2012: A doctor in St. Paul uses a medical device that makes it easier and safer to remove leads, wires the lead from pacemakers and defibrillators to the heart.
Jerry Holt, Star Tribune
To learn more
The U.S. Food and Drug Administration website has an excellent backgrounder for consumers on the Unique Device Identifier system for medical devices. For more information, go here.
Move forward on medical device tracking
- Article by: Editorial Board
- Star Tribune
- June 21, 2013 - 9:09 AM
You may not yet depend on a pacemaker, defibrillator, stent, joint implant or any of the other life-changing, potentially lifesaving products made by the medical device industry.
But chances are you or a family member will be a patient some day. The number of knee replacements performed annually is projected to soar 673 percent by 2030, for example, with hip replacements increasing by 174 percent in the same time frame.
That’s why it isn’t just the medical device industry that has a stake in the timely rollout of a long-overdue national system to better track the safety and whereabouts of devices once they’re on the market or in use. The millions of people in Minnesota and elsewhere who already rely on medical devices, and the millions more who will do so in the future, deserve to have this important new public health protection in place as soon as possible.
Whether that happens is now in the hands of the Obama administration, which has a frustrating history of foot-dragging when it comes to issuing the rules and regulations that make important new consumer protection laws a reality. The Food Safety Modernization Act and the Physician Payment Sunshine Act are two examples.
Regrettably, officials appear to be taking the same sluggish approach with medical device tracking.
This week, the administration missed a congressional deadline to issue the final regulations for the Unique Device Identifier (UDI) system. When this guidance will be issued is unclear.
The two agencies with the lead role on the issue — the U.S. Food and Drug Administration and the Office of Management and Budget — declined an editorial writer’s request to provide a date for the regulatory release. Troublingly, the Office and Management Budget sat on these rules for about a year the last time it reviewed them during the back-and-forth finalization process that takes place between agencies.
The OMB shouldn’t need another year to act on a safeguard supported by industry, consumer advocacy groups and respected physicians such as Dr. Robert Hauser of the Minneapolis Heart Institute and Dr. Robert Rea of Mayo Clinic.
It’s not as if the system is a new concept. Congress first passed a law calling for the UDI’s development in 2007, then passed another in 2012 with specific time frames for progress.
Implementation has understandably taken time. This is a complex undertaking that takes an important step beyond the device firms’ individual serial-numbering approaches, which are useful within a company but hard to decipher outside of it. Different companies also often use surprisingly similar numbering approaches for devices, creating additional confusion for those trying to glean information about the products.
The UDI system, in contrast, will establish a more uniform national coding system that more readily conveys information about the product and its origins to regulators, providers, hospitals and consumer advocates. A critical benefit: Collecting accurate device-specific information in the new system’s database should boost device safety surveillance and, if necessary, better manage recalls.
Critics, among them the prestigious Institute of Medicine, have long contended that postmarket surveillance of medical device safety is inadequate. A UDI system would help address a key concern raised by a 2011 Government Accountability Office report, which concluded that firms can have difficulty locating unsafe devices and removing them from the market.
The new system will likely become the global standard for tracking medical devices, which is why it’s commendable that so much time and thought has been put into it. It needs to be done right, but it also needs to get done.
“Recent device failures have shown the need to improve our ability to detect problems. A unique ID is a critical and necessary part of such a system,’’ said Dr. Joshua P. Rising, medical device director for Pew Charitable Trusts. “Until this rule is released, we run the risk of repeating history.”
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