Archive for FDA investigation

FDA Investigates Hospitals Failing to Report Deaths and Injuries

Three major Massachusetts hospitals have been investigated by the FDA following concerns that the hospitals were failing to report deaths and injuries caused by medical equipment. Massachusetts General, Brigham and Women’s, and UMass Memorial were among 17 other hospitals nationwide also investigated for the ill reporting.

The FDA is cracking down on reports of death and injuries that may have been caused by specific medical equipment in hospitals. The FDA is increasing their efforts to detect problems in certain equipment before widespread harm occurs. One main concern was based on the duodenoscopes, which is a medical instrument used to examine the small intestine. These instruments are used in more than 500,000 procedures in the United States each year, according to the FDA. This instrument has been linked to spreading infection in the body. The power morcellator device is also under investigation, based on speculation that the surgical device spreads uterine cancer.

The FDA investigation showed that 15 of the 17 hospitals were either late to report medical device related deaths or injuries or failed to report some altogether. The main concern for regulators is making sure that these reports are investigated and that changes are made to certain medical devices if there is a pattern of incidents.

It is required by hospitals to report any information that may suggest a medical device may have caused a serious injury or death within 10 days. Some hospitals under fault explained that some injuries and deaths were not reported because it was not certain that the medical devices were the the main cause of the problems.

At UMass Memorial Medical Center, the FDA found multiple failures in reporting for patients that were infected after undergoing procedures that used a duodenoscope. Three of the patients infected later died from their illnesses. The chief of gastroenterology at UMass Memorial, Dr. Dominic Nompleggi, explained that although infections were developed by patients, the hospital failed to link the same bacteria from the infections to the scopes, and therefore could not link the scopes to the patient’s illnesses.

There have been no legal actions taken against these hospitals by the FDA, because the main concern is to improve reporting for the safety of patients. The investigated hospitals will be closely watched for accurate reporting of medical instrument related injuries and deaths moving forward.