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FDA Plans Medical Device Tracking System to Catch Safety Problems

by Ryan L. Thompson on 07/17/2012

One of the biggest problems that Houston product liability lawyers have noted with recalls of medical devices over the past few years, is the slowness with which defective medical devices can be tracked after a defect has been identified.  There is no standardized ID system in place for devices like defibrillators that can be extremely dangerous if they are defective.  The Food and Drug Administration is now proposing a new rule that would require all medical devices to come with a unique code.

The ID code would be unique to each device, and would make it easier and simpler to track devices.  The unique identification would also allow companies to track down safety problems much quicker.

The installation of new identification codes for medical devices has been a long-time coming.  The medical device industry is one industry that could benefit greatly from the establishment of unique codes for each product.  After all, any defect in a medical device like a defibrillator or cardiac device, can prove serious and even fatal to a patient. 

However, the industry has lagged behind in this area, and federal regulators have neglected the need for such identification.  This is in spite of the fact that such codes are now required for most consumer goods.  In other words, you are more likely to have a unique identification code for your oven or toaster, than for your cardiac defibrillator. That is an outrageous state of affairs that greatly increases patient risks.

As part of the new rule, device manufacturers like Medtronic and Boston Scientific Corp. would install the identification code on most of their products.  The riskiest products like hip implants and cardiac devices will be the first to get the codes.  Those codes would also be fed into an online database, and doctors as well as regulators would be able to track down safety problems and inform patients much quicker.

Tags: Medical Device Mass Torts, Mass Torts

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