Inspections at 17 hospitals revealed widespread under-reporting of injuries and deaths associated with medical devices. The U.S. Food and Drug Administration is seeking to improve the under-reporting following the high profile safety concerns involving power morcellators and contaminated duodenoscopes.
A duodenoscope is a device that is inserted through the mouth and throat to treat problems in the pancreas and bile ducts. If a scope is contaminated, it can spread infections from one patient to another. Morcellators are used to remove uterine fibroids, but can spread cancerous tissue around and beyond the uterus.
Dr. Jeffrey Shuren, head of the FDA’s device division, stated in a blog that many of the incidents uncovered at the 17 hospitals should have been reported, but were not, which is in violation of the FDA’s reporting requirements. He went on to say, “We believe that these hospitals are not unique in that there is limited to no reporting to FDA or to the manufacturers.” In some instances, hospital staff were not aware of the FDA’s medical device requirements, nor were they trained to comply with it.
When someone is injured or dies as a result of negligence, financial recovery may be available. Such recovery is particularly important when permanent, life changing injuries are incurred. It is important to contact someone who understands the intricacies of the injured party’s right to recover.