FDA's new recall review indicates that medical device companies are more diligent about reporting. But there's still a lot of room for improvement.
Upon the recent release of FDA’s "Medical Device Recall Report: FY2003 to FY2012," headlines blared the fact that recalls—particularly Class I recalls—have skyrocketed over the past decade. While not inaccurate, the negative slant of these headlines conveyed the sense that there’s an escalating threat to patient safety or increasing negligence on industry’s part.
But neither is the case. In fact, the report states that the dramatic uptick in recalls is the positive outcome of a concerted effort by CDRH and the medical device industry to improve the quality and safety of devices, ultimately benefitting public health. The agency further asserts that better recall reporting by manufacturers can, over time, result in enhanced device performance.
It helps to put the numbers into perspective—especially in the face of a statistic as daunting as a 97% increase in the annual number of medical device recalls over the course of a decade. "The rate of recall lags industry growth," Steve Silverman, director of the Office of Compliance, assured The Wall Street Journal in advance of the report’s release.
Ultimately, industry should be commended for its increased diligence toward recall reporting in recent years. But there’s still plenty of work to do.
Continued emphasis on proactive recall reporting isn’t a bad place to start. While recall reporting has clearly improved over the past decade, underreporting remains a problem.
Beyond reporting, medical device manufacturers need to redouble their focus on medical device and software design. The report cites software design, device design, and nonconforming materials or components as the most frequent causes of recalls between FY2010 and FY2012, with 429, 425, and 429 associated recalls, respectively.
"To reduce the number of device design- and software-related recalls, firms may work to improve their understanding of appropriate design inputs, to increase their ability to verify that the device as designed addresses the inputs, and to better validate whether the device conforms to user needs," Jennifer Rodriguez, press officer for FDA’s Office of Media Affairs, recommended. "Improving purchasing controls may decrease the likelihood of a nonconforming material- or component-related recall."
Industry and FDA also need to step up communication efforts as they work toward the common goal of reducing the number and frequency of recalls. FDA invites industry input on guidances, encourages industry use of recall and adverse event reporting data, and seeks industry participation in workshops on such high-recall areas as AEDs, radiology devices, and infusion pumps, according to Rodriguez. The agency is also collaborating with manufacturers of battery-powered implants to determine "what is critical to the quality production of those devices," she added.
The information exchange goes both ways, though. "Companies today have a wealth of data available from forum discussions, social media conversations, and other portals that can be mined in real-time to proactively assess potential issues," said Kevin Pollack, vice president of recalls for Stericycle ExpertRecall. "Leveraging this data and sharing it with FDA, when appropriate, can help in early detection of an issue and also limit the size and scope of the event."
To that point, it’s imperative that manufacturers have a recall plan in place should the unfortunate need arise. And that plan needs to factor in global considerations, according to Pollack.
"As international supply chains and distribution networks increase in prevalence and complexity, creating what we call ‘recall sprawl,’ the challenges of recall management will increase," he said. "As part of this, medical device manufacturers should consider implementing control measures on a global scale. This could include components such as country-specific recall plans or on-site assessments to identify risks in standard operation procedures."
Recalls are an unfortunate yet inevitable part of the medical device industry; at present, there is no 100% certainty when it comes to the safety and effectiveness of a commercial product. FDA’s consolidation of 10 years worth of recall data is certainly evidence of that. But industry can—and should—take certain measures to better mitigate risk to patients and reputation.
|Learn more about regulatory challenges facing the medical device industry and how to solve them at MD&M East, June 9-12, 2014, in New York.|
[image courtesy of JSCREATIONZS/FREEDIGITALPHOTOS.NET]