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Keywords:

  • urology;
  • patient safety;
  • checklist;
  • error;
  • adverse event;
  • communication

Abstract

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Acknowledgement
  8. Conflict of Interest
  9. References
  10. Supporting Information

Objectives

  • To identify and assess potential hazards in robot-assisted urological surgery.
  • To develop a comprehensive checklist to be used in operating theatres with robotic technology.

Methods

  • Healthcare Failure Mode and Effects Analysis (HFMEA), a risk assessment tool, was used in a urology operating theatre with innovative robotic technology in a UK teaching hospital between June and December 2011.
  • A 15-member multidisciplinary team identified ‘failure modes’ through process mapping and flow diagrams.
  • Potential hazards were rated according to severity and frequency and scored using a ‘hazard score matrix’.
  • All hazards scoring ≥8 were considered for ‘decision tree’ analysis, which produced a list of hazards to be included in a surgical safety checklist.

Results

  • Process mapping highlighted three main phases: the anaesthesia phase, the operating phase and the postoperative handover to recovery phase.
  • A total of 51 failure modes were identified, 61% of which had a hazard score ≥8.
  • A total of 22 hazards were finalised via decision tree analysis and were included in the checklist.
  • The focus was on hazards specific to robotic urological procedures such as patient positioning (hazard score 12), port placement (hazard score 9) and robot docking/de-docking (hazard score 12).

Conclusions

  • HFMEA identified hazards in an operating theatre with innovative robotic technologies which has led to the development of a surgical safety checklist.
  • Further work will involve validation and implementation of the checklist.

Abbreviations
HFMEA

Healthcare Failure Mode and Effects Analysis

MDT

multidisciplinary team

Introduction

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Acknowledgement
  8. Conflict of Interest
  9. References
  10. Supporting Information

The operating theatre is a high-risk environment where patient safety takes priority. Adverse events, defined as inadvertent harm caused by medical error, are reported to be common, yet preventable in surgery. Data from developed countries suggest that up to 66% of adverse events are surgically related [1]; 13% of adverse events during surgery lead to disability and 4% lead to death [2]. Approximately half of these complications are thought to be avoidable. A retrospective review of 1014 medical records from two London hospitals found that 16.2% of adverse events were detected in general surgery; 43% of which were deemed preventable [3]. A review of an England and Wales error reporting database found that 446 184 patient safety incidents occurred in surgical settings over a period of 3 years [4].

Research has indicated that adverse events in surgery are primarily attributable to failures in non-technical skills such as communication, teamwork, leadership and decision-making [5-7]. Checklists have been used as an intervention to prevent these failures by promoting a team-working culture, standardising practice, allowing the detection of potential errors and improving patient safety as a whole. One example is the WHO surgical safety checklist. A large-scale study involving eight hospitals in eight diverse cities worldwide, showed that implementation of the WHO surgical safety checklist reduced mortality rates and postoperative complications by 0.7 and 4%, respectively [8]. In addition, de Vries et al. [9] reported that the use of a ‘Surgical Patient Safety System’ checklist in six hospitals resulted in a reduction in the postoperative complication rate from 27.3 per 100 patients before implementation to 16.7 per 100 patients after implementation.

Robot-assisted surgery is an intricate procedure involving communication and support from a multidisciplinary team (MDT). The increasing complexity of this type of surgery may have detrimental effects on patient safety [10]. This area of surgery is likely to benefit from a checklist or a safety barrier that allows standardisation and monitoring of this complex procedure. Various methods have been used to develop and validate safety barriers for the high-risk processes in healthcare environments. The Healthcare Failure Mode and Effects Analysis (HFMEA) protocol has been widely used across organisations. HFMEA is a powerful systems evaluation tool developed by the US Veterans Affairs National Centre for Patient Safety. It is a step-by-step process that involves the MDT in identifying potential causes of error within a system through the use of flow diagrams, hazards scoring and decision tree analysis. Potential errors are prioritised according to severity, frequency/probability, criticality, detectability and existing control measures. The final process includes taking steps to implement solutions, minimise errors and avoid adverse events [11]. HFMEA has been successfully used to assess failures in communication and information transfer in the surgical care pathway [12, 13] and in other areas of healthcare such as radiology [14, 15], oncology (including chemotherapy and radiotherapy) [16-19], prescriptions for medication and medication safety [20-22]. To our knowledge, there are no current publications on the validation of a checklist for robotic surgery using this method.

