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FDA Proposes Medical Device ID System


If a medical device such as a metal-on-metal (MoM) hip or synthetic vaginal mesh go bad in a patient, the current system has no way of identifying and tracking that medical device. There is no national registry in the U.S. as there is in Britain and Australia, so the recipient of the device gone bad or recalled can be located.

Unbelievably, if you have a Toyota that goes bad, you will be notified. But if you have a medical device permanently implanted in your body, you won’t be.  So now the FDA has proposed a rule that would require most medical devices to be fitted with a unique device identifier (UDI). The public has about 120 days to comment on the proposal.

The UDI would include information such as:

  • the batch in which the device was made
  • the serial number
  • an expiration date if it applies
  • the date the device was manufactured.

Also included in the proposal is an open database for medical device labels.

This information would be stored in a database called the Global Unique Device Identification Database which could be integrated with healthcare delivery, electronic medical records, inventory and accounting systems.

In the case of vaginal mesh, if there is a recall the UDI system can help the FDA identify a problem device sooner to better target the recall. In the case of an adverse event, the patient and/ or their doctor would be able to pinpoint the device that caused the complication.

“The safety of medical devices is a top priority for the FDA, Congress, the industry, and patients,” said FDA Commissioner Margaret A. Hamburg, M.D., in a statement published on the FDA’s Web site. “The unique identification system will enhance the flow of information about medical devices, especially adverse events and, as a result, will advance our ability to improve patient safety.”

The FDA has once again turned to the medical device industry to help formulate this proposal and to conduct pilot tests to identify any potential downfalls to the UDI system.

Consider other countries that do have national registries so they can keep track of medical devices implanted in patients. In the case of metal-on-metal hips, Australia’s national joint registry was the first to identify consistent complications with the DePuy ASR metal hip and issued its recall in 2009.

The U.S., without a registry, did not make the same discovery until August 2010, resulting in countless numbers of injuries that could have been prevented had the U.S. had in place a system not unlike what is used to recall defective automobile parts.

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