A week after an international group of journalists published a package of stories slamming the medical device industry, the FDA has issued its own report highlighting its accomplishments dating back to 2007.
The Medical Device Enforcement and Quality Report touts:
- Increased medtech manufacturer inspections and voluntary reporting of violative devices and adverse events;
- Targeted enforcement of regulations regarding particular devices;
- Firms’ corrective actions following inspections; and
- The use of regulations to promote device quality, not just compliance, through its Case for Quality pilot program launched this year.
The FDA had been preparing this report for quite some time, according to spokeswoman Deborah Kotz. The week before the International Consortium of Investigative Journalists (ICIJ) published its reports, the FDA outlined new regulatory goals. Last week, the agency released plans for modernizing the 510(k) clearance pathway.
Following a year-long investigation, the ICIJ series claimed that despite the positives that new, innovative medical devices bring, the industry as a whole is “unnecessarily putting millions of patients at risk of serious harm in its quest for profit.”
The journalists collected more than 8 million device-related health records over the course of the year-long investigation, the majority of which came from the more than 5.4 million adverse event reports filed with the FDA over the past 10 years. Over the past decade, more than 1.7 million injuries and approximately 83,000 deaths potentially related to medical devices have been reported. Nearly half a million of those reports mentioned an explant surgery to remove a device in connection with the reported events.
In its new report, the FDA said it conducted 2,952 inspections of medtech firms in 2017, up 46% from a decade ago. Foreign site inspections went up by 243% during the same time period. Cooperation with other countries’ regulatory bodies through the Medical Device Single Audit Program yielded an additional 600 inspection audits since 2013, the FDA said.
The agency highlighted its targeted, risk-based enforcement approach to particular kinds of troublesome devices, including infusion pumps, automated external defibrillators and radiation therapy devices made by multiple manufacturers. Firms are eight times more likely to report a recall and report three times more adverse events after the FDA has cited them for violations discovered during inspections, the report notes.
The number of adverse events reported to the FDA has doubled since 2009, according to the report. Firms cited for violating adverse-event reporting regulations subsequently reported more than three times the number of adverse events in 2017 compared to the year before the inspection, the agency noted. The FDA has also changed tactics since 2012, issuing fewer warning letters to companies in favor of interacting with them to induce corrective action.
“Our increased oversight has led to tangible results with improved compliance,” said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health (CDRH). “Today’s report also highlights results from a pilot initiative we launched this year using a third-party system to provide an assessment or appraisal of a firm to determine if there are any gaps in manufacturing processes or quality systems. This appraisal program is designed to improve manufacturing quality and processes and has led to 32 appraisals involving 18 manufacturers who reported overwhelmingly that the appraisal had a positive impact on the quality of their devices.”
