Three Massachusetts hospitals are among several nationwide cited by federal regulators for failing to properly report patient deaths and injuries that may have been caused by medical devices.
The Boston Globe reports that Massachusetts General, Brigham and Women's, and UMass Memorial were among 17 hospitals inspected last December by Food and Drug Administration. Regulators were concerned about infections possibly linked to contaminated instruments used to examine the small intestine. It was part of a renewed effort to detect problems before they cause widespread harm.
Inspectors found that Mass. General failed to report two patient deaths. The FDA faulted Brigham and Women's for failing to report one death and for submitting four reports on patient injuries late. UMass Memorial was cited for failure to report infections in patients, three of whom later died.