1. Basics of Cleaning, Sterilization and High Level Disinfection (HLD)
Cindy Turney CRCST, CBSPD
Infection Prevention
St. Luke’s Health System

2. AAMI Standards (Association for the Advancement of Medical Instrumentation)
The Joint Commission expects organizations to use evidence-based national guidelines,
such as the ANSI/ AAMI:
1. ST58:2013 "Chemical Sterilization and High-level Disinfection in Health Care Facilities“
2. ST79:2013 “Comprehensive guide to steam Sterilization and Sterility Assurance in
Healthcare Facilities”
3. ST91:2015 “Flexible and Semi-Rigid Endoscope Processing in Health Care Facilities”

3. Manufacturer's Instruction for Use (IFU)
The written IFU of the device manufacturer should ALWAYS be followed.
The reusable medical device manufacturer is responsible for ensuring that the device can be effectively cleaned and sterilized.
The IFU should be periodically reviewed for any updates
IFUs can be obtained through OneSource:

5. Training and Competencies
Training should be performed
Upon hire and prior to taking on responsibilities
When new items are purchased and initiated
By a competent trained individual
Competency
Should be verified by return demonstration or test
Must be verified prior to performing independently
Records must be maintained for each employee
Manufacturer Instructions for Use
Must be available and current for all instruments/equipment
Must also be reviewed and followed for any loaner instruments

6. SPAULDING CLASSIFICATIONS
Divides medical devices into categories by risk of infection
Critical: Objects that enter sterile body sites/tissues
ex: surgical stainless steel instruments
Such devices should be sterilized, which is defined as
the destruction of all microbial life.
Semi-critical: Objects that touch mucous membranes
ex: endoscopes, laryngoscopes, vaginal probes
These devices should receive at least high-level disinfection,
which is defined as the destruction of microbes but not all
Non-critical: Objects that touch only intact skin
ex: blood pressure cuffs, stethoscopes, blood glucose monitors

7. Disinfection Begins at Point-of-Use
Instruments should be maintained as free of gross soiled as possible during the surgical or other medical procedure.
Pre-cleaning should begin immediately after use.
Instruments should be cleaned according to the manufacturer’s IFU
Prevents biofilm (group of microorganisms which cells stick to each other and often adhere to a surface – difficult to remove)
Inspect for damage
Use approved enzymatic detergent
Instruments are to be kept moist until cleaning process begins
Reusable brushes must be disinfected or sterilized daily
Disinfection Begins at Point-of-Use

8. Biohazard label must be visible Transport as soon as possible
Transport of Soiled Instruments/Equipment
Bins with lids
containers must be solid/non-porous with a lid, puncture resistant, leak proof, closable
Impermeable bags
Closed Case Carts
Biohazard label must be visible
Transport as soon as possible

9. Decontamination Area Environmental controls
Room should be negative pressure
Temperature: 60-65˚ F
Humidity: 30-60%
Must be monitored and recorded daily
No fans permitted
Correct personal protective equipment (PPE) must be worn

10. Decontamination Decontamination includes manual cleaning, washer/disinfectors and ultrasonics
Dirty to clean workflow
Physical separation from clean area
Doors and pass through windows are to be kept closed
Proper lighting
Access to IFU’s
ultrasonics
Cart washers
washer/disinfectors
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Not Acceptable

11. Personal Protective Equipment (PPE)
Apply ALL of the following personal
protective equipment (PPE)
Mask
Face shield
Impervious long sleeve gown
Gloves
Hair Cover
Shoe covers.

12. Cleaning Always performed prior to disinfection or sterilization
Removes all body fluids and tissues
Use FDA approved hospital detergents (enzymatic, ph balanced )
Use detergents according to manufacturer’s IFU (proper ratio and temperature)
Always disassemble instruments according to manufacturer’s instructions for use
Includes manual cleaning, ultrasonics, and washer/disinfectors
Makes it safe to handle instruments for further reprocessing in clean area
PPE: Gloves, Gown, Face Shield
Detergent: do not use abrasive cleaner or saline solution. Abrasives place the instrument at risk for scratches that may harbor organisms.
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13. Cleaning Label solutions appropriately
Always disassemble instruments according to manufacturer’s instructions for use
Includes manual cleaning, ultrasonics, and washer/disinfectors
Makes it safe to handle instruments for further reprocessing in clean area
PPE: Gloves, Gown, Face Shield
Detergent: do not use abrasive cleaner or saline solution. Abrasives place the instrument at risk for scratches that may harbor organisms.
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14. Instrument Packaging Material
Pack contents to allow for steam penetration
Instruments must be in open position for sterilization
Instruments must not be clamped shut
Use tip protectors according to manufacturer’s instructions
Double pouch only if validated by Manufacture – never fold inside package
Perform QA checks prior to wrapping/packaging
Handle with care
Non-woven
Single layer (two layers sequentially wrapped)
One-step wrap (two layers bonded together; simultaneous wrap)
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15. Steam Parameters Sterilization times for surgical instruments
Prevacuum: 270˚ F , 4 minute exposure, 30 minute drying time
Gravity displacement: 250˚ F, 30 minute exposure, 30 minute drying time
Immediate-Use Steam Sterilization (IUSS) (formerly known as “Flash”)
Prevacuum: 270 ˚ F, 3-4 minute exposure, no drying
High-speed gravity: 2700F, 3-4 minute exposure, no drying
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16. Quality Assurance Monitoring in Steam Sterilization
Critical parameters for each load
Adequate temperature
Pressure
Time
Humidity
Use mechanical, chemical, and biological monitors to evaluate sterilizing conditions and effectiveness
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17. Types of Sterilization Monitors
Physical
Mechanical charts, printouts, or graphs
Biological
Measure lethality of cycle
Print-outs should be kept / documented in a log record whether or not the load performed as it should (ie. Cycle time, temp. and pressure.
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18. Chemical Indicators
Responds with characteristic chemical or physical change to one or more physical conditions within sterilizing chamber
Used to detect potential sterilization failures that could result from incorrect packaging or loading of sterilizer, or malfunctions of sterilizer
AAMI defines six classes of chemical indicators (CI) based on ability to monitor one or multiple sterilization parameters
Specific Tests
Special tests (Bowie-Dick/DART— used to assess the sterilizer has no vaccum leaks)
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19. Sterilization
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20. Hydrogen Peroxide (H202) Gas Plasma
Low temperature sterilization method with a short cycle and fast turnaround time
Suitable for heat sensitive and moisture sensitive medical devices
Non-toxic: no need for aeration
Parameters: temperature maintained between ˚ F, exposure time minutes
Items with small or long lumens not validated
Requires specific containers/monitors
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21. Hydrogen Peroxide Gas Plasma Sterilizer
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22. Ozone Sterilizer Cleared by FDA in 2003 for medical device use
Compatible with a wide range of materials
Inexpensive, non-toxic and environmentally friendly
Longer cycle times: typically 4.5 hours at 85-94˚ F
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23. Biological Indicators
Biological indicators (BI) are the only monitor that directly measures cycle lethality
Geobacillus stearothermophilus live spores
Ensure processed indicator and
control are from same lot
Sterilizers monitored on routine basis and with ALL implantable devices
Steam: at least weekly, preferably daily
ETO: every cycle
H2O2: at least daily
Ozone: every cycle
Implant: every cycle
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24. Steps for BI Use

