FDA Examines BPA in Medical Devices

A common chemical found in many polycarbonates and epoxy resins, Bisphenol A (BPA) is no stranger to controversy. In the past several years, BPA has been the subject of intense scrutiny stemming from reports of it leaching out of such products as aluminum cans and baby bottles. Toxicity experts have expressed "some concern" about exposure of children and infants to BPA. In light of this concern, FDA is now turning its attention to whether BPA-containing plastic parts used in medical devices may be leaching the controversial chemical into patients during certain procedures.The organization has launched two studies to investigate the matter and presented its plan to FDA's Science Board earlier this week. Previous studies have indicated that BPA mimics female reproductive hormones and could contribute to such afflictions as cardiovascular disease, diabetes, and liver problems. In an effort to evaluate the potential toxicity of BPA in medical devices, the studies will attempt to measure BPA exposure of pediatric patients receiving cardiopulmonary bypass and patients undergoing hemodialysis. These procedures were selected because patients are exposed to the chemical for long periods of time. Furthermore, BPA has been shown to leach when heated—a potential hazard in such procedures because warm blood passes through the plastic tubing and then recirculates in patients' bodies.FDA will assess the risks and benefits on a case-by-case basis of BPA leaching from medical devices if data reveals that exposure exceeded FDA's "tolerable" level. MedPage Today has an interesting on-camera interview with Jonathan Sackner-Bernstein, MD, of FDA explaining the study.BPA-free baby bottles are currently all the rage. Are BPA-free medical devices next?