Ethicon study indicates safety of polycarbonate medical devices

05/28/2013

Levels of residual bisphenol A (BPA) in devices molded from medical-grade polycarbonate are significantly below levels that represent a human health threat, according to independent research sponsored by Ethicon, a unit of Johnson and Johnson that uses polycarbonate.

The amount of BPA in a 10 gram sample of medical grade polycarbonate would result in a worst-case human exposure of 0.040 μg/kg/day. That is 1,250 less than the level that presents an "appreciable risk of deleterious effects during a lifetime" based on information from U.S. and European Union regulatory authorities.

That information was presented in a webinar this week by Jackie A. Anim, the subject matter expert for medical plastics at Ethicon. She said the company contracted NAMSA, a third-party lab, to study BPA in PC because of publicity concerning possible health effects of the material.
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