MEDICAL DEVICES: Bill Would Halt Reprocessing
Following a Los Angeles Times article on reprocessed medical devices and their link to "malfunctions, infections and adverse chemical reactions," Assemblyman Thomas Calderon (D-Montebello) announced he will introduce a bill banning such devices until their safety can be proven, the Times reports. Calderon said, "I want to make sure that reprocessing is safe. Part of the health care process is to have confidence in the system. In the absence of data, it's important to take a serious look" at reprocessing. The bill, which targets devices that make contact with bodily fluids, also requests "an industry standard for reprocessing, should the practice be proved safe," while requiring single-use reprocessing companies to register with the California Department of Health Services. The FDA is expected to determine the safety of reprocessing shortly. Calderon's bill will likely encounter opposition from reprocessors and hospitals seeking to minimize costs. Rick Wade, senior vice president of the American Hospital Association, said, "To ban reprocessing is to overreact. It would be a very disruptive measure that would not be in the best interest of the patient." He noted that it could force hospitals to cut costs in other areas and drive up waste treatment costs, posing an environmental hazard. He said, "The pressure should be on the FDA. They have the authority to regulate the practice." Assemblyman Martin Gallegos (D-Baldwin Park), chair of the Assembly Health Committee, said he expects the bill will "get strong support from the Legislature." A similar bill was passed in Illinois in 1997, but was so heavily amended that reprocessors gained key concessions (Westphal, 8/5).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.