Hospitals faulted for failing to report deaths, injuries
Federal regulators have faulted three large Massachusetts hospitals, along with a dozen more nationwide, for failing to properly report patient deaths and injuries that may have been caused by medical devices — part of a renewed effort to detect problems before they cause widespread harm.
Massachusetts General, Brigham and Women’s, and UMass Memorial were among 17 hospitals inspected last December by the FDA. Regulators were concerned about infections possibly linked to contaminated instruments called duodenoscopes, used to examine the small intestine, and about the spread of uterine cancer when a surgical device called a power morcellator, which cuts up tissue, is used.
Last month, the agency disclosed the inspection reports, showing that 15 of the 17 medical centers were either late in reporting cases in which patients were harmed by various devices or failed to report at all. The FDA inspection reports also disclosed other lapses.
Dr. Jeffrey Shuren, director of the FDA’s center for devices and radiological health, said in an Oct. 24 blog post on the agency’s website that the problems identified at these hospitals are hardly unique and, in fact, are widespread.
The Food and Drug Administration, device makers, and hospitals have been criticized for failing to act quickly when it appears a device may cause a threat. The FDA depends on hospitals to help identify new safety problems with devices and to report upswings in previously recognized problems.
Agency inspectors found that Mass. General failed to report the deaths of two patients, one of whom suffered a heart attack in the emergency department. The FDA withheld certain details from the reports, including descriptions of the devices involved — though Mass. General executives said the agency examined cases involving duodenoscopes as well as other devices.
Mass. General executives said a monitor was involved in the emergency department patient’s death, adding that they could not provide more information because of patient privacy concerns. The FDA said the hospital also failed to report a patient injury and was late in reporting the deaths of two surgery patients and an injury to another patient.
Dr. Elizabeth Mort, senior vice president of quality and safety, said Mass. General has a strong history of bringing forward device problems, but the FDA “is widening the net’’ of incidents that hospitals must report to the agency, manufacturers, or both.
The FDA “may be able to draw conclusions that one institution cannot draw,’’ she said.
Hospitals are required to report within 10 days information that “reasonably suggests that a medical device has or may have caused or contributed to’’ a serious injury or death of a patient.
Over the two-year period the FDA examined, Mass. General submitted seven mandatory reports, plus 72 voluntary reports about concerns with devices that did not involve patient harm, Mort said.
In cases cited by the agency, the hospital did not report them because “we didn’t necessarily think the device caused the problem,’’ Mort said. For example, a monitor did not detect that the patient had a pacemaker but it was not designed to do so, Mort said.
“They want us to report problems even when the device worked perfectly,’’ she said. “They are ramping up surveillance. If the design could be improved, the FDA wants to know about it.’’
The January report from the Senate Committee on Health, Education, Labor, and Pensions listed Mass. General as one of the hospitals with patient infections tied to contaminated duodenoscopes, which is apparently why the FDA inspected the hospital.
Mort said that in late 2014 and early 2015, Mass. General reported concerns about the device to the manufacturer and stopped using it. But in the end, extensive testing by the hospital was unable to tie patient infections to the instruments, despite the report’s initial conclusion.
The FDA faulted the Brigham for failing to report the death of one patient and for submitting four reports on patient injuries late. The patient, who died in December 2013, had undergone a procedure 18 months earlier with a power morcellator, often used during hysterectomies to shred tissue and extract it through small incisions.
The risk of morcellation was brought to public attention by Dr. Amy Reed. Soon after undergoing a hysterectomy at the Brigham in October 2013, follow-up tests on the removed tissue showed that she had an aggressive cancer, and that the cancerous tissue had been spread throughout her abdominal cavity during the surgery, sparking advanced cancer. She and her husband, Dr. Hooman Noorchashm, have fought an aggressive battle against morcellation and the hospital.
Brigham spokeswoman Erin McDonough said the hospital contacted the FDA by phone in March 2014 about the patient’s death and Reed’s case but did not believe they met the criteria for mandatory reporting.
“The device functioned as expected and was used in the way it was intended, although with unintended and tragic consequences,’’ she said in an e-mail. The FDA later issued a clarification, saying that such cases should be reported, and discouraged the use of morcellators through a safety advisory.
The four reports regarding injuries involved cardiac patients, McDonough said. But she said one case did not need to be reported and a second had misstated the date of the incident and was actually filed on time.
The FDA findings at UMass Memorial Medical Center in Worcester included failure to report infections in patients who had undergone a procedure with a duodenoscope. Three of those patients later died, but two of the patients had complicated illnesses, the FDA report said.
Dr. Dominic Nompleggi, chief of gastroenterology at UMass Memorial, said 14 patients developed infections. But he said the hospital was never able to find the same bacteria on the scopes, and therefore could not definitively link them to the infections. He said UMass Memorial reported the cases to Massachusetts public health officials but did not believe it also had to tell the FDA.
Hospitals use hundreds of medical devices, including imaging machines, heart testing devices,and in-vitro tests to make diagnoses; infusion pumps, ventilators, and robotics to provide treatment; and an array of implants to replace diseased joints and organs.
Chris Lavanchy, engineering director in the health devices division of ECRI Institute, a Pennsylvania-based patient safety organization, said over-reporting of incidents is also a problem. Hospitals report numerous cases in which it’s unclear if the device was related to the patient injury, making it hard for the FDA to untangle problems. Investigations become even more challenging when the injury involves the spread of cancer or infection, which can occur days or even years after the procedure.
The FDA did not take further action against the hospitals because it said they were all trying to improve reporting practices.
Spokeswoman Deborah Kotz said the agency recognizes “it may not be immediately apparent to health care providers that a patient’s exposure to a device may have caused or contributed to that patient’s death.’’
“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,’’ she said in an e-mail.