Although there may have been a drop in regulatory oversight due to the pandemic, this did not have an impact on the annual recall numbers in the medical device industry. In 2019, the total number of recalls reached 884; in 2020, that figure rose to 1100. Unfortunately, these numbers are expected to continue to go up this year, according to Chris Harvey, senior vice president of client services at Sedgwick. “The medical device industry has more recalls than any other industry out there, including automotive, pharmaceuticals, and food and beverage,” says Harvey. “There are a lot of medical devices out there, but I think there is still a bit of room for improvement when it comes to medical device safety.” In a Q&A with MedTech Intelligence, Harvey shared some of the takeaways from the Sedgwick Brand Protection 2021 State of the Nation Recall Index, along with some key medtech considerations for this year.
MTI: Regarding recalls, what do MedTech companies need to think about in 2021 and beyond?
Chris Harvey: 2019 had a dip in recalls but we saw that bounce back in 2020 to the higher levels reached in 2018. I expect to see a heightened level of recall numbers continue for 2021.
The couple of big factors are first, the pandemic and COVID-19 continuing, and the opportunity for manufacturers and new manufacturers to put out COVID-19-related products, whether for testing, treatment or prevention of it. Any time there’s a rush to market with certain types of products—and there needed to be in order to handle the pandemic response—you can potentially see more errors occur, which can lead to the product safety issues. The FDA’s emergency use authorization is allowing some products to hit the market faster than they would have through the 510(k) approval process. With that, I think there are things that can fall through the cracks and lead to product safety issues, which then can lead to recalls. Most companies will do the right thing; they will follow their normal procedures from a liability standpoint. But there may be some players (i.e., hand sanitizer manufacturers using methanol and mask manufacturers) that do not meet certain requirements. I think we’ll see that continue.
Companies need to ensure that, despite the distractions, they are monitoring the landscape and environment, their safety and compliance plans, and that they are conducting additional audits and inspections of their vendors and suppliers (including materials and ingredients suppliers) to ensure they are closing the gap on the potential opportunities for issues. Hopefully we’ll see the end of the pandemic towards the middle or end of this year, and [some] of these EUAs may come to an end. I think that’s where companies will need to look at and consult with a legal team on whether they will have to file 510(k)s if they want to continue to sell their devices once the EUAs are rescinded and what the impact will look like. It’s probably best to do that proactively upfront now. [We are] not sure what the FDA will require—the agency might require companies to stop manufacturing a product or may make them recall it. Companies need to keep their eye on that ball in particular.
The other area is the new administration under President Biden. It’s too early to determine what changes could occur, but budgets could increase. Oversight, enforcement and inspections could increase. Companies need to be prepared for changes.
Software issues will continue to be a top reason for recalls (as they’ve been for the last 18–19 quarters). The big thing with software, and especially AI learning, is the cybersecurity risks and the vulnerabilities. As those products are developed, it’s going to add enhancements to patient safety but at the same time could increase vulnerabilities that the agency is going to closely monitor and potentially have more oversight on as well.
MTI: The report mentioned the downtick in FDA inspections and how the agency is using online search (i.e., Google) to look for product issues (i.e., marketing). Are you noticing anything new in this area?
Harvey: We are seeing all agencies, including the FDA, use creative methods, one being reviewing how products are marketed online, along with social media to see whether there are particular complaints regarding certain products. That’s in addition to the virtual inspections they’re doing. Like any company with a work-from-home model right now that has done more virtual audits and inspections, I’m sure they are seeing they can save money on some of those activities. Are they going to continue it after the pandemic? Probably. It will be interesting to see if the agency [also] continues some of those activities. At the same time, once the pandemic is over, they will continue with their on-site investigations. While companies need to be prepared for that, we may see some combination of the creative methods to make sure companies are meeting requirements and standards, and not marketing products fraudulently.
MTI: Regarding recall activity, are you noticing any trends specific to product categories? Are there any areas in which regulatory authorities are paying more attention?
Harvey: Software is going to be the main area of focus, because it has been a top driver of recalls. We did see a spike of part issues (i.e., broken buttons, device pieces breaking off, damaged tubes, etc.), so we’ll keep a close eye there, because it is not usually a top cause. Mislabeling is always a big one, and there will continued focus there.