Updated FDA policies have led to more class I recalls in diagnostic radiology

FDA policy changes have led to an increase in class I medical device recalls related to radiology, proving that such policy changes can improve both the profession’s safety and its quality, according to a recent study published by the Journal of the American College of Radiology.

Comeron W. Ghobadi, MD, University of Chicago department of radiology, and colleagues studied data from the FDA Center for Devices and Radiological Health database for class I diagnostic radiological device recalls from Nov. 1, 2002, to July 12, 2015, looking for trends and potential implications for the future.

Ghobadi et al. counted a total of 13 different class I radiological device recalls in that timeframe. Nine of the class I recalls were associated with insufficient device design, while software design, employee training errors, and inappropriate labeling were attributed to at least one recall each.

Ghobadi and colleagues noted that class I recalls jumped with the passage of the Medical Device User Fee Amendments of 2012 (MDUFA III). The Medical Device User Fee and Modernization Act (MDUFMA) was originally enacted in 2002 due to concerns over the FDA’s performance reviewing medical devices. MDUFA II came in 2007, and MDUFA III followed in 2012, providing the FDA with a large mandate to collect user fees from the industry and improve its resource capacity.

“Since the enactment of MDUFA III, major recalls relating to diagnostic radiology devices have increased, suggesting a temporal relationship between increased FDA surveillance and manufacturer reporting,” the authors wrote. “All but one class I radiological device recall listed in the FDA database occurred after the enactment of MDUFA III. Three recalls relating to fluoroscopy systems were initially classified as class II recalls. Fifteen days after MDUFA III passed, these class II devices were upgraded to class I.”

MDUFA III’s enactment resulted in more recalls of all medical devices, not just those associated with radiology. The FDA reported that, from 2003 to 2012, there was a 97 percent increase in medical device recalls from all medical fields and all classes.

The authors also noted that 12 of the 13 radiological recalls were for devices that had been cleared through the FDA’s 510(k) pathway, which indicates that MDUFA III is effectively catching issues missed by the 510(k) process.

However, as Ghobadi and colleagues explained, the recently-passed 21st Century Cures Act would actually “reduce the stringency of application requirements and allow manufacturers to use less rigorous clinical data as support, including evidence from case reports and medical journals rather than new clinical trials.”

This, the authors concluded, leaves it up to radiologists and policymakers to maintain high standards.

“Although caution must be applied in drawing conclusions based on only 13 instances, our results indicate a continued need for vigilance regarding medical device approval, particularly for the 510(k) clearance pathway for diagnostic radiology devices,” the authors wrote. “Regulatory oversight has increased since the enactment of MDUFA III; however, the 21st Century Cures Act aims to reduce device approval requirements. Imaging devices will only become more complex in the future; thus, radiologists and policymakers must maintain the safety of such devices, to ensure patient and clinician confidence.”