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AAMI TIR67 2018

$140.32

AAMI TIR67:2018 – Promoting safe practices pertaining to the use of sterilant and disinfectant chemicals in health care facilities

Published By Publication Date Number of Pages
AAMI 2018 71
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This technical information report (TIR) provides additional guidance to sterile processing managers and others regarding compliance with occupational safety and environmental regulations.

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PDF Pages PDF Title
1 AAMI TIR67:2018; Promoting safe practices pertaining to the use of sterilant and disinfectant chemicals in health care facilities
3 Title page
4 AAMI Technical Information Report
Copyright information
5 Contents
6 Committee representation
9 Foreword
11 Introduction
12 1 Scope
2 Definitions
19 3 U.S. legal and regulatory structure
3.1 General considerations
3.2 Statutes
3.3 Regulations
3.4 General duties
20 3.5 Regulations vs. consensus standards
3.6 State and federal law
3.7 Summary of regulations for chemical sterilants and disinfectants
21 Table 1—Summary of regulations, standards, and recommendations for chemical sterilants and disinfectants
Table 2—Summary of regulations, standards, and recommendations for the use of chemical disinfectants and sterilants in the health care setting
22 4 Consensus and other standards
4.1 Consensus standards
4.1.1 AAMI standards
23 4.2 Nonconsensus standards
4.2.1 NIOSH
4.2.2 OSHA
24 4.2.3 ACGIH
4.2.4 AIHA
Table 3—Acute exposure guideline levels relevant to health care sterile processing
25 4.2.5 Other jurisdictions
4.3 Accreditation agencies
Table 4—Accreditation agencies applicable to health care
26 5 Occupational safety laws applicable to safe use of sterilant and disinfectant chemicals and other chemicals in health care
5.1 Occupational Safety and Health Act [29 USC 651]
5.2 Emergency action plans [29 CFR 1910.38]
27 5.3 Fire prevention [29 CFR 1910.39]
5.3.1 Cylinder storage
5.4 OSHA hazard communication standard (HazCom) [29 CFR 1910.1200]
5.4.1 General considerations
28 5.4.2 Written hazard communication program [29 CFR 1910.1200(e)]
5.4.3 Labeling of hazardous chemicals [29 CFR 1910.1200(f)]
29 Figure 1—GHS pictograms used to show chemical hazards
5.4.4 Safety data sheets (SDSs) [29 CFR 1910.1200(g)]
30 5.4.5 Training [29 CFR 1910.1200(h)]
5.4.6 Trade secrets [29 CFR 1910.1200(i)]
31 5.5 OSHA air contaminants standard [29 CFR 1910.1000]
Table 5—Occupational exposure limits
32 5.6 OSHA ethylene oxide standard [29 CFR 1910.1047]
5.6.1 General considerations
33 5.6.2 Personal monitoring
34 5.6.2.1 Exemption from personal monitoring
5.6.3 Area monitoring
5.6.4 Methods of compliance [29 CFR 1910.1047(f)]
5.6.4.1 Engineering controls
5.6.4.2 Compliance program [29 CFR 1910.1047(f)(2)]
5.6.4.3 Respiratory protection [29 CFR 1910.1047(g)]
35 5.6.4.4 Emergency situations [29 CFR 1910.1047(h)]
36 5.6.4.5 Medical surveillance [29 CFR 1910.1047(i)]
37 5.6.4.6 Hazard communication [29 CFR 1910.1047(j)(1)]
5.6.4.7 Signs and labels [29 CFR 1910.1047(j)(2)]
5.6.4.8 Information and training [29 CFR 1910.1047(j)(3)]
38 5.6.4.9 Records of exposure measurements [29 CFR 1910.1047(k)]
5.6.5 Single-chamber EO sterilization
5.6.6 EO storage
5.6.7 EO cartridge transportation
39 5.7 OSHA formaldehyde standard [29 CFR 1910.1048]
5.8 OSHA hazardous materials standard (Hazmat) [29 CFR 1910.120]
5.9 Access to employee exposure and medical records [29 CFR 1910.1020]
5.9.1 General considerations
40 5.9.2 Preservation of records [29 CFR 1910.1020(d)]
5.9.3 Access to records [29 CFR 1910.1020(e)]
41 5.9.4 Analyses using exposure or medical records [29 CFR 1910.1020(e)]
5.9.5 OSHA access [29 CFR 1910.1020(e)]
5.9.6 Trade secrets [29 CFR 1910.1020(f)]
42 5.9.7 Employee information [29 CFR 1910.1020(g)]
5.9.8 Transfer of records [29 CFR 1910.1020(h)]
5.10 Permit-required confined spaces [29 CFR 1910.146]
5.11 Hazardous (classified) locations [29 CFR 1910.307]
43 6 Environmental laws pertaining to chemical use in health care
6.1 General considerations
Table 6—Environmental laws pertaining to chemical use in health care
45 7 Hazard and risk analysis
7.1 Hazard and risk
7.2 Risk to employees
7.3 Risk and hazard assessment for existing or new chemicals
7.3.1 General considerations
7.3.2 Hazard assessment
46 Table 7—Lists of common hazards in OSHA Guidance to the Hazard Communication Standard
7.3.3 Risk assessment
47 7.3.3.1 General considerations
7.3.3.2 Procedure for risk assessment
48 7.4 Hazards and risk control measures
Table 8—Control measures for various exposure modes for chemicals
49 8 Promoting safe practices
8.1 Properties of sterilant and high-level disinfectant chemicals
50 Table 9—Exposure and control means for sterilant and HLD chemicals
52 8.2 Preventing exposure
8.2.1 Roles of people involved in safety
8.3 Engineering controls
8.3.1 General considerations
8.3.2 Ventilation, hoods, and exhaust
53 8.3.3 Vapor monitoring
8.4 Personal protective equipment (PPE)
8.4.1 General considerations [29 CFR 1910.132]
54 8.4.2 Respiratory protection [29 CFR 1910.134]
8.4.3 Written respiratory protection plan [29 CFR 1910.134]
55 8.4.4 Clothing
56 8.4.5 Eye and face protection [29 CFR 1910.133]
57 8.4.6 Gloves
58 Table 10—Chemical resistance chart for common gloves
59 9 Response to exposure
9.1 Medical services and first aid [29 CFR 1910.151]
60 9.2 Chemical spills
61 9.3 Medical surveillance
9.4 Reporting
9.4.1 OSHA reporting [29 CFR 1904]
62 9.4.2 FDA reporting [21 CFR 803]
63 9.4.3 Environmental reporting
Table 11—Reportable quantities for various chemical spills
9.4.4 Facility incident reporting
64 Annex A (informative) Contact information for occupational safety offices in states and territories
68 Bibliography
AAMI TIR67 2018
$140.32