Sterilizasyon: Teori, Uygulama, Kalite Yönetimi ve Güncel Yaklaşımlar

Authors

Murat Aral

Synopsis

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References

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

Paul S, Salunkhe S, Sravanthi K, Mane SV. Pioneering hand hygiene: Ignaz Semmelweis and the fight against puerperal fever. Cureus. 2024;16(10):e71689. doi:10.7759/cureus.71689

Jambholkar PC, Choudhari SG, Sharma M. Louis Pasteur: a legacy unmasked. Cureus. 2024;16(8):e68080. doi:10.7759/cureus.68080

Blevins SM, Bronze MS. Robert Koch and the ‘golden age’ of bacteriology. Int J Infect Dis. 2010;14(9):e744–e751. doi:10.1016/j.ijid.2009.12.003

Michaleas SN, Laios K, Charalabopoulos A, Samonis G, Karamanou M. Joseph Lister (1827–1912): a pioneer of antiseptic surgery. Cureus. 2022;14(12):e32777. doi:10.7759/cureus.32777

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, 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

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

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

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. 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

European Committee for Standardization (CEN). EN 14885:2018 — Chemical disinfectants and antiseptics: application of European Standards for chemical disinfectants and antiseptics. Brussels: CEN; 2018.

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

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

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

Giglia S, Alembath A, Hersey J. Defect detection sensitivity of bubble-point-type tests for sterilizing-grade membrane cartridge filters. Membranes (Basel). 2023;13(1):88. doi:10.3390/membranes13010088

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. 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. Selection of the ideal disinfectant. Infect Control Hosp Epidemiol. 2014;35(7):855–865. doi:10.1086/676877

ASTM International. ASTM F838 — Standard test method for determining bacterial retention of membrane filters utilized for liquid filtration. West Conshohocken, PA: ASTM International.

International Organization for Standardization (ISO). ISO 13408 (series) — Aseptic processing of health care products. 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

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

International Organization for Standardization (ISO) / European Committee for Standardization (CEN). EN ISO 11607 (Parts 1–2) — Packaging for terminally sterilized medical devices. Geneva/Brussels: ISO/CEN.

Shaffer HL, Harnish DA, McDonald M, Vernon RA, Heimbuch BK. Sterility maintenance study: dynamic and repeated handling effects on sterile packaging. Am J Infect Control. 2013;41(9):779–784.

Cavalli S, Caterino C, Nocera FP, Pizzano F, Schena R, Aragosa F, et al. A shelf-life study of sterilized packs in a veterinary teaching hospital. Vet Sci. 2023;10(2):101.

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

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

European Committee for Standardization (CEN). EN 868 (series) — Packaging materials for medical devices which are to be sterilized. Brussels: CEN.

ASTM International. ASTM F1608 — Standard test method for microbial ranking of porous packaging materials (exposure chamber method). West Conshohocken, PA: ASTM International.

ASTM International. ASTM F1980 — Standard guide for accelerated aging of sterile barrier systems for medical devices. West Conshohocken, PA: ASTM International.

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.

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

Rizan C, Bhutta MF. Environmental impact and life cycle financial cost of hybrid (reusable/single-use) instruments versus single-use equivalents in laparoscopic cholecystectomy. Surg Endosc. 2022;36(6):4067–4078. doi:10.1007/s00464-021-08728-z

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

Shaffer HL, Harnish DA, McDonald M, Vernon RA, Heimbuch BK. Sterility maintenance study: dynamic evaluation of sterilized rigid containers and wrapped instrument trays to prevent bacterial ingress. Am J Infect Control. 2015;43(12):1336–1341. doi:10.1016/j.ajic.2015.07.010

Cavalli S, Caterino C, Nocera FP, Pizzano F, Schena R, Aragosa F, et al. A shelf-life assessment of sterilized surgical instruments stored under controlled conditions: a comparative study of a single vs. double self-sealing pouch. Vet Sci. 2025;12(6):564. doi:10.3390/vetsci12060564

