European Commission Issues Guidelines for Assessing Risk-Benefit of Phthalates in Devices

The European Commission released final guidelines on how to perform a benefit-risk analysis for phthalates in medical devices.

Phthalates such as Di-2-ethlyhexyl phthalate (DEHP) are widely used in plastics and polymers in a variety of applications for medical devices. The interaction of phthalates with polymers is weak, so they may be released from the plastic product into the human body.

The guidelines describe how to evaluate possible alternatives for phthalates used in devices, including alternative materials, designs or medical treatments.

In addition to the impact on patients, the analysis should evaluate the risk for professional users exposed to the substance, the commission said.