July 3, 2012
By Anna Yukhananov, Reuters
Medical devices like hip implants and heart defibrillators will soon join the ranks of cars and toasters.
The Food and Drug Administration on Tuesday proposed a new rule that would require each medical device to have a unique code that could improve tracking and catch safety problems earlier. The proposal comes five years after Congress first mandated the codes.
While these codes are already present for most consumer goods, in the ubiquitous barcodes scanned at the grocery store, they have been absent from life-sustaining medical devices.
The FDA said under the rule, device makers like Boston Scientific Corp and Medtronic Inc would put the special code on most of their products, starting with the riskiest, like implants or pacemakers. Over-the-counter or low-risk devices, like bed pans, would not need the code.
The FDA would then put the codes, known as unique device identifiers (UDI), in a public database online. Doctors and regulators could detect safety problems more quickly and inform patients about flaws or dangers. Companies and hospitals could pull faulty devices from the market faster and more cheaply by knowing which products are affected.
…The FDA estimates it would cost U.S. companies about $550 million in total to implement the proposal over a ten-year time frame.