DEHP in medical devices

Medical devices are crucial to the high standards of modern healthcare that we now take for granted. The many thousands of different types of devices which exist today are advanced modern products that have to respond to highly specific performance requirements. PVC softened with DEHP is the ideal material.

Basic, indispensable requirements for the vast majority of medical devices are flexibility and strength. Soft PVC provides both of these. PVC catheters, for example, need to be soft to enter below the skin but also tough to work inside and outside of the body. Oxygen masks have to be firm but not harm facial skin.

Life-saving operations, such as open-heart surgery or treatment of babies, rely on soft PVC catheters and tubes because they do not ‘kink’ and so ensure the uninterrupted flow of fluids. Their especially smooth inner surface prevents blood clots or other disruptions.

Soft PVC can easily be sterilised, cutting down infections which could complicate or undermine treatment. Its transparency reduces potentially life-threatening mistakes with medicines and allows healthcare workers to see immediately if a fluid is running low. Labels can be printed directly onto PVC and cannot be worn off, thus resulting in increased safety.

Cost effective

If it were not for soft PVC, health care would be much more expensive, possibly prohibitively so for some groups in society. To ensure vital hygiene and to prevent cross infections almost all medical devices are designed for one-way use only. This makes price crucial at a time when medical budgets are under increasing pressure. PVC plasticised with DEHPis one of the few materials that is able to guarantee all the in-service qualities demanded by healthcare professionals while remaining affordable.

After use, the disposal of medical devices by appropriate means presents minimal environmental impact.

DEHP specified by regulators

European healthcare regulators clearly recognise the role of phthalates. The three European Union Directives relating to medical devices stipulate rigorous and exhaustive testing of materials and govern the materials that can be employed.

Di-(2-ethylhexyl) phthalate (DEHP) – the member of the phthalate family used in almost all PVC healthcare applications – is actually specified by the European Pharmacopoeia as the plasticiser for blood bags.

Labelling of medical devices containing DEHP

Since March 2010 it has become compulsary in the EU to label medical devices containing phthalates. For more information please see the section on herbal vaping