The present study aimed to assess and evaluate the safety of robot-assisted urological procedures via a multidisciplinary approach, using the HFMEA protocol, and ultimately to develop a surgical safety checklist to be used in urology operating theatres with innovative robotic technologies.

Methods

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Acknowledgement
  8. Conflict of Interest
  9. References
  10. Supporting Information

We used HFMEA to construct a checklist for urological procedures carried out with innovative robotic technology developed by the da Vinci® Surgical System in a busy teaching hospital in London, UK from June to December 2011. HFMEA uses a five-step method that involves the MDT in actively identifying and eliminating potential errors in a system [11] (Fig. 1).

figure

Figure 1. The five-step HFMEA methodology (adapted from the Veterans Affairs National Centre for Patient Safety [11].

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Step 1: Define the Topic

A high risk system, such as an operating theatre, was chosen for investigation.

Step 2: Assemble a Team

An MDT was assembled consisting of two theatre nurses, one recovery nurse, three urology registrars, five consultants, one anaesthetist and three medical students. An advisor (K.A.) was responsible for overseeing the process; and a team leader (N.K.) was responsible for liaising with the team, leading discussion and keeping record.

Step 3: Graphically Describe the Process

The team leader (N.K.) created a preliminary flow diagram based on MDT discussions and 30 h of observation of robot-assisted urological surgery. The main processes and sub-processes were identified (Fig. 2). The main processes were the anaesthesia phase, operating phase and handover phase. Failure modes, which are defined as the way by which a process can fail to achieve its expected goal, were identified for all sub-processes (Table 1).

figure

Figure 2. Flow diagram outlining the main processes and sub-processes identified using HFMEA.

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Table 1. Table outlining and defining all processes and sub-processes, including all failure modes, their hazard scoring and outcomes of the decision tree analysis
No.ProcessDefinitionFailure modeEffectsSeverityProbabilityHazard scoreSingle point weakness?Existing control measure?Detectable?Proceed?
Anaesthetic room
 1.WHO Surgical Safety Checklist completedTeam completes the WHO checklist including staff introductions, checking patient identity, consent, marking, allergies, antibiotic prophylaxis and blood loss.WHO checklist not completedUnexpected adverse events and errors occur; harm to patient224NYYN
 2.Relevant history checkedTeam check all relevant history such as any pre-medications, fasting time, drug/alcohol history or any obstructive airway conditionsRelevant history not checkedUnexpected adverse event.3412YNNY
 3.Jewellery/piercings/nail polish removedTeam ensures that all jewellery/piercings and nail polish are removedJewellery/piercing/nail polish not removedInterference with equipment/monitoring111NYYN
 4.Patient's airway is assessedPatient's airway is fully assessed and checked for dentures/crowns/bridges/loose tooth and any other obstructions.Airway not assessedAdverse events/respiratory related injury339YNNY
 5.Patient vitals signs ready to be monitoredPatient vital signs such as blood pressure, ECG, oxygen level are monitoredVital signs not monitoredAdverse events missed/not detected3412YYYN
 6.Equipment checkedAnaesthetic machine/monitoring equipment is checked for faults. Team ensures all equipment is connected to the mains electrical supply and switched on.Equipment not checked for faults, not connected properlyPatient not correctly ventilated/monitored.428YNNY
Operating theatre – before the procedure
 7.Surgical team wash handsAll staff present in the operating theatre wash handsSurgical team do not wash handsTransmission of infections248NYNN
 8.Operating team put on surgical gown and glovesThe operating surgeon, assisting surgeon and scrub nurse wear sterile surgical gowns and gloves. They must avoid touching anything that is not sterile.Operating team do not put on sterile gown and glovesTransmission of infections3412NNYN
 9.WHO Surgical Safety Checklist completedTeam completes the WHO checklist including staff introductions, checking patient identity, consent, marking, allergies, antibiotic prophylaxis and blood loss.WHO checklist not completedUnexpected adverse events and errors occur; harm to patient224NYNN
10.Details recorded on white boardDetails of the patient and the procedure are written on the white board.Details not written on white board or details are incorrect.Confusion/miscommunication amongst staff, possible injury to patient.224NNNN
11.Patient is secured on to the operating tablePatient's legs and torso are strapped and gel pads are placed under the arms, neck and shoulder blades.Strapping too tight or patient not secureRestricting blood flow, injury to patient4312NNNY
12.Operating table position is adjustedThe operating table position is adjusted using a remote control according to the correct level and inclination required for the procedure. The patient is positioned appropriately on to the operating table (for example Trendelenburg position for robotic surgeries).

