Special Approval Not Enough to Deter Medical Device Recall Management

By Howard Aughinbaugh

The U.S. Food and Drug Administration (FDA) may be next on the product safety hot seat. The Government Accountability Office (GAO) recently issued a report that found that some “high-risk” medical devices, including heart defibrillators and hip implants, have been approved for sale without being subject to the agency’s usual stringent oversight procedures. The FDA is also facing criticism over how it oversees recall management of defective devices. When the FDA is criticized for failing to appropriately manage recalls, you can expect that scrutiny to be quickly passed on to you as the manufacturer.

A GAO official in April discussed the Office’s findings with the Senate Special Committee on Aging, pointing out that 67 high-risk medical devices have been approved through the agency’s expedited 510(k) process since 2009. The 510(k) process only requires manufacturers to show that a device is similar to one already on the market. No human testing is required. The GAO argues that, when it comes to high-risk devices, similarity is not sufficient to establish safety.

The report also noted that the agency fails to monitor the reasons why these devices are recalled or document the closing out of the recall. One Los Angeles Times article suggested that, had the FDA monitored and analyzed the approximately 700 medical devices that were recalled each year from 2005 to 2009, the agency might have a better sense of what devices are safe and what risks are common among those that are not.

These two findings alone are a preview of changes we can expect from the FDA. Manufacturers must be aware of what these investigation by the GAO and Congress could mean for medical device approval in the future, but also how changes might impact recall management practices when a device is found to be unsafe.

Transparency with regulators is critical to maintaining a positive relationship with those who oversee your company. Whether your product might be at risk of losing federal approval, or if it is currently being tested for approval, stricter FDA requirements could be on their way.

To the extent possible, your company should begin using clinical trials to prove the safety of your products, regardless of whether those trials are required by the agency. Likewise, if you have managed a medical device recall in the past, be prepared to share with regulators all the   appropriate recall documentation to assist the agency as it considers what changes may need to be made and what previous recalls mean for future recall regulations, because the most effective regulations are those that are created and agreed upon by both manufacturers and regulators.

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.

One Response to “Special Approval Not Enough to Deter Medical Device Recall Management”