This recommended practice provides guidelines for the selection and use of liquid chemical sterilants (LCSs)/high-level disinfectants (HLDs) and gaseous chemical sterilizers that have been cleared for marketing by the U.S. Food and Drug Administration for use in hospitals and other health care facilities. Included within the scope of this recommended practice are functional and physical design criteria for chemical sterilization and high-level disinfection processing areas; staff qualifications, education, and other personnel considerations; criteria for selecting LCSs/HLDs and gaseous chemical sterilizers; safety and efficacy considerations in the use of LCSs/HLDs and gaseous chemical sterilizers; preparation of devices for processing by chemical sterilization or high-level disinfection; quality control methods; and quality process improvement. Definitions of terms and informative annexes are also provided.

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1	ANSI/AAMI ST58:2013/(R)2018, Chemical sterilization and high-level disinfection in health care facilities
2	Objectives and uses of AAMI standards and recommended practices
3	Title page
4	AAMI Recommended Practice Copyright information
5	Contents
9	Glossary of equivalent standards
10	Committee representation
12	Acknowledgments
13	Foreword
15	1 Scope 1.1 General 1.2 Inclusions
16	1.3 Exclusions
17	2 Definitions and abbreviations
23	3 Work area design considerations 3.1 General rationale 3.2 Processing area 3.3 Traffic control
24	3.4 Ventilation of processing areas and equipment 3.4.1 General considerations 3.4.2 General room ventilation 3.4.3 Local exhaust ventilation
26	3.5 Automated processing equipment for chemical sterilants/high-level disinfectants 3.5.1 Selection of equipment 3.5.2 Installation 3.5.3 Equipment location 3.6 Storage of chemical sterilants/high-level disinfectants
27	3.7 Disposal of chemical sterilant/high-level disinfectant waste 3.7.1 Chemical sterilant/high-level disinfectant solutions 3.7.2 Chemical solution containers 3.8 Regulatory requirements
28	4 Personnel considerations 4.1 General rationale 4.2 Qualifications 4.2.1 Supervisory personnel 4.2.2 Processing personnel
29	4.3 Training and continuing education 4.3.1 Processing personnel
30	4.3.2 Service personnel 4.3.3 Other personnel 4.4 Personal protective equipment 4.4.1 General considerations
31	4.4.2 Eye protection (liquid) 4.4.3 Skin protection (liquid) 4.4.4 Respiratory protection
32	4.5 Health and personal hygiene
33	5 Selection of liquid and gaseous chemical sterilants/high-level disinfectants 5.1 General rationale 5.2 Categories 5.3 LCS/HLD types
34	5.4 Gaseous chemical sterilization types 5.5 Selection criteria 5.5.1 General considerations
35	5.5.2 Health and safety considerations
36	5.5.3 Effectiveness
37	5.5.4 Materials compatibility
38	5.5.5 Cost-effectiveness 5.5.6 Matrix of selection criteria
39	6 Decontamination and preparation of instruments 6.1 General rationale 6.2 Receiving 6.2.1 Receiving of purchased items 6.2.1.1 General considerations 6.2.1.2 Newly purchased reusable items and repaired reusable items 6.2.1.3 Disposable items 6.2.2 Disposition of sterile items (issued but not used)
40	6.3 Handling, collection, and transport of contaminated items 6.3.1 General considerations 6.3.2 Separation of waste and reusable items at point of use
41	6.3.3 Care and handling of contaminated reusable items at point of use 6.3.4 Containment
42	6.4 Transport 6.4.1 Segregation of clean/sterile items 6.4.2 Transportation scheduling and routes 6.4.3 Transportation equipment 6.4.4 Hand transport