Patient is not positioned correctly;

Operating table not locked and is mobile.

Table malfunctions

Anaesthetist trying to move the table after the robot has been docked.

Patient obtains injury, surgery impeded4312NNNY
13.Patient is draped appropriatelyPatient is covered with sterile drapes and only the operating site is exposed. Anaesthetist working area (unsterile) is separated from the surgical site (sterile) by drapes.Inadequate drapingRisk of infections212NNYN
14.Hair removed from operating siteHair is removed with an electric clipper from the operating site

New, exchangeable clipper head not used

Excessive hair removal beyond the operating site

Risk of infections224NNYN
15.Antiseptic solution appliedAntiseptic solution is applied on the operating site and any excess solution is wiped off so that there is no pooling.Antiseptic solution not applied or not applied liberallyRisk of infections224NNYN
16.Adhesive drape appliedPlastic adhesive drape is applied to surgical site after antiseptic solution has been applied.Adhesive drape not appliedRisk of infections111NNYN
17.Equipment table positionedEquipment table positioned appropriately to allow easy access to instruments and maintain sterile field.

Equipment table inappropriately positioned.

Sterile field not maintained

Surgery impeded, risk of infections212NNYN
18.Surgical instruments countedAll instruments are counted before, during and after surgery and recorded in the patient's chart and white board. The count is audible and involves two members of staff, one of whom is part of the operating teamInstruments not counted or mistake in countingSurgical instrument/foreign object retained339NNNY
19.Faulty equipment checkedAny faults in the equipment used are checked before surgery, including surgical instruments, robot and monitoring equipment. Suitable trained staff conduct preliminary checks of robot.

Equipment not checked for faults

Robot fails preliminary checks

Robot malfunctions prior to starting the case and after anaesthetic administration

Surgery impeded, delays in operating list, injury to patient4312NNNY
20.Catheter inserted (if necessary)Some urological procedures such as a prostatectomy will require a catheter to be inserted before surgery.

Catheter site not sterilised

Instruments not sterilised

Problems with catheter insertion

Urinary infections

Patient discomfort

224NNYN
21.Marking for port placement (robotic/laparoscopic)Placement of ports (device that allows laparoscopic/robotic instruments to pass through the skin) are marked according to guidelines for the type of surgery to be performed.

Markings not made

Markings incorrect

Surgical complications

Injury/harm to patient

233NNNN
22.Port placement (robotic/laparoscopic)Ports are inserted according to guidelines for the type of surgery to be performed.Ports not inserted correctly

Surgical complications

Injury/harm to patient

339YNNY
23.Drape robot and armsThe robot, robot arms and all other instruments are draped with clear plastic covers. Draping should not be too tight and restrict robot arm movements

Failure to drape

Draping too restricting

Risk of infection111YNYN
24.Robot is docked and correctly positioned (robotic surgery)The robot is positioned close to the patient (either at the side or between the legs) so that the robot arms can be inserted.

Incorrect positioning

Communication failure in guiding the docking process

Injury to patient4312YNNY
25.Robot Brakes AppliedBrakes applied after dockingBrakes not appliedInjury to patient448YYNN
26.Robotic/Laparoscopic instruments insertedRobotic/laparoscopic instruments (such as scissors, electrocautery instruments and endoscopic camera) are inserted through ports.Instruments not correctly insertedInjury to patient339YYYN
27.Avoid possible arm collisionThe camera and instrument ports are placed to optimise range of movement and avoid possible arm collision.

