Disinfection and Sterilization Mary T. Post, RN, MS, CNS, CIC Infection Prevention Specialist Oregon Patient Safety Commission

Objectives Discuss: Current recommendations and standards for best practices in reprocessing surgical instruments and equipment Current recommendations and standards for quality assurance, monitoring, and documentation of the sterilization process Describe: Common findings identified by Oregon Healthcare Regulatory and Quality Improvement (HCRQI) and the Centers for Medicare & Medicaid Services ASC surveys related to disinfection and sterilization Rutala’s 14-Step protocol for disinfection/sterilization failures Discuss: utilization of tools designed to assist with ASC sterilization and disinfection practices

Who is at Risk? Staff: when processing instruments, staff are at risk of exposure to blood or body fluids Patients: microorganisms found on improperly processed items may cause infections during procedures Community: if hands are contaminated or if there is an infection from exposure to bloodborne diseases Staff: 1) thru open cuts on the hands or forearms. 2) chapped or cracked hands 3) injuries from needles or other sharp instruments such as scalpel blades 4) Splashes of blood or other fluids onto mucous membranes, such as the eyes. Community: Staff members can spread infections to their partners, family members or friends. Infections acquired by both patients and staff can lead to increased infections throughout the community. (e.g. MRSA, VRE).

Disinfection and Sterilization EH Spaulding believed that how an object will be disinfected depended on the object’s intended use Critical: objects that enter normally sterile tissue, the vascular system, or through which blood flows, should be sterile Semi-critical: objects that touch mucous membranes or skin that is not intact require a disinfection process (high-level disinfection (HLD) that kills all microorganisms except small numbers of bacterial spores Non-critical: objects that touch only intact skin require low-level disinfection

Processing “Critical” Patient Care Objects Classification: critical objects that enter normally sterile tissue, the vascular system, or through which blood flows Object: sterility Level of germicidal action: kill all microorganisms, including bacterial spores Examples: surgical instruments and devices, cardiac catheters, implants Method: steam, ethylene oxide, hydrogen peroxide plasma, hydrogen peroxide vapor, ozone

Processing “Semi-critical” Patient Care Objects Classification: semi-critical objects that come in contact with mucous membranes or skin that is not intact Object: free of all microorganisms except high numbers of bacterial spores Level of germicidal action: kills all microorganisms, except high numbers of bacterial spores Examples: respiratory therapy and anesthesia equipment, GI endoscopes, endocavitary probes, etc. Method: high-level disinfection

Selecting a Process Be certain to read the instrument manufacturer’s instructions for reprocessing Use the correct processing methodology for each instrument

Point-of-use Keeping instruments moist at the use location (e.g., operating/procedure room): Prevents biofilm development Protects instruments Facilitates decontamination and cleaning

Transport of Soiled Instruments/Equipment Bins with lids Impermeable color bags Closed/covered carts Closed sterilization container systems Biohazard label

Remember: Have a Dirty-to-Clean Work Flow Traffic flow Physical separation from all other areas of processing department Procedural barrier separation Ideally, doors are closed and pass through windows are closed

Decontamination Environment Room should be negative pressure Temperature: 60-65 F Humidity: 30-60% Temperature/humidity monitors available No fans or portable air conditioners

Decontamination The first step in processing instruments Safer to handle for whomever performs cleaning and further processing Reduces the number of organisms Eliminates fluids or tissue remains Removes contaminants that collect in joints, groves and teeth of items

Cleaning Wear appropriate personal protective equipment Disassemble or open items to be cleaned Scrub items underwater in tepid water and approved detergent (if appropriate) to prevent aerosolization Label solutions appropriately; fill to appropriate level in bin Rinse items several times to insure all detergent is removed Mechanical (tunnel) washers 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.

