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eLibrary > ANSI/AAMI ST91:2021, Flexible and semi-rigid endoscope processing in health care facilities >

ANSI/AAMI ST91:2021, Flexible and semi-rigid endoscope processing in health care facilities, 2021

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ANSI/AAMI ST91:2021, Flexible and semi-rigid endoscope processing in health care facilities, 2021

ANSI/AAMI ST91:2021; Flexible and semi-rigid endoscope processing in health care facilities
Title page
AAMI Standard
Copyright information
Contents Page
Committee representation
Acknowledgments
Foreword
Introduction
1 Scope [Go to Page]
1.1 Inclusions
1.2 Exclusions
2 Normative references
3 Terms and definitions [Go to Page]
3.1 automated endoscope reprocessor AER
3.2 bioburden
3.3 biofilm
3.4 biological indicators BIs
3.5 borescope
3.6 case/cassette
3.7 certification
3.8 challenge test pack
3.9 chemical indicators CIs
3.11 cleaning
3.12 clinical soil
3.13 competency
3.14 competency verification
3.15 CQI
3.16 critical device
3.17 critical water
3.18 decontamination
3.19 decontamination area
3.20 education
3.21 endoscope sheath
3.22 engineering controls
3.23 ethylene oxide (EO) sterilization
3.24 expiration date
3.25 expiration statement
3.26 exposure control plan
3.27 exposure time
3.28 gaseous and vapor chemical sterilization
3.29 high-level disinfectant HLD
3.30 high-level disinfection
3.31 high-risk endoscopes
3.32 hydrogen peroxide sterilization
3.33 hydrogen peroxide–ozone sterilization
3.34 iatrogenic
3.35 inspect
3.36 installation qualification IQ
3.37 instrument air
3.38 labeling
3.39 liquid chemical sterilant
LCS
3.40 liquid chemical sterilant processing system LCSPS
3.41 liquid-resistant material
3.42 lot control number
3.43 magnification
3.44 manufacturer's written instructions for use
IFU
3.45 medical device
3.46 minimum effective concentration MEC
3.47 minimum recommended concentration MRC
3.48 occupational exposure
3.49 operational qualification OQ
3.50 OSHA
3.51 performance qualification
PQ
3.52 personal protective equipment
PPE
3.53 point of use treatment
3.54 preventive maintenance
3.55 process challenge device PCD
3.56 processing
3.57 processing area
3.58 pseudoinfection
3.59 reprocessing
3.60 reusable containment device
3.61 reusable medical device
3.62 rigid sterilization container system
3.63 safety data sheet SDS
3.64 semi-critical device
3.65 shelf life
3.66 solid container
3.67 solution test strip
3.68 Spaulding classification
3.69 spore test strip
3.70 standard precautions
3.71 steam sterilization
3.72 sterile
3.73 sterile processing area
3.74 sterilization
3.75 sterilization cycle
3.76 sterilizer
3.77 terminal cleaning
3.78 terminal sterilization
3.79 training
3.80 user verification
3.81 utility water
3.82 validation
4 Design of endoscope processing area [Go to Page]
4.1 General considerations
4.2 Workflow [Go to Page]
4.2.1 General considerations
4.2.2 Physical separation
4.2.3 Traffic control
4.3 Physical facilities [Go to Page]
4.3.1 General space requirements [Go to Page]
4.3.1.1 Space requirements in the decontamination area
4.3.1.2 Space requirements in the preparation area
4.3.1.3 Space requirements for terminal sterilization
4.3.1.4 Space requirements for manual high-level disinfection or manual liquid chemical sterilization
4.3.1.5 Space requirements for automated high-level disinfection or liquid chemical sterilization
4.3.2 Sinks and accessories
4.3.3 Electrical systems
4.3.4 Floors and walls
4.3.5 Ceilings
4.3.6 Doors
4.3.7 Heating, ventilation, and air conditioning (HVAC) operating parameters
4.3.8 Lighting
4.3.9 Hand hygiene facilities
4.3.10 Emergency eyewash/shower equipment
4.3.11 Water quality
5 Environmental cleaning
6 Personnel [Go to Page]
6.1 General considerations
6.2 Policies and procedures
6.3 Education, training, and competency verification [Go to Page]
6.3.1 General considerations
6.3.2 Frequency of education, training, and competency verification
6.3.3 Responsibilities of personnel providing training
6.3.4 Education and training [Go to Page]
6.3.4.1 Personnel handling flexible endoscopes at the point of use
6.3.4.2 Endoscope processing personnel
6.3.5 Competency verification
6.3.6 Documentation
6.4 Standard precautions
6.5 Hand hygiene
6.6 Attire [Go to Page]
6.6.1 General considerations
6.6.2 Personal protective equipment
7 Decontamination processes [Go to Page]
7.1 General considerations [Go to Page]
7.1.1 The appropriate cleaning methods for flexible endoscopes are based on:
7.1.2 Endoscope, cleaning equipment, and cleaning solution IFU should be followed during the cleaning process for endoscopes. In the event of conflict, the endoscope manufacturer should be contacted for clarification. Cleaning steps include the follow...
