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.
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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.
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.
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.
- FDA's UDI page
- FDA's List of Recalled Medical Devices
- Unique Device Idientification Final Rule
- Pew's statement on Unique Device Identification Final Rule
- Unique Device Identification Draft Rule | Amendment
- Comments on the Health Information Technology Patient Safety Action and Surveillance Plan (Feb. 5, 2013)
- Comments on Stage 3 of the Meaningful Use of Health Information Technology (Jan. 15, 2013)
- Strengthening Our National System for Medical Device Postmarket Surveillance (Nov. 21, 2012)
- Pew Comments to the FDA Regarding the Unique Device Identification System (Nov. 8, 2012)
- Date added:
- Oct 3, 2013
- Medical Device Initiative
The Pew Charitable Trusts drafted a letter to the HIT Policy Committee, Meaningful Use Workgroup of the Office of the National Coordinator for Health Information Technology regarding the new meaningful use objective for the capture of unique device identifiers (UDIs) in electronic health records (EHRs). In the letter, Pew asks the committee to consider how the proposed objective for UDI capture advances several goals of the meaningful use program and addresses feedback previously provided.More info
On September 19, 2013, the House Medical Technology Caucus and The Pew Charitable Trusts held a briefing on how the Food and Drug Administration's (FDA's) new unique device identifier (UDI) system can improve patient care. Speakers discussed the implementation of FDA's new rule, as well as incorporation of UDI into healthcare delivery, particularly patients’ medical records, supply chain logistics and insurance claims.More info
"The U.S. Food and Drug Administration issued a long-awaited rule on Friday requiring companies to include codes on medical devices that will allow regulators to track the products, monitor them for safety and expedite recalls."More info
"Federal health regulators will begin tracking millions of medical devices, from pacemakers to hip replacements, using a new electronic system designed to protect patients by catching problematic implants earlier."More info
On September 12, Four House Democrats sent a letter to the Office of Management and Budget (OMB) calling for the release of long overdue regulations on unique device identifiers (UDI). Their message emphasized that a device identification system will enable the FDA to more quickly identify devices with safety problems and then swiftly correct or pull them from the market.More info
Five prominent health systems, known as The Healthcare Transformation Group (HTG), sent a letter to the White House’s Office of Management and Budget urging a prompt review of the unique device identifier (UDI) rule. Like Pew, HTG believes further delay of the rule’s release will impair the Food and Drug Administration’s ability to conduct important surveillance of medical devices.More info
"Medical groups and patient advocates are clamoring for the FDA to release a final rule requiring most medical devices distributed in the U.S. to carry a unique alphanumeric code allowing for better information tracking."More info
The Pew Charitable Trusts and the Premier healthcare alliance sent the White House Office of Management and Budget a letter regarding the review of a Food and Drug Administration rule to establish a unique device identifier (UDI) system. Given the importance of this new device identification system to improve patient care and the missed statutory deadline, in this correspondence Josh Rising of Pew and Blair Childs of Premier strongly urged the Director of the Office of Management and Budget (OMB) to promptly complete review of the UDI final rule.More info