The FDA made a major announcement earlier this week which will make medical devices a lot like mass-produced consumer devices such as cars and microwaves. The new proposed rule will require that each medical device manufactured be given a unique code which will help with tracking and hopefully assist the agency in catching safety problems earlier.
While similar codes are already found in almost all consumer products, the barcodes have been noticeably absent from such critical devices. The rule says that device makers will begin by placing barcodes on their riskiest devices, like implants or pacemakers. Over-the-counter or incredibly low-risk devices, think bedpans, will not be given a tracking code.
The FDA will then place all the codes in a public database which they hope will allow doctors and regulators to detect problems more quickly and notify affected patients in much less time about any dangers. Companies and hospitals will be able to access the database and quickly pull products that are affected by recalls or other problems. The codes will also benefit the device makers by helping to prevent counterfeit or stolen products from entering the supply chain.
The plan is for the code to be printed on labels for the device and also to be found in the devices themselves. The FDA is projecting the program will cost U.S. companies approximately $500 million to implement the proposal over the next ten years.
The rollout has been much slower than anticipated, with this announcement coming some five years after Congress first instructed the FDA to introduce such codes. The agency said it took its time rolling out the rules by testing a pilot program and by coming up with standard international codes that would work with regulators abroad, including those in Canada, the European Union and Japan.
Currently the public will have 120 days to comment on the proposed rule and the FDA will consider the feedback before making a final ruling which will likely happen in the next six months.
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Source: “FDA Plans IDs to Track Medical Device Safety,” by Anna Yukhananov, published at InsuranceJournal.com.