This article provides an overview of FDA’s medical device Unique Device Identification System Final Rule1 and explains why including UDIs in health information and in device recalls can improve patient safety. The author offers an anecdotal case study of a patient suffering symptoms that could have been connected to her hip replacement had UDI information and its communication been as efficient as Vehicle Identification Numbers (VINs) in identifying automobile owners in recalls. She makes the case for the importance of having UDIs included in a patients’ medical records and requiring manufacturers to include the UDI in product information.
Today, millions of patients rely on medical devices for their care, including life-saving implanted devices such as pacemakers and hip and knee replacements. The introduction of UDIs on medical devices means the devices are beginning to be recorded in inventory systems, health records and registries. Applying UDIs to medical device labels and scanning UDIs as part of medical device clinical, financial and regulatory transactions should result in more accurate and automated device identification as the device moves through distribution and patient use and, if necessary, is part of a device recall. To date, UDIs, even when appearing on the device label, are not consistently recorded as part of manufacturer or US Food and Drug Administration (FDA) recall notifications. Without the UDI, those managing recalls must depend upon text-based, non-standard device identifiers, a practice negatively impacting medical device supply chain efficiency, increasing overall healthcare costs and raising safety concerns for patients. The costs to patients and healthcare systems of ambiguous device identification information appearing in recall data have been cited in various business and government reports.2,3
A Patient’s Story
Changing the capture of device information to include UDIs as a standard part of patient and device data (e.g., electronic health records, recalls, adverse events) will significantly improve patient safety in two important ways. First, if the UDI of a product in inventory matches the UDI of a recalled or expired product then, as part of the device scanning process, health systems would be able to prevent the use of the recalled or expired device on a patient. Second, if a device has already been implanted and is subsequently recalled, a UDI recorded in a patient’s implant list in their health record enables automatic identification a patient who has received a recalled device. This information could be used by a patient’s caregivers to better recognize adverse events potentially associated with an implant.
Helen, a 78-year-old female who received a hip implant that was later recalled, is one case in point, offering insight into the role UDI can play to reduce patient harm. Helen received a hip replacement in 2012. She was happy to tell her family and friends that her procedure resulted in almost instant relief from pain and related how she regained mobility and function within days of the procedure. By 2016, Helen, and her husband, a family physician, had spent four years seeking out multiple specialists to treat her symptoms leading to diagnoses that included Parkinson’s disease, cardiomyopathy and Alzheimer’s disease. Her symptoms were not thought to be related to her hip replacement, but she finally found evidence that associated her symptoms with her implanted hip. Despite news reports on metal on metal hip implant recalls from as early as 1994, none of the specialists Helen saw were aware of the type or brand of her hip implant because the information was not included in her health records.4 Therefore, they did not recognize the symptoms as related to the device. Helen’s son, also a physician, was the first to suspect that her hip implant was a potential contributor to her ever-increasing number of symptoms. He ordered lab tests, which indicated her cobalt levels were more than 50 times the normal range. After going back to the original orthopedic surgeon, it was determined that Helen’s device was a recalled device. Helen and her family elected surgery to remove the implant and, as of late 2019, some, but not all of her symptoms, have resolved. If the UDI on Helen’s implant had been recorded and been part of the data used by her specialists to help understand her symptoms, the association between her symptoms and known adverse events related to her implanted device may have been identified much earlier. Even better, by linking the UDI of her device to the UDI of the recall information about her device, Helen would have been directly notified that her implant was recalled. Had that been the case, the long-term residual effects of elevated heavy metals she now suffers may have been greatly reduced or, better, prevented.
Stories like Helen’s are not uncommon. In November 2019, the FDA held a public meeting where FDA, patients, advocacy groups and researchers presented information on the impact of implants on patient safety.5 FDA issued a 152-page report describing immunological responses to metal implants, underscoring characteristics of both the device and patient-related factors, such as individual patient susceptibility potentially leading to patient harm.6 There are no easy answers to immunological responses to implant materials or to other adverse events impacting patients long after receiving an implant. However, there are data-driven actions available to health and regulatory agencies to reduce the long-term consequences experienced by Helen and other patients who suffer serious injury, or even death, resulting from implanted devices.
