The U.S. Food and Drug Administration is seeking to improve hospital reporting of injuries and deaths associated with medical devices after inspections at 17 hospitals revealed widespread under-reporting of such events.
The FDA initiated the inspections following high-profile safety scandals involving power morcellators and contaminated duodenoscopes.
Morcellators are used to remove uterine fibroids but can spread unsuspected cancerous tissue beyond the uterus. Duodenoscopes are threaded through the mouth and throat to treat problems in the pancreas and bile ducts. Contaminat