7.2 Point of use treatment [Go to Page]
7.2.1 General considerations
7.2.2 Procedure
7.3 Transport of contaminated endoscopes [Go to Page]
7.3.1 General considerations
7.3.2 Procedure
7.4 Leak testing [Go to Page]
7.4.1 General considerations
7.4.2 Leak testing procedures
7.4.3 Manual (dry) leak testing
7.4.4 Manual (wet) leak testing
7.4.5 Mechanical (dry) leak testing
7.4.6 Mechanical (wet) leak testing
7.4.7 Mechanical leak testing using an AER
7.4.8 Leak test failures
7.5 Cleaning [Go to Page]
7.5.1 General considerations
7.5.2 Detachable parts
7.6 Manual cleaning steps
7.7 Automated cleaning, rinsing, and drying
7.8 Inspection and cleaning verification [Go to Page]
7.8.1 General considerations
7.8.2 Visual inspection
7.8.3 Borescopic inspection
7.8.4 Cleaning verification
8 High-level disinfection, liquid chemical sterilization, and terminal sterilization systems for flexible endoscopes [Go to Page]
8.1 General considerations
8.2 High-level disinfectant systems and liquid chemical sterilant processing systems and procedures [Go to Page]
8.2.1 General considerations
8.2.2 Spill kits
8.2.3 Automated high-level disinfection and liquid chemical sterilization processes [Go to Page]
8.2.3.1 Automated high-level disinfection/liquid chemical sterilization features
8.2.3.2 Automated high-level disinfection/liquid chemical sterilization procedure
8.2.4 Manual high-level disinfection and liquid chemical sterilization processes [Go to Page]
8.2.4.1 Manual processing procedure
8.2.4.2 Manual rinsing
8.2.5 Endoscope drying [Go to Page]
8.2.5.1 General considerations
8.2.5.2 Manual drying
8.3 Terminal sterilization by gaseous or vaporized chemical sterilization processes [Go to Page]
8.3.1 General considerations
8.3.2 Packaging for terminal sterilization [Go to Page]
8.3.2.1 General considerations
8.3.2.2 Sterilization pouches
8.3.2.3 Sterilization wraps
8.3.2.4 Rigid sterilization containment systems
8.3.3 Terminal sterilization procedures
8.3.4 Ethylene oxide gas sterilization
8.3.5 Hydrogen peroxide and hydrogen peroxide–ozone sterilization
9 Sterile endoscope sheaths used as protective microbial barriers
10 Processing of endoscope accessories [Go to Page]
10.1 General considerations
10.2 Procedure
11 Storage of processed endoscopes [Go to Page]
11.1 General considerations
11.2 Storage of high-level disinfected or liquid chemically sterilized endoscopes [Go to Page]
11.2.1 Storage procedures
11.2.2 Storage cabinets [Go to Page]
11.2.2.1 Endoscope drying cabinets
11.2.2.2 Conventional drying cabinets
11.2.3 Identification of endoscopes during storage
11.2.4 Maximum safe storage time for high-level disinfected endoscopes [Go to Page]
11.2.4.1 General considerations
11.2.4.2 Risk assessment
11.2.5 Storage of liquid chemically sterilized endoscopes
11.3 Storage of terminally sterilized endoscopes and accessories [Go to Page]
11.3.1 General considerations
11.3.2 Storage area
12 Transport of processed endoscopes
13 Quality control [Go to Page]
13.1 General considerations
13.2 Establishing policy and procedures for quality assurance and safety program
13.3 Product identification and traceability
13.4 Documentation and record-keeping [Go to Page]
13.4.1 Documentation
13.4.2 Expiration dating for terminally sterilized endoscopes
13.5 Verification and monitoring of the cleaning process [Go to Page]
13.5.1 General Considerations
13.5.2 Visual inspection after manual cleaning
13.5.3 Cleaning verification tests for users
13.5.4 Testing cleaning efficacy
13.6 Monitoring of liquid chemical sterilization/high-level disinfection [Go to Page]
13.6.1 Monitoring of manual processes [Go to Page]
13.6.1.1 Physical monitors
13.6.1.2 Solution test strips or chemical monitoring devices [Go to Page]
13.6.1.2.1 General considerations
13.6.1.2.2 Using solution test strips or chemical monitoring devices
