Medical device safety problems prompt regulators to call for better reporting

Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by medical devices, comments that medical device problems have prompted regulators to call for better reporting. Congress required hospitals to report adverse events in 1990.

Safety concerns involving power morcellators and duodenoscopes prompted the U.S. Food and Drug Administration (FDA) to investigate how hospitals report injuries and deaths related to medical devices. Morcellators are gynecologic tools used during hysterectomy or uterine fibroid removal and may spread undetected cancers in women, worsening their prognosis. Duodenoscopes are specialized endoscopes used in gastrointestinally and contaminated duodenoscopes were linked to antibiotic-resistant bacteria outbreaks in several hospitals.

In December 2015, a number of hospitals were surveyed involving facilities where cancer was spread via morcellators or patients were infected through contaminated duodenoscopes. The inspection found that many cases were not submitted to the agency's adverse event report database; that hospitals had no system in place for staff to submit reports to the FDA or device makers; and that staff did not always know, or were not properly trained, concerning the mandate to report injuries and deaths associated with medical devices.

Jeffrey Shuren, M.D., J.D., Director of FDA's Center for Devices and Radiological Health wrote that, "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." He added that, "…we feel certain there is a better way to work with hospitals to get the real-world information we need, and 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."

Parker Waichman comments that improved reporting may benefit future patients. "The firm supports efforts to improve medical device adverse event reporting," said Keith Gitman, Managing Attorney at the firm. "Through improved reporting methods, manufacturers and regulators may identify medical device problems quicker."