FDA looks to ramp up reporting of device-related injuries, deaths

FDA sign

After FDA inspections turned up “limited to no reporting” of injuries or deaths stemming from the use of medical devices at 17 hospitals, the agency is setting out to improve the way it works with hospitals on device data collection and reporting.

In response to a number of device safety issues, the FDA kicked off inspections at 17 hospitals last December. The hospitals were chosen because there were reports of unintentional spread of uterine cancer through the use of power morcellators or of infections spread from patient to patient due to contaminated endoscopes, Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, in a blog post.

The inspections found that hospital staff were often not aware of or not trained to comply with FDA medical device reporting requirements, Shuren said. The agency also found that some hospitals did not file the required reports for device-related deaths or injuries at their sites. Some hospitals did not even have the infrastructure in place for reporting such events to manufacturers or the FDA.


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“Based on the number of user facilities in the United States and the number of reports we receive, we believe that these hospitals are not unique in that there is limited to no reporting to FDA or to the manufacturers at some hospitals,” Shuren said.

The FDA will work with hospitals on multiple ways that they can help promote the safe use of medical devices, according to the blog post. The conversation will include whether current reporting requirements should remain or be amended to take advantage of new software tools, and how hospitals can make the most of the National Evaluation System for Health Technology.

On December 5, the agency will hold a public workshop on the role of hospitals in data generation in post-market surveillance and hospital-based surveillance, as well as the integration of unique device identifiers into electronic hospital records.

In August last year, the FDA slammed three devicemakers, Olympus, Pentax and Fujifilm, with warning letters regarding their duodenoscopes. The letters chastised the companies for failing to report contamination problems with the endoscopes and, in some cases, for not making sure the devices had been adequately cleaned.

As for power morcellators, the FDA beefed up its oversight of the devices in 2014, recommending they not be used for hysterectomy or uterine fibroid removal procedures as they could spread hidden cancer in some patients. This met pushback from physicians who argued that the agency used flawed data to evaluate the device’s safety, and that restricting the use of power morcellators would limit options for women who need to undergo fibroid removal.

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