Ports are inadequately placed

Arm collision

Injury to patient, surgeon or anaesthetist

Disruption to surgery

3412YNNY
28.Instruments ready for easy exchangeEnsure all instruments (clipping, cutting, suction, irrigation etc) are laid out and ready for easy exchange between scrub nurse and assisting surgeonInstruments not ready/laid outDelay in surgery3412NNNN
29.Operating team position themselvesThe operating surgeon, assisting surgeon, scrub nurse and anaesthetist position themselves appropriately. In robotic surgery, the operating surgeon disposes of his/her gown and gloves and takes up position at the console, ready to begin the procedure.

Inadequate positioning

Communication problems in team (especially in robotic surgery when the operating surgeon is placed far away at the console)

Miscommunication leading to error and patient harm111NNYN
30.Check lead and assisting surgeon communication, adjust intercom volumeCheck that the lead surgeon (at the console) is able to communicate clearly and effectively with the assisting surgeon. The intercom volume may need to be adjusted to allow this.Miscommunication between lead and assisting surgeonInjury to patient, unexpected adverse events3412YNNY
31.Lead surgeon adjust working spaceLead surgeon should adjust their working space to avoid collisions between the master controllers and against the walls as well as to prevent fatigue and uncomfortable positioning

Uncomfortable positioning

Master controller collision

Disruption to surgery

Possible injury to patient

212NNNN
Operating theatre – after the procedure
32.Robotic/Laparoscopic instruments removed (laparoscopic/robotic)Robotic/laparoscopic instruments removed through ports.Instruments not removed carefullyInjury to patient236NNYN
33.Ports removed (laparoscopic/robotic)Ports removedPorts not removed carefullyInjury to patient339YYYN
34.Robot de-docking (robotic)Robot is steered away from the patient, back to resting position.Communication failure in guiding the de-docking processInjury to patient3412NNNY
35.Specimen retrieval bags removed (laparoscopic/robotic)If specimen retrieval bags are used, they are removed after the procedure, before sutures are done.

Specimen bag retained

Bag punctured, leakage of contents

Harm to patient339YNNY
36.Any other instruments (such as needles, swabs, vascular clips etc) removedSurgical team carefully check that any needles, vascular clips or swabs used are removed from the patient.Instruments not removed and retained within patientSerious injury to patient339NNNY
37.Sutures doneSutures are done and any wounds are closedSutures not done properlyDelayed healing, surgical site infections248NNNY
38.Specimens collected from patient correctly labelledSpecimens are correctly labelled with patient's details.Specimens not correctly labelledMix-up of lab results, patient management affected339YNNY
39.Surgical instruments countedAll instruments are counted before, during and after surgery and recorded in the patient's chart and white board. The count is audible and involves two members of staff, one of whom is part of the operating team.Instruments not counted or mistake in countingSurgical instrument/foreign object retained339NNNY
No.ProcessDefinitionFailure modeEffectsSeverityProbabilityHazard scoreSingle point weakness?Existing control measure?Detectable?Proceed?
40.Equipment sterilised

All instruments used during the procedure must be sterilised, including robotic arms and robot (if used), which is protected by plastic coverings.

All instruments are cleaned prior to procedure in accordance with manufacturer's instructions.

Equipment not fully sterilised and pre-procedure cleaning in accordance with manufacturer's instructions not doneTransmission of infections248NYNN
41.Equipment problems reportedAny faulty equipment (e.g. with robot maintenance or laparoscopic equipment) identified is reportedFaulty equipment not reportedFaulty equipment not replaced122YNNY
42.Surgical team wash handsAll staff present in the operating theatre wash hands followingSurgical team do not wash handsTransmission of infections133NNNN
43.Patient's chart updatedPatient chart filled in with details of the procedure, instructions for postoperative management and any particular problems/concerns.Patient chart not fully updatedMissing information, poor postoperative management339NNNY
44.Anaesthetist Present to Monitor Patient RecoveryAnaesthetist is present to monitor patient vital signs and recovery.Recovery not monitored carefullyPatient not reassured/supported during recovery339NNNY
45.Patient transferred from operating table to trolleyAll members of the team help transfer the patient using a slide. They ensure patient is secure throughout the transfer and that the operating table and trolley wheels are locked.Patient not secure during transfer, wheels are not lockedPatient obtains injury224NNYN
46.Recovery Plans DiscussedPatient recovery discussed, any concerns regarding recovery explored.Recovery plans not discussedImportant issues disregarded, recovery/post-operative management affected339NNNY
47.Evaluation of procedureDiscussion of any issues/concerns and ideas for improvement.Evaluation not conductedImportant issues disregarded, procedure not improved133NNNN
Handover to recovery
48.Patient presented to recovery teamRecovery team check details of the patient and the procedureWhole team not present, wrong patient brought inIneffective care, miscommunication regarding care.326NNNN
49.Accurate handover of details of the procedureAll relevant information regarding the procedure is passed on to the recovery team.Incomplete handover of informationIneffective care, miscommunication regarding care.339NNNY
50.Recovery plan discussedThe patient's recovery plan, any changes to the plan following surgery and any special circumstances are discussed.Recovery plan not discussedIneffective care, miscommunication regarding care.4312NNNY
51.Any complications discussedAny problems/complications during the procedure are discussed with the recovery teamProblems not discussedImportant issues overlooked, ineffective patient care4312NNNY

