WASHINGTON – 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 said 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.
Recent recalls have included tens of thousands of defibrillator wires made by St. Jude Medical, because of risks they can crack and cause the heart-zapping devices to malfunction. Johnson & Johnson has recalled more than 100,000 artificial hips since 2010 after discovering they are more likely to break down early, causing pain and inflammation.
The FDA will begin phasing in the new system in the coming year, requiring identification codes on high-risk devices such as heart stents and defibrillators. The tracking requirement will then be expanded to moderate-risk devices such as X-ray systems, surgical needles and power wheelchairs. Makers of those devices will have three years to implement the tracking codes. Many low-risk devices, such as bedpans and examination gloves, will be exempt from the requirements.
AdvaMed, the device industry’s main industry group, said in a statement that the rule is “a good step” toward improving device tracking and design. However, the group added that the system “will be costly and challenging endeavor, affecting all medical technology manufacturers. It is imperative that it is implemented correctly the first time.”
AdvaMed represents most large medical device manufacturers, including Medtronic Inc., Boston Scientific Corp. and Abbot Laboratories.