Sterilizasyon: Teori, Uygulama, Kalite Yönetimi ve Güncel Yaklaşımlar
Özet
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Referanslar
McDonnell G, Russell AD. Antiseptics and disinfectants: activity, action, and resistance. Clin Microbiol Rev. 1999;12(1):147–179. doi:10.1128/CMR.12.1.147
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Rowan NJ, Kremer T, McDonnell G. A review of Spaulding’s classification system for effective cleaning, disinfection and sterilization of reusable medical devices. Sci Total Environ. 2023;878:162976. doi:10.1016/j.scitotenv.2023.162976
McDonnell G, Burke P. Disinfection: is it time to reconsider Spaulding? J Hosp Infect. 2011;78(3):163–170. doi:10.1016/j.jhin.2011.05.002
McDonnell G, Russell AD. Antiseptics and disinfectants: activity, action, and resistance. Clin Microbiol Rev. 1999;12(1):147–179. doi:10.1128/CMR.12.1.147
Maillard J-Y, Pascoe M. Disinfectants and antiseptics: mechanisms of action and resistance. Nat Rev Microbiol. 2024;22(1):4–17. doi:10.1038/s41579-023-00958-3
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Donlan RM. Biofilms: microbial life on surfaces. Emerg Infect Dis. 2002;8(9):881–890. doi:10.3201/eid0809.020063
Bridier A, Briandet R, Thomas V, Dubois-Brissonnet F. Resistance of bacterial biofilms to disinfectants: a review. Biofouling. 2011;27(9):1017–1032. doi:10.1080/08927014.2011.626899
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Rutala WA, Weber DJ. Disinfection, sterilization, and antisepsis: an overview. Am J Infect Control. 2016;44(5 Suppl):e1–e6. doi:10.1016/j.ajic.2015.10.038
McDonnell G, Russell AD. Antiseptics and disinfectants: activity, action, and resistance. Clin Microbiol Rev. 1999;12(1):147–179. doi:10.1128/CMR.12.1.147
Maillard J-Y, Pascoe M. Disinfectants and antiseptics: mechanisms of action and resistance. Nat Rev Microbiol. 2024;22(1):4–17. doi:10.1038/s41579-023-00958-3
McDonnell G, Burke P. Disinfection: is it time to reconsider Spaulding? J Hosp Infect. 2011;78(3):163–170. doi:10.1016/j.jhin.2011.05.002
Rutala WA, Weber DJ. Selection of the ideal disinfectant. Infect Control Hosp Epidemiol. 2014;35(7):855–865. doi:10.1086/676877
Maillard J-Y. Bacterial target sites for biocide action. J Appl Microbiol. 2002;92(Suppl):16S–27S. doi:10.1046/j.1365-2672.92.5s1.3.x
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Rutala WA, Weber DJ. Disinfection, sterilization, and antisepsis: an overview. Am J Infect Control. 2016;44(5 Suppl):e1–e6. doi:10.1016/j.ajic.2015.10.038
Rowan NJ, Kremer T, McDonnell G. A review of Spaulding’s classification system for effective cleaning, disinfection and sterilization of reusable medical devices. Sci Total Environ. 2023;878:162976. doi:10.1016/j.scitotenv.2023.162976
Rutala WA, Weber DJ. Reprocessing semicritical items: an overview and an update on the shift from HLD to sterilization for endoscopes. Am J Infect Control. 2023;51(11 Suppl):A96–A106. doi:10.1016/j.ajic.2023.01.002
McDonnell G, Burke P. Disinfection: is it time to reconsider Spaulding? J Hosp Infect. 2011;78(3):163–170. doi:10.1016/j.jhin.2011.05.002
Kommission für Krankenhaushygiene und Infektionsprävention (KRINKO) beim RKI und des BfArM. Anforderungen an die Hygiene bei der Aufbereitung von Medizinprodukten. Bundesgesundheitsblatt. 2012;55(10):1244–1310. doi:10.1007/s00103-012-1548-6
International Organization for Standardization (ISO) / European Committee for Standardization (CEN). EN ISO 17664 (Parts 1–2) — Processing of health care products: information to be provided by the medical device manufacturer for the processing of medical devices. Geneva/Brussels: ISO/CEN.
Rutala WA, Weber DJ. Disinfection, sterilization, and antisepsis: an overview. Am J Infect Control. 2016;44(5 Suppl):e1–e6. doi:10.1016/j.ajic.2015.10.038
Alfa MJ. Medical instrument reprocessing: current issues with cleaning and cleaning monitoring. Am J Infect Control. 2019;47S:A10–A16. doi:10.1016/j.ajic.2019.02.029
McDonnell G, Russell AD. Antiseptics and disinfectants: activity, action, and resistance. Clin Microbiol Rev. 1999;12(1):147–179. doi:10.1128/CMR.12.1.147
Donlan RM. Biofilms: microbial life on surfaces. Emerg Infect Dis. 2002;8(9):881–890. doi:10.3201/eid0809.020063
Bridier A, Briandet R, Thomas V, Dubois-Brissonnet F. Resistance of bacterial biofilms to disinfectants: a review. Biofouling. 2011;27(9):1017–1032. doi:10.1080/08927014.2011.626899
Alfa MJ, Howie R. Modeling microbial survival in buildup biofilm for complex medical devices. BMC Infect Dis. 2009;9:56. doi:10.1186/1471-2334-9-56
Alfa MJ, Ribeiro MM, da Costa Luciano C, Franca R, Olson N, DeGagne P, et al. A novel polytetrafluoroethylene-channel model, which simulates low levels of culturable bacteria in buildup biofilm after repeated endoscope reprocessing. Gastrointest Endosc. 2017;86(3):442–451.e1. doi:10.1016/j.gie.2017.05.014
Moshkanbaryans L, Shah V, Tan LY, Jones MP, Vickery K, Alfa M, et al. Comparison of two endoscope channel cleaning approaches to remove cyclic build-up biofilm. J Hosp Infect. 2024;150:91–95. doi:10.1016/j.jhin.2024.05.014
Roberts CG. The role of biofilms in reprocessing medical devices. Am J Infect Control. 2013;41(5 Suppl):S77–S80. doi:10.1016/j.ajic.2012.12.008
Oda Y, Takashima Y, Hirata Y. The effect of corrosion inhibition of the novel pre-cleaning spray detergent on stainless steel in the presence of chloride ions and its enhanced detergency. Antimicrob Resist Infect Control. 2013;2(Suppl 1):P384. doi:10.1186/2047-2994-2-S1-P384
Masia MD, Dettori M, Deriu GM, Bellu S, Arcadu L, Azara A, et al. ATP bioluminescence for assessing the efficacy of the manual cleaning procedure during the reprocessing of reusable surgical instruments. Healthcare (Basel). 2021;9(3):352. doi:10.3390/healthcare9030352
Rosário W, Almeida T, Andrade B, Aoki I, Silva B, Aramayo M, Watanabe E, Ribeiro M, Bruna C, Graziano K. Evaluation of the presence of biofilms in corrosive points in surgical instruments after reprocessing. Hygiene. 2022;2(4):243–250. doi:10.3390/hygiene2040022
Zhang Z, Jin P, Toh HX, Tan SG, How MKB, Tan KY, et al. Sharps injuries and bloodborne pathogen exposure among healthcare workers: a 5-year surveillance in a teaching hospital in Singapore. Antimicrob Steward Healthc Epidemiol. 2025;5(1):e105. doi:10.1017/ash.2025.105
Rutala WA, Weber DJ. Reprocessing semicritical items: an overview and an update on the shift from HLD to sterilization for endoscopes. Am J Infect Control. 2023;51(11 Suppl):A96–A106. doi:10.1016/j.ajic.2023.01.002
Association for the Advancement of Medical Instrumentation (AAMI). ANSI/AAMI ST79:2010 (R2017) & A1:2010 & A2:2011 & A3:2012 & A4:2013 — Comprehensive guide to steam sterilization and sterility assurance in health care facilities. Arlington, VA: AAMI; 2013.