Step 4: Conduct a Hazard Analysis

Next, a hazard analysis was conducted through MDT focus groups and discussions. A hazard score was deduced by rating each failure mode according to its severity and probability. Severity described the level of harm that could result from the failure mode and is classified as minor, moderate, major or catastrophic. Probability was defined as the likelihood that harm could occur as a direct result of the failure mode, classified as remote, uncommon, occasional or frequent. A hazard score was calculated by multiplying the severity and probability ratings (Fig. 3). Once a hazard score had been calculated for each event, all failure modes with a hazard score ≥8 were chosen for further evaluation.

figure

Figure 3. HFMEA hazard scoring matrix (adapted from the Veterans Affairs National Centre for Patient Safety [11].

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Failure modes were further evaluated according to the decision tree analysis (Fig. 4). If the effect of a failure mode caused whole-system breakdown or an adverse event so severe that the procedure could not be continued, it was regarded as a ‘single point weakness’. Further screening included analysing whether there was an effective control measure in place and whether the failure mode was easily detectable.

figure

Figure 4. HFMEA decision tree (adapted from the Veterans Affairs National Centre for Patient Safety [11].

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Step 5: Actions and Outcome Measures

All failure modes identified in step 4 were included in the robotic surgery operating theatre checklist as a means of eliminating/controlling the hazards identified using the HFMEA.

Results

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Acknowledgement
  8. Conflict of Interest
  9. References
  10. Supporting Information

A surgical safety checklist was developed for robot-assisted urological surgery using HFMEA methodology. The HFMEA revealed the following:

  1. Three main processes comprising: the anaesthesia phase, the operating phase and the post-operative handover phase.
  2. A total of 51 sub-processes and failure modes (Table 1): six in the anaesthetic phase; 41 in the operating phase (25 were identified just before the procedure and 16 were identified just after the procedure); and four in the handover phase.
  3. A total of 31 failure modes (61%) had a hazard score ≥8 (Table 1): four (8%) in the anaesthetic phase; 13 (25%) in the operating phase before the procedure and 11 (22%) in the operating phase after the procedure; and three (6%) in the handover phase.
  4. Of the four failure modes in the anaesthetic phase, one was considered to have an existing control measure and was excluded. This was failure mode 3 (Table 1), where monitoring equipment served as an effective control measure for monitoring patent's vital signs.
  5. Of the 13 failure modes in the operating phase (before the procedure), five were considered to have an effective control measure in place or were highly detectable and were thus excluded. They were hand-washing, sterile glove/gowning, applying the brake on the robot, the insertion of laparoscopic instruments and surgeon positioning at the console (failure modes 6, 7, 25, 26 and 31, respectively [Table 1]).
  6. Of the 11 failure modes in the operating phase (after the procedure), two were considered to have an effective control measure or high detectability and were thus excluded. These were port removal and equipment sterilisation (failure modes 27and 34, respectively [Table 1]). An additional failure mode which included reporting faults with the robot or other equipment (failure mode 35 [Table 1]) was included despite having a low hazard score of 2. This is because faults with the robot can delay or prevent surgery acting as a single point weakness and faulty equipment may not be replaced owing to lack of formal reporting; thus there is low detectability and no existing control measure present;
  7. All three failure modes in the handover phase were included. These included accurate handover of details, discussion of recovery plans and any complications (failure modes 43–45, respectively [Table 1]);
  8. Based on the failure modes identified, a 22-item checklist was produced (Fig. 5) composed of four parts: ‘anaesthetic room’ (three checks), ‘operating theatre – before the procedure’ (eight checks), ‘operating theatre – after the procedure’ (eight checks) and ‘handover to recovery’ (three checks).
figure

Figure 5. Safety checklist for robot-assisted surgery.