Clean Work Area Where instrument packaging, sterilization, and storage should occur Should be positive pressure to the decontamination area Temperature range: 68 to 73 degrees F Humidity: 30-60 degrees

Drying Leave items disassembled, separated and open Allow to dry thoroughly before packaging Visually inspect items to be certain they are clean

Wrapping & Sealing Inspect wrapping to be sure it’s free from holes/damage Limit contents in each package to ensure processing is able to reach item surfaces thoroughly Pack contents so they can be opened and easily delivered onto a sterile field Use appropriate chemical monitor facing plastic (so it can be read) Pack scissors with tips pointed downward towards paper, ok to cover with cotton ball Chemical monitor: a) chemical indicator tape on outside of package b) Chemical indicator strip inside package Note: too many instruments in one package decreases appropriate sterilization to each item

Double Pouching Inside pouch smaller than outside pouch Inner pouch should not be folder over onto itself Perform only if validated for that by manufacturer

Labeling Identify contents and initials of person packaging items With a water resistant marker or labeler: Sterilization date: month/date/year Load number Sterilization equipment (if more than one autoclave) Statement: “Product not sterile if packaging is open, damaged. Check before using.” Labels on plastic side only for pouches; label on tape for wrapped package

Rigid Sterilization Containers Should be sized appropriately for the contained instruments (not too large, not too small) Lids need to be closed appropriately and should not be cracked, chipped, etc. Materials should be compatible with type of sterilizer chemicals in use

Sterilization Wrap Woven wrap Non-woven Single layer (two layers sequentially wrapped) One-step wrap (two layers bonded together; simultaneous wrap)

Quality Assurance Monitoring for Steam Sterilization Critical parameters for each load: Steam penetration Adequate temperature Pressure Time Use mechanical, chemical and biological monitors to evaluate sterilizing conditions and effectiveness

Sterilization Monitoring: Mechanical Indicators Cycle time, temperature, and pressure is displayed on sterilizer gauges with each instrument load A printout or graph documents these parameters

Sterilization Monitoring: Chemical Indicators (CI) 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 CI based on ability to monitor one or multiple sterilization parameters

Sterilization Monitoring: Chemical Indicators (CI) Indicate that item has been exposed to the sterilization process; does not prove sterilization has been achieved Should be placed inside each pack to verify steam penetration Should also be fixed to outside of each package to show it has gone through sterilization process

Class V and VI Integrators Chemical indicator that reacts to more than one of the critical parameters (steam penetration, temperature, pressure, time) Provides high level of quality assurance Must be used with a biological indicator Class VI Integrators (Emulating) are new and are being added to AAMI standards ST79 (must be used with a BI)

Sterilization Monitoring: Biological Indicators (BI) Closest to being ideal monitor and measure of effectiveness by challenging sterilization process against resistant spore (Bacillus spores) Monitors efficacy of air removal and steam penetration Use BI daily if sterilizer is used daily Use BI for every implant Use BI for every ETO run Need procedures for follow up if BI positive

Biological Indicators (BI) Steps for Use Write sterilizer number, load, and date on indicator Place in package in area most difficult to sterilize Run sterilizer per manufacturer’s directions Check chemical indicator for change If chemical indicator has changed, remove and place BI in incubator (must crush capsule to activate upon placing in incubator) Place a BI control (indicator that has not been processed) into incubator Incubate for specified time

Biological Indicators (BI) Steps for Use (cont.) Remove at regular intervals and visualize color change Incubation time varies with product Read and record results Test negative (purple) Test positive (yellow): sterilization process has failed due to improperly processed load, failure to meet temperature or exposure parameters, mechanical problems, etc. Note: Rapid-action BIs are automatically read by the incubator

Sterilization Preparation Textile packages on top Peel pouches on edge Instrument sets flat Rigid containers under wrapped packages Items should never touch sterilizer chamber walls Do not overfill!

Sterilization Sterilize prepared items according to the directions in the manufacturer’s manual for the specific sterilizer that you use Be certain the sterilizer receives scheduled routine maintenance as required by the manufacturer There are many OHSU clinics: each clinic may have a different autoclave model Be sure that routine cleaning & service is being completed. Paper side up

Immediate Use Sterilization See Flash Sterilization Clarification - FY2010 Ambulatory Surgical Center (ASC) Surveys http://www.cms.gov/SurveyCertificationGenInfo/downloads/SCLetter09_55.pdf Keep manufacturer’s instructions for all automated washing, disinfecting, and sterilizing equipment readily available to staff

CMS Questions CMS will ask ASCs: Is the sterilizer labeled for this cycle by the manufacturer? What is the sterilizer manufacturer-recommended load for that cycle? Is the containment device used labeled by its manufacturer for use in that cycle? For what load is the containment device recommended by its manufacturer?