International Organization for Standardization (ISO) / European Committee for Standardization (CEN). EN ISO 17664 (Parts 1–2) — Processing of health care products: information to be provided by the medical device manufacturer for the processing of medical devices. Geneva/Brussels: ISO/CEN.
Rutala WA, Weber DJ. Disinfection, sterilization, and antisepsis: an overview. Am J Infect Control. 2016;44(5 Suppl):e1–e6. doi:10.1016/j.ajic.2015.10.038
McDonnell G, Russell AD. Antiseptics and disinfectants: activity, action, and resistance. Clin Microbiol Rev. 1999;12(1):147–179. doi:10.1128/CMR.12.1.147
Alfa MJ. Medical instrument reprocessing: current issues with cleaning and cleaning monitoring. Am J Infect Control. 2019;47S:A10–A16. doi:10.1016/j.ajic.2019.02.029
Roberts CG. The role of biofilms in reprocessing medical devices. Am J Infect Control. 2013;41(5 Suppl):S77–S80. doi:10.1016/j.ajic.2012.12.008
Bridier A, Briandet R, Thomas V, Dubois-Brissonnet F. Resistance of bacterial biofilms to disinfectants: a review. Biofouling. 2011;27(9):1017–1032. doi:10.1080/08927014.2011.626899
Alfa MJ, Howie R. Modeling microbial survival in buildup biofilm for complex medical devices. BMC Infect Dis. 2009;9:56. doi:10.1186/1471-2334-9-56
Baxter RL, Baxter HC, Campbell GA, Grant K, Jones A, Richardson P, et al. Quantitative analysis of residual protein contamination on reprocessed surgical instruments. J Hosp Infect. 2006;63(4):439–444. doi:10.1016/j.jhin.2006.03.011
Rosário W, Almeida T, Andrade B, Aoki I, Silva B, Aramayo M, Watanabe E, Ribeiro M, Bruna C, Graziano K. Evaluation of the presence of biofilms in corrosive points in surgical instruments after reprocessing. Hygiene. 2022;2(4):243–250. doi:10.3390/hygiene2040022
Maillard J-Y, Pascoe M. Disinfectants and antiseptics: mechanisms of action and resistance. Nat Rev Microbiol. 2024;22(1):4–17. doi:10.1038/s41579-023-00958-3
Kato Y, Toga Y, Oda Y, Kawamukai E, Hirata Y. Study of enzymatic detergents with both cleaning efficacy and disinfecting action for medical devices. Antimicrob Resist Infect Control. 2015;4(Suppl 1):P37. doi:10.1186/2047-2994-4-S1-P37
Oda Y, Takashima Y, Hirata Y. The effect of corrosion inhibition of the novel pre-cleaning spray detergent on stainless steel in the presence of chloride ions and its enhanced detergency. Antimicrob Resist Infect Control. 2013;2(Suppl 1):P384. doi:10.1186/2047-2994-2-S1-P384
Masia MD, Dettori M, Deriu GM, Bellu S, Arcadu L, Azara A, et al. ATP bioluminescence for assessing the efficacy of the manual cleaning procedure during the reprocessing of reusable surgical instruments. Healthcare (Basel). 2021;9(3):352. doi:10.3390/healthcare9030352
Smith GWG, Goldie F, Long S, Lappin DF, Ramage G, Smith AJ. Quantitative analysis of residual protein contamination of podiatry instruments reprocessed through local and central decontamination units. J Foot Ankle Res. 2011;4:2. doi:10.1186/1757-1146-4-2
Association for the Advancement of Medical Instrumentation (AAMI). ANSI/AAMI ST98:2022 — Cleaning validation of health care products: requirements for development and validation of a cleaning process for medical devices. Arlington, VA: AAMI; 2022.
International Organization for Standardization (ISO) / European Committee for Standardization (CEN). EN ISO 15883 (series) — Washer-disinfectors. Geneva/Brussels: ISO/CEN.
Moshkanbaryans L, Shah V, Tan LY, Jones MP, Vickery K, Alfa M, et al. Comparison of two endoscope channel cleaning approaches to remove cyclic build-up biofilm. J Hosp Infect. 2024;150:91–95. doi:10.1016/j.jhin.2024.05.014
Association for the Advancement of Medical Instrumentation (AAMI). ANSI/AAMI ST79:2010 (R2017) & A1:2010 & A2:2011 & A3:2012 & A4:2013 — Comprehensive guide to steam sterilization and sterility assurance in health care facilities. Arlington, VA: AAMI; 2013.