43	6.4.5 Dedicated lifts 6.4.6 Transport between buildings 6.4.7 Off-site transportation 6.5 Aseptic presentation 6.5.1 Opening sterile packages
44	6.5.2 Removing items from sterile packaging and transferring them to the sterile field 6.5.3 Removing devices from HLD equipment and delivery to the point of use
45	6.6 Cleaning and other decontamination processes 6.6.1 General considerations 6.6.2 Preparation for cleaning 6.6.3 Disassembly
46	6.6.4 Cleaning 6.6.4.1 General considerations 6.6.4.2 Cleaning agents
47	6.6.4.3 Methods of cleaning 6.6.4.3.1 Selection of an appropriate method 6.6.4.3.2 Manual cleaning
48	6.6.4.3.3 Mechanical cleaning and disinfection
49	6.6.4.4 Cleaning procedures 6.6.4.4.1 Instruments
50	6.6.4.4.2 Devices with lumens
51	6.6.5 Rinsing 6.6.6 Drying, inspection, and verification of the cleaning process 6.6.7 Microbicidal processes
52	6.7 Packaging
53	7 Using chemical sterilants/high-level disinfectants safely and effectively 7.1 Introduction 7.2 General considerations 7.2.1 Establishing policies and procedures 7.2.2 Manufacturers’ written IFU 7.2.2.1 LCS/HLD manufacturer
54	7.2.2.2 Mechanical LCS/HLD equipment manufacturer 7.2.2.3 Gaseous chemical sterilization equipment manufacturer 7.2.3 Ensuring cleaning effectiveness
55	7.2.3.1 Excess moisture 7.3 General safety considerations 7.3.1 Introduction 7.3.2 Emergency procedures 7.3.2.1 Spill containment team 7.3.2.2 Spill containment plan
56	7.4 Liquid chemical sterilants/high-level disinfectants 7.4.1 General considerations 7.4.2 Relationship between LCSs and HLDs
57	7.4.3 Single vs. multi-use 7.4.4 Consideration for selection 7.4.4.1 General considerations 7.4.4.2 Process parameters 7.4.4.3 Water quality for dilution and rinsing 7.4.4.4 Containers used for solution storage
58	7.4.4.5 Monitoring of LCS/HLD
59	8 Device storage and transport 8.1 General rationale 8.2 Devices processed with LCSs/HLDs 8.3 Devices processed with gaseous chemical sterilants
60	9 Quality control 9.1 General rationale 9.2 Product identification and traceability 9.2.1 Lot control numbers 9.2.2 Cycle documentation and record-keeping
61	9.2.3 Expiration dating 9.3 Monitoring manual processes that use LCSs/HLDs 9.3.1 General considerations 9.3.2 Use of physical monitors
62	9.3.3 Solution test strips and chemical monitoring devices 9.3.3.1 General 9.3.3.2 Using solution test strips and chemical monitoring devices 9.3.3.3 Frequency of use 9.3.3.4 Interpretation 9.3.3.5 Inadequate processing
63	9.4 Monitoring automated processes that use LCSs/HLDs 9.4.1 General considerations 9.4.2 Use of physical monitors and process monitoring devices
64	9.4.3 Automated processing equipment malfunction 9.4.4 Inadequate processing
65	9.5 Monitoring gaseous chemical sterilization processes 9.5.1 Use of physical monitors 9.5.2 Gaseous chemical sterilizer malfunction
66	9.5.3 Chemical indicators 9.5.3.1 General considerations 9.5.3.2 Using chemical indicators 9.5.3.3 Nonresponsive or inconclusive chemical indicators 9.5.4 Biological indicators 9.5.4.1 General considerations
67	9.5.4.2 Using biological indicators and process challenge devices 9.5.4.3 Frequency of use of biological indicators and process challenge devices 9.5.4.4 Sterilizer qualification testing 9.5.4.4.1 General considerations
68	9.5.4.4.2 Qualification test procedure with BIs 9.5.4.4.3 Acceptance criteria 9.5.4.5 Routine testing 9.5.4.5.1 Technical information 9.5.4.5.2 Routine test procedure with BIs