25. Biological Indicators
Implantable devices should not be released until BI results are known
If emergency necessitates early release, an exception form should be used to communicate risk to provider
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26. Positive BI Result Record results - report and follow up immediately
Remove sterilizer from service until reason is determined
Check sterilizer records or logs to see if all other critical parameters were met
Mechanical (e.g., time, temperature, pressure) and chemical (e.g., internal and/or external)
Identify and correct any errors found
Retest sterilizer and evaluate mechanical, chemical, and biological monitors
Check if other items have failed indicators from previous loads
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27. When Monitors Indicate Failure Initiate Recall Process
Quarantine items/remove sterilizer from service
If reason is apparent (e.g., incorrect cycle selected, sterilizer loaded improperly), correct issue, repackage, and reprocess items
If reason is not apparent
Recall all items processed since last negative biological test
Any items used must be communicated to infection prevention and to provider responsible for care of patient
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28. Immediate Use Steam Sterilization
Should only be used in emergencies, not as a substitute for inadequate inventory or scheduling practices
Must be cleaned prior to sterilizing
IFU’s must be followed
Should not be done with implants except in critical emergencies - must record patient name and that all parameters were met
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29. High Level Disinfection
Semi-critical equipment is HLD or sterilized
Items are pre-cleaned according to manufacturer’s instructions prior to HLD
Medical devices and instruments must be visually inspected for residual soil and re-cleaned as needed before HLD
According to manufacturer instructions, chemicals used for high-level disinfection are
Prepared
Tested for appropriate concentration
Replaced
Documented to have been prepared and replaced
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30. HLD Parameters Wear PPE according to manufacturers IFU
Temperature: must meet parameters according to IFU- must be monitored and documented
Life cycle: disinfectant should be used only for the life span defined by the manufacturer
QA test: HLD should be testing prior to each use to ensure disinfectant is effective Use according to IFU testing must be done each time a new bottle is opened
Test strips: Use according to IFU – testing must be done each time a new bottle is opened and prior to each use – results must be documented
Disposal: Follow IFU – some product may need to be inactivated
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31. ALWAYS….
Wear appropriate PPE when working with high-level disinfectants (e.g., gloves, protective eyewear, masks, gowns, & hair covers)
Read the safety data sheet (SDS) for the product and ensure room meets safety requirements (e.g., ventilation)
Have eye wash station readily available
Chemical bins should be tightly covered when not in use
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32. Endoscope Reprocessing
Pre-clean: at point-of-use, remove debris by wiping exterior and aspirating detergent through air/water and biopsy channels, following all steps of IFU
Clean: mechanically clean with water and enzymatic detergent - thoroughly brush and flush according to IFU; always preform and document leak test
High-level disinfectant (HLD): immerse scope in HLD ensuring all channels are exposured for correct time and temp per IFU; if automatic endoscope preprocessor (AER) is used, review model-specific reprocessing protocols from both the endoscope and automatic endoscope preprocessor (AER) manufacturer
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33. Endoscope Reprocessing
Rinse: Thoroughly flush and rinse with sterile or filtered tap water; flush channels with alcohol or use AER
Store: hang in vertical position; protect from contamination in a well vented clean cabinet
Must be able to trace scopes to each patient use
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34. CRE Outbreaks Related to Contaminated ERCP Scopes
Began as early as April 2009 in Florida. Received little attention
Late : Multiple outbreaks traced to duodenoscopes (ERCP scopes), despite following FDA approved manufacturer cleaning instructions
2013: CDC advises FDA that it may not be possible to disinfect duodenoscopes following FDA approved manufacture cleaning instructions
FDA begins reviewing
: CRE outbreaks continue be reported, including many high profile medical centers
February 2015: FDA issues first specific warning related to duodenoscopes, even when all manufacturer cleaning instructions are followed
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35. Questions