You're Hit with a Medical Device Recall—Now What?

Peaking with the spectacular recall of metal-on-metal orthopedic implants in 2010, the flood of news about medical device recalls has become a staple of the business and mainstream media alike. And the news just keeps coming. Now we learn that medical device recalls increased more than 160% in the first quarter of 2012, affecting more than five times more units than in the previous quarter. According to the ExpertRECALL Index, a report that aggregates and tracks cumulative recall data from the Consumer Product Safety Commission and FDA, medical device recalls documented in FDA's first-quarter enforcement reports affected nearly 82 million units, representing a 508% increase over the previous quarter--a five-quarter high. Products impacted by the increase included alcohol prep pads, catheters, needles, latex gloves, and other medical device products.

The question is: What do you do when you're company is hit with a recall? How do you confront the crisis? Answering these questions is Mike Rozembajgier, vice president of recalls at Stericycle ExpertRECALL (Indianapolis), which publishes the ExpertRECALL Index. And hear from FDA experts on how to prevent and manage product recalls at the MD&M East Conference, May 21-24, Pennsyvania Convention Center, Philadelphia. --Bob Michaels

MPMN: What types of medical devices have contributed to the spike in the recall rate in the last quarter?

Rozembajgier: We have been monitoring the industry since we launched the ExpertRECALL Index a few quarters ago and have been at this for quite a while dealing with recalls. The types of devices that have contributed to the recent increase in recalls span a pretty wide range of products, including such implantables as stents, defibrillators, and guidewires used in the OR and material and physical capital equipment used in the hospital setting, where there are monitors and other equipment. But the recent recalls also include such orthopedic implantables as hips, knees, and joint-replacement technologies.

MPMN: So what's going on here? What factors or manufacturing practices are contributing to this spike in recalls?

Rozembajgier: We can pinpoint a few factors when determining how it is that we got into a situation in which we are seeing a lot of recalls. Certainly, what is going on in Washington, DC is a part of it. We see the FDA cracking down on all industries--in particular the medical device industry--and we can expect this trend to continue. And I think the impact of this trend will only continue as time goes on, since doctors, caretakers, and patients are keeping a closer eye on devices and reporting concerns earlier.

The rise in recalls and the number of repeat offenders is a little troublesome, given the increasing volume of medical devices that patients rely on to maintain and improve their health. One of the facts I learned when we began looking at the recall situation is that one-third of the companies that faced recalls in the first quarter were involved in more than one recall event. And we've seen this trend over the past five quarters. Thus, each and every quarter, we're seeing one-third of companies--not the same ones every quarter, however--that are experiencing multiple recalls. Thus, you have to ask, is the government doing all it can to make sure that we're performing appropriate testing upfront to approve devices? Are companies doing all they can to ensure that their quality groups are well aligned? Are manufacturers working closely with their source suppliers to ensure that they're doing all the right things to put good products into the marketplace? But more importantly, once a recall hits, do they take the right steps and follow the right procedures to conduct a probe in a fast, effective manner?

MPMN: What are right steps?

Rozembajgier: Here's the key for medical device firms: The components manufacturers are critically important. Surely, manufacturers want to put good products into the marketplace, and they do so each and every day. But there are situations in which they have products that need to be recalled. How do they go about working with their own quality, regulatory, and risk departments to determine the appropriate measures before putting products out on the shelf and making sure that they're effective? Above and beyond that, a lot of what we talk to firms about when they're doing recall planning and testing, mock recalls, and recall preparedness is whether they are performing those tests with their source manufacturers. Do they have a good feel for the types of procedures and testing that the suppliers go through as they bring complex components together to create a medical device?

MPMN: If you're a supplier company, what should you do to reduce the risk that the product you're working on will be hit with a recall? If such companies aren't doing the right thing, what should they be doing?

Rozembajgier: There are a couple of factors that come into play here. Certainly, suppliers are going to want to feel good about the current quality measures that they have in place to perform trend analyses. They're going to want to maintain close contact with the OEMs they supply to ensure that the appropriate quality tests and recall preparedness drills--or mock recalls--are being followed so that there are no surprises if and when they are faced with a crisis such as a recall. They should ensure that the recall is handled in an effective manner.

MPMN: Do you think that there is perhaps a dearth of proper quality control measures in place?

Rozembajgier: We look at recall situations on a case-by-case basis. I would not want to say that all companies lack proper quality controls because there are many good life-saving devices that help people stay active and healthy. Particularly in the case of complex devices with many components, OEMs have to continue to keep a close eye on them so that they feel confident about the processes and procedures they and their suppliers maintain. Because a recall situation is going to vary from case to case, it's necessary for the companies involved to determine what the specific recall danger or health risk is and what caused it to occur. For example, they must ask themselves, is the recall the result of a medical device component malfunction? Is it related to the manner in which the device is being implanted or used? Is it the result of manufacturing equipment malfunctioning? A variety of drivers can cause a recall to occur, and you need to isolate the causes to determine how to take preventive measures down the road.

For medical device suppliers and OEMs alike, recall preparedness is crucial. How well are companies prepared to handle a recall if and when it hits? Have they been through the paces? Have they performed the appropriate analyses? Have they identified their core teams for dealing with the situation? By ensuring that they can effectively manage the crisis when it is upon them, companies can ensure, first, that their customers are protected and, second, that their medical devices and brands are protected.