Accelerated Medical Device Approval Linked to Product Recalls

By Howard Aughinbaugh

A new study of recalled medical devices highlights the need for thorough safety checks before products are put on the market. This month, a study conducted by the National Research Center for Women & Families and published in the Archives of Internal Medicine found that the majority of the medical devices recalled since 2005 were originally approved using the “accelerated” 510(K) process. Medical device manufacturers embraced the 510(K) for its efficiency, but they probably did not consider its potential impact on recall management.

According to the study, 80 out of 113, or 70 percent of recalled products were approved for distribution through 510(K), an abbreviated FDA approval process designed for low and moderate risk devices. Those outside the medical device industry may be surprised to learn that the FDA approval process normally does not include human testing or manufacturing plant inspections. Because most new devices are now cleared for sale through 510(K), we can expect that pattern to continue.

Diana Zuckerman, one of the study’s researchers, argues that the “findings reveal critical flaws in the current FDA device review system and its implementation that will require either congressional action or major changes in regulatory policy.” Everyone from activist groups and trade organizations to regulatory agencies have voiced their opinions and reactions to the study, and some experts believe that the findings are likely to spur regulatory and congressional action. According to the Washington Post, the FDA is already considering further modifications to the medical device approval process to raise safety standards. 

With the FDA more carefully regulating products, setting stricter standards, and ordering more recalls, manufacturers should be sure that their products have passed several rounds of safety checks before the go on sale – whether or not those checks are required by the regulators. Regardless of whether a longer approval process becomes the dominant FDA inspection method, medical device manufacturers must be careful to do their due diligence to make sure their products are safe.

Companies should also increase their communications efforts with customers and distributors. Zuckerman suggested that the study’s results could “shock” patients as they “learn how often new medical products using different materials, made by a different manufacturers, are not scientifically tested in humans to see how well they work.”

Communicating with these critical audiences is essential to managing a successful business. And by communicating with key audiences now, before a recall, you can build up a goodwill bank that will serve you well as the medical device industry faces increased scrutiny from lawmakers and regulators. If and when a recall is required, continued transparency and communication will help position your company for recall compliance and could even enhance your brand once the recall is over.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.