Medical devices including catheters, defibrillators, heart stents, and artificial joints will carry unique identification numbers under a plan proposed by the US Food and Drug Administration to improve patient safety.
The program would apply to most medical devices and cost as much as $68.4 million a year, according to a pending rule proposal made public on the FDA’s website. The plan would be implemented over seven years to allow companies, doctors, hospitals, and regulators to prepare and spread out the costs.
Bar codes or other technology that identifies models and the details of medical devices, including batch numbers, serial numbers, and expiration dates, would help regulators trace product flaws, failures, and incompatibility before the risks to users become widespread. An FDA database would also enable the public to look up general details about any type of medical device, the agency said.
“By making it possible to rapidly and definitively identify a device and key attributes that affect its safe and effective use, the rule would reduce medical errors,” the FDA said. The plan would help to “extract useful information from adverse event reports, pinpoint the particular device at issue and thereby gain a better understanding of the underlying problems, and take appropriate, better focused, corrective action.”
The proposed rule, which would apply to most medical devices distributed in the US, will be published in the Federal Register within a week. Companies and the public will have 120 days to offer input on the changes, which could be revised based on those comments.