Even before the report came out, medical device manufacturers were on the attack. The New York Times reports that medical device makers and industry trade groups had launched a pre-emptive strike on a government-commissioned report well ahead of its release this Friday.
The report calls on the U.S. Food and Drug Administration to establish a new process for screening out dangerous or ineffective medical devices. The report focuses particularly on moderate-risk devices, such as external heart defibrillators, pain pumps, and artificial hips. The report also called for a new way to track the performance of implanted devices.
The stakes are high. For device manufacturers, more stringent safety regulations could mean a dent in the $6.7 billion in sales (2009) of artificial hips and knees and the multi-billion dollar sales of other devices. According to The New York Times, these devices “have one of the highest profit margins of any medical product.”
The report comes on the heels of well-documented reports of artificial hip replacements that passed FDA approval but then failed in thousands of patients. One hip replacement product, which featured ”metal-on-metal“ components, was eventually recalled after numerous reports of patient injures. Researchers in England reported that the hip replacements could cause soft tissue damage. Orthopedic specialists stated that the new surgeries to replace the defective parts were often more complex the original surgeries carried a higher risks of permanent damage.
The Institute of Medicine (IOM), one of the nation’s most respected authorities on health care, assembled the panel reviewing the regulation of medical devices. Device manufacturers and various trade groups have been attempting to discredit the report, according to the Times.
After Friday’s release of the report, the Advanced Medical Technology Association issued a prepared statement in which it claimed the report did not deserve “serious consideration,” the Times reports.
We believe that patient safety should come before profit in the regulation of medical devices.
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