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Medical Device Tracking: Experts Call for Registry to Aid Recalls

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By Admin on October 07, 2009 2:11 PM

Currently, there is no system in place to track most of the medical devices routinely implanted into patients, such as plates, screws, fasteners, and artificial joints. Often even doctors do not receive word of a medical device's recall. Experts call for creation of a system to track the devices so that once recalled, doctors and patients know about it.

In a nice summary of the need for such medical device tracking system, MSNBC notes that though the number of medical device recalls is soaring, there is nothing to guarantee that doctors or even the patients who have such devices in their bodies ever get word.

Unlike auto recalls, where the auto industry has a centralized system to track parts throughout their lifetime, medical device recalls often suffer the fate of many other product recalls: a notice goes up on the FDA website, distributors get notified, but beyond that, there is no mechanism to track the product to the end consumer (or patient).

Some specific medical devices are tracked, including breast implants, pacemakers and heart valves. Most however, are not.

According to MSNBC, the first 7 moths of 2009 saw more than 1,000 medical device recalls, with over 100 of them Class 1 recalls (meaning their was a "reasonable probability of adverse health consequences or death").

Here is the database of all medical device recalls. A quick query reveals voluminous recalls -- a virtual sea of recall information which most doctors are unlikely to peruse on a regular basis.

The FDA does maintain a list of the medical device recalls it considers most vital to consumers.

What might help? Many are calling for varying types of registries which would track medical devices, serial numbers, doctors and patients so that once a recall went into effect, those most affected could be informed.

Devices associated with artificial joints are a particular area of concern. Due to a surge in their use, along with the fact that they break or experience relatively more problems than many other devices, the FDA is exploring creation of a registry to track them.