As we work to balance the desire to return to “business as usual” amid recent surges in COVID-19 cases, some of the biggest challenges in product safety and regulatory enforcement lie ahead. COVID-19 is surging again in Texas, Florida and Arizona, increasing demand for ventilators, respirators, and other medical equipment and personal-protection devices.
The spotlight is on the medical device industry as it faces pressure to aid those stricken by the pandemic, while at the same time working to mitigate increased risks usually associated with hurried manufacturing and quality control procedures.
Despite how long we’ve been at it, we still can’t predict what’s coming down the pike because there’s no precedent for what we’re living through. As we dive into the impact of COVID-19 on product safety, it’s vital to examine recent recall activity. Each quarter we examine all medical device recall activity. The latest recall index revealed that recalls continued at a steady pace through the first quarter. While software issues were the top cause of recall events for the 16th consecutive quarter, quality and out-of-specification issues were among the top causes based on units impacted. Then, as the second quarter started, we began to see a downturn in recall activity, much like what we experienced during the government shutdown of 2019.
That said, we need to clarify that the recall numbers we’re able to collect and analyze from regulatory databases may be incomplete given the current environment. For example, the CDC’s recall of coronavirus tests is not accounted for in first-quarter numbers. We also can’t be sure the numbers fully cover the growing number of recalls of hand sanitizers and face masks that we’re seeing around the globe. These are events that warrant close scrutiny once we’re past the worst of this pandemic in order to best prepare ourselves for the next viral outbreak. This is particularly true for companies that recently entered this space to support frontline healthcare providers with medical devices.
Any slump we’re experiencing now will likely continue until FDA resumes its day-to-day oversight activity, retracts emergency authorizations, and puts an end to regulatory discretion. Then expect a rush of activity as the FDA moves full speed ahead to lock down an industry that multiplied overnight.
In fact, we’re already seeing evidence that this prediction is likely to be reality. In June alone, FDA revoked emergency use authorization for an antibody test, revised emergency use authorizations for respirator use, and issued warning letters to companies for inappropriate marketing activity.
In the same month, Stephen M. Hahn, M.D., FDA Commissioner of Food and Drugs announced, “the FDA has maintained the same pace of meeting its goals on review of applications for medical products during the pandemic that it has maintained in recent years.” That’s welcome news for an industry that is working tirelessly to meet medical device demand and find treatment and vaccine options for the COVID-19 response. However, even this achievement carries some baggage.
A research letter published in JAMA Internal Medicine earlier this year found that the faster a new medical device is approved, the sooner it’s likely to be recalled. While there are limitations to the data, the two conclusions they draw are startling. First, medical devices approved by priority review were twice as likely to be recalled. Second, devices that received a priority review were recalled 6.5 months sooner once they entered the market. That means even the experienced medical device and healthcare companies are at risk of a recall or other regulatory enforcement action in this environment.
While the recall process hasn’t changed, the business environment has. It’s critical you take that into account now—long before you face your next recall. The following are the top five factors to consider when you do.
1. Manage Your Supply Chain. We’ve talked about supply chain challenges many times before. But more than ever it comes down to this: Do you trust your suppliers, manufacturing plants, and processing plants to live up to your quality and safety standards 100% of the time? If not, it’s probably an issue you need to address now.
2. Support Your Team. Employees across the organization are stressed, trying to balance work and life in a whole new way. The added pressure means mistakes are much more likely to occur. Knowing that, take the opportunity to identify vulnerabilities and assess potential risks within your organization and throughout your supply chain. Pinpoint possible missteps that could cause a slip in quality or potential contamination and implement additional measures to prevent them. But also realize reputational risks aren’t exclusively tied to your quality and safety departments. Is your sales team adequately prepared to work with retailers and business partners? Can your customer service team handle consumer call volume?
3. Consider What Health Systems and Medical Professionals are Going Through. No one is feeling the stress of the pandemic response more than those on the frontlines—doctors, nurses, hospitals and healthcare systems, and administrators. Keep that in mind if you need their time and support. In fact, when it comes to a recall, take as much of the response off their plate as possible. Deploy a field force to handle any fixes if you can. They’ll appreciate you for it.
4. Plan for Interruptions. If COVID-19 taught us one thing, it’s how many distractions and business interruptions can be caused by a single event completely out of our hands. Take the time now to think about how to prepare for the disruptions you’ve already experienced and any others you can dream up. It could be things like extra support for your customer service center, more storage space, or access to additional resources to move product. Then identify and lock down any potential solutions to those challenges. It will save you valuable time in the months to come.
5. Be Smart about Regulatory Issues. Whether you’ve been in this game for a while or you entered the medical device industry temporarily, make sure you know your regulatory requirements. In doing so, keep in mind, it’s not just your products that will be scrutinized, but the facilities and processes you used to make them. You certainly don’t want to risk your reputation for a product you never intended to manufacture long-term. Slips in compliance will likely cost you much more if caught once emergency authorizations and enforcement discretion is lifted.
New market entrants in particular face significant risk. As product shortages were realized, many consumer product companies, distillers and hobbyists jumped in to make up for the lack of supply in devices, particularly personal protection equipment. Their actions are permitted under the FDA’s emergency authorizations, but that doesn’t mean all products are created equal in the eyes of regulators—both in terms of quality and where and how they were manufactured.
None of what we’re identifying or recommending is really new. But the environment we all find ourselves in at this moment places new emphasis on doing things the right way and increases the negative consequences for poor performance.