69	9.5.4.5.3 Acceptance criteria 9.5.4.6 Positive biological indicator results 9.5.4.7 Microbiological testing
70	9.6 Product release 9.7 Product testing 9.7.1 General considerations
71	9.7.2 Gaseous chemical sterilization processes
72	9.7.3 LCS/HLD automated processing equipment 9.8 Product recalls 9.8.1 General considerations
73	9.8.2 Recall procedure 9.8.3 Recall order 9.8.4 Recall summary report 9.8.5 Outbreak report
74	10 Quality process improvement 10.1 General rationale 10.2 Quality process 10.2.1 General considerations 10.2.2 Risk analysis
75	10.2.3 Decontamination 10.2.4 Liquid chemical sterilization, high-level disinfection, and gaseous chemical sterilization
76	10.3 Functional areas for product and process improvement 10.3.1 Workplace design 10.3.2 Processing policies and procedures
77	10.3.3 Product use 10.4 Implementation of product and process improvements
79	Annex A Microbial lethality, materials compatibility, and toxicity A.1 Introduction A.2 Microbial lethality
81	A.3 Materials compatibility A.3.1 General considerations
82	A.3.2 Effects on polymeric materials A.3.3 Effects on metals
83	A.3.4 Conclusion A.4 Toxicity
85	Annex B Glutaraldehyde solutions B.1 Introduction B.2 Properties and applications of glutaraldehyde
86	B.3 Effective use of glutaraldehyde
87	B.4 Safe use of glutaraldehyde B.4.1 Occupational exposure B.4.1.1 General considerations B.4.1.2 Health effects of glutaraldehyde B.4.1.2.1 Potential health effects of short-term exposure
88	B.4.1.2.2 Potential health effects of long-term exposure B.4.1.3 Occupational exposure limits B.4.1.4 Personal protective equipment and first aid B.4.1.4.1 Eye protection
89	B.4.1.4.2 Skin protection B.4.1.4.3 Respiratory protection B.4.2 Ventilation B.4.3 Preparing activated solutions B.4.4 Pouring activated solutions B.4.5 Transporting solutions B.4.6 Storing activated and unused solutions
90	B.4.7 Immersing items to be high-level disinfected or sterilized B.4.8 Rinsing high-level-disinfected or sterile items
91	B.5 Procedures for cleaning up glutaraldehyde spills B.5.1 General considerations B.5.2 Deactivating chemicals B.5.3 Drips and splashes B.5.4 Large spills
92	B.6 Disposal of glutaraldehyde solutions
93	Annex C Hydrogen peroxide solutions C.1 Introduction C.2 Properties and applications of hydrogen peroxide C.3 Effective use of hydrogen peroxide solutions
94	C.4 Safe use of hydrogen peroxide solutions C.4.1 Occupational exposure C.4.1.1 General considerations C.4.1.2 Health effects of hydrogen peroxide C.4.1.2.1 Potential health effects of short-term exposure C.4.1.2.2 Potential health effects of long-term exposure C.4.1.3 Occupational exposure limits C.4.1.4 Personal protective equipment and first aid C.4.1.4.1 Eye protection C.4.1.4.2 Skin protection
95	C.4.1.4.3 Respiratory protection C.4.2 Ventilation C.4.3 Pouring solutions C.4.4 Transporting solutions C.4.5 Storing unused solutions C.4.6 Immersing items to be high-level disinfected or sterilized
96	C.4.7 Rinsing disinfected or sterile items C.5 Hydrogen peroxide spills C.6 Disposal of hydrogen peroxide solutions C.7 Vapor monitoring
97	Annex D Ortho-phthalaldehyde solutions D.1 Introduction D.2 Properties and applications of OPA D.3 Effective use of OPA
98	D.4 Safe use of OPA D.4.1 Occupational exposure D.4.1.1 General considerations D.4.1.2 Health effects of OPA D.4.1.2.1 Potential health effects of short-term exposure D.4.1.2.2 Potential health effects of long-term exposure D.4.1.3 Occupational exposure limits D.4.1.4 Personal protective equipment and first aid D.4.1.4.1 Eye protection D.4.1.4.2 Skin protection
