Plasticisers for medical applications

Softness and flexibility are key properties for medical devices. This is, for example, crucial for tubing that goes inside the body, which must be as soft as possible for optimum patient treatment and comfort. In order to make PVC medical devices soft and flexible, a plasticiser (US: plasticizer) is added to the PVC compound.

A wide range of plasticisers for medical applications are now included in the European Pharmacopoeia, which sets Europe’s legal and scientific standards to delivering high quality medicines in Europe and beyond. This broad range of plasticisers allows medical devices manufacturers to develop high performance medical PVC solutions to best serve patients and medical professionals.

Alternatives to DEHP now in the European Pharmacopoeia

The phthalate DEHP used to be the main plasticizer in medical PVC due to its technical properties and low cost. The substance has been under increasing scrutiny by regulatory and medical authorities, and in the EU its continued use in medical devices after 2020 will require robust justification.

As part of their commitment to innovation, continuous improvement of safety, performance and cost-efficiency, companies within the medical PVC value chain have progressively made available a wide range of alternatives to DEHP plasticiser for medical applications, which are approved by the European Pharmacopeia. These include:

Justification needed for continued use of DEHP in medical applications

Since 2010, in the EU, all medical devices containing phthalates classified as CMR , such as DEHP must be labeled accordingly. In 2017 the EU adopted new Medical Device Regulations, which will come into force in 2020. The new Regulation will strictly restrict the use of CMR phthalate (including DEHP) and encourage the use of alternatives. Continued use of DEHP above 0.1% will require robust justification by medical device manufacturers. This justification shall be based upon:

  • An analysis of the user exposure to the CMR from the device
  • An analysis of possible alternative plasticisers
  • An argumentation on the reasons why possible alternatives are inappropriate to use
  • Where applicable and available, the latest relevant Scientific Committee guidelines (expected in 2020)

PVCMed Alliance’s commitment

The PVCMed Alliance is committed to proactively contribute to this scientific process, always providing the best solutions to medical professionals contributing to affordable quality healthcare for all. We have contributed to the Danish Environmental Protection Agency's 2014 report on alternatives to DEHP and classified phthalates in medical devices, which identified ten potential alternative plasticisers already in use. Following the report, PVCMed Alliance co-organised an international conference in Copenhagen in 2014 with attendance from a broad range of stakeholders.

The Alliance is planning to continue to contribute in the future.