Some of the nation’s largest and most prominent hospitals failed to report medical device-related deaths or serious injuries, according to FDA findings from inspections dated December 2015 through April 2016.
On October 24, 2016, the FDA announced the hospitals that didn’t report deaths as required were Advocate Lutheran General in Park Ridge, Illinois; Huntington Memorial Hospital; Reading Hospital and Medical Center in West Reading, Pennsylvania; Allegheny General Hospital in Pittsburgh; New York-Presbyterian; and two in Boston—Brigham and Women’s Hospital and Massachusetts General.
The agency said those that failed to report serious injuries in time were UCLA; Cedars-Sinai; Virginia Mason Medical Center in Seattle; UMass Memorial Medical Center in Worcester, Massachusetts; and Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire.
Postmarket Reporting Requirements
Once a device has been allowed on the market, the agency has several postmarket surveillance tools. One of these is a reporting directive requiring hospitals and others to report medical device-related deaths or serious injuries to both FDA and the manufacturer of the device. To implement this, the FDA set up a network of about 300 hospitals, called MedSun (the Medical Product Safety Network), with whom the agency works interactively to better understand and report on device use in the real-world environment.
Jeff Shuren, M.D., JD, director of FDA’s Center for Devices and Radiological Health, wrote in a blog post that the agency initiated inspections of 17 hospitals in December 2015 after reports of events at these facilities related to the spread of uterine cancer from the use of morcellators or the spread of infections associated with contaminated duodenoscopes.
Shuren continued that these events appeared to be the kind that would have fallen under current medical device reporting requirements, but the agency did not see corresponding adverse event reports in the adverse event (MAUDE) database.
Inspection Lessons
From the inspections, Shuren said the agency learned three important lessons:
- First, some hospitals didn’t submit required reports for deaths or serious injuries related to devices used at their facilities, and in some cases, they did not have adequate procedures in place for reporting device-related death or serious injury events to the FDA or to the manufacturers.Based on the number of user facilities in the U.S. and the number of reports received by the FDA, Shuren said, “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.”
- Second, Shuren noted that hospital staff often were not aware of nor trained to comply with all of FDA’s medical device reporting requirements.
- Third, he wrote that the agency feels certain there is a better way to work with hospitals to get the real-world needed information. “We should work with the hospital community to find that right path, especially in light of developments in the creation and evaluation of electronic health information.”
Unique Challenges
The agency’s evaluation of medical device safety presents “unique” challenges not seen with drugs and biologics, said Shuren. He attributes this to greater diversity and complexity of medical devices today; the rapid technological advances and iterative nature of medical device product development; the interface between the technology and the user and, in some cases, a relatively short product life cycle that can be measured in months, not years.
For some hospitals with significant violations, Shuren said the agency received a response that was “not adequate.” Those hospitals indicated their willingness to work with the agency and the agency does not believe any additional action regarding these hospitals is necessary. Some hospitals also expressed willingness to work with the FDA on more efficient and effective ways to collect the needed information.
Workshop for Improvements
To that end, the FDA will hold a public workshop on December 5, 2016, to solicit input and advice on improving hospital-based surveillance systems and the broader role of using hospitals to evaluate how well devices work in the clinical setting.
To read the summaries of the FDA inspections, click here.
