Protecting Human Health Through Better Device Tracking

Fact Sheet October 3, 2013 Read time:

Projects: Medical Device Initiative

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.

Why We Need Better Medical Device Tracking

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.

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 FDA 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 the Unique Device Identifier System Will Work

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.

Manufacturers will 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.

FDA will create a public database—the Global UDI Database—linking the device identifier to other basic information about the product.

The UDI will allow 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 will 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.

From Rule to Implementation

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.

Related links