By James Walsh, Star Tribune (Minneapolis) –
MINNEAPOLIS — Want to know if anybody else has had a problem with your model of artificial hip? Worried that a new defibrillator is not all the manufacturer says it’s cracked up to be?
On Tuesday, the U.S. Food and Drug Administration proposed a new system to better track high-risk medical devices after they have gone public, giving patients, doctors, regulators and consumer advocates access to information about specific products. Every high-risk medical device, from pacemakers to stents, will be labeled with a unique identification code in an effort the FDA says will improve patient safety.
“The safety of medical devices is a top priority for the FDA, Congress, industry and patients,” said FDA Commissioner Dr. Margaret A. Hamburg. “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.”
Dr. Robert Hauser, a senior consulting cardiologist at the Minneapolis Heart Institute at Abbott Northwestern Hospital, has long called for better tracking of medical devices after they have been implanted to improve patient safety. He said the proposed rule “is a good step, provided the FDA follows through and begins to analyze safety data in a timely manner so that product problems can be identified early. Otherwise it will be just another expensive tool.”
Called a Unique Device Identifier, or UDI, the code would provide basic information about the device, such as the name of the manufacturer, the type of device, the model of the device and an expiration date. It could also include a batch or lot number to help officials better track devices that have been recalled.
That information will be stored in a UDI database that is accessible to the public, although the FDA said that no identifying patient information will be included.
Officials say the system will help the FDA identify product problems more quickly, move more rapidly to pull harmful devices, and improve patient safety. The FDA will take public comment on the proposal for the next 120 days.
According to details in the proposal, implementing the system will cost an estimated $68 million per year. It is unclear how those costs might be passed along.
Officials at medical technology giants Medtronic and St. Jude Medical were not available for comment Tuesday, according to company spokespeople.
Janet Trunzo, senior executive vice president for technology and regulatory affairs for the Advanced Medical Technology Association, or AdvaMed, said her organization supports a UDI system “that if appropriately implemented, holds the promise of more accurate and consistent post-market surveillance and more rapid medical technology improvements.”
AdvaMed is reviewing the details of the proposal and will submit comments to the FDA later, she said. “It is important to understand that any benefit from a UDI system depends on device users consistently and effectively utilizing the UDI system for recalls tracking, adverse event reporting, and within electronic health records.”
The FDA plans to phase in the system over the next seven years, focusing on the highest-risk medical devices first. Low-risk devices would be exempt from some or all of the requirements. Over-the-counter devices sold in stores also would be exempt.
Consumers Union, the advocacy arm of Consumer Reports, issued a statement Tuesday applauding the FDA for the proposal and said it will also file formal comments later this year.
“These regulations are long overdue and are critical for protecting patients from faulty and dangerous medical devices,” said Lisa Swirsky, senior policy analyst for Consumers Union. “Effective post-market surveillance of medical devices depends on having UDI in place. Once it is fully implemented, this system will enhance the FDA’s ability to identify problem medical devices more quickly and inform patients when their safety is at risk.”