13.6.1.2.3 Frequency of use
13.6.1.2.4 Interpretation
13.6.1.2.5 Inadequate processing
13.6.2 Monitoring of automated processes [Go to Page]
13.6.2.1 General considerations
13.6.2.2 Use of physical monitors and process monitoring devices
13.6.2.3 Automated processing equipment malfunction
13.6.2.4 Inadequate processing
13.6.3 Microbiological surveillance of endoscopes
13.7 Monitoring gaseous and vapor chemical sterilization processes [Go to Page]
13.7.1 Physical monitors
13.7.2 Gaseous and vaporized chemical sterilizer malfunction
13.8 Chemical indicators [Go to Page]
13.8.1 General considerations
13.8.2 Using chemical indicators
13.8.3 Nonresponsive or inconclusive chemical indicators
13.9 Biological indicators [Go to Page]
13.9.1 General considerations
13.9.2 Using biological indicators and process challenge devices
13.10 Sterilizer testing [Go to Page]
13.10.1 General considerations
13.10.2 Qualification test procedure and acceptance criteria
13.10.3 Routine test procedure
13.10.4 Routine test acceptance criteria
13.10.5 Positive BI results
13.10.6 Positive BI microbiological verification testing
13.11 Product release
13.12 Product recalls [Go to Page]
13.12.1 General considerations
13.12.2 Recall procedure
13.12.3 Recall order
13.12.4 Recall summary report
13.13 Outbreak report
13.14 Quality process improvement [Go to Page]
13.14.1 General considerations
13.14.2 Risk analysis
13.14.3 Point of use
13.14.4 Decontamination
13.14.5 Liquid chemical sterilization, high-level disinfection, and gaseous and vaporized chemical sterilization
13.14.6 Functional areas for product and process improvement [Go to Page]
13.14.6.1 Workplace design
13.14.6.2 Processing policies and procedures
13.14.6.3 Product use
13.14.6.4 Implementation of product and process improvements
14 Device repair and loaned endoscopes [Go to Page]
14.1 General considerations
14.2 Point of use detection and communication
14.3 Processing area detection and communication
14.4 Health care facility point of repair transfer
14.5 Return to health care facility from repair
14.6 Loaned endoscopes [Go to Page]
14.6.1 Policy and procedure
14.7 Use of loaned endoscopes during microbial surveillance
14.8 Quality measures for repairs
15 New product evaluation [Go to Page]
15.1 General rationale
15.2 Considerations
Annex A (informative) Alternatives for keeping cool in the processing environment [Go to Page]
A.1 Introduction
A.2 Decontamination environment
A.3 Protective attire
A.4 Alternative cooling methods for personnel working in the decontamination area/room
Annex B (informative) Purchase considerations in selecting AERs and LCSPSs
Annex C (normative) Reference material for repairs [Go to Page]
C.1 Repair of flexible endoscopes
C.2 Loaned flexible endoscopes
C.3 Qualification considerations for repair providers
Annex D (informative) Manufacturer’s written instructions for use (IFU) conflict management
Annex E (informative) Endoscope visual inspection [Go to Page]
E.1 General considerations
E.2 Overview
E.3 Anatomy of an endoscope
E.4 Visual Inspection process
E.5 Implementation of visual inspection of endoscopes
E.6 Borescope inspection of an endoscope
E.7 Damaged adhesive
E.8 Inspection of components [Go to Page]
E.8.1 Light guide connector, light guide tube, control body (including valves and switches)
E.8.2 Insertion tube
E.8.3 Biopsy port
E.8.4 Distal tip
E.8.5 Bending section
E.8.6 Channel
Annex F (informative) User verification of cleaning processes0F [Go to Page]
F.1 General considerations
F.2 Markers (analytes) [Go to Page]
F.2.1 ATP
F.2.2 Protein
F.2.3 Hemoglobin
F.2.4 Carbohydrates
F.3 Cleaning verification tests for users [Go to Page]
F.3.1 Verification tests for ultrasonic cleaners
F.3.2 Verification test for mechanical washers
