Radiology device failures propel doubling of medical device recalls

The number of annual medical device recalls increased by 97 percent between 2003 and 2012, and radiology devices played a leading role in the growth trend, according to a report from the Center for Devices and Radiological Health.

During the 10-year study period, 176 linear accelerators and 115 CT scanners were recalled. In addition, 153 image-processing systems were recalled, making radiology the leader among medical specialties for device recalls.

Software failures caused the majority of recalls associated with linear accelerators, the device that generated the most recalls over 10 years. Among the software issues found were interoperability between treatment planning and treatment delivery systems, human factors associated with user interfaces, and dose calculation.

In fact, software design failure was the most common cause of all recalls, accounting for 15.1 percent from 2008 to 2012. Twelve of the 20 top device categories with recalls generated by software were radiological device categories.

The CDRH attributed the increase in the number of radiology device recalls to increased media attention to over-exposure incidents and FDA activities related to reducing unnecessary exposure in 2010, including a two-day meeting that engaged the radiology and vendor communities.

Between 2010 and 2012, the number of radiology device recalls increased from slightly more than 100 annually to 250. “Some firms conducting recalls during this time period acknowledged to FDA that they had become more vigilant in reporting recalls,” according to the report.

The root of most issues with radiology devices was the clinical use of the technology rather than the technology itself, the authors wrote. "For the most part, the radiology problems have not been with the technology itself, but rather with the clinical use of the technology," according to the report.

The report was prompted by the Recall Process Improvement initiative begun by CDRH in 2010, intended to reduce recall-processing times and improve communications.

In other findings, time on the market was not observed to be a significant factor in recalls.  Between 2004 and 2012, the percentage of products recalled within one year of introduction remained constant at 10%.  The recall rate for devices on the market for more than 15 years, likewise consistently represent 10% between 2004 and 2012.

Companies with 21 CFR 806 violations following FDA inspections were singled out with radiology as a primary driver of the overall increase in recalls. The section of the Code of Federal Regulations that obligates device makers to inform the FDA when they recall a product or correct a problem with patient-safety implications is 21 CFR 806. Device makers that receive the inspectional 806 observations following FDA inspections tend to improve recall reporting, the report authors observe.

The authors concluded the report on an upbeat note, linking the increased number of recalls to more proactive reporting by industry: “The recall data analysis suggests that the increase in the number of recalls between FY 2003 and FY 2012 can be largely attributed to improved reporting by firms that were cited with 806 reporting violations and by manufacturers of radiology devices. We have seen greater reporting by industry and a more concerted effort by CDRH and industry working together to improve the quality and safety of medical devices.”