The FDA must close loopholes and uphold higher safety standards when screening, approving and monitoring medical devices, The New York Times editorial board wrote in an opinion piece on May 4.
The board cited the nearly 2 million injuries and more than 80,000 deaths that have reportedly been caused by faulty medical devices in the last decade as proof for the need for stricter FDA regulations regarding new healthcare technology.
Those faulty and sometimes life-threatening devices, many of which were approved after minimal or no clinical testing and were not closely monitored once on the market, include vaginal mesh — the source of approximately $8 billion across more than 100,000 legal claims in the past 10 years — textured breast implants that have been linked to a rare immune system cancer, toxic metal hip replacements and misfiring surgical staplers, among many others.
In the op-ed, the board suggested three "reasonable changes" to the FDA's approval process and post-market monitoring that could prevent further harm: close loopholes that allow companies to bypass clinical testing before bringing a product to market; establish and enforce the use of a global device registry where patient outcomes are reported and monitored; and create more separation between the medical device industry and healthcare providers to eliminate any quid pro quo dealings.
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