“Numerous” safe plasticisers for PVC medical devices, report finds

The Danish Environmental Protection Agency, the Danish Health and Medicines Authority and the PVC Information Council Denmark (a PVCMed Alliance partner) have disclosed the results of the report ‘Alternatives to classified phthalates in medical devices’.

The Danish Environmental and Health authorities are presenting the conclusions of the report, which is based on the evaluation of ten existing PVC plasticisers.

“The report concludes that most of the alternatives to DEHP that we evaluated for their human health and environmental hazard profiles are considered to be appropriate alternatives, but data is lacking for some of the alternatives, before a toxicological assessment can be carried out,” said Shima Dobel from the Danish Environmental Protection Agency.

The PVCMed Alliance partners provided data on these plasticisers to the Danish authorities. “Many different plasticisers have been developed and are increasingly being used in a wide array of medical applications allowing medical professionals to benefit from PVC’s unique properties for patient comfort, economic affordability and hospital hygiene. We encourage the value chain to commit to continuous improvement of safety in order to develop innovative products for all PVC healthcare applications,” said Brigitte Dero, PVCMed Alliance representative.

The report outlines the need for certain types of medical devices to be “extremely soft and flexible” and “be able to offer the most efficient and qualitative treatment of patients”. PVC-based healthcare applications require an assortment of technical properties including flexibility and resilience, softness, sterilisability, chemical stability, biocompatibility, clarity and transparency, durability and dependability, resistance to chemical stress cracking, low cost, and many others.

“PVCMed believes this is a crucial discussion in order to continue ensuring patient safety and quality healthcare, even more so at a time of on-going review of the EU medical devices legislation and the SCENIHR (Scientific Committee on Emerging and Newly Identified Health Risks) scientific opinion on the use of phthalates in medical devices,” said Ole Grøndahl Hansen, Director of the PVC Information Council Denmark and project manager for the PVCMed Alliance.