Safety first

As the European Parliament just voted on the Medical Devices Regulation, discussions on classified phthalates and particularly DEHP (di(2-ethylhexyl) phthalate) in medical devices and healthcare applications are currently more prominent than ever.

The assessment of existing potential alternatives to classified phthalates for PVC medical devices has been the object of a recent report by the Danish environment and health authorities: “Alternatives to Classified Phthalates in Medical Devices ”. As part of its commitment to supporting all stakeholders involved in the manufacturing, buying and use of medical devices, the members of the PVCMed Alliance provided data to the Danish Environmental Protection Agency and the Danish Health and Medicines Authority. PVCMed is an alliance of the PVC medical industry chain represented by PVC resin and plasticiser producers and PVC converters.

Alternatives to classified phthalates for medical devices

In their report, the Danish authorities outline that the benefits that materials such as plasticised PVC offer - by allowing the most efficient and qualitative treatment of patients - outweighs the potential concerns regarding the presence of some phthalates in a number of medical devices. However, PVCMed believes it is important to continue to innovate in this area to ensure the use of efficient medical devices without compromising patient safety and comfort.

The Danish authorities concluded the report by saying that there are alternatives to DEHP which, as regards to human health and environment hazard profiles, are safe and appropriate for use in medical devices. 

PVC’s fundamental role in healthcare

PVC-based healthcare applications have a fundamental role in the quality of healthcare thanks to PVC’s technical properties including softness, sterilisability, clarity and transparency, durability and dependability, resistance to chemical stress cracking, flexibility and resilience, low cost, and many more. The properties of plasticised-PVC are essential for certain types of medical devices which, for example, need to be made extremely soft and flexible. Concerns raised over DEHP should not impact the use of PVC as a material of choice for healthcare applications.  

PVCMed member companies are actively addressing concerns over the use of DEHP in healthcare applications. They support the supply chain as well as medical professionals in their willingness to use the appropriate plasticisers, while keeping all the key properties of PVC. Many different plasticisers have been developed and are increasingly being used in a wide array of medical applications allowing medical equipment purchasers to benefit from PVC’s unique properties for patient comfort, economic affordability and hospital hygiene. PVCMed encourages the value chain to commit to continuous improvement of safety in order to develop innovative products for all PVC healthcare applications.

On 27 March, an event was held in Copenhagen on the occasion of the publication of the report. During her speech, Christel Schaldemose, a member of the European Parliament, stressed the importance of having efficient medical equipment to save lives and said that,“if no alternative to classified phthalates are available for some medical devices, these products should remain allowed.”

The conference brought together the industry, healthcare professionals, environmental and health authorities and NGOs. All agreed that the mutual benefit of collaboration between them is the key to finding innovative solutions for quality healthcare.

PVCMed believes this type of collaboration and open dialogue is crucial in order to continue ensuring patient safety and quality healthcare, even more so at a time of a new Medical Devices Regulation and on-going review of the SCENIHR (Scientific Committee on Emerging and Newly Identified Health Risks) scientific opinion on the use of phthalates in medical devices