title: DEHP-plasticised PVC: relevance to blood services.
abstract: 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.
authors.affiliation: Department of Quality Assurance, Welsh Blood Service, Pontyclun, Mid Glamorgan, UK. janet.sampson@wales.nhs.uk
authors.forename: J
authors.initials: J
authors.lastname: Sampson
authors.forename: D
authors.initials: D
authors.lastname: de Korte
mesh_terms: D000014:Abnormalities, Drug-Induced / Q000209:etiology*; D000328:Adult; D000818:Animals; D001771:Blood Banks; D001781:Blood Component Removal / Q000009:adverse effects / Q000295:instrumentation*; D001793:Blood Preservation / Q000295:instrumentation*; D002144:Callithrix; D002648:Child; D006224:Cricetinae; D004051:Diethylhexyl Phthalate / Q000009:adverse effects* / Q000493:pharmacokinetics / Q000633:toxicity; D004781:Environmental Exposure; D004864:Equipment and Supplies / Q000009:adverse effects; D004968:Estrogens, Non-Steroidal / Q000009:adverse effects* / Q000633:toxicity; D005262:Feminization / Q000139:chemically induced*; D005289:Ferrets; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D008297:Male; D051379:Mice; D010795:Phthalic Acids / Q000009:adverse effects / Q000633:toxicity; D010968:Plasticizers / Q000009:adverse effects*; D011143:Polyvinyl Chloride; D011356:Product Labeling; D051381:Rats; D018675:Toxicity Tests; D065227:Transfusion Reaction
chemical_list: D004968:Estrogens, Non-Steroidal; D010795:Phthalic Acids; D010968:Plasticizers; C032279:phthalic acid; D011143:Polyvinyl Chloride; D004051:Diethylhexyl Phthalate