Rise in recalls and paperwork highlight a missed UDI opportunity

Sept. 22, 2022

This month, we return to a perennial topic, recall management, prompted in part by the latest Sedgwick Recall Index, which shows significant increases in the number of medical device recalls, as well as a conversation I had recently that highlights the continued missed opportunity to use unique device identifiers (UDIs) to expedite and streamline the recall process.

Let’s start with the conversation. It occurred during the first meeting of the Strategic Marketplace Initiative (SMI) Clinical Integration Council’s data enablement subgroup. On the call, I noted that a primary driver for the US FDA UDI rule was to improve recall management. When calculating the economic impact of the regulation, as required under the Paperwork Reduction Act, the federal government justified the cost to manufacturers by noting how UDIs “could more effectively target and manage medical device recalls.” On the call, Jack Koczela from Froedtert Health showed the subgroup the stack of recall notices he had received in just a matter of days. (See photo below.) Clearly, as subgroup co-chair Ginger Henry from Legacy Health noted, “We have not reduced the amount of paperwork.”

Part of the problem is that the vast majority of recall notices are still paper-based documents physically sent to providers and distributors, according to the UDI Impacts on Recall Management Work Group Report from the AHRMM Learning UDI Community.  Also, while some progress has been made over the years, many notices still do not include UDIs. The FDA only lists the UDI as one of several ways that manufacturers can identify recalled products, and as the AHRMM report notes, manufacturers say a lack of an “explicit requirement from the FDA and/or health care providers” is a primary barrier to their greater use of the UDI in recall notices. 

Let’s explore why this is a problem. To realize the full value of UDIs for recall management, both providers and suppliers need to incorporate the standard identifiers in their technology systems in order to automate processes. On the hospital side, that would entail using UDIs in purchase orders, in inventory management systems, and (at a minimum in the case of implantable devices) in electronic health records. That way, in the event of a recall, providers could rely on technology, not people, to search the records to determine 1) if the product in question had been purchased, 2) if it is being stored somewhere and/or 3) if it was used on a patient and if so whom. Unfortunately, when the UDI is provided in a paper-based document, such as a pdf, providers must at a minimum manually transcribe the information into their internal systems or databases to generate a query. But automated matching is still dependent upon the hospital having used the UDI as a standard way of identifying and documenting products.

In light of the continuing labor shortages plaguing hospitals, the use of UDI to reduce manual processes and associated paperwork takes on even more significance, especially given the recent increase in the number of recall events. The Sedgwick Recall Index found that in the second quarter (Q2) of 2022, the number of medical device recall events grew 34 percent over the prior quarter, hitting the highest per quarter number in five years. Among those recall events, the primary reason was safety, marking only the second time in six years that safety has topped the list. More importantly, the number of Class I recalls, in which the FDA believes there is a “reasonable probability” use of the product could cause “serious adverse health consequences or death,” grew nearly 25 percent compared to Q1 and reached the highest level in more than 15 years. Unfortunately, early July data also raises alarm bells, with increases in both the monthly average for the number of recall events and in the number of units impacted.

That said, there is some good news to report. Since 2016, there has been a marked increase in the use of UDIs in recall notices, from virtually none to up to 25 percent in 2021. But inconsistencies remain in how that data is displayed. For example, in a recent defibrillator recall, one manufacturer identified the recalled products in a pdf by listing several GS1 Global Trade Item Numbers (GTINs), which are UDI compliant device identifiers, followed by a listing of the serial numbers associated with each GTIN. A much more effective approach would have been for the manufacturer to provide the information in a in a standardized digital electronic format and to have included the full UDI, which includes not only the device identifier, but also the production data, such as lot or serial number and expiry date.

While disappointing, this is not the time to give up on UDI. The vast majority of medical devices, regardless of class, now bear UDIs, and clearly from the increased inclusion in recall notices, the market is more aware of what they are and their value. Now it is a matter of encouraging greater use by providers and helping manufacturers understand why and how their customers can use the identifiers. It’s both a labor reduction and response timing issue for providers, a matter of reputation management and customer service for manufacturers, and most importantly, a safety issue for patients and clinicians. We’ve got the tool; now we just have to use it. 

References:
1.   https://marketing.sedgwick.com/acton/media/4952/2022-us-product-safety-and-recall-index-report-edition-2
2.   https://www.ahrmm.org/system/files/media/file/2021/09/UDI-DI-Recall-Impact-Report.pdf