CMS Questions (cont.) CMS will observe staff perform equipment reprocessing: Sterilization Critical equipment is sterilized Items are pre-cleaned according to manufacturer’s instructions or evidence-based guidelines prior to sterilization Medical devices and instruments are visually inspected for residual soil and re-cleaned as needed before packaging and sterilization A chemical indicator is placed in each load A biologic indicator is performed AT LEAST weekly and with all implantable loads

CMS Questions (cont.) Each load is monitored with mechanical indicators (e.g., time, temperature, pressure) Documentation for each piece of sterilization equipment is maintained and up to date and includes results from each load Items are appropriately contained and handled during the sterilization process to assure that sterility is not compromised prior to use After sterilization, medical devices and instruments are stored in a designated clean area so that sterility is not compromised Sterile packages are inspected for integrity and compromised packages are reprocessed

Additional CMS Questions Is the chemical indicator used labeled for use in this cycle by its manufacturer? If a biological indicator is used, is it labeled for use in this cycle by its manufacturer? If the cycle is used frequently, is it checked regularly with a biological indicator?

Documentation Use company documentation booklet or the sterilizer load documentation sheet to document: Sterilizer number and/or location Load number Sterilizer operator Cycle exposure time and temperature Biological indicator use: documentation and results Recall documentation (if applicable) Retain records for seven years Documentation records are to be sent to Infection Control @first of every month for JACHO recommendations. Make sure you indicate on the documentation, your clinic.

If BI Test is Positive 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 meet Mechanical (time, temperature, pressure) and chemical (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

If BI Test is Positive If repeat BI is negative and critical parameters are met, return sterilizer to service If still positive: Have sterilizer serviced Can repeat BI using different manufacturer or lot Need written protocol for positive BIs and recall process when indicated

Recall Process Initiated when load sterility is questioned Recall all items processed between the failed biological (positive failure) indicator and the previous BI (negative failure) Notify departments of the recall and collect unused items with questionable sterility Implement Rutala’s 14 step investigation process

Transporting All carts used to carry sterile items and supplies are to be covered and cleaned routinely Cover single items that are hand carried Do not carry them under your arms Sterile supplies and contaminated supplies are to be transported separately

Storage Closed cabinet that does not crush, bend, compress, or puncture packages If no cabinet: covered plastic container Open storage: lowest acceptable shelf 12” from floor & highest shelf 18” from ceiling Sterile supplies are considered contaminated if contact with wet or contaminated surfaces, including the floor Use sterile supplies on a “first in, first out” basis Visually inspect packaging for integrity and labeling prior to use Shelf acceptability is to allow sprinkler systems to work effectively if there is a fire, and off the floor to avoid dust, dirt etc.

Loaner Instrument Policy Hot topic If you borrow instruments from another facility, have a policy Manufacturer’s instructions should be reviewed and available onsite to staff Be certain the right process for reprocessing is used (e.g., temperature, time, method, etc.) Keep a documentation log

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2011 Since 2003, changes in: High-level disinfectants Automated endoscope reprocessors Endoscopes Endoscopic accessories However, efficacy of decontamination and high-level disinfection is unchanged and the principles guiding both remain valid Additional outbreaks of infection related to suboptimal infection prevention practices during endoscopy or lapses in endoscope reprocessing (unfamiliarity with endoscope channels, accessories, attachments; gaps in infection prevention at ASC) Examples: failure to sterilize biopsy forceps between patients Lapses in reprocessing tubing used in channel irrigation

Endoscope Reprocessing Pre-clean: at point-of-use, remove debris by wiping exterior and aspiration of detergent through air/water and biopsy channels Clean: mechanically cleaned with water and enzymatic cleaner HLD/Sterilize: immerse scope and perfuse HLD/ sterilzant through all channels for exposure time (>2% glut at 20m at 20 degrees); if AER used, review model-specific reprocessing protocols from both the endoscope and AER manufacturer

Endoscope Reprocessing (cont.) Rinse: scope and channels rinsed with sterile water, filtered water, or tap water; flush channels with alcohol and dry Dry: use forced air to dry insertion tube and channels Store: hang in vertical position to facilitate drying; stored in a manner to protect from contamination

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2011 Unresolved issues Interval of storage after which endoscopes should be reprocessed before use Data suggest that contamination during storage for intervals of 7-14 days is negligible

