selective reportingLow riskThe pre-specified outcomes are reported
Similar recruitment of groupsLow riskThis study includes the same 14 hospitals for before and after intervention. There was minimum change in the number of FTE (0.6%) during the study period
Adjustment for baseline differencesUnclear riskNot reported in the analysis
Free of other biasLow riskThe study appears to be free of other types of bias

L'Ecuyer 1996 2wva

MethodsStudy design: Cluster Randomised Controlled Trial. Object of randomisation: nursing divisions. Three-armed trial with separate control groups
ParticipantsUSA. Nursing personnel from general, medical, surgical and intensive-care units performing intravenous therapy. Number studied: 73,454 patient days (980,392 productive hours worked). Intervention three n=19,436. Control n=19,550
InterventionsUse of needleless intravenous device 2-way valve. Passive system no need for activation. Control groups used standard IV needle systems
OutcomesOutcome: Reported needlestick injures per 1000 patient-days and 1000 productive hours worked
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Incomplete outcome data addressed
All outcomes
Low risk 
Similar recruitment of groupsHigh risk 
Free of other biasHigh risk 

L'Ecuyer 1996 mbc

MethodsStudy design: Cluster Randomised Controlled Trial. Object of randomisation: nursing divisions.Three-armed trial with separate control groups
ParticipantsUSA. Nursing personnel from general, medical, surgical and intensive-care units performing intravenous therapy. Number studied: 73,454 patient-days (980,392 productive hours worked). Intervention two n=3840. Control n=2487 patient-days
InterventionsUse of needleless intravenous device metal blunt cannula. Passive system no need for activation. Control groups used standard IV needle systems
OutcomesOutcome: Reported needlestick injures per 1000 patient-days and 1000 productive hours worked
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Incomplete outcome data addressed
All outcomes
Low risk 
Similar recruitment of groupsHigh riskThe nursing divisions selected to participate to the study were from the same hospital. The recruitment time period of 2-way device differed from the PBC. The PBC was selected to replace the MBC (after four months) due to staff dissatisfaction
Free of other biasHigh risk 

L'Ecuyer 1996 pbc

MethodsStudy design: Cluster Randomised Controlled Trial. Object of randomisation: Nursing divisions. Three-armed trial with separate control groups
ParticipantsUSA. Nursing personnel from general, medical, surgical and intensive-care units performing intravenous therapy. Number studied: 73,454 patient days (980,392 productive hours worked). Intervention one n=15,737. Control n=12,404
InterventionsUse of needleless intravenous device: plastic blunt cannula. Passive system no need for activation. Control groups used standard IV needle systems
OutcomesOutcome: Reported needlestick injures per 1000 patient-days and 1000 productive hours worked
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationUnclear risk"Four groups of nursing divisions were prospectively randomised to use one of the two safety devices"
Allocation concealmentUnclear riskNo information about allocation concealment is available
Blinding
All outcomes
Unclear riskno information available on blinding
Incomplete outcome data addressed
All outcomes
Low riskSelected nursing division were assigned to either the intervention (MBC then replaced by PBC, and 2-way). The MBC was replaced after four months due to staff dissatisfaction. Authors reported all outcomes data for the intervention and control group
Free of selective reportingUnclear risk"Intravenenous-therapy related injuries were categorized further as follows: low-risk injuries involved needles without direct blood contact; intermediate risk injuries involved needles likely to have occult blood present and high risk injuries involved needles in direct contact with blood." However, there is no information available based on this categorization stipulated in the method section
Similar recruitment of groupsHigh riskThe nursing divisions selected to participate to the study were from the same hospital. The recruitment time period of 2-way device differed from the PBC. The PBC was selected to replace the MBC (after four months) due to staff dissatisfaction
Adjustment for baseline differencesUnclear riskThe demographics of the workers (age, sex, years of experience) are not reported. The adjustment for baseline differences is not reported in the analysis
Free of other biasHigh risk

"Study participants generally have ready access to the traditional devices, which may contaminate the evaluation, so much attention must be focused on appropriate experimental device distributions and traditional device removal prior to study initiation."