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Discussion

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Acknowledgement
  8. Conflict of Interest
  9. References
  10. Supporting Information

We used HFMEA protocol to assess and evaluate the safety of robot-assisted urological procedures and this led to the development of a surgical safety checklist to be used in urology operating theatres with innovative robotic technologies. This 22-item checklist was produced as a result of the in-depth, systematic analysis of all failure modes identified through the HFMEA. The hazard scoring and decision tree analysis were the key determinants of which hazards were finally included in the checklist. As the HFMEA is very much MDT-centred, the content of the checklist was dependent on those hazards which the MDT considered to be important in their work environment. Many other details, such as briefing, checking patient identity, consent, marking, allergies, antibiotic prophylaxis and blood loss, were not covered by the checklist. Although these aspects are of great importance to patient safety, many of them are already covered by other checklists, e.g. the WHO surgical safety checklist [8], which was deemed to be an existing control measure for these hazards. In addition, the aim of the present investigation was not to replace these generalised checklists but to introduce additional checks specific to robotic procedures that are not fully covered by other, more generic checklists.

Using the HFMEA we identified specific hazards, e.g. patient positioning, port placement, robot docking/de-docking and robotic and laparoscopic equipment checks, which were considered to be important in robot-assisted urological procedures and which are not extensively covered by other checklists. For example, lack of correct and secure patient positioning scored very highly on the hazard analysis (hazard score 12) and was deemed to lack existing control measures and have low detectability. Patient positioning is an important consideration in robotic and laparoscopic surgery as optimum positioning is required to access pelvic and retroperitoneal organs and to increase ease of robot docking, but this issue is not addressed in generic checklists that are in widespread use. Also, poor positioning is often overlooked in surgery as a cause of iatrogenic harm such as peripheral nerve injury and compartment syndrome [23]. Improper positioning of the upper limbs has been shown to cause ulnar nerve damage (compression of the cubital tunnel of an extended and pronated arm against table), brachial plexus injuries (hyperabduction of shoulder or excessive flexion of head to the contralateral side), and radial nerve injuries (pressure on the spiral groove by inadvertently allowing the arm to hang off the table) [23-25]. Moreover, prolonged Trendelenburg positioning during robot-assisted radical prostatectomy has been shown to cause venous pooling in the upper extremities leading to laryngeal oedema requiring reintubation, posterior ischaemic optic neuropathy, and brachial plexus neuroplexia caused by compression of the shoulder braces used to prevent cephalad sliding [26, 27].

Other considerations in robot-assisted urological surgery include port placement and robot docking. In open surgeries, access to the surgical field can be manipulated by retraction, patient repositioning or increasing the size of the incision; however, in robotic procedures, once the robot has been docked, the patient must remain stationary for the rest of the procedure. Visualisation and manipulation of the surgical field is achieved with a minimal incision through laparoscopic instruments inserted through carefully placed ports. Proper docking and port placement is crucial in allowing adequate intra-abdominal mobility and reach of instruments, avoiding external arm collision and safe and comfortable access for the assisting surgeon [28]. Accordingly, robot docking/de-docking and correct/safe port placement scored highly on the HFMEA (hazard scores 12 and 9, respectively).

Equipment checking and reporting of equipment faults with the robot or any other instruments was also deemed important and included in the checklist. One study reported 11 cases of technical issues with robotic technologies, including malfunction of robotic arms, light or camera cords, power failure leading to re-boot and port placement issues [29]. Dealing with these issues and reporting equipment fault is important in order to prevent disruptions to surgery.

