- Associated Press - Monday, November 28, 2016

BOSTON (AP) - Three Massachusetts hospitals are among several nationwide cited by federal regulators for failing to properly report patient deaths and injuries that may have been caused by medical devices.

The Boston Globe (https://bit.ly/2fWqzmy ) reported that Massachusetts General, UMass Memorial and Brigham and Women’s were among 17 hospitals inspected last December by the Food and Drug Administration. Regulators were concerned about infections possibly linked to contaminated instruments used to examine the small intestine. It was part of a renewed effort to detect problems before they cause widespread harm.

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.

Inspectors found that Mass General failed to report the deaths of two patients, one of whom suffered a heart attack in the emergency department.

In those cases, the hospital did not report them because “we didn’t necessarily think the device caused the problem,” said Dr. Elizabeth Mort, the hospital’s senior vice president of quality and safety.

The FDA faulted Brigham and Women’s for failing to report one death and for submitting four reports on patient injuries late. The death involved a patient treated with a device that shreds tissue.

Brigham and Women’s spokeswoman Erin McDonough said the hospital did not think the patient death needed to be reported because the device functioned as intended.

UMass Memorial was cited for failure to report infections in patients who later died not from the infection but from the underlying illness.

The hospital was never able to find the same bacteria on the devices and therefore could not definitively link them to the infections, said Dr. Dominic Nompleggi, its chief of gastroenterology.

UMass Memorial reported the cases to state public health officials but did not believe it had to inform the FDA, he said.


Information from: The Boston Globe, https://www.bostonglobe.com

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