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

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”

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: www.onesourcedocs.com

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

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

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

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

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

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 11/10/201811/10/2018 Not Acceptable

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.

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. 11/10/201811/10/2018

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. 11/10/201811/10/2018

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) 11/10/201811/10/2018

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 11/10/201811/10/2018

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 11/10/201811/10/2018

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. 11/10/201811/10/2018

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) 11/10/201811/10/2018

Sterilization 11/10/201811/10/2018

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 104-131˚ F, exposure time 28-75 minutes Items with small or long lumens not validated Requires specific containers/monitors 11/10/201811/10/2018

Hydrogen Peroxide Gas Plasma Sterilizer 11/10/201811/10/2018

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 11/10/201811/10/2018

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 11/10/201811/10/2018

Steps for BI Use

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 11/10/201811/10/201811/10/201811/10/201811/10/2018

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 11/10/201811/10/2018

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 11/10/201811/10/2018

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 11/10/201811/10/2018

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 11/10/201811/10/2018

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 11/10/201811/10/2018

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 11/10/201811/10/2018

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 11/10/201811/10/2018

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 11/10/201811/10/2018

CRE Outbreaks Related to Contaminated ERCP Scopes Began as early as April 2009 in Florida. Received little attention Late 2011-2013: 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 2014-2015: 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 11/10/201811/10/2018

Questions