The HFMEA results identified relevant and important hazards in robot-assisted urologic surgery for inclusion in the checklist, but the present investigation has a few limitations. One is that the narrow focus on robot-assisted urological surgery may mean that the results/checklist is not applicable to other areas of surgery or medicine; however, the nature of the HFMEA requires a focused approach for in-depth and detailed analysis which identifies all possible failure modes in a system. This may not be possible or practical if the scope of the investigation is too large. van Tilburg et al. [30], who used HFMEA to analyse medication errors in a paediatric oncology ward, suggested that a more specific focus may prevent an ‘overload of failure modes’ or a superficial analysis leading to generalisation of failure modes and recommendations.

Another consideration is whether the HFMEA method was appropriate for the development of a checklist. A checklist, by definition is an all-inclusive list of tasks carried out in a specific order. The focus of this definition is on the comprehensiveness of the checklist, the fact that it encompasses every single step in the process; however, HFMEA is a system of reduction where all but the highest scoring hazards, with an arbitrary cut-off point of 8 on the hazard analysis, or those hazards not considered to be a single point weakness are excluded from further analysis. This could result in some steps being missed from the checklist. The decision analysis ensures, however, that all hazards that are not further analysed have either pre-existing control measures or are highly detectable. HFMEA can therefore produce a more focused checklist tailored to the needs of the MDT in their immediate environment.

Another issue is that with an innovative field such as robotic surgery, methods and technologies are constantly updated. This could mean that the checklist has to be frequently revised to keep abreast of any changes. We hope that by describing the process of HFMEA in a surgical setting, operating theatre teams will be able to follow the method and assess hazards in new methods and technologies. This may allow the checklist to be updated within individual institutions according to the MDT's needs, but full participation from the MDT would be required as the process may be potentially costly or time-consuming.

A more general consideration is whether HFMEA is a suitable and reliable method for analysing risk in a healthcare setting. Habraken et al. [31] analysed user feedback on 13 HFMEA analyses carried out in Dutch healthcare settings and found that 20.8% of respondents reported HFMEA to be too time-consuming and 7.8% of respondents had difficulty carrying out the risk assessment, including hazard scoring and using the decision tree; however, 90.3% of healthcare professionals felt that the results of the HFMEA were meaningful and 87.1% expected an improvement in safety as a result. Shebl et al. [32] tested the reliability of HFMEA within UK hospitals by comparing the results of two separate HFMEAs conducted at two different hospital sites on the same topic. Their results showed only a 17% match in failure modes identified in the two groups with marked differences in the hazard analysis scores, indicating that HFMEA has poor reliability, but the perceptions and needs of the MDT in the two different settings may have differed significantly, leading to differences in hazard analysis. Thus, HMFEA appears to be a useful method for analysing risk within a healthcare setting, provided there is sufficient input and cooperation from the MDT. Disadvantages can include excessive use of time and resources and difficulty assessing reliability.

Future plans and developments include implementation and validation of the checklist within urology operating theatres and evaluating its effectiveness in robot-assisted procedures. It is anticipated that the use of the checklist will encourage a culture of safety and awareness within the operating theatre, but it is unlikely that a simple, technical solution such as a checklist can be the sole driver of significant culture change without support and cooperation from all members of the team. Mahajan [33] found that significant barriers to widespread adoption of a checklist, such as the WHO surgical safety checklist, included cultural factors, organisational hierarchy, logistics and timing, and misuse of the checklist. These issues should be anticipated and dealt with before implementation.

In conclusion, HFMEA has been successfully used to assess risk within the operating theatre and identify potential failure modes in robot-assisted urological surgery. The results of the hazard analysis led to the development of a 22-item surgical safety checklist tailored for use in operating theatres that use robotic technologies. Focus was placed on those hazards which are most important in robotic urological procedures such as patient positioning, docking and de-docking, port insertion and equipment failure reporting. Further research will involve validation and implementation of the checklist within operating theatres with robotic technologies to assess the effectiveness of the intervention. It is anticipated that findings will be transferable to other high-risk processes in healthcare.

Acknowledgement

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Acknowledgement
  8. Conflict of Interest
  9. References
  10. Supporting Information

The research was supported by the National Institute for Health Research (NIHR) Biomedical Research Centre based at Guy's and St Thomas' NHS Foundation Trust and King's College London. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.

References

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Acknowledgement
  8. Conflict of Interest
  9. References
  10. Supporting Information

Supporting Information

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Acknowledgement
  8. Conflict of Interest
  9. References
  10. Supporting Information
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