VALUE. DELIVERED. Call the same thing the same thing:
UDIs in recalls and beyond by Karen Conway, Vice President, Healthcare Value, GHX I
have been researching and writing about the value of unique device identifiers (UDI) for nearly 15 years, but it really all comes down to this: Call the same thing the same thing regardless of what you are doing with the thing.
For those who have not been with me on
this nearly 15-year journey, the U.S. Food and Drug Administration, UDI regulation requires manufacturers to assign and label their products with UDIs, and publish addi- tional information about those products in the FDA’s Global UDI Database (GUDID). The UDI itself is made up of two parts: 1) the device identifi er (UDI-DI) representing a specifi c version or model of a product at a particular unit of measure, and 2) the produc- tion identifi er (UDI-PI), which includes data related to production of a specifi c device, e.g., the lot, batch or serial number, expira- tion date, etc.
The ability for multiple stakeholders (manufacturers, distributors, and hospitals, etc.) to identify products in a consistent manner across the product lifecycle offers myriad benefi ts from better patient safety to greater supply chain effi ciencies and cost savings. When the rule was published in 2013, the primary focus was the ability to identify and manage devices associated with adverse events and subject to recalls more quickly, thereby getting potentially danger- ous devices off the market faster and mak- ing the lives of patients safer. (See Standard Prac� ces, July 2019).
The good news: The percentage of medi- cal device recall notices containing UDIs has grown nearly 10-fold since 2016, the year the highest risk devices (Class III) were fi rst required to bear UDIs. Deadlines for less risky devices have since followed. The bad news: Still less than 20 percent of those notices (and less than one-quarter of those for implantable devices) contain UDIs today.
This caught the attention of the Association
of Healthcare Resource & Materials Learning UDI Community (LUC), which launched a workgroup to study the value of UDIs for recalls, and develop recommendations to achieve those benefi ts. After two years of work by more than 70 representatives from across the healthcare supply chain, the group has published a comprehensive report at
www.ahrmm.org/luc. Here are a few key fi ndings and recommendations.
Highly manual, variable, and error prone The workgroup found significant varia- tion in not only the information included, but also the process by which recalls are communicated and managed. Most of that information is shared in paper-based formats, which require manual (and in turn, error prone) entry by stakeholders into multiple technology systems. As a result, the ability to fi nd and remove recalled products from the market can be delayed.
Manufacturers have a variety of means to report recalls to the FDA, but most are handled via emails using pdfs and excel documents. Across those submissions, there is variability in the data shared, including UDIs.
Manufacturers notify providers almost exclusively via mail or delivery service, e.g., FedEx, although some mostly fee-based systems handle this for subscribing hospitals and health systems.
UDI data is needed across multiple systems by multiple stakeholders
Currently, when manufacturers issue recall notices, they blanket the market (both dis- tributors and healthcare delivery organiza- tions). When providers receive such notices, they often have to query multiple systems: enterprise resource planning (RP) and other procurement software, inventory manage- ment systems and electronic health records (EHRs), to determine if they bought the prod- uct, if they have the product on hand, and/ or if they used the product in patient care. The challenge is: UDI is just one of the codes that the FDA says manufacturers can use to identify the product being recalled, and as a result, manufacturers often choose a pro- prietary number, such as a catalog number. Providers, on the other hand, sometimes cre- ate their own proprietary numbers to docu- ment products in their respective technology systems. As a result, when it comes to look- ing to see if they bought, stored or used the devices, they may not have the corresponding identifi er in their systems. This can critically delay their response, creating the potential to
38 October 2021 • HEALTHCARE PURCHASING NEWS •
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use the devices in patient care and making it hard to track down patients who may have a recalled device implanted in them. Providers are also only mandated to record UDIs for implantable devices in patient records as part of the U.S. Core Data Set, which means they may or may not have record of all recalled products used in patient care.
Beyond the patient safety aspects, this lack
of a consistent identifi er makes recall man- agement a time consuming and expensive process. Based on real world examples, the workgroup found that managing a single recall, depending on the kind of device, can cost a provider from $480 to more than $3,000 per recall.
Recommendations A primary recommendation of the work- group is to urge Congress and the FDA to create a structured electronic recall process leveraging the data and process used by the GUDID. By using APIs and/or download- ing capabilities similar to those used for the GUDID, data about recalled products could be electronically populated in dis- tributor and provider systems, while the FDA could stand up a searchable database as a single source of information about all recalled products.
Currently, the US FDA manages nine dif-
ferent sites where data on medical device recalls is stored, often containing different information. The manual processes involved can also delay posting recalls in these systems from weeks to even months. Leveraging the GUDID, standardizing how recalls are reported (using a standard template and data elements) and enabling automated queries could save time for all involved, not to men- tion supporting the needs of patients. The success of such a system requires
coordination among a variety of parties in the healthcare ecosystem: • Manufacturers should use the full UDI (both DI and PI) in their recall notices.
• Distributors and providers should also leverage the UDI in their respective sys- tems to know if they bought, are storing and/or used a product in patient care. For- tunately, many RP and HR systems can hold the UDIs, especially with the increas- ing prevalence of cloud-based systems.
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