Rutala WA, Weber DJ. Disinfection, sterilization, and antisepsis: an overview. Am J Infect Control. 2016;44(5 Suppl):e1–e6. doi:10.1016/j.ajic.2015.10.038
Alfa MJ, Olson N, DeGagne P. Automated washing with the Reliance Endoscope Processing System and its equivalence to optimal manual cleaning. Am J Infect Control. 2006;34(9):561–570. doi:10.1016/j.ajic.2006.01.010
Ofstead CL, Wetzler HP, Snyder AK, Horton RA. Endoscope reprocessing methods: a prospective study on the impact of human factors and automation. Gastroenterol Nurs. 2010;33(4):304–311. doi:10.1097/SGA.0b013e3181e9431a
Baxter RL, Baxter HC, Campbell GA, Grant K, Jones A, Richardson P, et al. Quantitative analysis of residual protein contamination on reprocessed surgical instruments. J Hosp Infect. 2006;63(4):439–444. doi:10.1016/j.jhin.2006.03.011
Smith GWG, Goldie F, Long S, Lappin DF, Ramage G, Smith AJ. Quantitative analysis of residual protein contamination of podiatry instruments reprocessed through local and central decontamination units. J Foot Ankle Res. 2011;4:2. doi:10.1186/1757-1146-4-2
Rosário W, Almeida T, Andrade B, Aoki I, Silva B, Aramayo M, Watanabe E, Ribeiro M, Bruna C, Graziano K. Evaluation of the presence of biofilms in corrosive points in surgical instruments after reprocessing. Hygiene. 2022;2(4):243–250. doi:10.3390/hygiene2040022
Roberts CG. The role of biofilms in reprocessing medical devices. Am J Infect Control. 2013;41(5 Suppl):S77–S80. doi:10.1016/j.ajic.2012.12.008
Alfa MJ, Howie R. Modeling microbial survival in buildup biofilm for complex medical devices. BMC Infect Dis. 2009;9:56. doi:10.1186/1471-2334-9-56
Moshkanbaryans L, Shah V, Tan LY, Jones MP, Vickery K, Alfa M, et al. Comparison of two endoscope channel cleaning approaches to remove cyclic build-up biofilm. J Hosp Infect. 2024;150:91–95. doi:10.1016/j.jhin.2024.05.014
Oda Y, Takashima Y, Hirata Y. The effect of corrosion inhibition of the novel pre-cleaning spray detergent on stainless steel in the presence of chloride ions and its enhanced detergency. Antimicrob Resist Infect Control. 2013;2(Suppl 1):P384. doi:10.1186/2047-2994-2-S1-P384
Kato Y, Toga Y, Oda Y, Kawamukai E, Hirata Y. Study of enzymatic detergents with both cleaning efficacy and disinfecting action for medical devices. Antimicrob Resist Infect Control. 2015;4(Suppl 1):P37. doi:10.1186/2047-2994-4-S1-P37
Alfa MJ, Olson N, Murray BL. Comparison of clinically relevant benchmarks and channel sampling methods used to assess manual cleaning compliance for flexible gastrointestinal endoscopes. Am J Infect Control. 2014;42(1):e1–e5. doi:10.1016/j.ajic.2013.08.007
Masia MD, Dettori M, Deriu GM, Bellu S, Arcadu L, Azara A, et al. ATP bioluminescence for assessing the efficacy of the manual cleaning procedure during the reprocessing of reusable surgical instruments. Healthcare (Basel). 2021;9(3):352. doi:10.3390/healthcare9030352
Alfa MJ. Medical instrument reprocessing: current issues with cleaning and cleaning monitoring. Am J Infect Control. 2019;47S:A10–A16. doi:10.1016/j.ajic.2019.02.029
McDonnell G, Russell AD. Antiseptics and disinfectants: activity, action, and resistance. Clin Microbiol Rev. 1999;12(1):147–179. doi:10.1128/CMR.12.1.147
Rutala WA, Weber DJ. Disinfection, sterilization, and antisepsis: an overview. Am J Infect Control. 2016;44(5 Suppl):e1–e6. doi:10.1016/j.ajic.2015.10.038
Vassey M, Budge C, Poolman T, Jones P, Perrett D, Nayuni N, et al. A quantitative assessment of residual protein levels on dental instruments reprocessed by manual, ultrasonic and automated cleaning methods. Br Dent J. 2011;210(9):E14. doi:10.1038/sj.bdj.2011.144
Alfa MJ, Olson N, DeGagne P. Automated washing with the Reliance Endoscope Processing System and its equivalence to optimal manual cleaning. Am J Infect Control. 2006;34(9):561–570. doi:10.1016/j.ajic.2006.01.010
Ofstead CL, Wetzler HP, Snyder AK, Horton RA. Endoscope reprocessing methods: a prospective study on the impact of human factors and automation. Gastroenterol Nurs. 2010;33(4):304–311. doi:10.1097/SGA.0b013e3181e9431a
Secker TJ, Leighton TG, Offin DG, Birkin PR, Hervé RC, Keevil CW. A cold water, ultrasonically activated stream efficiently removes proteins and prion-associated amyloid from surgical stainless steel. J Hosp Infect. 2020;106(4):649–656. doi:10.1016/j.jhin.2020.09.021
Kanegsberg B, Kanegsberg E. Parameters in ultrasonic cleaning for implants and other critical devices. J ASTM Int. 2006;3(4):1–8. doi:10.1520/JAI13387
Kato Y, Toga Y, Oda Y, Kawamukai E, Hirata Y. Study of enzymatic detergents with both cleaning efficacy and disinfecting action for medical devices. Antimicrob Resist Infect Control. 2015;4(Suppl 1):P37. doi:10.1186/2047-2994-4-S1-P37
McDonnell G, Russell AD. Antiseptics and disinfectants: activity, action, and resistance. Clin Microbiol Rev. 1999;12(1):147–179. doi:10.1128/CMR.12.1.147
Oda Y, Takashima Y, Hirata Y. The effect of corrosion inhibition of the novel pre-cleaning spray detergent on stainless steel in the presence of chloride ions and its enhanced detergency. Antimicrob Resist Infect Control. 2013;2(Suppl 1):P384. doi:10.1186/2047-2994-2-S1-P384
Alfa MJ. Medical instrument reprocessing: current issues with cleaning and cleaning monitoring. Am J Infect Control. 2019;47S:A10–A16. doi:10.1016/j.ajic.2019.02.029
Masia MD, Dettori M, Deriu GM, Bellu S, Arcadu L, Azara A, et al. ATP bioluminescence for assessing the efficacy of the manual cleaning procedure during the reprocessing of reusable surgical instruments. Healthcare (Basel). 2021;9(3):352. doi:10.3390/healthcare9030352
Baxter RL, Baxter HC, Campbell GA, Grant K, Jones A, Richardson P, et al. Quantitative analysis of residual protein contamination on reprocessed surgical instruments. J Hosp Infect. 2006;63(4):439–444. doi:10.1016/j.jhin.2006.03.011
Smith GWG, Goldie F, Long S, Lappin DF, Ramage G, Smith AJ. Quantitative analysis of residual protein contamination of podiatry instruments reprocessed through local and central decontamination units. J Foot Ankle Res. 2011;4:2. doi:10.1186/1757-1146-4-2
Moshkanbaryans L, Shah V, Tan LY, Jones MP, Vickery K, Alfa M, et al. Comparison of two endoscope channel cleaning approaches to remove cyclic build-up biofilm. J Hosp Infect. 2024;150:91–95. doi:10.1016/j.jhin.2024.05.014
International Organization for Standardization (ISO) / European Committee for Standardization (CEN). EN ISO 15883 (series) — Washer-disinfectors. Geneva/Brussels: ISO/CEN.
Association for the Advancement of Medical Instrumentation (AAMI). ANSI/AAMI ST79:2010 (R2017) & A1:2010 & A2:2011 & A3:2012 & A4:2013 — Comprehensive guide to steam sterilization and sterility assurance in health care facilities. Arlington, VA: AAMI; 2013.
Roberts CG. The role of biofilms in reprocessing medical devices. Am J Infect Control. 2013;41(5 Suppl):S77–S80. doi:10.1016/j.ajic.2012.12.008
Rutala WA, Weber DJ. Disinfection, sterilization, and antisepsis: an overview. Am J Infect Control. 2016;44(5 Suppl):e1–e6. doi:10.1016/j.ajic.2015.10.038
Alfa MJ, Olson N, DeGagne P. Automated washing with the Reliance Endoscope Processing System and its equivalence to optimal manual cleaning. Am J Infect Control. 2006;34(9):561–570. doi:10.1016/j.ajic.2006.01.010
Ofstead CL, Wetzler HP, Snyder AK, Horton RA. Endoscope reprocessing methods: a prospective study on the impact of human factors and automation. Gastroenterol Nurs. 2010;33(4):304–311. doi:10.1097/SGA.0b013e3181e9431a
McDonnell G, Russell AD. Antiseptics and disinfectants: activity, action, and resistance. Clin Microbiol Rev. 1999;12(1):147–179. doi:10.1128/CMR.12.1.147
Alfa MJ, Olson N. Comparison of washer-disinfector cleaning indicators: impact of temperature and cleaning cycle parameters. Am J Infect Control. 2014;42(2):e23–e26. doi:10.1016/j.ajic.2013.10.005
Alfa MJ, Olson N, Al-Fadhaly A. Cleaning efficacy of medical device washers in North American healthcare facilities. J Hosp Infect. 2010;74(2):168–177. doi:10.1016/j.jhin.2009.06.030
International Organization for Standardization (ISO) / European Committee for Standardization (CEN). EN ISO 15883 (series) — Washer-disinfectors. Geneva/Brussels: ISO/CEN.
