The FDA recently cracked down on three major Massachusetts hospitals–Mass. General, Brigham and Women’s, and UMass Memorial–for not adequately reporting patient deaths and injuries caused by medical devices. Federal regulators also faulted a dozen additional medical centers across the nation–including well-known hospitals in Los Angeles, Boston, and New York–as part of an effort to detect problems before they cause widespread harm.
Regulators inspected 17 Massachusetts hospitals over a two-year period with a focus on contaminated instruments, which have the potential to spread infection. There was particular concern over duodenoscopes, which are used to view the small intestine, and the power morcellator, a surgical device that breaks up tissue and may spread uterine cancer in women.
The FDA regulates a broad range of medical devices, including complicated, high-risk medical devices, like artificial hearts, and relatively simple, low-risk devices, like tongue depressors, as well as devices that fall somewhere in between, like sutures. The FDA has the authority to regulate medical devices before and after they reach the marketplace.
Under federal rules, hospitals have 10 days to report serious injuries potentially caused by devices to the manufacturer, and they must notify both the manufacturer and the FDA within 10 days when a death occurs. Manufacturers are required to file reports to the FDA within 30 days of an injury or death that may have been caused by a device. For the most serious problems that would require immediate action to avoid major public health harm, companies have five days to report them to the FDA.
Last month, the agency disclosed the inspection reports, which revealed that 15 of the 17 Massachusetts hospitals were either late in reporting or did not report at all cases in which patients were infected by medical instruments. The director of the FDA’s center for devices and radiological health recently wrote on the agency’s website that these types of problems are widespread. “We believe that these hospitals are not unique in that there is limited to no reporting to the FDA or to the manufacturers at some hospitals.”
In addition to contaminated devices, the inspections also revealed other issues. The FDA found that Mass. General failed to report two patient deaths–one of which was caused by a heart attack in the hospital’s emergency room. The FDA also indicated that the hospital neglected to report a patient injury and was late in reporting deaths during two surgeries.
While specific details regarding the devices involved were withheld from the reports, Mass. General executives indicated that a monitor was involved in one patient’s death. They also said the FDA examined cases involving duodenoscopes but could not reveal more, based on patient privacy concerns. Relatedly, a January Senate report listed Mass. General as one of the hospitals with patient infections related to contaminated duodenoscopes. This report encouraged the FDA to inspect that particular hospital as part of its investigation.
A Mass. General quality and safety representative said the hospital has a strong record of reporting device problems, but the FDA is widening what hospitals are required to report, and “they are ramping up surveillance.”
According to the representative, the hospital did not report the cases recently cited by the FDA because they weren’t sure the device caused the problem. She expanded that the FDA expects them to report problems even when the device worked perfectly.
The FDA cited Brigham and Women’s for failing to report one death and for submitting four late reports on patient injuries. UMass Memorial was faulted for not reporting infections in patients who later died not from the infection but from the underlying illness. UMass’ chief of gastroenterology stated they failed to report these incidents because the hospital could not with certainty link the bacteria to the infections at issue.
The FDA considers prompt reporting of device-related patient injuries and deaths crucial to improving patient care and the safety of medical devices.
If you have been harmed by someone else’s negligence, you may need the assistance of a medical malpractice lawyer to seek compensation. At the Neumann Law Group, our Massachusetts attorneys provide trustworthy legal representation to victims all over the state. Contact us toll-free at 800-525-NEUMANN or use our online form to set up a free consultation.
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