5 Steps To Prepare For A Software-Related Recall Of Your Medical Device

By Kevin Pollack, VP, Stericycle

It is hard to argue about the benefits of technological innovation. As technology gets more advanced, products get better, and lives can be improved. From a manufacturing perspective, however, the ubiquitous nature of technology in many products presents challenges — including product recalls.

As technology has grown more pervasive in products, so has the number of recalls related to software glitches. This is particularly evident in the medical device sector. According to Stericycle data, since 2012, the industry has seen 280 recalls due to software errors, contributing to more than 783,000 recalled units. A recent report from Transparency Market Research values the global medical device connectivity market at $33.5 billion by 2019, making it likely that software errors will continue to lead to recalls.

Accordingly, cybersecurity is an increasing concern as medical devices become more connected to the internet, hospital networks, and other medical equipment. In addition to premarket concerns, though, industry manufacturers must be prepared for the eventuality of a recall.

Manufacturers of technologically driven medical devices that are designed to receive software upgrades, such as pacemakers or infusion pumps, should take notice — the spotlight is on them. Just this month, the Library of Congress issued exemptions to the Digital Millennium Copyright Act (DMCA) that make it possible for independent researchers to begin examining medical devices for software issues. This could reveal more problems with medical devices and potentially lead to more recalls.

Operating under the glare of that spotlight, manufacturers must understand that software-related recalls are a departure from the traditional approach, and should revisit their traditional recall plan. In fact, Stericycle’s recently released Q3 2015 Recall Index found that 28 percent of medical device companies had more than one recall — and one company had 23 recalls — during the third quarter of 2015 alone.

The chief difference between a software-related recall and a traditional recall centers on the recall remedy. For example, during a medical device recall involving a hardware issue, the recalling company would send out a replacement part or, in some cases, an entirely new unit. But a software-related recall, depending on its nature, could be resolved through a simple software update. In some cases, this could be handled by the manufacturer sending affected consumers USB drives with the correct technology. In other scenarios, the resolution might be further simplified enabling consumers to download the software fix from a secure site.

These methods benefit the manufacturer and consumer alike. There is relatively little downtime before the product is operational again, and there is less stress on the supply chain.

Any recall, software related or otherwise, has many moving parts — consumer notification, product retrieval and processing, and regulatory reporting, to name a few. Below are five steps that manufacturers should take before a recall hits:

1. Keep testing and documents up-to-date — Continually test your software, and ensure documentation is up-to-date and easily accessible. The FDA requires the software developer to perform testing during production. In addition to increasing safety, improving performance, and speeding up time-to-market, reliable testing can ensure a medical device manufacturer’s products are of the highest quality before they hit the market, as well as streamline the production process overall. By keeping up-to-date records, a manufacturer can quickly take action and identify a solution if a problem occurs in the field.
2. Develop a recall plan and appoint a dedicated recall team — An effective recall plan helps manufacturers quickly and efficiently locate the recalled product, remove it from the marketplace, and protect the public. Make sure the plan clearly defines the roles and responsibilities of each member of the recall management team. This will ensure there is no confusion about who is doing what during a recall.
3. Have copies of recall plans from your partners, suppliers, and vendors — Creating your own recall plan is just the first step: It’s also crucial that any company you do business with is prepared for the inevitability of a recall. Companies throughout the supply chain should conduct recall drills regularly in order to evaluate recall capacity and procedures.
4. Practice makes perfect — Planning is just one piece of the bigger picture. Medical device manufacturers need to put their recall plans to the test and conduct periodic recall readiness assessments, or “mock recalls.” This helps organizations prepare for a recall and make necessary updates and improvements to their recall plans. Organized mock recalls can be the difference between an effective recall with a quick resolution and one that has a negative impact on brand reputation and revenue.
5. Think globally — Medical device manufacturers marketing product in the U.S., Canada, and Europe have a complex set of regulations to navigate. Bringing a new product to the global market inherently introduces complexities related to classification and regulation, as well as creates significant challenges for companies faced with a product recall. It’s vital that manufacturers are familiar with regulatory variances, and working with a third-party consultant is one way companies can address the requirements associated with international recalls. Engaging expert consultants can be invaluable in streamlining the recall process, as they have local knowledge of regulatory variances and cross-border logistics, and can help organizations evaluate their landscape and plan their recall approach long before an event occurs.

Without the appropriate plan, expertise, and systems in place, a recall can cause irreparable brand damage and put the public at risk. But understanding, and preparing for, the eventuality of a recall will position your company well for whatever happens in the future.