Rosário W, Almeida T, Andrade B, Aoki I, Silva B, Aramayo M, Watanabe E, Ribeiro M, Bruna C, Graziano K. Evaluation of the presence of biofilms in corrosive points in surgical instruments after reprocessing. Hygiene. 2022;2(4):243–250. doi:10.3390/hygiene2040022
Alfa MJ. Medical instrument reprocessing: current issues with cleaning and cleaning monitoring. Am J Infect Control. 2019;47S:A10–A16. doi:10.1016/j.ajic.2019.02.029
Masia MD, Dettori M, Deriu GM, Bellu S, Arcadu L, Azara A, et al. ATP bioluminescence for assessing the efficacy of the manual cleaning procedure during the reprocessing of reusable surgical instruments. Healthcare (Basel). 2021;9(3):352. doi:10.3390/healthcare9030352
Baxter RL, Baxter HC, Campbell GA, Grant K, Jones A, Richardson P, et al. Quantitative analysis of residual protein contamination on reprocessed surgical instruments. J Hosp Infect. 2006;63(4):439–444. doi:10.1016/j.jhin.2006.03.011
Smith GWG, Goldie F, Long S, Lappin DF, Ramage G, Smith AJ. Quantitative analysis of residual protein contamination of podiatry instruments reprocessed through local and central decontamination units. J Foot Ankle Res. 2011;4:2. doi:10.1186/1757-1146-4-2
Vassey M, Budge C, Poolman T, Jones P, Perrett D, Nayuni N, et al. A quantitative assessment of residual protein levels on dental instruments reprocessed by manual, ultrasonic and automated cleaning methods. Br Dent J. 2011;210(9):E14. doi:10.1038/sj.bdj.2011.144
Moshkanbaryans L, Shah V, Tan LY, Jones MP, Vickery K, Alfa M, et al. Comparison of two endoscope channel cleaning approaches to remove cyclic build-up biofilm. J Hosp Infect. 2024;150:91–95. doi:10.1016/j.jhin.2024.05.014
Secker TJ, Leighton TG, Offin DG, Birkin PR, Hervé RC, Keevil CW. A cold water, ultrasonically activated stream efficiently removes proteins and prion-associated amyloid from surgical stainless steel. J Hosp Infect. 2020;106(4):649–656. doi:10.1016/j.jhin.2020.09.021
Kato Y, Toga Y, Oda Y, Kawamukai E, Hirata Y. Study of enzymatic detergents with both cleaning efficacy and disinfecting action for medical devices. Antimicrob Resist Infect Control. 2015;4(Suppl 1):P37. doi:10.1186/2047-2994-4-S1-P37
Association for the Advancement of Medical Instrumentation (AAMI). ANSI/AAMI ST79:2010 (R2017) & A1:2010 & A2:2011 & A3:2012 & A4:2013 — Comprehensive guide to steam sterilization and sterility assurance in health care facilities. Arlington, VA: AAMI; 2013.
Rutala WA, Weber DJ. Disinfection, sterilization, and antisepsis: an overview. Am J Infect Control. 2016;44(5 Suppl):e1–e6. doi:10.1016/j.ajic.2015.10.038
McDonnell G, Russell AD. Antiseptics and disinfectants: activity, action, and resistance. Clin Microbiol Rev. 1999;12(1):147–179. doi:10.1128/CMR.12.1.147
Rosário W, Almeida T, Andrade B, Aoki I, Silva B, Aramayo M, Watanabe E, Ribeiro M, Bruna C, Graziano K. Evaluation of the presence of biofilms in corrosive points in surgical instruments after reprocessing. Hygiene. 2022;2(4):243–250. doi:10.3390/hygiene2040022
Oda Y, Takashima Y, Hirata Y. The effect of corrosion inhibition of the novel pre-cleaning spray detergent on stainless steel in the presence of chloride ions and its enhanced detergency. Antimicrob Resist Infect Control. 2013;2(Suppl 1):P384. doi:10.1186/2047-2994-2-S1-P384
Kato Y, Toga Y, Oda Y, Kawamukai E, Hirata Y. Study of enzymatic detergents with both cleaning efficacy and disinfecting action for medical devices. Antimicrob Resist Infect Control. 2015;4(Suppl 1):P37. doi:10.1186/2047-2994-4-S1-P37
Alfa MJ, Olson N, Al-Fadhaly A. Cleaning efficacy of medical device washers in North American healthcare facilities. J Hosp Infect. 2010;74(2):168–177. doi:10.1016/j.jhin.2009.06.030
Liu M, Zu Q, Zheng L, et al. Investigation of microbiological non-compliance of endoscopic final rinse water associated with opportunistic premise plumbing pathogens contamination in connecting tube. Sci Rep. 2026;16:10783. doi:10.1038/s41598-026-46256-9
Lipscomb IP, Sihota AK, Keevil CW. Comparative study of surgical instruments from sterile-service departments for presence of residual gram-negative endotoxin and proteinaceous deposits. J Clin Microbiol. 2006;44(10):3728–3733. doi:10.1128/JCM.01280-06
Roberts CG. The role of biofilms in reprocessing medical devices. Am J Infect Control. 2013;41(5 Suppl):S77–S80. doi:10.1016/j.ajic.2012.12.008
Bridier A, Briandet R, Thomas V, Dubois-Brissonnet F. Resistance of bacterial biofilms to disinfectants: a review. Biofouling. 2011;27(9):1017–1032. doi:10.1080/08927014.2011.626899
Alfa MJ. Medical instrument reprocessing: current issues with cleaning and cleaning monitoring. Am J Infect Control. 2019;47S:A10–A16. doi:10.1016/j.ajic.2019.02.029
Seavey R. Troubleshooting failed sterilization loads: process failures and wet packs/loads. Am J Infect Control. 2016;44(5 Suppl):e29–e34. doi:10.1016/j.ajic.2016.03.001
International Organization for Standardization (ISO) / European Committee for Standardization (CEN). EN 285 — Sterilization: steam sterilizers: large sterilizers. Geneva/Brussels: ISO/CEN.
Miguel EA, Laranjeira PR, Ishii M, Pinto TJA. Analysis of water quality over non-condensable gases concentration on steam used for sterilization. PLoS One. 2022;17(9):e0274924. doi:10.1371/journal.pone.0274924
International Organization for Standardization (ISO) / European Committee for Standardization (CEN). EN ISO 15883 (series) — Washer-disinfectors. Geneva/Brussels: ISO/CEN.
Association for the Advancement of Medical Instrumentation (AAMI). ANSI/AAMI ST79:2010 (R2017) & A1:2010 & A2:2011 & A3:2012 & A4:2013 — Comprehensive guide to steam sterilization and sterility assurance in health care facilities. Arlington, VA: AAMI; 2013.
