Mar 25, 2014

A new report by the US Food and Drug Administration shows a 97% increase in recalls of medical devices between fiscal years 2003 and 2012 due to stepped up public safety efforts by both regulators and industry. The agency attributes its findings to improved incident reporting primarily among manufacturers of radiological devices and by firms previously cited for 21 CFR Part 806 observations.

In terms of raw numbers, US medical device recalls grew from 604 in 2003 to 1,190 in 2012. Numbers of recalls for Class I and II devices increased more or less steadily during that timeframe, according to FDA research; Class III device recall numbers showed more variance from year to year.

Software-related issues most common recall cause

FDA researchers found that software design failures accounted for the most common recall causes, making up about 15% of all device recalls between 2010 and 2012. Given how more and more devices have been developed with significant software components in recent years, these percentages should come as little or no surprise. Other common recall causes included change and process control issues, material and component problems, and problems with packaging or labeling of devices.

Radiological devices were most often involved in software-related recalls, according to the report; other types of devices with software-caused recalls over the past several years include chemistry, cardiovascular and general hospital equipment.

Domestic manufacturers more likely to be recalled

When FDA researchers found that the bulk of medical devices recalled between 2010 and 2012 were manufactured in the US: about 80% of all recalled devices in each of those years were made in the US. Why?

The FDA suggests that better recall reporting on the part of US-based firms combined with under-reporting of recalls by foreign registrants may explain these figures. Domestic manufacturers also have higher chances of undergoing FDA quality management system inspections. But recall rates for foreign-made devices may increase once the new multinational Medical Device Single Audit Program (MDSAP) launches, according to the report. The MDSAP will provide FDA reviewers with more access to inspectional data from manufacturers in Australia, Canada and Brazil that market their devices in the US.

Spinning results? 

Although the FDA and industry have touted the study results as proof of more effective incident monitoring and reporting, Emergo Group Vice President of Quality Consulting Richard Vincins argues that these numbers show how much more work needs to be done to better address recall issues.

"The results of this study are most interesting to me because design controls were implemented almost twenty years ago to help prevent device recalls, yet there has been this increasing trend," says Vincins. "Even though organizations may be more compliant today in terms of reporting of device recalls, I can still see a continued need to assure proper design and development processes are implemented."

Vincins sees evidence for these quality assurance needs particularly when it comes to software, which may require firms to review their verification and validation processes to avoid or curtail recall actions.

"I have observed over the years that as medical devices become more complex, manufacturers must implement proper design controls, design change management, verification testing, and validation testing to help them save valuable dollars on the bottom line and reduce regulatory oversight."

Stewart Eisenhart


  • Stewart Eisenhart