A dozen hospitals worldwide, including three large hospitals in Massachusetts, have been faulted by Federal regulators for failing to properly report the injuries and deaths. Due to a lack of effort by medical facilities to detect problems with certain medical devices, these devices may have caused significant harm.
Massachusetts General Hospital, Brigham and Women’s Hospital, and UMass Memorial Hospital were three of seventeen hospitals inspected last December by the Food and Drug Administration (FDA). Duodenoscopes, which are used to examine the small intestine, were a concern for regulators, who acknowledged the fact that this instrument could have a possible link to infections. Another device that regulators connect with the possible spread of uterine cancer is a known as a power morcellator, which is used my physicians to cut tissue. Fifteen out of seventeen medical centers were found to have either missed or failed to report cases in which patients were harmed by devices. Director of the FDA’s center for devices and radiological health, Dr. Jeffrey Shuren, stated that the problems that were identified at these hospitals are widespread.
The FDA depends on hospitals to identify new safety problems with devices and to report any problems. Simply, there is no excuse for a defective medical device to be used in the care of patients, and equally impermissible for a care provider to fail to issue a report once a defect is known. Mass General Hospital, for example, failed to report the death of two patients. These two patients both suffered heart attacks. Hospitals are required to report with 10 days information about a medical device that may cause or has caused a serious injury or death of a patient. Dr. Elizabeth Mort, Senior Vice President of Quality and Safety at Mass General, stated that her hospital did not report the incidents because they did not believe the device was at fault for the patient’s harm.
There are numerous patient safety concerns raised by the growing use of advanced medical devices. The attorneys at Swartz & Swartz, P.C. have the resources and experience necessary to assist with any questions or concerns you may have regarding your medical care, or care provided to a loved one. Please contact our Boston, Massachusetts office at (617) 742-1900, or toll-free at (800) 545-3732.