Association for the Advancement of Medical Instrumentation (AAMI). ANSI/AAMI ST108:2023 — Water for the processing of medical devices (supersedes AAMI TIR34:2014). Arlington, VA: AAMI; 2023.
Secker TJ, Leighton TG, Offin DG, Birkin PR, Hervé RC, Keevil CW. A cold water, ultrasonically activated stream efficiently removes proteins and prion-associated amyloid from surgical stainless steel. J Hosp Infect. 2020;106(4):649–656. doi:10.1016/j.jhin.2020.09.021
Baxter RL, Baxter HC, Campbell GA, Grant K, Jones A, Richardson P, et al. Quantitative analysis of residual protein contamination on reprocessed surgical instruments. J Hosp Infect. 2006;63(4):439–444. doi:10.1016/j.jhin.2006.03.011
Rutala WA, Weber DJ. Disinfection, sterilization, and antisepsis: an overview. Am J Infect Control. 2016;44(5 Suppl):e1–e6. doi:10.1016/j.ajic.2015.10.038
Roberts CG. The role of biofilms in reprocessing medical devices. Am J Infect Control. 2013;41(5 Suppl):S77–S80. doi:10.1016/j.ajic.2012.12.008
Bridier A, Briandet R, Thomas V, Dubois-Brissonnet F. Resistance of bacterial biofilms to disinfectants: a review. Biofouling. 2011;27(9):1017–1032. doi:10.1080/08927014.2011.626899
Alfa MJ, Howie R. Modeling microbial survival in buildup biofilm for complex medical devices. BMC Infect Dis. 2009;9:56. doi:10.1186/1471-2334-9-56
Seavey R. Troubleshooting failed sterilization loads: process failures and wet packs/loads. Am J Infect Control. 2016;44(5 Suppl):e29–e34. doi:10.1016/j.ajic.2016.03.001
Rosário W, Almeida T, Andrade B, Aoki I, Silva B, Aramayo M, Watanabe E, Ribeiro M, Bruna C, Graziano K. Evaluation of the presence of biofilms in corrosive points in surgical instruments after reprocessing. Hygiene. 2022;2(4):243–250. doi:10.3390/hygiene2040022
Oda Y, Takashima Y, Hirata Y. The effect of corrosion inhibition of the novel pre-cleaning spray detergent on stainless steel in the presence of chloride ions and its enhanced detergency. Antimicrob Resist Infect Control. 2013;2(Suppl 1):P384. doi:10.1186/2047-2994-2-S1-P384
McDonnell G, Russell AD. Antiseptics and disinfectants: activity, action, and resistance. Clin Microbiol Rev. 1999;12(1):147–179. doi:10.1128/CMR.12.1.147
Alfa MJ, Olson N, Al-Fadhaly A. Cleaning efficacy of medical device washers in North American healthcare facilities. J Hosp Infect. 2010;74(2):168–177. doi:10.1016/j.jhin.2009.06.030
Moshkanbaryans L, Shah V, Tan LY, Jones MP, Vickery K, Alfa M, et al. Comparison of two endoscope channel cleaning approaches to remove cyclic build-up biofilm. J Hosp Infect. 2024;150:91–95. doi:10.1016/j.jhin.2024.05.014
Baxter RL, Baxter HC, Campbell GA, Grant K, Jones A, Richardson P, et al. Quantitative analysis of residual protein contamination on reprocessed surgical instruments. J Hosp Infect. 2006;63(4):439–444. doi:10.1016/j.jhin.2006.03.011
Smith GWG, Goldie F, Long S, Lappin DF, Ramage G, Smith AJ. Quantitative analysis of residual protein contamination of podiatry instruments reprocessed through local and central decontamination units. J Foot Ankle Res. 2011;4:2. doi:10.1186/1757-1146-4-2
Alfa MJ. Medical instrument reprocessing: current issues with cleaning and cleaning monitoring. Am J Infect Control. 2019;47S:A10–A16. doi:10.1016/j.ajic.2019.02.029
Lipscomb IP, Sihota AK, Keevil CW. Comparative study of surgical instruments from sterile-service departments for presence of residual gram-negative endotoxin and proteinaceous deposits. J Clin Microbiol. 2006;44(10):3728–3733. doi:10.1128/JCM.01280-06
Secker TJ, Leighton TG, Offin DG, Birkin PR, Hervé RC, Keevil CW. A cold water, ultrasonically activated stream efficiently removes proteins and prion-associated amyloid from surgical stainless steel. J Hosp Infect. 2020;106(4):649–656. doi:10.1016/j.jhin.2020.09.021
Association for the Advancement of Medical Instrumentation (AAMI). ANSI/AAMI ST79:2010 (R2017) & A1:2010 & A2:2011 & A3:2012 & A4:2013 — Comprehensive guide to steam sterilization and sterility assurance in health care facilities. Arlington, VA: AAMI; 2013.
International Organization for Standardization (ISO) / European Committee for Standardization (CEN). EN ISO 17664 (Parts 1–2) — Processing of health care products: information to be provided by the medical device manufacturer for the processing of medical devices. Geneva/Brussels: ISO/CEN.
Rutala WA, Weber DJ. Disinfection, sterilization, and antisepsis: an overview. Am J Infect Control. 2016;44(5 Suppl):e1–e6. doi:10.1016/j.ajic.2015.10.038
Rutala WA, Weber DJ. Reprocessing semicritical items: an overview and an update on the shift from HLD to sterilization for endoscopes. Am J Infect Control. 2023;51(11 Suppl):A96–A106. doi:10.1016/j.ajic.2023.01.002
Rowan NJ, Kremer T, McDonnell G. A review of Spaulding’s classification system for effective cleaning, disinfection and sterilization of reusable medical devices. Sci Total Environ. 2023;878:162976. doi:10.1016/j.scitotenv.2023.162976
McDonnell G, Russell AD. Antiseptics and disinfectants: activity, action, and resistance. Clin Microbiol Rev. 1999;12(1):147–179. doi:10.1128/CMR.12.1.147
Maillard J-Y, Pascoe M. Disinfectants and antiseptics: mechanisms of action and resistance. Nat Rev Microbiol. 2024;22(1):4–17. doi:10.1038/s41579-023-00958-3
Setlow P. Spores of Bacillus subtilis: their resistance to and killing by radiation, heat and chemicals. J Appl Microbiol. 2006;101(3):514–525. doi:10.1111/j.1365-2672.2005.02736.x
Rutala WA, Weber DJ. Guideline for disinfection and sterilization of prion-contaminated medical instruments. Infect Control Hosp Epidemiol. 2010;31(2):107–117. doi:10.1086/650197
Yu X, Zhang Q, Deng X, Liang J, Hao S, Chen J, et al. A comparative study of four Bowie-Dick test under the condition of pressure steam sterilizer simulating gas leakage. Medicine (Baltimore). 2020;99(50):e23653. doi:10.1097/MD.0000000000023653
International Organization for Standardization (ISO) / European Committee for Standardization (CEN). EN 285 — Sterilization: steam sterilizers: large sterilizers. Geneva/Brussels: ISO/CEN.
