The FDA is cracking down on hospitals who it says are not adequately reporting injuries and/or deaths related to medical devices, the agency said in a recent blog post. This comes after some hospital inspections revealed serious incidents were not reported to them.
Jeffrey Shuren, Director of FDA's Center for Devices and Radiological Health, said in the past they had not enforced universal reporting requirements for hospitals and other facilities that use medical devices.
However, Shuren wrote that after several "high profile" device safety incidents occurred they initiated inspections at 17 hospitals in December 2015 where events had been reported, including events related to the spread of uterine cancer from the use of morcellators or spread of infection due to the use of duoendoscopes.
Learn on-demand, earn credit, find products and solutions. Get Started >>
Duodenoscopes are flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine and are used in procedures involving the upper gastrointestinal system. Contaminated scopes can spread infections from one patient to another. Morcellators are surgical instruments to slice into small pieces large masses of tissues during laparoscopic surgery, allowing them to be removed through the small opening that has been made.
"While these events appeared to be the kind that would have fallen under our current medical device reporting requirements, we did not see corresponding adverse event reports in our adverse event (MAUDE) database," Shuren wrote.
He said the inspections drove home several key points: some hospitals didn't submit required reports for deaths or serious injuries related to devices used at their facilities. Moreover, some hospitals didn't even have proper procedures in place for reporting device-related death or serious injury events to FDA or to the manufacturers. More importantly, he said the FDA believes the issue reaches across the country.
"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. We want to work with all hospitals to address these issues," Shuren wrote.
Also, the inspections revealed that hospital staff were frequently unaware of or not trained to comply with the FDA's medical device reporting requirements.
Shuren said the FDA believes there's a better way to work with hospitals to get the real-world information they need, and it is essential to work with hospitals, not against them, in finding the right way to move forward.
"For some hospitals with significant violations of the regulation, FDA received a response that we determined was not adequate to address those violations, and we engaged with these facilities to facilitate an effective path to compliance. These hospitals indicated their willingness to work with us and address the violations, and at this time, we do not believe any additional action with regard to these hospitals is necessary."
The FDA plans to hold a workshop on December 5th to gather input on how to improve hospital-based surveillance systems, and how the facilities can better evaluate how well devices function in the clinical setting.