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Earl Gregg Swem Library

Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff

Categories: Consumer Info/Protection,Health/Medical,Laws/Regulations

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM253010.pdf

New guidance documents to enhance the safety of reusable medical devices and prevent the spread of infectious agents.  Follows an outbreak of infections traced to reused duodenoscopes.  From the Food and Drug Administration