International Organization for Standardization (ISO). ISO 11140 (series) — Sterilization of health care products: chemical indicators. Geneva: ISO.
Seavey R. Troubleshooting failed sterilization loads: process failures and wet packs/loads. Am J Infect Control. 2016;44(5 Suppl):e29–e34. doi:10.1016/j.ajic.2016.03.001
Miguel EA, Laranjeira PR, Ishii M, Pinto TJA. Analysis of water quality over non-condensable gases concentration on steam used for sterilization. PLoS One. 2022;17(9):e0274924. doi:10.1371/journal.pone.0274924
Seavey R. Immediate use steam sterilization: moving beyond current policy. Am J Infect Control. 2013;41(5 Suppl):S46–S48. doi:10.1016/j.ajic.2012.10.029
Crall VD, Lewis CL, Risnear A, Miller J, Sherer J, Ayres AM, Snyder GM. Immediate-use steam sterilization and the effect on surgical site infection risk in an acute care facility. Antimicrob Steward Healthc Epidemiol. 2024;4(1):e138. doi:10.1017/ash.2024.408
Hutzler L, Kraemer K, Iaboni L, Berger N, Bosco JA. A hospital-wide initiative to eliminate preventable causes of immediate use steam sterilization. AORN J. 2013;98(6):597–607. doi:10.1016/j.aorn.2013.10.006
Rutala WA, Weber DJ. Sterilization of 20 billion medical devices by ethylene oxide (ETO): consequences of ETO closures and alternative sterilization technologies/solutions. Am J Infect Control. 2023;51(11 Suppl):A82–A95. doi:10.1016/j.ajic.2023.01.020
Rosário W, Almeida T, Andrade B, Aoki I, Silva B, Aramayo M, Watanabe E, Ribeiro M, Bruna C, Graziano K. Evaluation of the presence of biofilms in corrosive points in surgical instruments after reprocessing. Hygiene. 2022;2(4):243–250. doi:10.3390/hygiene2040022
International Organization for Standardization (ISO). ISO 17665:2024 — Sterilization of health care products: moist heat. Geneva: ISO.
Association for the Advancement of Medical Instrumentation (AAMI). ANSI/AAMI ST79:2010 (R2017) & A1:2010 & A2:2011 & A3:2012 & A4:2013 — Comprehensive guide to steam sterilization and sterility assurance in health care facilities. Arlington, VA: AAMI; 2013.
Rutala WA, Weber DJ. Disinfection, sterilization, and antisepsis: an overview. Am J Infect Control. 2016;44(5 Suppl):e1–e6. doi:10.1016/j.ajic.2015.10.038
Rutala WA, Weber DJ. Reprocessing semicritical items: an overview and an update on the shift from HLD to sterilization for endoscopes. Am J Infect Control. 2023;51(11 Suppl):A96–A106. doi:10.1016/j.ajic.2023.01.002
McDonnell G, Russell AD. Antiseptics and disinfectants: activity, action, and resistance. Clin Microbiol Rev. 1999;12(1):147–179. doi:10.1128/CMR.12.1.147
Maillard J-Y, Pascoe M. Disinfectants and antiseptics: mechanisms of action and resistance. Nat Rev Microbiol. 2024;22(1):4–17. doi:10.1038/s41579-023-00958-3
Setlow P. Spores of Bacillus subtilis: their resistance to and killing by radiation, heat and chemicals. J Appl Microbiol. 2006;101(3):514–525. doi:10.1111/j.1365-2672.2005.02736.x
Miyamoto T, Okano S, Kasai N. Inactivation of Escherichia coli endotoxin by soft hydrothermal processing. Appl Environ Microbiol. 2009;75(15):5058–5063. doi:10.1128/AEM.00122-09
Lipscomb IP, Sihota AK, Keevil CW. Comparative study of surgical instruments from sterile-service departments for presence of residual gram-negative endotoxin and proteinaceous deposits. J Clin Microbiol. 2006;44(10):3728–3733. doi:10.1128/JCM.01280-06
Miguel EA, Laranjeira PR, Ishii M, Pinto TJA. Analysis of water quality over non-condensable gases concentration on steam used for sterilization. PLoS One. 2022;17(9):e0274924. doi:10.1371/journal.pone.0274924
Rosário W, Almeida T, Andrade B, Aoki I, Silva B, Aramayo M, Watanabe E, Ribeiro M, Bruna C, Graziano K. Evaluation of the presence of biofilms in corrosive points in surgical instruments after reprocessing. Hygiene. 2022;2(4):243–250. doi:10.3390/hygiene2040022
Seavey R. Troubleshooting failed sterilization loads: process failures and wet packs/loads. Am J Infect Control. 2016;44(5 Suppl):e29–e34. doi:10.1016/j.ajic.2016.03.001
Alfa MJ. Medical instrument reprocessing: current issues with cleaning and cleaning monitoring. Am J Infect Control. 2019;47S:A10–A16. doi:10.1016/j.ajic.2019.02.029
Rutala WA, Weber DJ. Guideline for disinfection and sterilization of prion-contaminated medical instruments. Infect Control Hosp Epidemiol. 2010;31(2):107–117. doi:10.1086/650197
Rutala WA, Weber DJ. Sterilization of 20 billion medical devices by ethylene oxide (ETO): consequences of ETO closures and alternative sterilization technologies/solutions. Am J Infect Control. 2023;51(11 Suppl):A82–A89. doi:10.1016/j.ajic.2023.01.020
Rowan NJ, Kremer T, McDonnell G. A review of Spaulding’s classification system for effective cleaning, disinfection and sterilization of reusable medical devices. Sci Total Environ. 2023;878:162976. doi:10.1016/j.scitotenv.2023.162976
International Organization for Standardization (ISO). ISO 20857:2010 — Sterilization of health care products: dry heat: requirements for the development, validation and routine control of a sterilization process for medical devices. Geneva: ISO.
Rutala WA, Weber DJ. Sterilization of 20 billion medical devices by ethylene oxide (ETO): consequences of ETO closures and alternative sterilization technologies/solutions. Am J Infect Control. 2023;51(11 Suppl):A82–A89. doi:10.1016/j.ajic.2023.01.020
Rutala WA, Weber DJ. Disinfection, sterilization, and antisepsis: an overview. Am J Infect Control. 2016;44(5 Suppl):e1–e6. doi:10.1016/j.ajic.2015.10.038
McDonnell G, Russell AD. Antiseptics and disinfectants: activity, action, and resistance. Clin Microbiol Rev. 1999;12(1):147–179. doi:10.1128/CMR.12.1.147
Maillard J-Y, Pascoe M. Disinfectants and antiseptics: mechanisms of action and resistance. Nat Rev Microbiol. 2024;22(1):4–17. doi:10.1038/s41579-023-00958-3
Setlow P. Spores of Bacillus subtilis: their resistance to and killing by radiation, heat and chemicals. J Appl Microbiol. 2006;101(3):514–525. doi:10.1111/j.1365-2672.2005.02736.x
Maillard J-Y. Bacterial target sites for biocide action. J Appl Microbiol. 2002;92(Suppl):16S–27S. doi:10.1046/j.1365-2672.92.5s1.3.x
Alfa MJ. Medical instrument reprocessing: current issues with cleaning and cleaning monitoring. Am J Infect Control. 2019;47S:A10–A16. doi:10.1016/j.ajic.2019.02.029
Lipscomb IP, Sihota AK, Keevil CW. Comparative study of surgical instruments from sterile-service departments for presence of residual gram-negative endotoxin and proteinaceous deposits. J Clin Microbiol. 2006;44(10):3728–3733. doi:10.1128/JCM.01280-06
International Organization for Standardization (ISO). ISO 10993-7:2008 (R2012) — Biological evaluation of medical devices: Part 7: ethylene oxide sterilization residuals. Geneva: ISO.