99	D.4.1.4.3 Respiratory protection D.4.2 Ventilation D.4.3 Pouring solutions D.4.4 Transporting solutions D.4.5 Storing opened solutions D.4.6 Immersing items to be high-level disinfected
100	D.4.7 Rinsing disinfected items D.5 OPA spills
101	D.6 Disposal of OPA solutions D.7 Vapor monitoring
102	Annex E Peracetic acid–hydrogen peroxide solutions E.1 Introduction E.2 Properties and applications of peracetic acid–hydrogen peroxide solutions
103	E.3 Effective use of peracetic acidhydrogen peroxide solutions
104	E.4 Safe use of peracetic acid–hydrogen peroxide solutions E.4.1 Occupational exposure E.4.1.1 General considerations E.4.1.2 Health effects of peracetic acid and hydrogen peroxide E.4.1.2.1 Potential health effects of short-term exposure E.4.1.2.2 Potential health effects of long-term exposure E.4.1.3 Occupational exposure limits
105	E.4.1.4 Personal protective equipment and first aid E.4.1.4.1 Eye protection E.4.1.4.2 Skin protection E.4.1.4.3 Respiratory protection E.4.2 Ventilation E.4.3 Pouring solutions E.4.4 Transporting solutions
106	E.4.5 Storing solutions E.4.6 Immersing items to be high-level disinfected or sterilized E.4.7 Rinsing disinfected or sterile items
107	E.4.8 Transport and storage of processed devices E.5 Peracetic acid–hydrogen peroxide spills E.6 Disposal of peracetic acid–hydrogen peroxide solutions E.7 Vapor monitoring
108	Annex F Sodium hypochlorite solutions F.1 Introduction F.2 Properties and applications of sodium hypochlorite solutions F.3 Effective use of sodium hypochlorite solutions
109	F.4 Safe use of sodium hypochlorite solutions F.4.1 Occupational exposure F.4.1.1 General considerations F.4.1.2 Health effects of sodium hypochlorite F.4.1.2.1 Potential health effects of short-term exposure F.4.1.2.2 Potential health effects of long-term health exposure F.4.1.3 Occupational exposure limits F.4.1.4 Personal protective equipment and first aid F.4.1.4.1 Eye protection
110	F.4.1.4.2 Skin protection F.4.1.4.3 Respiratory protection F.4.2 Ventilation F.4.3 Pouring solutions F.4.4 Transporting solutions F.4.5 Storing solutions F.4.6 Immersing items to be high-level disinfected or sterilized
111	F.4.7 Rinsing disinfected or sterile items F.4.8 Transport and storage of processed devices F.5 Sodium hypochlorite spills F.6 Disposal of sodium hypochlorite solutions F.7 Vapor monitoring
112	Annex G Chemical vapor sterilants using alcohol and formaldehyde G.1 Introduction G.2 Properties and applications of chemical vapor sterilants G.3 Effective use of chemical vapor sterilizers
113	G.4 Safe use of chemical vapor sterilizers G.4.1 Occupational exposure G.4.1.1 General considerations G.4.1.2 Health effects of formaldehyde and alcohol G.4.1.2.1 Potential health effects of short-term exposure G.4.1.2.2 Potential health effects of long-term health exposure G.4.1.3 Occupational exposure limits G.4.1.4 Personal protective equipment and first aid G.4.1.4.1 Eye protection G.4.1.4.2 Skin protection G.4.1.4.3 Respiratory protection G.4.2 Ventilation G.4.3 Safety guidelines
114	G.5 Chemical vapor spills G.6 Disposal of chemical vapor sterilants G.7 Vapor monitoring
115	Annex H Hydrogen peroxide gas sterilization H.1 Introduction H.2 Properties and applications of hydrogen peroxide gas sterilization systems H.3 Effective use of hydrogen peroxide gas sterilizers
