Chris Harvey, senior vice president of client services and Amanda Combs, recall consultant for Sedgwick, provides some insight into the company’s report which saw a record number of recalls in the medical device industry.
Last year the US recorded the fewest number of medical device recalls by the Food and Drug Administration (FDA) in the past 10 years. However, it wasn’t all good news for the industry. While the number of recalls was down, the average recall size and the total number of recalled units both reached a 10-year high, with 602.5 million units impacted.
It is unclear what specific factors contributed to this increase. What is certain is that recalls have grown and become increasingly complex. As a consequence, medical device manufacturers need to be certain their manufacturing processes comply with all state and federal regulations and that they are prepared with a well-tested recall plan.
This planning will be even more critical once the COVID-19 public health emergency (PHE) is declared to be over and some of the protections for companies are gone. The ability to market products under Emergency Use Authorization (USA) instead of full FDA approval and immunity from some litigation afforded by the Public Readiness and Emergency Preparedness Act (PREP Act) granted some safeguards to companies who were trying to respond quickly to the public need for pandemic supplies.
As the FDA shifts resources away from pandemic response and back to more normal operations, an increase in inspections and enforcement actions will likely follow. This reinforces the need for businesses to be sure nothing has lapsed in their product safety practices during the pandemic, when they may have seen a change in workers, production processes, suppliers, and other factors in their operations.
One area that the FDA will be watching closely is medical devices that shift from being marketed under a USA to receiving full market approval through normal FDA authorization. FDA issued draft guidance in December 2021 outlining the steps companies need to take: Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. There was a similar guidance issued at the same time for devices being marketed under PHE enforcement policies: Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.
Both proposals provide companies with 180 days to comply with the transition plans once the PHE is declared to be over. For more than a year, the FDA has been urging medical device companies to begin transitioning to “normal” procedures by submitting marketing applications. If companies have heeded this advice, the transition may be smoother.
The FDA has stated that it does not intend to object to companies continuing to distribute medical devices with 510 (k) applications under review if those products were previously marketed under the PHE provisions and certain conditions have been met.
Companies that decide to seek full FDA approval for products that had an USA can expect to enjoy a head start for the approval timeline because they will have data from the product’s time in the market, and FDA will have experience with those companies and their products.
One of the areas companies will want to pay particular attention to in the transition away from EUAs is Good Manufacturing Practice (GMP) compliance and registration requirements. According to attorneys John Fuson and Andrew Kaplan with Crowell & Mooring, a lot of EUAs waived certain regulatory obligations in those areas. Once those waivers are lifted, companies will face greater regulatory risk.
Fuson and Kaplan recommend that companies review their manufacturing processes, especially any company that was not producing approved medical devices before the pandemic. Meeting the strict requirements for GMP can be difficult and will require that companies have clear systems, quality control guidelines, standard operating procedures, and other processes in place. These companies should also plan on being inspected by the FDA as a new manufacturer.
The loss of protections afforded by the PREP Act presents another risk for companies once the PHE status is revoked, according to Fuson and Kaplan. That increased risk of possible tort litigation will be a significant factor in many manufacturers’ decisions whether to continue manufacturing pandemic-related supplies. This is particularly true for companies that changed their normal operations to produce new lines of products in response to the public health crisis.
As COVID rates drop, it is reasonable to expect that the end of the public health emergency is in sight. Now is the time for medical device companies to take a close look at their safety processes, supply chains and recall plans. That is true any manufacturer – not just those marketing products under a USA.
Companies need to do an internal assessment now to be sure they are ready for an increase in enforcement, more regulatory oversight, and more liability. And if they are not prepared, they should look at their internal team and external partners as soon as possible to get them there before the inspectors come calling.