Moghimi N, Park SI. Leakage assessment of flexible pouches using dye penetration test with correlation to modeled bacterial aerosol challenge test. Food Sci Biotechnol. 2017;26(4):947–953. doi:10.1007/s10068-017-0134-y

Li G, Xia F, Chen X, Chen R, Li Q. Enhancing sterilization supply management: a pre-post study on the impact of an integrated information system in a multi-campus hospital setting. BMC Health Serv Res. 2026;26(1):188. doi:10.1186/s12913-026-14477-3

Fayard C, Lambert C, Guimier-Pingault C, Levast M, Germi R. Assessment of residual moisture and maintenance of sterility in surgical instrument sets after sterilization. Infect Control Hosp Epidemiol. 2015;36(8):990–992. doi:10.1017/ice.2015.110

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

International Organization for Standardization (ISO) / European Committee for Standardization (CEN). EN ISO 11607-2:2020 — Packaging for terminally sterilized medical devices: Part 2: validation requirements for forming, sealing and assembly processes. Geneva/Brussels: ISO/CEN.

ASTM International. ASTM F88 — Standard test method for seal strength of flexible barrier materials. West Conshohocken, PA: ASTM International.

ASTM International. ASTM F1929 — Standard test method for detecting seal leaks in porous medical packaging by dye penetration. West Conshohocken, PA: ASTM International.

ASTM International. ASTM F2096 — Standard test method for detecting gross leaks in packaging by internal pressurization (bubble test). West Conshohocken, PA: ASTM International.

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.

ASTM International. ASTM F1886 — Standard test method for determining integrity of seals for flexible packaging by visual inspection. West Conshohocken, PA: ASTM International.

ASTM International. ASTM F1980 — Standard guide for accelerated aging of sterile barrier systems for medical devices. West Conshohocken, PA: ASTM International.

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

Fayard C, Lambert C, Guimier-Pingault C, Levast M, Germi R. Assessment of residual moisture and maintenance of sterility in surgical instrument sets after sterilization. Infect Control Hosp Epidemiol. 2015;36(8):990–992. doi:10.1017/ice.2015.110

Shaffer HL, Harnish DA, McDonald M, Vernon RA, Heimbuch BK. Sterility maintenance study: dynamic evaluation of sterilized rigid containers and wrapped instrument trays to prevent bacterial ingress. Am J Infect Control. 2015;43(12):1336–1341. doi:10.1016/j.ajic.2015.07.010

Cavalli S, Caterino C, Nocera FP, Pizzano F, Schena R, Aragosa F, et al. A shelf-life assessment of sterilized surgical instruments stored under controlled conditions: a comparative study of a single vs. double self-sealing pouch. Vet Sci. 2025;12(6):564. doi:10.3390/vetsci12060564

Dunkelberg H, Schmelz U. Determination of the efficacy of sterile barrier systems against microbial challenges during transport and storage. Infect Control Hosp Epidemiol. 2009;30(2):179–183. doi:10.1086/593208

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

Bal B, Balaraju A. Overview of the central sterilization supply department, an integral part of the hospital. J Infect Dev Ctries. 2025;19(3):325–334. doi:10.3855/jidc.18646

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 11607 (Parts 1–2) — Packaging for terminally sterilized 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

Rodrigues SB, de Souza RQ, Graziano KU, Erzinger GS, Souza O. Performance evaluation of chemical, biological and physical indicators in the process of sterilization under the effect of non-condensable gases. J Hosp Infect. 2021;108:1–6. doi:10.1016/j.jhin.2020.11.005

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

Kirk B, Seto WH. A comparison of ISO 11140-1 specified type 4 versus type 5 internal chemical indicators for monitoring sterile packs in steam sterilization processes. Antimicrob Steward Healthc Epidemiol. 2025;5(1):e139. doi:10.1017/ash.2025.10139

International Organization for Standardization (ISO) / European Committee for Standardization (CEN). EN ISO 11140 (series) — Sterilization of health care products: chemical indicators. Geneva/Brussels: ISO/CEN.

