On Sept. 20, the U.S. Food and Drug Administration issued final regulations that will require each medical device label to bear a unique code to help track the product when it is used in patient care.
Failures of medical devices in the past two decades demonstrate the need for more rigorous and timely oversight of these products to help ensure the safety of the public.
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.
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 will work:
|“A consistent and clear way to identify medical devices will result in more reliable data on how medical devices are used. In turn, this can promote safe device use by providers and patients as well as faster, more innovative, and less costly device development.."
— Dr. Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health, announcing the release of the UDI final rule Sept. 20.
1. Finalized: 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.
Overall, Pew strongly supports swift implementation of the UDI system and has filed comments with FDA regarding its draft rule.
After a review of comments from Pew, device manufacturers, and other health policy stakeholders, FDA issued the final UDI regulations Sept. 20. Read the statement from Josh Rising, director of Pew's medical device initiative, on the final rule.
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. Pew has sent additional letters on the importance of including UDI in patients' records and continues to work with the Office of the National Coordinator in encouraging hospital and clinician adoption of this new device identification system.
Additionally, Pew recommends that insurers, including the Centers for Medicare & Medicaid Services, create UDI entries on their claims forms.