Public Consultation on the safety of medical devices containing DEHP- plasticized PVC or other plasticizers on neonates and other groups possibly at risk (2014 update)

Public health community

Public Consultation on the safety of medical devices containing DEHP- plasticized PVC or other plasticizers on neonates and other groups possibly at risk (2014 update)

Final Opinion on
The safety of medical devices containing DEHP- plasticized PVC or other plasticizers on neonates and other groups possibly at risk (2015 update)

The main focus of this Opinion, which is an update of the 2008 SCENIHR Opinion, is on the potential risk for patients exposed to DEHP or similar plasticising compounds leaching from medical devices. Exposure of the general population to plasticizers has also been addressed. The assessment also includes information on currently available plasticizers as well as some proposed alternatives to DEHP in medical devices for neonates and for other patient groups.

Final opinion

A public consultation on this opinion was opened on the website of the non-food Scientific Committees from 22 October to 30 November 2014. Information about the public consultation was broadly communicated to national authorities, international organisations and other stakeholders.

15 organisations and individuals participated in the public consultation providing 69 comments to different chapters and sections of the Opinion. Each submission was carefully considered by the SCENIHR and the scientific Opinion has been revised to take account of relevant comments. The literature has been accordingly updated with relevant publications.

Each submission was carefully considered by the SCENIHR and the scientific opinion has been revised to take account of relevant comments. The literature has been accordingly updated with relevant publications.

The electronic template provided with the documents should be used exclusively for the submission of comments, with reference made to the line and page numbers.

Results of the public consultation on SCENIHR's preliminary opinion on DEHP

Content of the opinion:

Use of PVC medical devices may lead to a higher exposure to DEHP compared to everyday sources affecting the general population. Examples of medical procedures with a potential for high exposure to DEHP are multiple procedures in preterm neonates, haemodialysis, heart transplantation or coronary artery bypass graft surgery, massive blood transfusion of red blood cells and plasma or peritoneal dialysis. The Opinion also focuses on these sorts of clinical procedures that result in high DEHP exposure.

Based on the available scientific evidence, SCENIHR considers that:

• Adult patients undergoing haemodialysis have the highest exposure, due to the chronic nature of the treatment.
• Children are potentially at higher risk, particularly neonates and infants due to their low body weight are particularly prone to high level of exposure on a body weight basis.
• • There is evidence suggesting that DEHP causes the most severe reproductive toxicity in animal studies, when compared to other alternative plasticizers. There is therefore a strong need to develop and collect data on exposure of alternative materials in the actual conditions of use in order to refine the knowledge on their toxicological profile. The possibility of replacing DEHP with these products could then be considered, taking account the efficacy of the treatment as well as the toxicological profile and leaching properties of the alternative materials.

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