If it seems like an awful lot of medical devices are malfunctioning, and being recalled from the market, that’s because they are.
The report, by the FDA’s Center for Devices and Radiological Health (CDRH), covered 2003 through 2012. Even though the number of medical device recalls increased 97% during the study period, the feds said that’s not necessarily a bad thing, because it shows greater scrutiny of what manufacturers are trying to sell to health-care providers and consumers.
“Concerted efforts to improve the quality and safety of medical devices on the part of both CDRH and the industry has resulted in greater numbers of recalls reported – and greater benefit for the public health,” the report says. “We attribute this increase to: enhanced awareness by device firms, including those that were cited for reporting violations; and specific CDRH efforts to improve medical device safety.”
Among the agency’s most common oversight targets:
- infusion pumps;
- external defibrillators.
But any device can malfunction, can be poorly made, can be improperly used or implanted. So patients and their loved ones should always check out medical devices their doctors recommend. For guidance on what devices tend to be problematic, and what questions to ask, link to our Medical Device Safety page here.