The FDA’s Medical Product Safety Network, MedSun, recently awarded Tulane Medical Center a Certificate of Outstanding Contribution in Promoting Patient Safety for calling attention to a potential issue that could have harmed endoscopy patients nationwide. Staff at Tulane reported concerns with regard to an inadequate disinfection process based on manufacturer’s instructions for a piece of endoscopy equipment. Earlier this year, nurses in Tulane Medical Center’s Endoscopy Unit stopped the introduction of a new piece of equipment when they realized the manufacturer’s written instructions for the disinfectant process didn’t seem right. The instructions differed from the guidance provided by the vendor and were inconsistent with CDC guidelines related to high-level disinfection.
The Tulane nurses shared their concern with the pump manufacturer, and when they did not satisfactorily change the instructions, the Tulane team filed a report with FDA’s Medical Product Safety Network (MedSun). The FDA uses reports made by direct-care users in the MedSun database to improve the safety of devices in development and to optimize safe use in the field. As a result, the manufacturer changed the disinfection instructions to make them compliant with national guidelines and resolved patient safety concerns nationwide.