The LA Times reported that the Food and Drug Administration is to revise, patch up and enhance its procedures on handling safety issues with pacemakers, stents, defibrillators and other medical devices it regulates:
How the FDA handles safety issues with the products it regulates already is under scrutiny and is expected to receive even more attention from Democrats now that they will be the majority party in Congress.
With medical devices in particular, concern grew after last year’s slew of high-profile recalls or safety warnings affecting more than 200,000 defibrillators.
It also calls for streamlining the now-disjointed way the agency collects reports of possible problems from multiple sources, including manufacturers and doctors.
Proposals include expansion of a pilot program that collects safety reports in real time from hospitals, as well as tapping into medical device data amassed by the Veterans Affairs Department, the Defense Department and the Centers for Medicare and Medicaid Services.
The FDA also wants all medical devices marked with a unique number, which would allow them to be better tracked in a recall.
Better device tracking and data collection, if used properly (that’s a big if), could provide vast improvements in device quality and tracking. Of course, all this tracking and data collection can’t be paid for in Medgadget Bucks, so in the end the taxpayer or consumer will end up footing the bill. However, as more medical treatments are delivered via engineered devices, the public seems willing to pay for increased peace of mind.
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