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HomeOpinion on the safety of medical devices containing DEHP plasticized PVC or other plasticizers on neonates and other groups possibly at risk (2015 update)
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The present Opinion is an update carried out by the SCENIHR on its previous 2008 Opinion on the safety of medical devices containing di(2-ethylhexyl) phthalate (DEHP) or alternative plasticizers for their polyvinylchloride (PVC) based components. Even though most of the 2008 opinion remains valid, new studies on DEHP activity and alternative agents are available. Therefore, the scientific information published from 2008 and onwards was reviewed and evaluated by the SCENIHR. The Opinion is mainly concerned with the potential health risks for patients with high exposure to DEHP or related plasticizing compounds leaching from medical devices. Food is the primary source of exposure to DEHP for the general population. The range of body burden values from all sources excluding medical and occupational exposure is estimated at 1- 30 μg/kg bw/d (probabilistic calculations). For infants and children, the 95th percentile is estimated at 6-17 μg/kg bw/d. The most recent biomonitoring studies (measuring primary and secondary excreted DEHP metabolites) suggest a current median exposure of 2 to 5 μg/kg bw/d, whereas the 95th percentile is estimated to be between 6 and 17 μg/kg bw/d. Use of PVC medical devices may lead to a higher exposure to DEHP compared to everyday sources affecting the general population. Several procedures such as exchange transfusion of blood in neonates, extracorporeal membrane oxygenation (ECMO) treatment of neonates and adults, total parenteral nutrition (TPN) in neonates, haemodialysis, enteral nutrition in neonates and adults, heart transplantation or coronary artery bypass graft surgery, massive blood transfusion of red blood cells and plasma or peritoneal dialysis may lead to high exposure to DEHP potentially leaching from the device used. The extent of exposure largely depends upon the type of device, the number and duration of medical procedures.
- Published:
- Corporate author(s): Directorate-General for Health and Consumers (European Commission)
- Themes: Health policy
- Subject: dangerous substance , health risk , medical device , plastics , public health , toxic substance
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| ISSN 1831-4783 | ISBN 978-92-79-35606-3 | DOI 10.2772/45179 | Catalogue number ND-AS-14-003-EN-N |
- Released on EU publications website:
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