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

2. 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

3. 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).

4. 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

5. 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

6. 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

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

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

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

10. 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

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

12. 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

13. 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.

14. 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: degrees

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

16. 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

17. 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

18. 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

19. 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

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

21. 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

22. 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

23. 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

24. 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

25. 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)

26. 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

27. 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

28. 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

29. 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!

30. 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

31. Immediate Use Sterilization
See Flash Sterilization Clarification - FY2010 Ambulatory Surgical Center (ASC) Surveys
Keep manufacturer’s instructions for all automated washing, disinfecting, and sterilizing equipment readily available to staff

32. 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?

33. 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

34. 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

35. 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?

36. 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 of every month for JACHO recommendations.
Make sure you indicate on the documentation, your clinic.

37. 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

38. 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

39. 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

40. 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

41. 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.

42. 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

43. 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

44. 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

45. 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

46. Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 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

47. 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

48. 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

49. 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

50. 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

51. 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

52. 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

53. 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

54. 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

55. 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

56. 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

57. 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

58. 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