The FDA has initiated two studies to determine whether plastic components might be leaching BPA — a common chemical used in many everyday plastic items — into patients during cardiopulmonary bypass and hemodialysis.

Previous food packaging and container studies have shown that BPA mimics female reproductive hormones and may be linked to cardiovascular disease, diabetes, and liver abnormalities. For medical device studies, the FDA will track pediatric patients undergoing cardiopulmonary bypass at the Children's National Medical Center in Washington and hemodialysis patients at the University of Michigan in Ann Arbor. The agency will also look at existing literature that examined BPA's effect on patients exposed via medical devices.

The effects of exposure to products that can alter estrogen pathways is a concern for physicians, especially in the pediatric population, says Jonathan Sackner-Bernstein, a cardiologist and associate director of Post Market Operations with the FDA's Center for Devices and Radiologic Health.

During cardiopulmonary bypass, patients are exposed to surfaces containing BPA for hours as a machine oxygenates the blood and circulates it through the body. Similarly, during dialysis, patients are hooked up to machines containing a variety of plastic components for four hours, three times a week. Because the BPA contained in plastic leaches out when heated, patients may be at risk for BPA-related health problems as their warm blood passes through the plastic tubing and recirculates into their bodies.

If data show that exposure to BPA during medical procedures is higher than the FDA's “tolerable” level, the agency would weigh risk vs. benefit on a case-by-base basis to determine whether treatment should be altered or stopped, say Sackner-Bernstein.

While there are currently no BPA-free plastics available for use in medical devices, Sackner-Bernstein says the FDA is looking into alternatives for food and devices.