A recent report released by the FDA indicates over a dozen hospitals nationwide, including three in Massachusetts alone, have been cited for failing to report patient injuries and deaths due to faulty medical devices. The FDA inspected 17 hospitals over a two-year period as part of an improved attempt to ensure problems such as these are identified and stopped before becoming a widespread issue that puts countless patients in harm’s way while undergoing treatment in a hospital setting. Massachusetts General Hospital, UMass Memorial, and Brigham and Women’s Hospital were all identified as having been in violation.
Federal regulators expressed their concerns over the possible spread of infections due to contaminated medical instruments and devices, including duodenoscopes used to examine the small intestine and power morcellators, which are surgical devices used to cut tissue and have been linked to the spread of uterine cancer in women exposed to the tainted tools.
Among other infringements, the FDA found Massachusetts General Hospital had failed to report two patient deaths, while citing Brigham and Women’s for failing to report one death and filing reports regarding four patient injuries late. They also discovered UMass Memorial had failed to report numerous patient injuries entirely, wherein three of the patients later died.
One of the unreported deaths at Mass General was the result of a heart attack suffered in the Emergency Room. Though representatives for the hospital said they used a monitor in the situation, they continued to state they could not release any further information due to patient privacy rights. However, they maintain they actively adhere to regulatory guidelines involving the reporting of device safety and/or malfunction. Hospitals are given 10 days to provide any and all information they can regarding faulty equipment they believe “has or may have caused or contributed to” patient injury or death.
Mass General’s senior vice president of quality and safety, Dr. Elizabeth Mort, said over the two-year examination period, the hospital presented 72 voluntary reports and 10 mandatory reports related to device safety concerns, none of which involved any injury or harm to patients. She said the incidents in question were not reported to the FDA because “we didn’t necessarily think the device caused the problem.”
In the case of the patient who died of a heart attack, the monitor used did not indicate the patient had a pacemaker because it was not designed to do so, with Mort saying, “They want us to report problems even when the device worked perfectly. They are ramping up surveillance. If the design could be improved, the FDA wants to know about it.”
In a blog posted on October 24 to their website, the FDA’s director of the center for devices and radiological health, Dr. Jeffery Shuren, wrote the issues surrounding contaminated or faulty equipment are far more prevalent than most know and should not be considered isolated incidents at a mere handful of facilities; a frightening revelation for anyone who must trust that their health and well-being is a top priority when undergoing necessary medical treatment in a hospital.
FDA spokeswoman Deborah Kotz stated in an email she understands health care providers may not always be aware patients’ infections, injury or death are the result of exposure to faulty or contaminated devices, but “nevertheless, the FDA considers hospital reporting of device-related patient deaths and serious injuries to be critical to improving the safety of medical devices and improving patient care overall.”
One can hope these recent findings will encourage all hospitals and their staff throughout the nation to keep a more critical eye on both their patients and the equipment designed to heal instead of harm. It can’t be argued a hospital stay is a dreaded one; such dread shouldn’t be compounded by the fear of a graver illness or death. Equipment can be replaced; a human life cannot.
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