NSI reported in the study group may have been caused by the use of the traditional device. Based on the information available, it is not possible to separate NSI caused by the new devices or traditional ones

Mendelson 1998

MethodsStudy design: Controlled Before-After Study with Cross-Over
ParticipantsUSA. Health care workers in sixteen nursing units excluding pediatrics, obstetrics-gynaecology and intensive care, performing procedures which required the use of IV systems. We estimated that the number of workers in each groups was around 220. All IV insertions in the selected units during a period of six months. Eight units belonged to the intervention group and eight units to the control group, and the roles were switched in the middle of the study period
InterventionsUse of a needleless intermittent intravenous access system with a reflux valve. Control group used a conventional heparin lock
OutcomesOutcome: Number of reported percutaneous injuries per study week. Secondary outcomes: Local complications at insertion site, bacteraemia of patients, device-related complications, staff satisfaction and cost analysis
NotesStudy includes information about costs; We calculated the RR (SE) for needlestick injuries of the intervention and the control group based on our estimates of the number of persons and the number of needlestick injuries reported by the authors. We added 0.5 to fill empty cells
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationHigh riskNo randomisation
Allocation concealmentHigh riskNo randomisation
Blinding
All outcomes
Unclear riskNo information about blinding
Incomplete outcome data addressed
All outcomes
Low riskAuthors indicated that study was completed in 16 medical and surgical units. The outcome data appears to be reported for the 16 units. No outcome data at the unit level
Free of selective reportingLow riskAll expected outcomes are reported and correspond to the ones mentioned in the method section
Similar recruitment of groupsLow riskThe intervention and control groups were from the same hospital. There is no information about the FTE change during study period. The study was completed within a short period of time (25 weeks), staff difference between before and after intervention is unlikely to be different
Adjustment for baseline differencesUnclear riskAuthors specified that the wards for the control and intervention were similar in terms of staff-to-patient ratio and the type of illness of the patients. The units were different in terms of speciality for the control and intervention group. No information is available to compare the control and intervention groups for the number of staff, working experience, age and sex. Adjustment for baseline differences is not reported in the analysis
Free of other biasHigh riskThe outcome, NSI, is reported by study weeks. There is no information about number of FTE or number of devices used. Although the staff-to-patient ratios were similar, we do not know if the number or type of procedures were similar in both groups

Prunet 2008 active

MethodsStudy design: Randomised Controlled Trial. Object of randomisation: procedures. Two intervention arms and one control arm
ParticipantsFrance. Anaesthetist physicians and anaesthetist nurses in the operating room and emergency performing IV infusion. Number studied: 759 procedures. Intervention group two n=254. Control group n=254 (divided over the two arms)
InterventionsIntervention two: use of active safety catheter (Insyte Autoguard). Control group used the Vialon traditional non-safety catheter (the control group was divided over the two intervention arms)
OutcomesOutcome: 1. Number of cases in which the patient's blood stained the operator's skin, gloves, mask, or any other clothing; 2. Number of cases in which the patient's blood stained the stretcher or floor. Secondary outcome: Ease of use and sense of protection
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationLow risk"the type of venous catheter to use was determined randomly in a three ball ballot box."
Allocation concealmentLow risk"The choice of the catheter was randomised by using a single blinded envelope method"
Blinding
All outcomes
Unclear riskNo information on blinding available
Incomplete outcome data addressed
All outcomes
Unclear riskNo information reported about the number of excluded patients
Free of selective reportingLow riskExpected outcomes reported in introduction correspond to the ones mentioned in the method section
Similar recruitment of groupsLow riskStudy uses randomisation
Adjustment for baseline differencesLow riskAdequate randomisation, no additional adjustment needed in the analysis
Free of other biasLow riskThe study appears to be free of other types of bias