Rutala WA, Weber DJ. Selection of the ideal disinfectant. Infect Control Hosp Epidemiol. 2014;35(7):855–865. doi:10.1086/676877
Rosário W, Almeida T, Andrade B, Aoki I, Silva B, Aramayo M, Watanabe E, Ribeiro M, Bruna C, Graziano K. Evaluation of the presence of biofilms in corrosive points in surgical instruments after reprocessing. Hygiene. 2022;2(4):243–250. doi:10.3390/hygiene2040022
Rowan NJ, Kremer T, McDonnell G. A review of Spaulding’s classification system for effective cleaning, disinfection and sterilization of reusable medical devices. Sci Total Environ. 2023;878:162976. doi:10.1016/j.scitotenv.2023.162976
Rutala WA, Weber DJ. Reprocessing semicritical items: an overview and an update on the shift from HLD to sterilization for endoscopes. Am J Infect Control. 2023;51(11 Suppl):A96–A106. doi:10.1016/j.ajic.2023.01.002
International Organization for Standardization (ISO) / European Committee for Standardization (CEN). EN ISO 11135:2014 — Sterilization of health care products: ethylene oxide: requirements for the development, validation and routine control of a sterilization process for medical devices. Geneva/Brussels: ISO/CEN.
Association for the Advancement of Medical Instrumentation (AAMI). ANSI/AAMI ST58:2024 — Chemical sterilization and high-level disinfection in health care facilities (supersedes AAMI ST41:2008). Arlington, VA: AAMI; 2024.
Rutala WA, Weber DJ. Guideline for disinfection and sterilization of prion-contaminated medical instruments. Infect Control Hosp Epidemiol. 2010;31(2):107–117. doi:10.1086/650197
Seavey R. Troubleshooting failed sterilization loads: process failures and wet packs/loads. Am J Infect Control. 2016;44(5 Suppl):e29–e34. doi:10.1016/j.ajic.2016.03.001
Rutala WA, Weber DJ. Sterilization of 20 billion medical devices by ethylene oxide (ETO): consequences of ETO closures and alternative sterilization technologies/solutions. Am J Infect Control. 2023;51(11 Suppl):A82–A89. doi:10.1016/j.ajic.2023.01.020
Rutala WA, Weber DJ. Disinfection, sterilization, and antisepsis: an overview. Am J Infect Control. 2016;44(5 Suppl):e1–e6. doi:10.1016/j.ajic.2015.10.038
McDonnell G, Russell AD. Antiseptics and disinfectants: activity, action, and resistance. Clin Microbiol Rev. 1999;12(1):147–179. doi:10.1128/CMR.12.1.147
Maillard J-Y, Pascoe M. Disinfectants and antiseptics: mechanisms of action and resistance. Nat Rev Microbiol. 2024;22(1):4–17. doi:10.1038/s41579-023-00958-3
Setlow P. Spores of Bacillus subtilis: their resistance to and killing by radiation, heat and chemicals. J Appl Microbiol. 2006;101(3):514–525. doi:10.1111/j.1365-2672.2005.02736.x
Maillard J-Y. Bacterial target sites for biocide action. J Appl Microbiol. 2002;92(Suppl):16S–27S. doi:10.1046/j.1365-2672.92.5s1.3.x
Rowan NJ, Kremer T, McDonnell G. A review of Spaulding’s classification system for effective cleaning, disinfection and sterilization of reusable medical devices. Sci Total Environ. 2023;878:162976. doi:10.1016/j.scitotenv.2023.162976
Rutala WA, Weber DJ. Selection of the ideal disinfectant. Infect Control Hosp Epidemiol. 2014;35(7):855–865. doi:10.1086/676877
Alfa MJ, Howie R. Modeling microbial survival in buildup biofilm for complex medical devices. BMC Infect Dis. 2009;9:56. doi:10.1186/1471-2334-9-56
Moshkanbaryans L, Shah V, Tan LY, Jones MP, Vickery K, Alfa M, et al. Comparison of two endoscope channel cleaning approaches to remove cyclic build-up biofilm. J Hosp Infect. 2024;150:91–95. doi:10.1016/j.jhin.2024.05.014
Alfa MJ. Medical instrument reprocessing: current issues with cleaning and cleaning monitoring. Am J Infect Control. 2019;47S:A10–A16. doi:10.1016/j.ajic.2019.02.029
Secker TJ, Leighton TG, Offin DG, Birkin PR, Hervé RC, Keevil CW. A cold water, ultrasonically activated stream efficiently removes proteins and prion-associated amyloid from surgical stainless steel. J Hosp Infect. 2020;106(4):649–656. doi:10.1016/j.jhin.2020.09.021
International Organization for Standardization (ISO) / European Committee for Standardization (CEN). EN ISO 14937:2009 — Sterilization of health care products: general requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices. Geneva/Brussels: ISO/CEN.
International Organization for Standardization (ISO). ISO 22441:2022 — Sterilization of health care products: low temperature vaporized hydrogen peroxide: requirements for the development, validation and routine control of a sterilization process for medical devices. Geneva: ISO.
Rutala WA, Weber DJ. Reprocessing semicritical items: an overview and an update on the shift from HLD to sterilization for endoscopes. Am J Infect Control. 2023;51(11 Suppl):A96–A106. doi:10.1016/j.ajic.2023.01.002
Association for the Advancement of Medical Instrumentation (AAMI). AAMI TIR17:2024 — Compatibility of materials subject to sterilization. Arlington, VA: AAMI; 2024.
