The U.S. Food and Drug Administration (FDA) has issued a proposed rule that would require manufacturers of medical devices, with certain exceptions, to place a unique identifier on the label of medical devices. Some medical devices would also need to be directly marked with the unique identifier.
Why We Need Better Medical Device Tracking
Failures in the past two decades of medical devices demonstrate the need for more rigorous and timely oversight of these products to help ensure the safety of the public.
- Metal-on-metal hip replacements, which have been implanted in an estimated 500,000 Americans, fail at higher rates than those made of other material. A metal-on-metal artificial hip model was removed from the Australian market in 2009 because of safety concerns, and a year later, regulators in the United Kingdom issued safety alerts on the class of products as a whole. Only years later, did the U.S. Food and Drug Administration take steps, including a proposal to increase the regulation of the metal-on-metal hip.
- Life-threatening failures with implantable cardioverter-defibrillator leads — which hundreds of thousands of people use to detect and correct abnormal heart rhythms — resulted in several recent recalls because of product design defects. Multiple researchers pointed to these lead failures as evidence of deficiencies in FDA’s post-market surveillance system for medical devices; the agency is charged with monitoring the continued safety and effectiveness of approved devices.
According to the Government Accountability Office, "gaps in the medical device recall process limit firms' and FDA’s ability to ensure that the highest-risk recalls are implemented effectively and terminated in a timely manner." GAO found that companies were unable to correct or remove all products in 53 percent of completed recalls because they had no way to effectively track all of the devices in use by the public.
The lack of a consistent tracking system delays the identification of problematic devices and leads to inefficient and incomplete recalls, potentially leaving patients vulnerable to harm for prolonged periods.
How a Unique Device Identifier System Would Work
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The proposed UDI rule "was also another smart way to regulate. It addresses safety and innovation as partners in medical device development and surveillance. It addresses post- and pre-market activities together. And it was crafted without unnecessary burden on industry."
— Dr. Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, announcing the release of the proposed UDI rule in July 2012 |
A unique device identifier, or UDI, is an alphanumeric code placed on a device or its label that identifies the make and model of the product and provides other clinically relevant information, such as an expiration date. The use of identifiers would enable FDA, manufacturers, patients, and clinicians to track medical devices and generate performance data on them. Here's how it would work:
Manufacturers would affix the unique device identifier directly to the medical device label and, where appropriate, to the product itself. Such specificity would speed the identification of faulty devices.
A device’s identifier would be added to relevant records, including, for example, a hospital’s purchase order, a doctor’s procedure documentation, a patient’s electronic health record, and an insurer’s claim forms.
The UDI would allow the FDA to connect the various databases that track adverse events, recalls, approvals, and device performance. This network would be used to assess product functionality, identify safety problems earlier, and prompt additional study or action as needed.
When FDA and manufacturers need to investigate potentially faulty devices and initiate a recall, the UDI system would allow them to more quickly confirm the product failure and notify the affected doctors and patients. Doctors and patients would also be able to access the Global UDI Database directly for recall information.
Next steps: From Rule to Implementation
1. Finalize FDA’s unique device identifier rule
In 2007, Congress mandated that FDA establish a unique device identifier system. After several years of delay, legislators again prompted the agency to speed up implementation. FDA released its draft rule in the summer of 2012 and received public comments in the fall. FDA's regulations will govern which devices require an identifier (some will be exempt), what data the Global UDI Database will contain, and the deadlines for meeting these requirements, among other details.
Pew filed comments on Nov. 7, 2012, with FDA regarding its draft rule. Overall, Pew strongly supports swift implementation of the UDI system but also calls on FDA to:
- Tighten the timeline requiring identifiers to be affixed to medical devices.
- Limit exemptions, particularly for devices sold in retail establishments and products implanted for fewer than 30 days.
- Clarify that all medium- and high-risk devices intended for repeated use, such as hospital infusion pumps, should have UDIs directly affixed (as opposed to the identifier being solely on the package or label).
- Improve the Global UDI Database by including data on recall alerts and hyperlinks to approval applications, making it easily accessible to clinicians and patients and allowing for quick modifications.
- Ensure consistency of identifiers by limiting the number of standards used to create and place them.
- Collaborate with other federal and state agencies to encourage health care systems, insurers, and doctors to include the identifiers in electronic health records and other large databases.
- Hold manufacturers accountable by penalizing them for devices that do not meet UDI standards.
2. Promote UDI use
Once FDA’s unique device identifier system is in place, doctors, hospitals, and insurers can include the UDI in their records. Without this step, identifiers would have limited value. Pew and the American College of Cardiology, a group representing 40,000 physicians, nurses, pharmacists, and other health professionals, urged the Office of the National Coordinator for Health IT to ensure that identifiers are included in electronic health records by updating related standards to include a device ID field.
To further encourage providers to document UDIs, Pew supports financial incentives to promote the capture of device identifiers in electronic health records.
Additionally, Pew recommends that insurers, including the Centers for Medicare & Medicaid Services, create UDI entries on their claims forms.
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