UDI: a Source of Improved Recall Data
Requiring manufacturers to include the UDI and product information, a Device Identifier (UDI-DI) and a Production Identifier (UDI-PI), in an FDA recall notification when the UDI is available on the label would be a major step toward improving recall management. As an effective means for protecting the public, an FDA-regulated product may be recalled, removed from the market or require a specific problem be corrected, when the product is either defective or potentially harmful. Recalls are almost always voluntary. Sometimes a company discovers a problem and recalls a product on its own. Other times, a company recalls a product after FDA has identified an issue. Only in rare cases will FDA request a recall.7
Any regulated device is potentially subject to a recall, but recalls on implanted devices are of particular concern due to increases in the number of implantable device procedures, the significant impact on patient’s health and safety and the fact implant recalls may not occur until many years after the date the device was implanted. In 2010, more than 719,000 total knee replacements and 332,000 total hip replacements were performed. The number of these procedures has risen in recent years given an aging and more active population.8,9 Like Helen, patients assume the implanted devices being used in these procedures have met FDA regulatory requirements and, if the device is recalled, they will be notified immediately by FDA, the manufacturer or their health provider, and be given specific instructions on what actions to take. In other words, patients, especially those with implanted medical devices, should have the same expectations as they would for automobile recalls, which are accompanied by widespread public news announcements. In addition to news reports, auto owners receive mailed notices from the manufacturer with the details of why the recall occurred and how to address the problem. The notice arrives in the owner’s mailbox because of the link between auto owner and the auto’s Vehicle Identification Number (VIN) gotten through the motor vehicle registration process. The VIN is a unique identifier associated with the car. The owner’s registration number is unique to the owner. This type of public notice and link between patient and device would be possible with the consistent introduction and use of UDIs in health records, registries, adverse events information gathering and recalls.
UDI’s Role in Improving Recalls
FDA’s UDI regulation, designed to establish a system for the identification of medical devices through distribution and use, was published in 2013. The regulation’s implementation was initiated, in part, to significantly improve recall notification and management. The rule highlights several public health objectives, including a need for ‘more rapid, more efficient resolution of device recalls because delays in identifying recalled devices can result in the continued use of those devices on patients and involves an increased risk for patient harm.’10 Recalls were cited over 20 times in the UDI regulation, including being one of the justifications for the economic burden incurred by manufacturers to put the UDI on the labels of their devices. The UDI regulation includes the following two major requirements for affected device manufacturers:
- Include a UDI on device labels and packages, except in cases where the UDI rule specifies exceptions or alternatives. If a device is intended for more than one use and intended to be reprocessed before each use, the device labeler also must mark the UDI directly on the device.
- Submit device information to the Global Unique Device Identification Database (GUDID) enabling it to be available for public access through the AccessGUDID, an FDA maintained public resource containing up to 62 data elements (e.g., company, brand, description, whether a product is labeled as containing latex).
The full UDI is composed of two parts: a Device Identifier (UDI-DI) and a Production Identifier (UDI-PI). The UDI-DI is unique for each record appearing in AccessGUDID and is assigned to each model/version a manufacturer puts into commercial distribution. The UDI-PI is composed of at least one or more of the following: lot, serial, expiration date, manufacturer date and distinct identification code for a Human Cell and Tissue Product (HCT/P). The UDI-DI and UDI-PI are generally assigned to each level of packaging.
Since 2013, FDA and device manufacturers have dedicated significant resources to UDI implementation. Currently, the UDI appears in both a human readable and scannable format on the label of Class III, Class II, implantable/life supporting/life sustaining and some Class I medical devices regulated by the US FDA.11 As of this writing, Figure 1 shows that there are more than 2.3 million UDI-DI records in GUDID made publicly available in AccessGUDID.12