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Regulatory Focus™ > News Articles > 2020 > 1 > Unique Device Identification and Recall Management: Starting with the Patient in Mind

Unique Device Identification and Recall Management: Starting with the Patient in Mind

Posted 09 January 2020 | By Terrie Reed, MS 

Unique Device Identification and Recall Management: Starting with the Patient in Mind

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.
 
Introduction
 
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:
 
  1. 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.
  2. 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
 
Figure 1. US FDA Statistics on Submissions to GUDID

 

The Office of National Coordinator for Health IT (ONC), the Center for Medicare and Medicaid Services (CMS), healthcare systems, standards development organizations, IT vendors, researchers and others refer to the UDI regulation as a means for improving the accuracy of device identification in patient records in the US, especially for implantable devices such as Helen’s. More than 200 Electronic Health Record (EHR) vendors have met Office of the National Coordinator for Health Information Technology (ONC) and Centers for Medicare and Medicaid Services (CMS) requirements describing how to capture the UDI for implantable devices in a patient’s health records, create a patient’s implantable device list and pass along UDI information as part of US Core Data for Interoperability.13,14 The number of healthcare systems having implemented UDI continues to grow, supporting better links between a patient’s implanted device and UDI as a standard device identifier.
 
Recall Data Challenges
 
In January 2018, RAPS featured an article covering recall basics, increases in recall data trends and highlighting data quality and process concerns.15 Additional data analytics concerns with recall data include:
 
  • lack of structured data in recall submissions to FDA
  • absence of a standard for electronic recall data transfer from manufacturer and FDA to affected healthcare systems and patients
  • low percentage of manufacturer/FDA inclusion of UDI-DI and, when included, not as a structured field within recall databases
 
When both the UDI-DI and UDI-PI are included in a recall notice, it is possible to link the recalled device to impacted patients and, in turn, improve the overall recall management process as envisioned in the UDI regulation. Recall notices do not appear in AccessGUDID because FDA has a separate recall database that includes UDI in accordance with regulatory conforming amendments published as part of the UDI rule.16,17 The UDI conforming amendments set health system and industry expectations so that the number of UDI-DIs appearing in the FDA recall enforcement reports would increase as the number of medical devices labelled with UDIs increased and as those products were subject to recalls.
 
As of this writing, there appears to be a much lower number of UDIs in recalls than would be expected based upon the ever-increasing availability of UDI on device labels and in AccessGUDID. Even when a UDI does appear in a recall notice, it is not in a separate field but part of a text field, such as ‘Recall description’ or ‘Code’ containing miscellaneous identifiers separated by commas, making it difficult to distinguish the UDI from other data. Figure 2 shows FDA data indicating only 10 percent of all reported recalls during mid-2018 to fall 2019 included UDIs.18 In an independent analysis, 77 percent of the 1375 implants currently reported as recalled between 2018-2019 have UDI data available in AccessGUDID, but only 24 percent of the recall notices for those products included UDI in any format.19 Imagine if only 24 percent of the 914 automobile recalls in 2018 included links to the VIN number and were not able to be directly linked to the auto owner.20 The expectations is for a very high percentage of automobile recalls to be linked to VIN numbers and auto owners to be notified of those recalls; yet that same expectation is not available to patients with implantable devices. Lack of consistent, clear UDI information in recall data reduces how well a standard identifier, such as a UDI, can accurately identify a recalled product before it is used on a patient and how well a recall can be linked to a patient who received an implant subsequently recalled.
 
Figure 2. US FDA Statistics: Percent of all Recalls Including UDI (June 2018 to September 2019)
 
Summary
 
The UDI regulation offers a pathway to transform recall management processes protecting patients from harm caused by recalled products. Participants in the device ecosystem have shown their support for UDIs by adding UDIs to the label of the device, building publicly accessible data (AccessGUDID), creating regulations to promote the use of UDI in health records and registries. A key next step is for manufacturers and FDA to consistently and accurately supply the UDI (both UDI-DI and UDI-PI) in all recalled product notifications, especially those involving implants, to promote patient safety. Including UDIs in recalls could contribute to a “tipping point” for UDI adoption, significantly improving the ability of regulators, manufacturers, patients and care providers to monitor and track recalls and adverse events associated with a device, especially implanted devices.
 
