Friday, March 9, 2018

When safety reporting leads to change

SAFETY FIRST: Peter L. Slavin, MD, MGH president, third from left, with staff from the MGH Neurology and Radiology Departments

At the MGH, staff put patient safety first. So when a patient in the 3-T MRI scanner reported he was feeling a heating sensation on his neck, the procedure was stopped and staff immediately began to investigate the cause.

They identified a specific continuous electroencephalogram (cEEG) lead – that was manufactured to be longer than the other leads attached tothe patient’s scalp – to be the cause of the heating. MRI leadership – working with Neurology Quality Assurance and Clinical Neurophysiology/EEG Lab leadership – filed a safety report, while Imaging staff and the Center for Quality & Safety staff specialists also reported the issue to the U.S. Food & Drug Administration’s (FDA) Medical Product Safety Network (MedSun).

“MGH has reported many products to the FDA MedSun website since 2009, including 64 reports in 2017,” said John Murphy, RN, staff specialist in the MGH Center for Quality & Safety. “The feedback from front-line staff, who use these products daily, is invaluable to manufacturers.” Through working with the manufacturer, it was discovered the MGH was the only site using the MRI-compatible long leads that were causing issue.

“Staff are encouraged to enter a safety report and to alert their manager when a product is or could present a risk for harm to a patient or staff member,” Murphy said.

The FDA Center for Devices and Radiological Health recognized the MGH – specifically members of the MGH Radiology and Neurology Departments – for contributing to this significant safety action. Staff gathered March 5 outside the MRI Unit to receive their FDA Certificates for Outstanding Contribution in Promoting Patient Safety With Medical Devices.

“Congratulations to the entire team,” said Aneesh Singhal, MD, vice chair of Neurology. “This is such great validation of our quality and safety improvement process.”



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