Prunet 2008 passive

MethodsStudy design: Randomised Controlled Trial. Object of randomisation: procedures. Two intervention arms and one control arm
ParticipantsFrance. Anaesthetist physicians and anaesthetist nurses in the operating room and emergency performing IV infusion. Number studied: 759 procedures. Intervention group one n=251, Control group n=254 (divided over the two arms)
InterventionsIntervention 1: use of passive safety catheter (Introcan Safety). Intervention 2: use of active safety catheter (Insyte Autoguard). Control group used the Vialon non-safety catheter
OutcomesOutcome: 1. Number of cases in which the patient's blood stained the operator's skin, gloves, mask, or any other clothing; 2. Number of cases in which the patient's blood stained the stretcher or floor. Secondary outcome: Ease of use and sense of protection
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationLow risk"the type of venous catheter to use was determined randomly in a three ball ballot box."
Allocation concealmentLow risk"The choice of the catheter was randomised by using a single blinded envelope method"
Blinding
All outcomes
Unclear riskNo information on blinding available
Incomplete outcome data addressed
All outcomes
Unclear riskNo information reported about the number of excluded patients
Free of selective reportingLow risk"If the operator considered the patient's vein unsuitable for placing an 18 G catheter, the patient was excluded from the protocol
Similar recruitment of groupsLow riskNot reported but adequate randomisation to the control or intervention group
Adjustment for baseline differencesLow riskAdequate randomisation, no additional adjustment needed in the analysis
Free of other biasLow riskThe study appears to be free of other types of bias

Reddy 2001

MethodsStudy design: Interrupted Time-Series Study
Participants

USA. Healthcare workers with direct patient contact, excluding physicians, or ancillary workers who may have been in areas where medical procedures had taken place during a six-year period

Number studied: 3011 FTE for the pre-intervention period (three years) and 3992 FTE for the post-intervention period (three years)

InterventionsImplementation of safety syringes and needleless intravenous systems. It was unclear if these were active or passive. Co-intervention: Educational in services attended by some or all healthcare workers
OutcomesOutcome: Reported needlestick injuries per 100 full time employees
Notes

Baseline incidence rate by 100 FTE per year

Year Incidence rate

1994 10.6%

1995 10.3%

1996 6.4%

Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationUnclear riskna
Allocation concealmentUnclear riskna
Blinding
All outcomes
Unclear riskna
Incomplete outcome data addressed
All outcomes
Unclear riskna
Free of selective reportingUnclear riskna
Similar recruitment of groupsUnclear riskna
Adjustment for baseline differencesUnclear riskna
Free of other biasUnclear riskna

Richard 2001

MethodsStudy design: Interrupted Time-Series Study
ParticipantsIndia. Hospital healthcare workers during a seven-year period. Number studied: Not reported
InterventionsIntervention: 1. Introduction of sharps containers; 2. Education on blood borne pathogens and the importance of safe sharps disposal
OutcomesOutcome: Number of reported needlestick injuries due to improper disposal per total number of reported needlestick injuries
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationUnclear riskna
Allocation concealmentUnclear riskna
Blinding
All outcomes
Unclear riskna
Incomplete outcome data addressed
All outcomes
Unclear riskna
Free of selective reportingUnclear riskna
Similar recruitment of groupsUnclear riskna
Adjustment for baseline differencesUnclear riskna
Free of other biasUnclear riskna

Rogues 2004

MethodsStudy design: Interrupted Time-Series
Participants

France. 3600 bed university hospital, sharp injuries reported on an annual of 8500 FTE (2900 nurses)

Number of phlebotomist nurses, not reported

Interventions

1. re-sheathable winged steel needles and Vacutainer blood collecting tube and 2. vacutainer blood collecting tubes with recapping sheaths. Each product required the healthcare worker to activate the safety feature immediately after phlebotomy. We regarded both devices as one intervention. The two safety mechanisms required two-handed activation and were thus active

Pre-intervention period (four years) and post-intervention period (three years)

Outcomesoutcomes: phlebotomy-related PIs (vacuum-tube + winged steel needle) per 100 devices purchased
Notes

Baseline rate: Number of phlebotomy PI reported for first two years but no denominator available

For third year of baseline, rate was 18.8 phlebotomy PI related per 100,000 purchased devices

Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationUnclear riskna
Allocation concealmentUnclear riskna
Blinding
All outcomes
Unclear riskna
Incomplete outcome data addressed
All outcomes
Unclear riskna
Free of selective reportingUnclear riskna
Similar recruitment of groupsUnclear riskna
Adjustment for baseline differencesUnclear riskna
Free of other biasUnclear riskna

