(Washington, D.C.) — Consumers Union submitted testimony for Wednesday’s House hearing on reauthorizing the Medical Device User Fee and Modernization Act, citing concerns that the Food and Drug Administration is taking a “hands-off” approach toward regulating medical devices. The high volume of injuries, and even deaths, caused by unsafe medical devices remains a serious problem requiring careful consideration by the FDA and Congress.
Every year, 1.3 million Americans are injured in medical product related adverse events. In 2006, 452,000 emergency room visits resulted from injuries related to medical devices, and 58,000 of these patients either died at the hospital, or were hospitalized. Consumers Union strongly agrees with the importance of ensuring access to life-saving medical devices and technology, but these tragic numbers demonstrate that rapid access must be balanced with reliable evidence of safety and effectiveness and increased attention to post-market safety monitoring.
Click here to read Consumers Union’s suggestions for improving MDUFMA, which is up for reauthorization this year.