The European Commission has now released final guidelines from SCHEER on how to perform a benefit-risk analysis for phthalates in medical devices, following a public meeting to discuss the draft guideline in April.
As a result of the public availability of the draft, 197 submissions from 19 contributors (providing 378 comments and additional references) provided input to different chapters and subchapters of the document. The vast majority of comments came from industry and were requesting clarifications.
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.