Sossai 2010

MethodsStudy design: Interrupted Time-Series
ParticipantsHealthcare workers from a hospital in Italy. The overall number of employees varied from 4447 and 4636 individuals from 2003 to 2007
InterventionsSharps awareness program and passively activated Introcan safety IV catheter system. This has a self-activating safety clip that automatically shields the needle’s sharp bevel during retraction of the needle after cannula insertion. With regard to design and handling, this safety catheter is identical to the conventional catheter
OutcomesNSI with catheters and sharps
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationUnclear riskna
Allocation concealmentUnclear riskna
Blinding
All outcomes
Unclear riskna
Incomplete outcome data addressed
All outcomes
Unclear riskna
Free of selective reportingUnclear riskna
Similar recruitment of groupsUnclear riskna
Adjustment for baseline differencesUnclear riskna
Free of other biasUnclear riskna

Valls 2007

MethodsStudy design: Controlled Before-After Study
ParticipantsSpain 350 bed general hospital. 1000 workers, seven wards assigned to intervention and five wards assigned as a control group
Interventions1. Educational session which included a three-hour presentation and two hours of hands-on training. 2. Safety devices which included blood-culture collection tubes with a needle sheath, blood-gas syringes with needle sheath, lancets with retractable single use puncture sticks, safety devices catheter and blunt needles. It was unclear if these devices were active or passive. Vacuum phlebotomy systems without needle sheaths were used prior the beginning of the study
OutcomesOutcomes: number of percutaneous injuries per 100,000 patient-days. With the exception of the emergency department, NSI injuries per 100,000 patients
NotesInformation available on the cost of safety engineered devices; we used the rate ratios as reported by the authors
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationHigh riskNot randomised
Allocation concealmentHigh riskNot randomised
Blinding
All outcomes
Unclear riskNo information is provided about blinding
Incomplete outcome data addressed
All outcomes
Unclear riskThe intervention includes several wards. For the baseline, authors reported NSI rate for the different wards. This level of information is not available for the intervention as authors grouped the different medical wards into one category
Free of selective reportingHigh riskFigure 1: only absolute number is reported, no information available on the denominator for the study period
Similar recruitment of groupsHigh riskResearchers selected the wards for the intervention group, potentially introducing selection bias. The study was completed at the hospital at different times. Authors do not specify if the staff FTE and characteristics remain similar before and during intervention
Adjustment for baseline differencesUnclear riskThe demographics of the workers (age, sex, years of experience) are not reported. Adjustment for baseline differences is not reported in the analysis
Free of other biasHigh risk"injury reporting was voluntary during the pre intervention and intervention periods. However, the nurses in charge of the study carried out active surveillance reporting of injuries during the intervention period." This might have increased the number of cases reported

van der Molen 2011

MethodsStudy design: Cluster-RCT
ParticipantsNetherlands. Workers of voluntarily participating hospital wards (academic hospital). Demographics and working experience of staff included. Number studied: 796 participants. Intervention one (safety device + workshop)=267 participants (seven wards), intervention two (workshop only)=263 (eight wards), control group=266 (eight wards)
Interventions

Intervention one (NW): one-hour PowerPoint workshop about NSIs, introduction/demonstration by supplier of new device, plus replacement of existing injection needles on the ward with injection needle with safety device. The safety device had to be activated by the workers

Intervention two (W) only received workshop, no new needle device)

OutcomesSelf-reported number of NSIs within six-month period and official hospital database registered NSIs
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationUnclear riskNo information on randomisation process
Allocation concealmentUnclear riskNo information on allocation concealment
Blinding
All outcomes
Unclear riskNo information available on blinding
Incomplete outcome data addressed
All outcomes
High risk

A. Questionnaire-based NSI

1. Baseline:

Workshop + device group: Data missing on 99/267 (37%)

Workshop group: Data missing on 102/263 (39%)

Control group: Data missing on 100/266 (38%)

2. At six months:

Workshop + device group: Data missing on 197/267 (74%)

Workshop group: Data missing on 179/263 (68%)

Control group: Data missing on 180/266 (68%)

3. 12 months:

Workshop + device group: Data missing on 187/267 (70%)

