Reprocessing of Single-use Medical Devices: Hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Sixth Congress, Second Session ... June 27, 2000, Volume 4
U.S. Government Printing Office, 2000 - Disposable medical devices - 215 pages
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ADDM adverse events agency approval balloon biofilm biopsy forceps Boston Scientific Corporation CDRH Chairman Cleveland Clinic Clorox cost demonstrate designed device manufacturers disposable devices draft guidance electrophysiology electrophysiology catheters endoscopic Enforcement Priorities Guidance ensure EP catheters exemption FDA Prioritization Scheme FDA Proposed Strategy FDA's FDCAct FEIGAL Feltner flowcharts GAO report guidance document health care facilities healthcare Heinrich hospitals informed consent intended issue labeled for single lumen MDR reports medical device reprocessing medical devices OEMs original equipment manufacturers oversight patient injuries patient safety performance premarket requirements PTCA public health regulation regulatory reproc reprocessed devices reprocessed single reprocessed SUDs reprocessing and reuse resterilization result reusable devices Reuse of Single Reuse of Single-Use Risk Categorization risk devices safely reprocessed safety and effectiveness Senator COLLINS Senator DODD single use devices single-use medical devices specific standards sterilization studies submitted SUD reprocessing testing third-party reprocessors tion Warning Letter