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[30] A. Srinivasan, L.L. Wolfenden, S. Xiaoyan, K. Mackie, et al., An outbreak of Pseu-
domonas aeruginosa infections associated with flexible bronchoscopes, N. Engl. J. Med.
348 (January 6, 2003) 221–227.
[31] Filthy surgical instruments: The hidden threat in America’s operating room, in: How
Dirty Medical Devices Expose Patients to Infection, February 22, 2012. iWatch News.
[32] Preventable Tragedies: Superbugs and how Ineffective Monitoring of Medical De-
vice Safety Fails Patients. United States Senate, Health, Education, Labor and Pensions
Committee, Patty Murray Ranking Member Minority Staff Report, January 13, 2016.
[33] AAMI TIR30:2011, A compendium of processes, materials, test methods, and accept-
ance criteria for cleaning reusable medical devices, Association for the Advancement of
Medical Instrumentation, Arlington, VA, 2006.
[34] ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Comprehen-
sive guide to steam sterilization and sterility assurance in health care facilities, Associa-
tion for the Advancement of Medical Instrumentation, Arlington, VA, 2013.