F.4 A program for verification of the efficacy of the manual cleaning during endoscope processing: An example
Annex G (informative) Effects of simethicone on flexible endoscopes
Annex H (informative) Safety considerations for high-level disinfectants and liquid chemical sterilants [Go to Page]
H.1 Glutaraldehyde solutions [Go to Page]
H.1.1 Introduction
H.1.2 Properties and applications of glutaraldehyde
H.1.3 Effective use of glutaraldehyde [Go to Page]
H.1.3.1 Safe use of glutaraldehyde [Go to Page]
H.1.3.1.1 General considerations for occupational exposure
H.1.3.2 Health effects of glutaraldehyde [Go to Page]
H.1.3.2.1 Potential health effects of short-term exposure
H.1.3.2.2 Potential health effects of long-term exposure [Go to Page]
H.1.3.2.2.1 Occupational exposure limits
H.1.3.2.3 Personal protective equipment and first aid [Go to Page]
H.1.3.2.3.1 Eye protection
H.1.3.2.3.2 Skin protection
H.1.3.2.3.3 Respiratory protection
H.1.3.3 Ventilation
H.1.3.4 Preparing activated solutions
H.1.3.5 Pouring activated solutions
H.1.3.6 Transporting solutions
H.1.3.7 Storing activated and unused solutions
H.1.3.8 Immersing items to be high-level disinfected or sterilized
H.1.3.9 Rinsing high-level-disinfected or sterilized items
H.1.4 Procedures for cleaning up glutaraldehyde spills [Go to Page]
H.1.4.1 General considerations
H.1.4.2 Deactivating chemicals
H.1.4.3 Drips and splashes
H.1.4.4 Large spills
H.1.5 Disposal of glutaraldehyde solutions
H.2 Hydrogen peroxide solutions [Go to Page]
H.2.1 Introduction
H.2.2 Properties and applications of hydrogen peroxide
H.2.3 Effective use of hydrogen peroxide solutions
H.2.4 Safe use of hydrogen peroxide solutions [Go to Page]
H.2.4.1 Occupational exposure [Go to Page]
H.2.4.1.1 General considerations
H.2.4.1.2 Health effects of hydrogen peroxide [Go to Page]
H.2.4.1.2.1 Potential health effects of short-term exposure
H.2.4.1.2.2 Potential health effects of long-term exposure
H.2.4.1.3 Occupational exposure limits
H.2.4.1.4 Personal protective equipment and first aid [Go to Page]
H.2.4.1.4.1 Eye protection
H.2.4.1.4.2 Skin protection
H.2.4.1.4.3 Respiratory protection
H.2.4.2 Ventilation
H.2.4.3 Pouring solutions
H.2.4.4 Transporting solutions
H.2.4.5 Storing unused solutions
H.2.4.6 Immersing items to be high-level disinfected or sterilized
H.2.4.7 Rinsing disinfected or sterilized items
H.2.5 Hydrogen peroxide spills
H.2.6 Disposal of hydrogen peroxide solutions
H.2.7 Vapor monitoring
H.3 Ortho-phthalaldehyde solutions [Go to Page]
H.3.1 Introduction
H.3.2 Properties and applications of OPA
H.3.3 Effective use of OPA
H.3.4 Safe use of OPA [Go to Page]
H.3.4.1 Occupational exposure [Go to Page]
H.3.4.1.1 General considerations
H.3.4.1.2 Health effects of OPA [Go to Page]
H.3.4.1.2.1 Potential health effects of short-term exposure
H.3.4.1.2.2 Potential health effects of long-term exposure
H.3.4.1.3 Occupational exposure limits
H.3.4.1.4 Personal protective equipment and first aid [Go to Page]
H.3.4.1.4.1 Eye protection
H.3.4.1.4.2 Skin protection
H.3.4.1.4.3 Respiratory protection
H.3.4.2 Ventilation
H.3.4.3 Pouring solutions
H.3.4.4 Transporting solutions
H.3.4.5 Storing opened solutions
H.3.4.6 Immersing items to be high-level disinfected
H.3.4.7 Rinsing disinfected items
H.3.5 OPA spills
H.3.6 Disposal of OPA solutions
H.3.7 Vapor monitoring
H.4 Peracetic acid–hydrogen peroxide solutions [Go to Page]
H.4.1 Introduction
H.4.2 Properties and applications of peracetic acid–hydrogen peroxide solutions
H.4.3 Effective use of peracetic acid-hydrogen peroxide solutions
H.4.4 Safe use of peracetic acid–hydrogen peroxide solutions [Go to Page]
H.4.4.1 Occupational exposure [Go to Page]
H.4.4.1.1 General considerations
H.4.4.1.2 Health effects of peracetic acid and hydrogen peroxide [Go to Page]
H.4.4.1.2.1 Potential health effects of short-term exposure
