AP: FDA Requires Unique Codes to Track Medical Devices, Improve Recalls and Patient Safety

Publication: The Associated Press


09/20/2013 - Federal health regulators will begin tracking millions of medical devices, from pacemakers to hip replacements, using a new electronic system designed to protect patients by catching problematic implants earlier.

The Food and Drug Administration published new rules Friday that require most medical devices sold in the U.S. to carry a unique code, identifying its make, manufacture date and lot number. The codes will be stored in a publicly accessible database to help regulators, doctors and companies monitor safety issues with devices.

The tracking system has been promoted by doctors and public safety advocates for years. Other industries, from food processors to automakers, have used unique identification codes to track their products through the supply chain for decades.

 “The rule that came out today is a victory for patients, hospitals and clinicians,” said Josh Rising, director of Pew Charitable Trusts’ medical device initiative. “Up until now medical devices were among the only products on the market that could not be uniquely identified. This is going to be a tremendous victory for all of those interested in improving the performance of devices.”

Rising says doctors, hospitals and insurers will be able to add the codes to patients’ medical records, helping them to quickly identify people who have received problematic implants and devices.

The FDA tracking system follows years of highly-publicized recalls involving defibrillators, artificial hips and drug pumps, which have been plagued by design and manufacturing flaws."

Read the full article from The Associated Press

 

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