Workshop group: Data missing on 160/263 (60%)

Control group: Data missing on 192/266 (74%)

B. Hospital registry NSI

No missing outcome data

Free of selective reportingLow riskAll outcomes stated in the methods section reported
Similar recruitment of groupsLow riskParticipants were randomised within the same hospital
Adjustment for baseline differencesLow riskThere is difference among the groups in regards to sex and working experience. These differences may have influenced the results. For example, there are 17% apprentice nurse in the intervention group compared to 7% in the control group. "the differences in individual and job characteristics between the intervention groups and the control group at baseline were examined using generalized estimated equations (GEE) correcting for wards."
Free of other biasLow riskThe study appears to be free of other types of bias

Zakrzewska 2001

MethodsStudy design: Controlled Before-After Study
ParticipantsUK. Staff of a dental clinic dealing exclusively with patients with blood-borne viruses during a five-year period. Number studied: approximately 600 workers. Intervention group n = approximately 300. Control group n = approximately 300
InterventionsIntroduction of a safety syringe and training on its use by the manufacturer. The safety device had to be activated by the worker. Control group continued using non-disposable metal syringes after having received education on safety issues. Co-interventions: Testing of safety devices, ensuring adequate supplies and means of disposal, involvement of key partners, protocol for the change over
OutcomesOutcome: Number of reported sharps injuries per 1000,000 hours worked; number of sharps injuries related to syringes per total number of sharps injuries
NotesIncludes information about cost
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationHigh riskNot an RCT
Allocation concealmentHigh riskNot an RCT
Blinding
All outcomes
Unclear riskNo information on blinding
Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data
Free of selective reportingUnclear riskIn the method section, authors do not pre-specify their outcome measures concretely
Similar recruitment of groupsUnclear risk

The number of students and qualified staff remains constant throughout the pre-intervention period and during intervention over the five-year study period. It is unclear if pre- and post-intervention group are composed of students with similar years of experience.

For the concurrent control group, researchers provided limited information. It is unclear if the individuals in this group performed similar tasks as the pre- and post-intervention group. Authors just indicated that a busy surgical unit was used as the control

Adjustment for baseline differencesLow riskAuthors reported the participant's profession and working experience. The intervention and control groups appear comparable in terms of working experience. No information to enable comparing the control and intervention unit to assess homogeneity of the two groups
Free of other biasHigh risk

1. "In view of the increased bulk of the safety syringes new waste disposal bins had to be ordered and distributed round the clinics."

This co-intervention may have affected the number of NSI but it is not possible to determine

2. Possible conflict of interest: "We are indebted to Septodont for their supplies, training and help."

Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion
Casey 2006Study design (commentary paper)
Chaillol 2010Study design (surveillance data)
Chiarello 1995Study design (not original research, the paper describes the steps for evaluating safety-engineered devices)
Cullen 2006Study design (surveillance study follow up by expert analysis stating which NSI could have been prevented)
Emanuel 2011Study design (letter to the editor, not original research)
Ford 2011Main outcome does not include NSI (“The aim of the evaluation was to assess the range of sharp safety hypodermic needle devices available in the UK, in terms of device performance and user acceptability. The evaluation was not designed to assess reductions in needlestick injury rates.”)
Goossens 2011Study design (no comparison group)
Guerlain 2010Study design (no comparison group)
Hotaling 2009ITS but insufficient data points
Iinuma 2005Study design (surveillance data)
Lamontagne 2007Study design (surveillance data)
Laramie 2011Study design (surveillance data)
Sibbitt 2011Study design (no comparison group)
Steuten 2010Study design (literature review - not original research)
Tosini 2010Study design (surveillance data)

Characteristics of studies awaiting assessment [ordered by study ID]

Ferrario 2012

MethodsTime series
Participantshealth care workers
Interventionsdevices ?
Outcomesneedle stick injuries ?
Notes 

Perry 2012

MethodsTime series
ParticipantsHealth care workers
InterventionsRegulations
OutcomesSharps injuries
Notes 

Phillips 2012

MethodsTime series
ParticipantsHealth care workers
InterventionsLegislation
OutcomesNeedle stick injuries
Notes 

Ancillary