Morcellator Cancer Deaths, Duodenoscope Infection Risks Spur FDA Meeting On Hospitals Reporting Medical Device Problems
Federal health regulators are holding a meeting today to discuss how to get hospitals to improve their reporting practices when they witness medical devices that are problems for patients.
The FDA is holding a public workshop today with the goal of getting hospitals to report medical device problems more frequently, and as soon as problems occur. The FDA has found reporting lapses linked to a number of recent health concerns, including the spread of cancer cells by power morcellators during laparoscopic hysterectomies, and the spread of infections linked to contaminated duodenoscopes.
In both cases, hospitals knew there were problems with widely used medical devices, but failed to report those issues to the FDA, which may have delayed the agency from acting to prevent more injuries, illnesses and deaths nationwide.
The public workshop was first announced in late October in the Federal Register. It is being held today from 8:30 a.m. until 5:30 p.m. at the Fishers Lane Conference Center in Rockville, Maryland. The workshop will focus on the role of hospitals in evidence generation, and their role in the National Medical Device Evaluation System.
The workshop comes about a year after the FDA inspected 17 hospitals nationwide, and discovered that the hospitals had known there were problems with power morcellators and contaminated duodenoscopes.
In a blog post in October, the day the public workshop was announced, the director of the FDA’s Center for Devices and Radiological Health, Dr. Jeffrey Shuren, warned that federal law requires hospitals to report medical device problems, even though the agency has not taken stringent enforcement actions to ensure compliance.
“Although FDA has recognized that requiring all hospitals and other user facilities to report may provide limited added value and could entail unnecessary costs that take away from patient care, we have not yet established the program limiting reporting to a subset of user facilities,” Shuren wrote. “In the past, we have not enforced universal reporting requirements for hospitals and other user facilities.”
However, the agencies inspections revealed that some hospitals failed to report serious injuries or deaths linked to medical device problems, and in some cases did not have adequate reporting policies in place. Some of the inspections revealed that not only were some hospital staff not trained to comply with mandatory reporting requirements, they were not even aware they existed.
“Based on the number of user facilities in the United States and the number of reports we receive, we believe that these hospitals are not unique in that there is limited to no reporting to FDA or to the manufacturers at some hospitals,” Shuren wrote. “We want to work with all hospitals to address these issues.”
The meeting also comes after some lawmakers introduced the “Medical Device Guardian’s Act” in June, which would require doctors and hospitals to report when patients suffer an adverse event due to a medical device. The legislation proposed to provide doctors with protection from liability when they made such reports. The bill’s sponsors directly tied the legislation to the lack of reporting by hospitals surrounding morcellator cancer risks.
Power morcellators are medical devices used during laparoscopic hysterectomies and myomectomies, allowing surgeons to cut up the uterus and uterine fibroids through a small incision in the abdomen. The procedures were often recommended instead of open procedures over the past decade, since they generally limit the risk of complications and reduce recovery time.
Since 2014, the devices have been largely abandoned by hospitals and surgeons, after it was discovered that morcellation may spread lyomyosarcoma, endometrial stromal sarcoma or other undiagnosed cancers that may be hidden within the uterus, causing the previously contained cancer to rapidly spread throughout the body.
Since warnings about the link between cancer and morcellation were issued by federal regulators in April 2014, the medical community has largely abandoned the use of morcellators, and Johnson & Johnson’s Ethicon unit, which was previously the main manufacturer of the device, stopped selling the tool.
Johnson & Johnson has faced dozens of morcellation lawsuits brought on behalf of women who suffered upstaged uterine cancer after a laparoscopic procedure, and wrongful death claims by family members who had died of such cancers.
While most of those cases have been resolved through morcellator settlement agreements, a number of other morcellator manufacturers continue to face claims alleging that they failed to warn the medical community about cancer risks.
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