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Public Health (07-07-2015)

Final Opinion on the safety of medical devices containing DEHP (phthalates)

The Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) has published the final Opinion on the safety of medical devices containing DEHP-plasticized PVC or other plasticizers on neonates and other groups possibly at risk.

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.

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 DEHP1 are multiple procedures in preterm neonates, haemodialysis (a medical procedure to remove fluid and waste products from the blood), 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.

More information:

1 The exposure during the listed procedures is caused by the use of various types of medical devices including blood bags, tubing like catheters, intubation tubes and intravenous catheters and other medical devices made of PVC.