Rutala WA, Weber DJ. Guideline for disinfection and sterilization of prion-contaminated medical instruments. Infect Control Hosp Epidemiol. 2010;31(2):107–117. doi:10.1086/650197
Rutala WA, Weber DJ. Sterilization of 20 billion medical devices by ethylene oxide (ETO): consequences of ETO closures and alternative sterilization technologies/solutions. Am J Infect Control. 2023;51(11 Suppl):A82–A89. doi:10.1016/j.ajic.2023.01.020
Rutala WA, Weber DJ. Disinfection, sterilization, and antisepsis: an overview. Am J Infect Control. 2016;44(5 Suppl):e1–e6. doi:10.1016/j.ajic.2015.10.038
Rowan NJ, Kremer T, McDonnell G. A review of Spaulding’s classification system for effective cleaning, disinfection and sterilization of reusable medical devices. Sci Total Environ. 2023;878:162976. doi:10.1016/j.scitotenv.2023.162976
McDonnell G, Russell AD. Antiseptics and disinfectants: activity, action, and resistance. Clin Microbiol Rev. 1999;12(1):147–179. doi:10.1128/CMR.12.1.147
Maillard J-Y, Pascoe M. Disinfectants and antiseptics: mechanisms of action and resistance. Nat Rev Microbiol. 2024;22(1):4–17. doi:10.1038/s41579-023-00958-3
Setlow P. Spores of Bacillus subtilis: their resistance to and killing by radiation, heat and chemicals. J Appl Microbiol. 2006;101(3):514–525. doi:10.1111/j.1365-2672.2005.02736.x
Maillard J-Y. Bacterial target sites for biocide action. J Appl Microbiol. 2002;92(Suppl):16S–27S. doi:10.1046/j.1365-2672.92.5s1.3.x
Rutala WA, Weber DJ. Reprocessing semicritical items: an overview and an update on the shift from HLD to sterilization for endoscopes. Am J Infect Control. 2023;51(11 Suppl):A96–A106. doi:10.1016/j.ajic.2023.01.002
Rutala WA, Weber DJ. Selection of the ideal disinfectant. Infect Control Hosp Epidemiol. 2014;35(7):855–865. doi:10.1086/676877
Alfa MJ. Medical instrument reprocessing: current issues with cleaning and cleaning monitoring. Am J Infect Control. 2019;47S:A10–A16. doi:10.1016/j.ajic.2019.02.029
Alfa MJ, Howie R. Modeling microbial survival in buildup biofilm for complex medical devices. BMC Infect Dis. 2009;9:56. doi:10.1186/1471-2334-9-56
Moshkanbaryans L, Shah V, Tan LY, Jones MP, Vickery K, Alfa M, et al. Comparison of two endoscope channel cleaning approaches to remove cyclic build-up biofilm. J Hosp Infect. 2024;150:91–95. doi:10.1016/j.jhin.2024.05.014
Secker TJ, Leighton TG, Offin DG, Birkin PR, Hervé RC, Keevil CW. A cold water, ultrasonically activated stream efficiently removes proteins and prion-associated amyloid from surgical stainless steel. J Hosp Infect. 2020;106(4):649–656. doi:10.1016/j.jhin.2020.09.021
International Organization for Standardization (ISO) / European Committee for Standardization (CEN). EN ISO 14937:2009 — Sterilization of health care products: general requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices. Geneva/Brussels: ISO/CEN.
Rutala WA, Weber DJ. Guideline for disinfection and sterilization of prion-contaminated medical instruments. Infect Control Hosp Epidemiol. 2010;31(2):107–117. doi:10.1086/650197
Rutala WA, Weber DJ. Disinfection, sterilization, and antisepsis: an overview. Am J Infect Control. 2016;44(5 Suppl):e1–e6. doi:10.1016/j.ajic.2015.10.038
Rutala WA, Weber DJ. Sterilization of 20 billion medical devices by ethylene oxide (ETO): consequences of ETO closures and alternative sterilization technologies/solutions. Am J Infect Control. 2023;51(11 Suppl):A82–A89. doi:10.1016/j.ajic.2023.01.020
Rowan NJ, Kremer T, McDonnell G. A review of Spaulding’s classification system for effective cleaning, disinfection and sterilization of reusable medical devices. Sci Total Environ. 2023;878:162976. doi:10.1016/j.scitotenv.2023.162976
McDonnell G, Russell AD. Antiseptics and disinfectants: activity, action, and resistance. Clin Microbiol Rev. 1999;12(1):147–179. doi:10.1128/CMR.12.1.147
Maillard J-Y, Pascoe M. Disinfectants and antiseptics: mechanisms of action and resistance. Nat Rev Microbiol. 2024;22(1):4–17. doi:10.1038/s41579-023-00958-3
Setlow P. Spores of Bacillus subtilis: their resistance to and killing by radiation, heat and chemicals. J Appl Microbiol. 2006;101(3):514–525. doi:10.1111/j.1365-2672.2005.02736.x
Maillard J-Y. Bacterial target sites for biocide action. J Appl Microbiol. 2002;92(Suppl):16S–27S. doi:10.1046/j.1365-2672.92.5s1.3.x
Alfa MJ. Medical instrument reprocessing: current issues with cleaning and cleaning monitoring. Am J Infect Control. 2019;47S:A10–A16. doi:10.1016/j.ajic.2019.02.029
Lipscomb IP, Sihota AK, Keevil CW. Comparative study of surgical instruments from sterile-service departments for presence of residual gram-negative endotoxin and proteinaceous deposits. J Clin Microbiol. 2006;44(10):3728–3733. doi:10.1128/JCM.01280-06
Rutala WA, Weber DJ. Selection of the ideal disinfectant. Infect Control Hosp Epidemiol. 2014;35(7):855–865. doi:10.1086/676877
Rutala WA, Weber DJ. Guideline for disinfection and sterilization of prion-contaminated medical instruments. Infect Control Hosp Epidemiol. 2010;31(2):107–117. doi:10.1086/650197
International Organization for Standardization (ISO) / European Committee for Standardization (CEN). EN ISO 11137 (series) — Sterilization of health care products: radiation. Part 1: requirements for development, validation and routine control; Part 2: establishing the sterilization dose; Part 3: guidance on dosimetric aspects. Geneva/Brussels: ISO/CEN.
Association for the Advancement of Medical Instrumentation (AAMI). AAMI TIR33:2005 — Sterilization of health care products: radiation: substantiation of a selected sterilization dose: method VDmax. Arlington, VA: AAMI; 2005.
Rutala WA, Weber DJ. Reprocessing semicritical items: an overview and an update on the shift from HLD to sterilization for endoscopes. Am J Infect Control. 2023;51(11 Suppl):A96–A106. doi:10.1016/j.ajic.2023.01.002
Rutala WA, Weber DJ. Disinfection, sterilization, and antisepsis: an overview. Am J Infect Control. 2016;44(5 Suppl):e1–e6. doi:10.1016/j.ajic.2015.10.038
Rowan NJ, Kremer T, McDonnell G. A review of Spaulding’s classification system for effective cleaning, disinfection and sterilization of reusable medical devices. Sci Total Environ. 2023;878:162976. doi:10.1016/j.scitotenv.2023.162976
Rutala WA, Weber DJ. Sterilization of 20 billion medical devices by ethylene oxide (ETO): consequences of ETO closures and alternative sterilization technologies/solutions. Am J Infect Control. 2023;51(11 Suppl):A82–A89. doi:10.1016/j.ajic.2023.01.020
McDonnell G, Russell AD. Antiseptics and disinfectants: activity, action, and resistance. Clin Microbiol Rev. 1999;12(1):147–179. doi:10.1128/CMR.12.1.147
Maillard J-Y, Pascoe M. Disinfectants and antiseptics: mechanisms of action and resistance. Nat Rev Microbiol. 2024;22(1):4–17. doi:10.1038/s41579-023-00958-3
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Association for the Advancement of Medical Instrumentation (AAMI). ANSI/AAMI ST79:2010 (R2017) & A1:2010 & A2:2011 & A3:2012 & A4:2013 — Comprehensive guide to steam sterilization and sterility assurance in health care facilities. Arlington, VA: AAMI; 2013.
Association for the Advancement of Medical Instrumentation (AAMI). ANSI/AAMI ST91:2021 — Flexible and semi-rigid endoscope processing in health care facilities. Arlington, VA: AAMI; 2021.
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