Hospital Inspections Identify Need for Improved Event Reporting

CDRH wants to improve medical device post-market data by improving hospital (user) reporting of adverse events. Following high-profile device safety issues occurring in hospitals in 2015, such as the spread of uterine cancer from the use of morcellators or the spread of infections associated with contaminated duodenoscopes, FDA inspected 17 hospitals that were at the center of the adverse events but did not report the incidents to FDA or the manufacturers, according to a blog posting from CDRH director Jeff Shuren. From those inspections, the agency, he says, 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 FDA or to the manufacturers. 
• Second, hospital staff often were not aware of nor trained to comply with all of FDA’s medical device reporting requirements.
• Third, there is a better way to work with hospitals to get the real-world information the agency needs, so more work will be directed at finding the right path. 

“In order to effectively address these issues,” Shuren says, “we will work with the hospital community on what role they should play in assuring the safe use of medical devices. This work will include how they can effectively participate in the National Evaluation System for health Technology (NEST), and whether or not current reporting requirements should remain, be modified, or eliminated in light of more effective modern tools, such as software tools to conduct active surveillance of electronic health information that contains unique device identifiers.  In many cases, our inspections of these 17 hospitals turned up violations of FDA’s medical device reporting regulation. 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.”

Moving forward, FDA will hold a public workshop 12/5 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. “We encourage all hospital stakeholders — from clinicians to IT system managers — to attend and discuss current hospital-based surveillance efforts, the role of hospitals in evidence generation and future opportunities for hospital-based surveillance,” Shuren says. “We’d also like their input on the incorporation of unique device identifiers (UDIs) into electronic health records to aid in the future development of evidence generation efforts, including the support of better device development, surveillance and health care delivery... Hospitals are our partners in building the infrastructure for NEST. Together we can build a state-of-the-art system that not only quickly identifies life-threatening problems caused by medical devices but also expedites patient access to crucial life-saving devices.”