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Ethicon study indicates safety of polycarbonate medical devices

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.

Interesting highlights of the research include:

  • The grades of polycarbonate used in healthcare (and also automotive) are significantly safer than grades used for consumer applications. "The amount of BPA extracted from a PC drinking cup was significantly greater than amounts detected in the automotive or medical grade PCs," she reported.
  • Sterilization did not impact the automotive and medical-grade polycarbonates, but sterilized drinking cups however, showed a difference in the amount of BPA when extracted by ethanol.

"Global purchasing organizations around the world are now making purchasing decisions based upon potential presence of listed chemicals in products," Anim said. "Tools such as decision trees have been developed to help maintain the BPA exposure to level below 50 microgram/kg/day."

The US EPA Reference Dose (Rfd) and EU Tolerance Daily Intake (TDI) value are 50 μg/kg/day.

The Webcast was sponsored by Styron, a major producer of polycarbonate, and also included Dr. Steve Hentges, executive director of the polycarbonate/BPA Global Group at the American Chemistry Council.

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