Rutala WA, Jones SM, Weber DJ. Comparison of a rapid readout biological indicator for steam sterilization with four conventional biological indicators and five chemical indicators. Infect Control Hosp Epidemiol. 1996;17(7):423–428. doi:10.1086/647333

Li G, Xia F, Chen X, Chen R, Li Q. Enhancing sterilization supply management: a pre-post study on the impact of an integrated information system in a multi-campus hospital setting. BMC Health Serv Res. 2026;26(1):188. doi:10.1186/s12913-026-14477-3

International Organization for Standardization (ISO) / European Committee for Standardization (CEN). EN ISO 15882 — Sterilization of health care products: chemical indicators: guidance for selection, use and interpretation of results. Geneva/Brussels: ISO/CEN.

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, Jones SM, Weber DJ. Comparison of a rapid readout biological indicator for steam sterilization with four conventional biological indicators and five chemical indicators. Infect Control Hosp Epidemiol. 1996;17(7):423–428. doi:10.1086/647333

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

Vesley D, Nellis MA, Allwood PB. Evaluation of a rapid readout biological indicator for 121°C gravity and 132°C vacuum-assisted steam sterilization cycles. Infect Control Hosp Epidemiol. 1995;16(5):281–286. doi:10.1086/647108

Rodrigues SB, de Souza RQ, Graziano KU, Erzinger GS, Souza O. Performance evaluation of chemical, biological and physical indicators in the process of sterilization under the effect of non-condensable gases. J Hosp Infect. 2021;108:1–6. doi:10.1016/j.jhin.2020.11.005

Setlow B, Korza G, Setlow P. Analysis of α-glucosidase enzyme activity used in a rapid test for steam sterilization assurance. J Appl Microbiol. 2016;120(5):1326–1335. doi:10.1111/jam.13074

Alfa MJ, Olson N, DeGagne P, Jackson M. Evaluation of rapid readout biological indicators for 132°C gravity and 132°C vacuum-assisted steam sterilization cycles using a new automated fluorescent reader. Infect Control Hosp Epidemiol. 2002;23(7):388–392. doi:10.1086/502071

International Organization for Standardization (ISO) / European Committee for Standardization (CEN). EN ISO 11138 (series) — Sterilization of health care products: biological indicators. Geneva/Brussels: ISO/CEN.

International Organization for Standardization (ISO). ISO 14161 — Sterilization of health care products: biological indicators: guidance for the selection, use and interpretation of results. 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

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

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

Rodrigues SB, de Souza RQ, Graziano KU, Erzinger GS, Souza O. Performance evaluation of chemical, biological and physical indicators in the process of sterilization under the effect of non-condensable gases. J Hosp Infect. 2021;108:1–6. doi:10.1016/j.jhin.2020.11.005

van Doornmalen J, Kopinga K. Review of surface steam sterilization for validation purposes. Am J Infect Control. 2008;36(2):86–92. doi:10.1016/j.ajic.2007.02.002

Kirk B, Seto WH. A comparison of ISO 11140-1 specified type 4 versus type 5 internal chemical indicators for monitoring sterile packs in steam sterilization processes. Antimicrob Steward Healthc Epidemiol. 2025;5(1):e139. doi:10.1017/ash.2025.10139

Li G, Xia F, Chen X, Chen R, Li Q. Enhancing sterilization supply management: a pre-post study on the impact of an integrated information system in a multi-campus hospital setting. BMC Health Serv Res. 2026;26(1):188. doi:10.1186/s12913-026-14477-3

International Organization for Standardization (ISO). ISO 17665:2024 — Sterilization of health care products: moist heat. Geneva: ISO.

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) / 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.

International Organization for Standardization (ISO) / European Committee for Standardization (CEN). EN ISO 11137 (series) — Sterilization of health care products: radiation. Geneva/Brussels: ISO/CEN.