H.4.4.1.2.2 Potential health effects of long-term exposure
H.4.4.1.3 Occupational exposure limits
H.4.4.1.4 Personal protective equipment and first aid [Go to Page]
H.4.4.1.4.1 Eye protection
H.4.4.1.4.2 Skin protection
H.4.4.1.4.3 Respiratory protection
H.4.4.2 Ventilation
H.4.4.3 Pouring solutions
H.4.4.4 Transporting solutions
H.4.4.5 Storing solutions
H.4.4.6 Immersing items to be high-level disinfected or sterilized
H.4.4.7 Rinsing disinfected or sterilized items
H.4.4.8 Transport and storage of processed devices
H.4.5 Peracetic acid–hydrogen peroxide spills
H.4.6 Disposal of peracetic acid–hydrogen peroxide solutions
H.4.7 Vapor monitoring
H.5 Hydrogen peroxide gas sterilization [Go to Page]
H.5.1 Introduction
H.5.2 Properties and applications of hydrogen peroxide gas sterilization systems
H.5.3 Effective use of hydrogen peroxide gas sterilizers
H.5.4 Safe use of hydrogen peroxide gas sterilizers [Go to Page]
H.5.4.1 Occupational exposure [Go to Page]
H.5.4.1.1 General considerations
H.5.4.1.2 Health effects of hydrogen peroxide [Go to Page]
H.5.4.1.2.1 Potential health effects of short-term exposure
H.5.4.1.2.2 Potential health effects of long-term exposure
H.5.4.1.3 Occupational exposure limits
H.5.4.1.4 Personal protective equipment and first aid [Go to Page]
H.5.4.1.4.1 Eye protection
H.5.4.1.4.2 Skin protection
H.5.4.1.4.3 Respiratory protection
H.5.4.2 Ventilation
H.5.4.3 Safety guidelines
H.5.5 Spills
H.5.6 Sterilant disposal
H.5.7 Vapor monitoring
H.6 Hydrogen peroxide–ozone sterilization [Go to Page]
H.6.1 Introduction
H.6.2 Properties and applications of hydrogen peroxide–ozone gas sterilization systems
H.6.3 Effective use of hydrogen peroxide–ozone gas sterilization
H.6.4 Safe use of hydrogen peroxide-ozone gas sterilizer [Go to Page]
H.6.4.1 Occupational exposure [Go to Page]
H.6.4.1.1 General considerations
H.6.4.1.2 Health effects of hydrogen peroxide [Go to Page]
H.6.4.1.2.1 Potential health effects of short-term exposure
H.6.4.1.2.2 Potential health effect of long-term exposure
H.6.4.1.3 Health effects of ozone [Go to Page]
H.6.4.1.3.1 Potential health effects of short-term exposure
H.6.4.1.3.2 Potential health effects of long-term exposure
H.6.4.1.4 Occupational exposure limits [Go to Page]
H.6.4.1.4.1 Hydrogen peroxide
H.6.4.1.4.2 Ozone
H.6.4.1.5 Personal protective equipment and first aid [Go to Page]
H.6.4.1.5.1 Eye protection
H.6.4.1.5.2 Skin protection
H.6.4.1.5.3 Respiratory protection
H.6.4.2 Ventilation
H.6.4.3 Safety guidelines
H.6.5 Spills
H.6.6 Sterilant disposal
H.6.7 Vapor monitoring
H.7 Ethylene oxide sterilization [Go to Page]
H.7.1 Introduction
H.7.2 Properties and applications of ethylene oxide sterilization
H.7.3 Effective use of ethylene oxide sterilization
H.7.4 Safe use of ethylene oxide sterilizers [Go to Page]
H.7.4.1 Occupational exposure [Go to Page]
H.7.4.1.1 General considerations
H.7.4.1.2 Health effects of ethylene oxide [Go to Page]
H.7.4.1.2.1 Potential health effects of short-term exposure
H.7.4.1.2.2 Potential health effects of long-term exposure
H.7.4.1.3 Occupational exposure limits
H.7.4.1.4 Personal protective equipment and first aid [Go to Page]
H.7.4.1.4.1 Eye protection
H.7.4.1.4.2 Skin protection
H.7.4.1.4.3 Respiratory protection
H.7.4.2 Ventilation
H.7.4.3 Safety guidelines
H.7.5 Spills and leaks
H.7.6 Sterilant disposal
H.7.7 Vapor monitoring
Annex I (informative) Endoscope microbiocidal methods
Annex J (informative) Endoscope storage risk assessment
Annex K (informative) Endoscope drying [Go to Page]
K.1 Introduction
K.2 Importance of drying [Go to Page]
K.2.1 Literature review
K.3 Drying verification
K.4 Outstanding issues
K.5 Summary
K.6 Commonly accepted terminology
Bibliography [Go to Page]

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