The U.S. Food and Drug Administration (FDA) last week alleged that a dozen hospitals failed to properly report problems linked to medical devices following inspections in late 2015 and early 2016.
National Public Radio reported that the hospitals in question, according to FDA officials, were symptoms of faulty reporting throughout the country. But the report also noted that observers questioned the agency’s ability to identify those issues.
“FDA is looking to improve the way we work with hospitals to modernize and streamline data collection about medical devices,” Jeffrey Shuren, director of the agency’s Center for Devices and Radiological Health, wrote in a blog post.
Shuren wrote that the FDA conducted inspections at 17 hospitals linked to problems with medical devices — particularly contaminated duodenoscopes and morcellators associated with uterine cancers.
Twelve hospitals, NPR reported, did not promptly report problems linked to patient injury or death, including high-profile providers Massachusetts General, New York-Presbyterian and Ronald Reagan UCLA Medical Center and Cedars-Sinai Medical Center.
(Image credit: AP Photo/Andrew Harnik)
Hospitals are required under federal law to report potential device-related injuries or deaths within 10 days to both FDA and device manufacturers.
In addition to not reporting problems for months — or at all — Shuren wrote that some providers did not have proper procedures to do so in the first place. Hospital staff, he added, were often unaware or improperly trained to comply with FDA medical device reporting standards.
The FDA does not enforce potentially costly and unnecessary universal reporting requirements on hospitals, but Shuren vowed to work with hospitals to strengthen its evaluation system.
“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 device,” Shuren wrote.
Hospitals cited by the agency, meanwhile, indicated their willingness to cooperate with that effort, and Shuren wrote that the agency does not “believe any additional action with regard to these hospitals is necessary.”
Huntington Hospital in Pasadena, Calif., for example, told NPR that it has “taken steps to ensure rigorous compliance going forward” after an outbreak of infections involving duodenoscopes.
Filed Under: Industry regulations + certifications