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.

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.

Bal B, Balaraju A. Overview of the central sterilization supply department, an integral part of the hospital. J Infect Dev Ctries. 2025;19(3):325–334. doi:10.3855/jidc.18646

Lin X, Wu J. Identification of key control points in instrument reprocessing of hospital central sterile supply department and its association analysis with surgical site infection. Front Public Health. 2026;14:1844524. doi:10.3389/fpubh.2026.1844524

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

Li G, Xia F, Chen X, Chen R, Li Q. Enhancing sterilization supply management: a pre-post study on the impact of an integrated information system in a multi-campus hospital setting. BMC Health Serv Res. 2026;26(1):687. doi:10.1186/s12913-026-14477-3

International Organization for Standardization (ISO). ISO 13485:2016 — Medical devices: quality management systems: requirements for regulatory purposes. Geneva: ISO.

European Committee for Standardization (CEN). EN 16442 — Controlled atmosphere storage cabinet for sterile medical devices. Brussels: CEN.

United Kingdom Department of Health. Health Technical Memorandum 01-01: Management and decontamination of surgical instruments (medical devices) used in acute care. London: Department of Health.

Deutsches Institut für Normung (DIN). DIN 58953 — Sterilisation: Sterilgutversorgung. Berlin: DIN.

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.

World Health Organization (WHO) / Pan American Health Organization (PAHO). Decontamination and reprocessing of medical devices for health-care facilities. Geneva: WHO; 2016.

Shuai J, Liu M, Hou J, Chen Y, Jiang J, Yu J, Yin L. Central sterile supply department management on hospital-associated infections: a systematic review and meta-analysis. Rev Inst Med Trop Sao Paulo. 2025;67:e16. doi:10.1590/S1678-9946202567016

Shuai J, Liu M, Hou J, Chen Y, Jiang J, Yu J, Yin L. Central sterile supply department management on hospital-associated infections: a systematic review and meta-analysis. Rev Inst Med Trop Sao Paulo. 2025;67:e16. doi:10.1590/S1678-9946202567016

International Organization for Standardization (ISO). ISO 9001:2015 — Quality management systems: requirements. Geneva: ISO.

International Organization for Standardization (ISO). ISO 13485:2016 — Medical devices: quality management systems: requirements for regulatory purposes. 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.

Bal B, Balaraju A. Overview of the central sterilization supply department, an integral part of the hospital. J Infect Dev Ctries. 2025;19(3):325–334. doi:10.3855/jidc.18646

Li G, Xia F, Chen X, Chen R, Li Q. Enhancing sterilization supply management: a pre-post study on the impact of an integrated information system in a multi-campus hospital setting. BMC Health Serv Res. 2026;26(1):188. doi:10.1186/s12913-026-14477-3

Pan W, Yi L, Hu T, Huang J, Huang Y. An action research study of quality improvement in instrument packaging procedures for the central sterile supply department. Sci Rep. 2024;14(1):3764. doi:10.1038/s41598-024-54237-z

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

Lin X, Wu J. Identification of key control points in instrument reprocessing of hospital central sterile supply department and its association analysis with surgical site infection. Front Public Health. 2026;14:1844524. doi:10.3389/fpubh.2026.1844524

Shuai J, Liu M, Hou J, Chen Y, Jiang J, Yu J, Yin L. Central sterile supply department management on hospital-associated infections: a systematic review and meta-analysis. Rev Inst Med Trop Sao Paulo. 2025;67:e16. doi:10.1590/S1678-9946202567016

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

Rideout K, Teschke K, Dimich-Ward H, Kennedy SM. Considering risks to healthcare workers from glutaraldehyde alternatives in high-level disinfection. J Hosp Infect. 2005;59(1):4–11. doi:10.1016/j.jhin.2004.07.003

Takigawa T, Endo Y. Effects of glutaraldehyde exposure on human health. J Occup Health. 2006;48(2):75–87. doi:10.1539/joh.48.75

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

Zhang HQ, Cheng P, Ji FH, Peng K. Occupational noise in the central sterile supply department: a narrative review of exposure, mechanisms, and control. Healthcare (Basel). 2026;14(15):2358. doi:10.3390/healthcare14152358

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.