References
 
  1. Unique Device Identification System. A Rule by the Food and Drug Administration. Federal Register. 24 September 2013. https://www.federalregister.gov/documents/2013/09/24/2013-23059/unique-device-identification-system. Accessed 8 January 2020.
  2. “Medical Devices: FDA Should Enhance its Oversight of Recalls.” 22 June 2011. General Accounting Office (GAO) Report.
  3. Fuhr T, Makarova E, Silverman S and Telpis V. ”Capturing the Value of Good Quality in Medical Devices.” February 2018. McKinsey and Company Pharmaceuticals and Medical Products.
  4. Cohen D. “Hip Implants: how safe is metal on metal?” BMJ. 3 March 2012. Vol. 344, p. 8-12.
  5. “November 13-14, 2019: Immunology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement.” FDA website. https://www.fda.gov/advisory-committees/advisory-committee-calendar/november-13-14-2019-immunology-devices-panel-medical-devices-advisory-committee-meeting-announcement?utm_campaign=2019-11-25%20CDRH%20New&utm_medium=email&utm_source=Eloqua#event-materials. Accessed 8 January 2020.
  6. “Biological Responses to Metal Implants.” US FDA CDRH OPEQ OSEL Report. September 2019. https://www.fda.gov/media/132446/download. Accessed 8 January 2020.
  7. “Recalls, Market Withdrawals and Safety Alerts.” FDA website. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts. Accessed 8 January 2020.
  8. Wolford M, Palso K and Bercovitz A. Hospitalization for Total hip Replacement Among Inpatients Aged 45 and Over: United States, 2000-2010. Center for Disease Control National Center for Health Statistics (CDC NCHS). Data Brief No. 186. February 2015.
  9. Williams S, Wolford M and Bercovitz A. Hospitalization for Total Knee Replacement Among Inpatients Aged 45 and Over: United State, 2000-2010, Center for Disease Control National Center for Health Statistics (CDC NCHS). Data Brief No. 210. September 2015.
  10. Department of Health and Human Service Food and Drug Administration 21 CFR Parts 16, 801, 803, et al. Unique Device Identification System; Final Rule. Federal Register website. https://www.govinfo.gov/content/pkg/FR-2013-09-24/pdf/2013-23059.pdf. Accessed 8 January 2020.
  11. “UDI Basics.” FDA website. https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/udi-basics. Accessed 8 January 2020.
  12. Ibid.
  13. “About the ONC Health IT Certification Program.” Office of National Coordinator for Health IT website. https://www.healthit.gov/topic/certification-ehrs/about-onc-health-it-certification-program. Accessed 8 January 2020.
  14. “Certified Health IT Product List.” ONC website. https://chpl.healthit.gov. Accessed 8 January 2020.
  15. Mezher M. “Device Recalls in 2017: Making Sense of the Numbers.” Regulatory Focus. January 2018. Regulatory Affairs Professional Society.
  16. “Medical Device Recalls.” FDA website. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm. Accessed 8 January 2020.
  17. “Enforcement Reports.” FDA website. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/enforcement-reports. Accessed 8 January 2020.
  18. 9th Summit of the Healthcare Transformation Group. Baton Rouge, LA. 23 October 2019. https://www.healthcaretransformationgroup.com/summit. Accessed 8 January 2020.
  19. “High-Risk Medical devices Part III: UDI Usage in Implant Recall Events.” Symmetric Health Solutions website. https://www.symmetrichealthsolutions.com/blog/udi-usage-recalls. Accessed 8 January 2020.
  20. National Highway Traffic Safety Administration website. http://nhtsa.gov. Accessed 8 January 2020.
 
About the Author
 
Terrie Reed, MS, has spent her career advocating for better use of data to inform healthcare system decision making. She has crossed disciplines and career sectors in positions that have included systems engineer, quality analyst, medical librarian, health IT application developer, program developer, information scientist, policy developer, research manager, associate director and senior advisor for Unique Device Identification (UDI) adoption. She recently left FDA to work as a consultant, offering her expertise in regulatory policy, systems analysis and informatics to advance improvement in device evaluation and patient decision-making through the global adoption of structured data standards, including UDI, across the medical device ecosystem. She may be contacted at tzreed@me.com.
 
Cite as: Reed T. “Unique Device Identification and Recall Management: Starting with the Patient in Mind.” Regulatory Focus. January 2020. Regulatory Affairs Professionals Society.
 

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