FDA dings hospitals over medical device adverse event reporting failures

The FDA today released a list of hospitals tagged over inadequate medical device reporting issues, naming 17 in a review covering the period between April, 2016 and now.

Included on the list are Los Angeles’ Cedars-Sinai Medical Center, Boston’s Brigham and Woman’s Hospital and Massachusetts General Hospital, UCLA’s Ronald Reagan Medical Center and Pittsburgh, Penn.’s Allegheny General Hospital.

The most common negative mark from the FDA related to a failure to submit a Form 3500A after “becoming aware of information that reasonably suggests that a device has or may have caused or contributed to the death of a patient of the facility,” according to the FDA release. A total of 12 of the 17 facilities were dinged on not submitting the forms within the 10 days the federal watchdog requires.

The agency dinged 10 facilities on issues related to written medical device reporting procedures, most of which had not been developed or implemented at the hospitals.

The Park Ridge, Ill.-based Advocate Lutheran General Hospital was the FDA’s largest offender, with 7 different Form FDA 483 observations listed relating to medical device reporting issues, including failing to develop written MDR procedures, failing to include all information necessary on submissions and other reporting issues.

The agency said it has held telephone regulatory meetings with all of the mentioned facilities to address the deviations, and has not yet received an appropriate response.

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