Monitoring Temperature of High-Level Disinfectant Advanced Sterilization Products, May 2011 Regulatory and accrediting organizations have increased their scrutiny of HLD temperatures and often request objective evidence that reprocessing temperatures meet requirements In many cases, the ambient temperature of a reprocessing area is sufficient to ensure the minimum reprocessing temperature is maintained during HLD - BUT NOT ALL The basin with solution may need to be warmed before the processing begins The minimum temperature should be maintained or exceeded throughout the soaking time; warmers available on market Regulators have asked users to conduct daily temperature monitoring of HLD and record on the log along with MEC

Steris System - Peracetic Acid 0.2% SS1 Processor: tabletop liquid peracetic acid system Used for instruments such as endoscopes FDA has advised users to transition to alternative processing methods New STERIS System 1E approved by FDA for HLD Multiple concerns: for latest info see FDA and STERIS websites

CMS High-level Disinfection (HLD) Semi-critical equipment is HLD or sterilized Items are pre-cleaned according to manufacturer’s instructions or evidence-based guidelines prior to HLD Medical devices and instruments are visually inspected for residual soil and re-cleaned as needed before HLD HLD equipment is maintained according to manufacturer instructions Chemicals used for high-level disinfection are: Prepared according to manufacturer instructions Tested for appropriate concentration according to manufacturer’s instructions Replaced according to manufacturer’s instructions Documented to have been prepared and replaced according to manufacturer’s instructions

CMS HLD (cont.) Instruments requiring high-level disinfection are: Disinfected for the appropriate length of time as specified by manufacturer’s instructions or evidence-based guidelines Disinfected at the appropriate temperature as specified by manufacturer’s instructions on evidence-based guidelines Items that undergo HLD are allowed to dry before use Following HLD, items are stored in a designated clean area in a manner to prevent contamination

Oregon Sterilization/High-Level Disinfection Replacement solution expiration date not documented Concentration of the HLD not documented Endoscopes were not stored in a clean, covered container The citation for high level disinfection (HLD) was received for not documenting the expiration date of the replacement solution and the concentration of the HLD

Single-use Devices CMS will look for single-use devices (SUD): If SUDs are reprocessed, they are devices that are approved by the FDA for reprocessing If SUDs are reprocessed, they are reprocessed by an FDA-approved reprocessor

Contracted Sterilization or HLD Services If contracting sterilization or HLD services offsite, CMS will confirm there is a contract or other documentation of an arrangement for offsite sterilization or HLD by viewing it

Failure to Follow Disinfection & Sterilization Principles These events are relatively frequent; however, not commonly appreciated: Human errors: time setting of 132 degree C steam sterilizer at 0 min rather than 4 min Failure to sterilize items after cleaning Exposure time on AER set at 1 min rather than 12 min of OPA Specula do not need to be disinfected/sterilized between uses Equipment failures: biopsy port caps not secure System problems: unwrapped specula

Disinfection & Sterilization Failures Deficiencies leading to infections have occurred when there has been failure to follow disinfection and sterilization principles These failures resulted from human error, equipment failures or system problems Discuss a 14-step method for managing a failure incident

Rutala’s 14 Step Protocol for Disinfection/Sterilization Failure Confirm disinfection or sterilization reprocessing failure Impound any improperly disinfected/sterilized items Do not use the questionable disinfection/sterilization unit (e.g., sterilizer, automated endoscope reprocessor) until proper functioning can be assured Inform key stakeholders Conduct a complete and thorough evaluation of the cause of the disinfection/sterilization failure Prepare a line listing of potentially exposed patients Assess whether disinfection/sterilization failure increases patient risk for infection

Rutala’s 14 Step Protocol for Disinfection/Sterilization Failure 8. Inform expanded list of stakeholders of the reprocessing issue 9. Develop a hypothesis for the disinfection/sterilization failure and initiate corrective action 10. Develop a method to assess potential adverse patient events 11. Consider notification of state and federal authorities 12. Consider patient notification 13. Develop long-term follow up plan 14. Perform after-action report

EDUCATION and DOCUMENTATION is critical! Toolkit Contents Sterilization Competency Checklist (3.03) Endoscope Reprocessing Competency Checklist (3.05) EDUCATION and DOCUMENTATION is critical! Policies for sterilization, high-level disinfection, loaner instruments, immediate-use sterilization, single use devices Documentation forms: Sterilizer Load (3.02), Immediate Use (3.07), Loaner Instrument (3.11) Web links to multi-society standards and resources