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FDA Cites Hospitals Over Reporting Procedures

12/21/16 11:03 AM

Three Massachusetts hospitals are in the spotlight after federal regulators say they failed to properly report patient deaths and injuries that may have been caused by medical devices. Massachusetts General, Brigham and Women's and UMass Memorial were among the 17 hospitals nationwide inspected by the FDA last December over concerns about infections possibly linked to contaminated instruments.

The FDA is ramping up their surveillance after being criticized in the past for not acting quickly when it appears a device may be a threat to a patient. The agency says it's becoming a widespread issue that needs reinforcement since the agency relies on hospitals to help identify safety problems.

Last month, the FDA released the inspection reports showing 15 of the 17 medical centers were either late reporting cases, or failed to report at all.

Massachusetts General

FDA inspectors claim the hospital failed to report the deaths of two patients and a patient injury, and was late reporting the deaths of two surgery patient, as well as an injury to another patient. The agency is withholding certain details from the report, including the devices involved. But the Boston Globe reached out to Mass. General Executives who say some cases involved duodenoscopes, which the hospital stopped using until they were able to confirm the instrument was not linked to any patient infections.

The duodenoscope, used to examine the small intestine, contains small working parts which if not thoroughly cleaned and disinfected could cause harm to the patient.

In cases cited by the FDA, the hospital says it did not report them because they did not believe the device cause the problem. On the defense, the hospital says over the two-year period reviewed by the FDA, they submitted seven mandatory reports and 72 voluntary reports about concerns with devices that did not cause harm.

Brigham and Women's

This hospital was faulted by the FDA for failing to report the death of one patient and for four late reports on patient injuries, which the hospital say involved cardiac patients.

In the case of the patient death in December 2013, the patient died 18 months after undergoing a procedure involving a power morcellator, used to shred tissues and extract it during hysterectomies. Two months before that, a doctor undergoing a hysterectomy at Brigham reported the risk of morcellation after the device spread cancerous tissue throughout her body during the surgery.

Since then, the FDA issued a safety advisory discouraging the use of morecellators.

UMass Memorial

FDA findings show the medical center did not report infections in patients who had undergone a procedure with a duodenoscope. The FDA report says three of those patients later died, however, two had complicated illnesses.

UMass Memorial says 14 patients developed infections stemming from procedures with a duodenoscope, but never found the same bacteria on the scopes to definitely linking them to the infections. The hospital reported the cases to Massachusetts public health officials, but did not know they also had to tell the FDA.

Hospitals are required to report within 10 days if a medical device is believed to have caused of contributed to an injury or death of a patient. The FDA is not taking further action against the hospital because they are all trying to improve reporting practices.

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