FDA Cites Gaps in Medical Device Quality

While device industry revenues have grown over the past decade, serious adverse events have outpaced that growth by 8 percent each year, highlighting a gap in device quality, according to a report from the U.S. Food and Drug Administration (FDA) and information on the AAMI website.

The report, "Understanding Barriers to Medical Device Quality," was released Oct. 31 as the result of an initiative launched by the FDAs Center for Devices and Radiological Health to understand and improve gaps in device quality. The report includes recommendations for both industry and federal regulators.

While medical device flaws may vary by device, some sources of error are pervasive throughout the field, the report reads. Identifying and addressing systemic barriers may yield improvements in medical device quality on a large scale.

The agency analyzed information from the Manufacturer and User Facility Device Experience Database, searched other databasesincluding case study librariesand interviewed FDA and industry leaders for the report. The analysis found that cardiovascular, in vitro diagnostic, and general hospital/surgical devices account for nearly 60 percent of the adverse event reports.

The report cites failures in device design and manufacturing process control as the reason for more than half of all product recalls.

Our efforts revealed that there are systemic gaps within the medical device industrys quality approach that result in these issues, the report says. Attempts to improve quality are hindered by challenges within the industry as well as specific aspects of the agency's regulatory approach.

Manufacturers, according to the FDA, are grappling with a series of challenges which are impeding quality, such as the increasing complexity of devices, time to market competition, and cost pressures.

The report listed seven opportunities for manufacturers to improve quality, such as:

- Incorporating robust postproduction monitoring and feedback into design and manufacturing that goes beyond the base requirements
- Creating incentives for design engineers to achieve quality outcomes
- Improving the design and reliability engineering, specifically through the validation of actual product use, design-for-reliability and manufacturability

The report also identified several steps that the FDA can take to help, such as clarifying agency expectations and requirements, and learning from regulators of similar high-tech and complex industries.

To read the report: http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/UCM277323.pdf