FDA

Lawyers prompt for medical device failure reporting

Feb 17, 2017 | Cara Livernois

Technology is prone to breaking from time to time but when the technology within a medical device fails, lives are at risk. Parker Waichman LLP, a law firm protecting patients injured by medical devices, have commented on the safety concerns involving morcellators and duodenoscopes. These comments ask regulators to enforce reporting of medical device injuries.

Morcellators, gynecologic tools that may spread undetected cancers to women, and duodenoscopes, specialized endoscopes linked to antibiotic-resistant bacteria outbreaks, pose risks to patient’s overall health, yet reporting these incidents is few. Parker Waichman LLP hopes regulators will uphold hospitals to report these medical devices injuries as often as other incidents.

“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.”

In Dec. of 2015, multiple hospitals where these devices had spread disease were surveyed. Results showed that many cases of injuries caused by medical devices were not submitted to the adverse event report database, hospitals had no system to submit these reports and the FDA or device producers and that hospital staff were not properly trained to report these injures.

“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,” said Jeffrey Shuren, M.D., J.D., Director of FDA’s Center for Devices and Radiological Health. “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.”

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