- Recent inspections at 17 hospitals revealed widespread underreporting of medical device-related adverse events, according to an FDA blog post.
- The inspected hospitals were associated with reports of morcellators spreading uterine cancer or infections linked to contaminated duodenoscopes. Some hospitals failed to submit required adverse event reports or didn’t have procedures in place for reporting injuries and deaths to the FDA or manufacturers.
- In hopes of addressing these issues, the agency plans on holding a public workshop Dec. 5 on ways to enhance hospital-based surveillance, and how hospitals can be used for assessing how well devices perform in clinical settings.
Contributing to underreporting of deaths and serious injuries at hospitals, the inspections found some hospital staff weren’t briefed on FDA device reporting requirements, and some were unaware of them altogether, writes Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health.
Shuren said the 17 hospitals are likely “not unique” in underreporting device-related events, adding the FDA wants to work with all hospitals to address these issues. As part of that effort, the agency is inviting hospitals to weigh in on whether current reporting requirements should be changed or eliminated. Shuren pointed out software tools can now monitor unique device identifiers in electronic health records to identify safety issues and trends.
In 2014, the FDA warned that morcellators — used to mince uterine fibroids so that they can be more easily removed — could inadvertently spread uterine cancer. Last year, the agency issued warning letters to Pentax Medical, Olympus, and other duodenoscope makers for various manufacturing and reporting deviations. The devices have been linked to superbug outbreaks at at least 25 U.S. hospitals.
More recently, the FDA and the CDC issued warnings to U.S. healthcare providers that certain heater-cooler devices had been contaminated with Mycobacterium chimaera and put patients at risk of a life-threatening infection. The LivaNova PLC Stöckert 3T heater-cooler is used in more than 250,000 open-heart surgeries a year, according to the CDC. At least 28 non-tuberculosis mycobacteria infections in three states have been caused by its use, Michael Bell, deputy director of the CDC’s Division of Healthcare Quality Promotion told Healthcare Dive.
Medical device big data is one of ten 2017 regulatory focus areas the FDA’s Center for Devices and Radiological Health outlined in a report released earlier this year. “By enhancing the performance of digital health and strengthening device cybersecurity, we will improve the safety and reliability of interconnected medical devices,” the report said.