The Medical Product Safety Network (MedSun) is an event reporting program launched in 2002 by the U.S. Food and Drug Administration’s Center for Devices and Radiological Health. The primary goal for MedSun is to work collaboratively with the clinical community and partner healthcare facilities, as well as manufacturers to identify, understand and solve problems with the use of medical devices. Recently, Brigham and Women’s Faulkner Hospital submitted a report to MedSun that resulted in a manufacturer action.
“In this case, surgeons and operating room staff members reported incorrect measurements/calibrations on various Conformis iTotal Hip Replacement devices,” says Senior Risk Manager Allyson Hammerstedt, Esq. “Our OR Materials Management team alerted the company and the Risk Management and Patient Safety Department reported the issue and affected lot numbers to MedSun. Notably, the team’s collaboration and due diligence resulted in a class II recall of the product by Conformis.
For their efforts, BWFH was awarded with a certificate signed by the Director of the Center for Devices and Radiological Health Dr. Jeffrey Shuren. The certificate recognizes BWFH’s contribution to a significant safety action.
At BWFH, when you report an adverse event, or a near miss event, related to a problem with a medical device in RL Solutions, that information is relayed by Brigham and Women’s Faulkner Hospital’s Risk Management team to the FDA through MedSun. In these events, remember to save the device’s packaging in order for Risk Management to provide MedSun with the information needed. Questions? Contact Allyson Hammerstedt at 617-983-7970.
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