Kovaleva J, Peters FTM, van der Mei HC, Degener JE. Transmission of infection by flexible gastrointestinal endoscopy and bronchoscopy. Clin Microbiol Rev. 2013;26(2):231–254. doi:10.1128/CMR.00085-12

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

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

Ofstead CL, Heymann OL, Quick MR, Eiland JE, Wetzler HP. Residual moisture and waterborne pathogens inside flexible endoscopes: evidence from a multisite study of endoscope drying effectiveness. Am J Infect Control. 2018;46(6):689–696. doi:10.1016/j.ajic.2018.03.002

Alfa MJ, Singh H. Impact of wet storage and other factors on biofilm formation and contamination of patient-ready endoscopes: a narrative review. Gastrointest Endosc. 2020;91(2):236–247. doi:10.1016/j.gie.2019.08.043

Larsen S, Russell RV, Ockert LK, et al. Rate and impact of duodenoscope contamination: a systematic review and meta-analysis. EClinicalMedicine. 2020;25:100451. doi:10.1016/j.eclinm.2020.100451

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

International Organization for Standardization (ISO) / European Committee for Standardization (CEN). EN ISO 15883-4 — Washer-disinfectors: Part 4: requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes. Geneva/Brussels: ISO/CEN.

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.

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

Thomas JG, Chenoweth CE, Sullivan SE. Iatrogenic Creutzfeldt-Jakob disease via surgical instruments. J Clin Neurosci. 2013;20(9):1207–1212. doi:10.1016/j.jocn.2013.01.007

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

Heinzer D, Avar M, Pfammatter M, Moos R, Schwarz P, Buhmann MT, et al. Advancing surgical instrument safety: a screen of oxidative and alkaline prion decontaminants using real-time quaking-induced conversion with prion-coated steel beads as surgical instrument mimetic. PLoS One. 2024;19(6):e0304603. doi:10.1371/journal.pone.0304603

Fichet G, Antloga K, Comoy E, Deslys JP, McDonnell G. Prion inactivation using a new gaseous hydrogen peroxide sterilisation process. J Hosp Infect. 2007;67(3):278–286. doi:10.1016/j.jhin.2007.08.020

World Health Organization (WHO). WHO infection control guidelines for transmissible spongiform encephalopathies. Geneva: WHO; 2000.

Association for the Advancement of Medical Instrumentation (AAMI) / International Organization for Standardization (ISO). AAMI/ISO TIR22442-4:2011 (R2016) — Medical devices utilizing animal tissues and their derivatives: Part 4: principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes. Arlington, VA: AAMI; 2016.

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. 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

Schalli M, Kogler B, Miorini T, Gehrer M, Reinthaler FF. High-speed dental instruments: an investigation of protein-contaminated dental handpieces with the bicinchoninic acid assay in dental offices in Styria, Austria. Int J Environ Res Public Health. 2023;20(3):1670. doi:10.3390/ijerph20031670

Fruhauf A, Fernandez de Grado G, Scholler J, Offner D. Compliance of the dryness of dental handpieces for their sterilization under various treatment conditions. Hygiene. 2024;4(2):231–237. doi:10.3390/hygiene4020019

Cutler Peck CM, Brubaker J, Clouser S, Danford C, Edelhauser HE, Mamalis N. Toxic anterior segment syndrome: common causes. J Cataract Refract Surg. 2010;36(7):1073–1080. doi:10.1016/j.jcrs.2010.01.030

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

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.

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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November 6, 2026

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ISBN-13 (15)

978-625-362-199-5

Publication date (01)

2026

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