Phthalates are the most widely used plasticisers in the world and have been in medical use since 1955. Di(2-ethylhexyl)phthalate (DEHP) is present in many industrial and domestic products, and is a common plasticiser used in blood bags and tubing sets. Concerns have been raised by environmental groups that DEHP exposure may result in gender birth defects and the feminisation of boys although there were no studies performed of intravenous exposure to DEHP on higher mammals or humans which report similar effects.
This article reports on the toxicology of DEHP and considers concerns regarding its use in the context of transfusion medicine. The benefits of using DEHP are evaluated and the use of alternative plasticisers to DEHP is explored. The article reports on international and European regulatory recommendations for DEHP use in transfusion medicine and examines the impact of legislation on the medical devices and blood industries. The article also reviews labelling considerations for blood components and offers some guidance for blood establishments in respect of DEHP use.