116	H.4 Safe use of hydrogen peroxide gas sterilizers H.4.1 Occupational exposure H.4.1.1 General considerations H.4.1.2 Health effects of hydrogen peroxide H.4.1.2.1 Potential health effects of short-term exposure H.4.1.2.2 Potential health effects of long-term exposure H.4.1.3 Occupational exposure limits H.4.1.4 Personal protective equipment and first aid H.4.1.4.1 Eye protection H.4.1.4.2 Skin protection
117	H.4.1.4.3 Respiratory protection H.4.2 Ventilation H.4.3 Safety guidelines H.5 Spills H.6 Sterilant disposal H.7 Vapor monitoring
118	Annex I Ozone sterilization I.1 Introduction I.2 Properties and applications of ozone as a sterilant I.3 Effective use of ozone sterilizers
119	I.4 Safe use of ozone sterilizers I.4.1 Occupational exposure I.4.1.1 General considerations I.4.1.2 Health effects of ozone I.4.1.2.1 Potential health effects of short-term exposure I.4.1.2.2 Potential health effects of long-term exposure I.4.1.3 Occupational exposure limits I.4.1.4 Personal protective equipment and first aid I.4.1.4.1 Eye protection I.4.1.4.2 Skin protection I.4.1.4.3 Respiratory protection I.4.2 Ventilation I.4.3 Safety guidelines I.5 Spills and leaks
120	I.6 Sterilant disposal I.7 Vapor monitoring
121	Annex J Government regulation J.1 Introduction J.2 FDA regulation of medical devices J.2.1 Statutory authority J.2.2 FDA regulatory classification of medical devices J.2.2.1 Classification process
122	J.2.2.2 Class I devices J.2.2.3 Class II devices J.2.2.4 Class III devices J.3 History of FDA regulation of LCSs/HLDs
123	J.4 Current FDA regulation of LCSs/HLDs J.4.1 Premarket notification submissions J.4.2 Labeling
124	J.5 FDA medical device reporting (MDR) regulation
125	J.6 OSHA regulation of chemical sterilants/high-level disinfectants J.6.1 General J.6.2 Occupational exposure limits
126	J.6.3 Safety Data Sheets J.6.4 OSHA area offices, regional offices, state-plan offices, and consultation project state directory
127	J.7 State and local regulations
128	Annex K Occupational exposure to bloodborne pathogens (29 CFR Part 1910.1030) §1910.1030 Bloodborne pathogens
142	Annex L User verification of cleaning processes L.1 General considerations
143	L.2 Markers
144	L.3 Cleaning verification tests for users
147	Annex M Example of documentation of premature release of implants
149	Annex N Gas and vapor monitoring N.1 General considerations N.2 Instrumentation N.2.1 Monitoring methods
151	N.2.2 Reliability and use of instrumentation N.3 Procedures N.3.1 Monitoring sites
152	N.3.2 Frequency of monitoring N.3.3 Time-weighted average and ceiling exposures N.3.4 Record-keeping
153	N.4 Selecting vapor-monitoring equipment or services N.4.1 General considerations N.4.2 Personal and area monitoring N.4.3 Personal monitoring
154	N.4.4 Area monitoring N.4.5 Devices available for vapor monitoring N.4.5.1 Characteristics and ratings of air monitoring devices
155	N.4.5.2 Diffusion and sample-draw continuous monitors N.4.5.3 Active sampling devices
156	N.4.5.4 Passive sampling devices N.4.5.5 Questions that should be asked of monitoring device manufacturers
157	N.5 Contracted services N.5.1 General considerations
158	N.5.2 Finding contract service organizations N.5.3 Selection criteria
160	Annex O Bibliography O.1 Cited references
168	O.2 For further reading

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Standard Title	ANSI/AAMI ST58:2013/(R)2018 – Chemical sterilization and high-level disinfection in health care facilities
Published Code	AAMI
Publication Date	2013
Pages Count	168

AAMI ST58 2013 RA 2018

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