Even before COVID-19 hit the United States, resulting in hospitals scrambling for personal protective equipment (PPE), supply chains were already dealing with recalls of more than nine million surgical gowns and 2.5 million surgical packs that might contain some of the gowns in question. Now, experts are predicting a spike in recalls, in part as a result of steps taken by the U.S. Food and Drug Administration to help hospitals manage supply shortages. Compounding the problem is the way recalls are reported by manufacturers, distributors, third parties and the FDA itself.
In late May, Stericycle published its U.S. Recall Index for the first quarter of 2020 that predicted an increase in medical device recalls once “the FDA’s emergency use authorizations [EUA] and enforcement discretion ends.” Since the COVID-19 crisis began, the FDA has issued hundreds of EUAs allowing usage of certain products otherwise not approved for medical use or for the unapproved uses of otherwise approved products. One of the first COVID-related EUAs was for PPE; on March 3, the agency authorized emergency medical use of NIOSH “filtering facepiece respirators” that had otherwise only been approved for general (not medical) use. The FDA has also used its emergency powers to expedite review of new products, such as new diagnostic tests, and changes to the components used in previously approved products, such as ventilators, to meet the dramatic spikes in demand. In its report, Stericycle cited a research letter from JAMA Internal Medicine that found a positive correlation between the time it takes to approve a medical device and the time before it is recalled once placed on the market. As the Stericycle report authors noted: “We are predicting a surge in product recalls…once the economy and country get back to “normal.”
But even in normal times, tracking and managing recalls is anything but standard practice. Last year, the AHRMM Learning UDI Community launched a UDI Impact on Recalls workgroup, which is exploring how the use of unique device identifiers (UDIs) can help providers more easily identify 1) if they have purchased any of the recalled products and/or 2) if they had used any of the recalled devices in patient care. When the final UDI rule was published in 2013, the economic analysis noted the potential for UDIs “to more effectively target and manage medical device recalls.” Based on the compliance dates that have now passed, UDIs should be assigned and displayed on the labels of medical devices regardless of class (although the FDA says it does not intend to enforce UDI labelling requirements for Class I and non-classified – lowest risk – products before Sept. 24, 2022).
Unfortunately, the way the FDA has structured recall submissions and makes that data publicly available can make it hard for hospitals to effectively track and manage recalls. Information on recalls is posted on nine different portals, databases and websites, each of which reports the data slightly differently (See list below). There is also a delay between the time the FDA receives the recall submission and when it is made available to the public.
For example, the Stericycle report uses data from the FDA’s weekly recall enforcement reports, which list the medical recalls posted during a given week. The problem is, the FDA may not post a recall for weeks, sometimes months, after the date it was initiated by the manufacturer. As such, a product may have been recalled but not yet included in the enforcement reports.
A recall for the same product can also be posted by multiple organizations: the manufacturer, the distributor, even a third party. As a result, a hospital could receive a recall notice from the manufacturer and start searching to see if it either bought or used the product. Then, when the distributor or another party submits a recall notice for the same product, the hospital may not realize it is the same recall and start the search all over again. In other cases, a recalled product may have been originally manufactured by one company (Company A), but with heightened merger and acquisition activity, it may now be owned by another manufacturer (Company B). If the “recalling organization” is listed as Company B, the hospital might mistakenly determine it did not buy any product from Company B and dismiss the recall notice, when it actually did buy the recalled product from Company A.
A third problem – and perhaps the most significant – has to do with lack of standardization in how products are identified in recall notices. In the Regulatory Procedures Manual, the FDA instructs recalling organizations to “clearly identify the product(s)” and lists “Unique Device Identifier (if applicable)” as just one of the ways a product can be identified. As a result, there is no consistency in how recalling organizations identify products in recall notices, with many only using catalog or model numbers, which are not unique to a product and could by themselves be associated with numerous products from different manufacturers.
On the flip side, the exact same product may have a different proprietary number based on the vendor (e.g., distributor or manufacturer) that sold it, which is particularly problematic for hospitals that may have purchased the product from different distributors or direct from the manufacturer. Use of multiple vendors has been common during COVID-19 as hospitals have sought to address product shortages. Other manufacturers have used one or more of the UDI compliant codes, such as a GS1 Global Trade Item Number (GTIN) or HIBC Labeler Identification Code (LIC), but they do not always specify that the code is the UDI.
Finally, for those using the FDA’s Recall Database search tool, there is only one field for product code, and without consistency, it is hard to know which code to use. If use of UDIs was the standard way to identify a product for multiple purposes, from purchase orders to recall notices, and by the multitude of organizations and functions, from supply chain to clinicians, distributors to manufacturers, it would be much easier to identify and remove the affected products from circulation. Most importantly, it would minimize the chances of a recalled product being used in patient care and help identify patients who may have been treated with a recalled device.
In future issues of Standard Practices, we will report on the additional findings and recommendations from the UDI Impact on Recalls work group. In the meantime, let me hear how you are managing recalls in the midst of COVID-19 and if and how you believe UDIs could make your life easier and healthcare safer.
