UDI, recalls and labor shortages - time for a reset?

This month, we return to the topic of recalls, but with an added lens - the labor shortages and the need to reduce unnecessary and often error-ridden manual work. In past columns, we have discussed the value of unique device identifiers (UDIs) to support the automation of processes around recalls. UDIs, as a reminder, are the U.S. FDA-mandated identifiers for medical devices, which manufacturers must assign to their products, at each packaging level, and include on the label of their products (in human and machine-readable formats). My premise has been that IF UDIs were adopted broadly across the healthcare supply chain as THE way to identify medical devices, e.g., in purchase orders, inventory management systems, electronic health records, etc., we could rely more on technology to help providers determine 1) if they purchased a recalled product, 2) if that product is being held in inventory and if so, where, and 3) if it was used in patient care and documented in electronic patient records. But, this is a simple view, and the reality is, UDIs alone will not get us where we need to be. We need to look more closely at the current processes and regulations around recall management.

The issue of workforce shortages is also worthy of exploration from a variety of perspectives. Since the global pandemic, hospitals and healthcare systems continue to suffer from labor shortages. While most are among nursing staff, many supply chain departments also have unfilled positions; this is important given that supply chain is being asked to take on the more supply chain-related tasks that nurses had been handling in a pre-pandemic environment. Suppliers, too, have reported challenges in recruiting and retaining staff. In coverage of some of the more high-profile recalls of late, staffing shortages at the FDA have also been noted as to why the agency relies on manufacturers to self-report safety issues with their devices and why most recalls are considered “voluntary” (although the FDA has mechanisms to mandate a recall if necessary).

To explore these issues further, let’s take a closer look at how recalls are typically handled today. According to the U.S. FDA, the manufacturer, as the recalling firm, is responsible for notifying its customers, which it says “can be accomplished by telegrams, mailgrams or first-class letters conspicuously marked...medical device recall.” For this reason, manufacturers spend millions each year sending paper-based recall notices via one of the major overnight delivery services. With the rise in recalls in recent years, many providers have now designated recall coordinators, but many manufacturers still send multiple notices to multiple locations at each of their individual accounts. Because manufacturers must also update the FDA on the status of the recall response, the notices include a means, often a postcard, for providers to return with information on how they have responded. If manufacturers do not hear back, they will often send a second, third, even a fourth notice, further increasing the avalanche of paper sent to their customers. NotiSphere, a technology company in the recall space, estimates half a million trees are consumed annually to support these paper-based processes and that does not even consider the greenhouse emissions from transporting those notices or the substantial costs involved.

As a result of this paper-based, voluntary and scattershot approach, NotiSphere has documented numerous downstream issues:

• On average it takes more than two weeks for a recall notice to reach the official “recall coordinator”

• Many recall notices do not apply to the healthcare providers to which they were sent (they did not buy the product), resulting in extra and unnecessary work (as much as 95% of the time)

• Confusion over the term “voluntary” may cause some providers to ignore the recall or at a minimum fail to respond to manufacturers.

On the other hand, some providers will respond to recalls beyond what is necessary. For example, some recalls only relate to specific batches or lots, but because it can be cumbersome to manually match the lot and serial numbers on the recall notice with the physical products, the provider may remove more devices than necessary. As discussed in prior columns, use of the full UDI, which includes both the device identifier and the production data (lot, serial number, expiry date), can help identify which products are covered by the recall and which are not. But the lack of an automated, machine to machine process continues to limit the ability to leverage that value.

The good news is that the percentage of recall notices including the UDI has risen substantially in recent years. Unfortunately, the paper-based processes still limit the ability to automate the response. Further, providers still need to determine if they need to respond (did they buy it) and if so, where is it? As healthcare delivery continues to move outside the acute care hospital and into the community and patient homes, product locations are proliferating. Further, the nature of how hospitals are reimbursed limits the level of granularity of data in patient records as to what products were used in their care. If not chargeable, those products may not be specifically documented. In other cases, not all products, e.g., those sold directly to consumers in addition to healthcare providers, are not subject to the UDI regulation; these products can range from bandages to self-powered wheelchairs.

As we seek to automate processes (to address labor shortages and the costs of healthcare) and improve recall response (for patient and healthcare worker safety), it is once again incumbent upon the myriad players in healthcare (both public and private) to come together to explore these issues at the system level. It starts with education, helping providers and suppliers better understand each other’s current processes and regulatory requirements and expectations, followed by process mapping to identify where we can potentially eliminate and/or improve how work is done. If the industry (providers, suppliers and solution providers) can come together, we can speak with a single and more authoritative voice to regulators, offering ideas on how to update the regulatory requirements such that they meet the needs of all parties, to ensure the safety and efficacy of not just devices, but of the entire recall process itself.