8/9/2015. Fundamentals of Cleaning and Decontamination. Disclosure. Learning Objectives

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Infection Prevention Division 3M Sterile U Network Fundamentals of Cleaning and Decontamination 1 3M 2012. All Rights Reserved.

com Sterilization Tech Line 1-800-441-1922 Option 2 2 3M 2014 All rights reserved.

1 Infection Prevention Division 3M Sterile U Network Fundamentals of Cleaning and Decontamination 1 3M All Rights Reserved. Disclosure Vickie Edwards, BS, CSPDT Field Technical Consultant Infection Prevention Division 3M Health Care vledwards2@mmm.com Sterilization Tech Line Option 2 2 3M 2014 All rights reserved. Learning Objectives 1 Describe the best practices for cleaning and decontamination. 2 Describe the current recommended practices for use of personal protective equipment. 3 Discuss the current recommended practices for cleaning verification. 3 3M 2014 All rights reserved. 1

The Joint Commission (TJC) Standard IC.02.02.01 The hospital reduces the risk of infections associated with medical equipment, devices and supplies.

2 The Joint Commission (TJC) Standard IC The hospital reduces the risk of infections associated with medical equipment, devices and supplies. Failure to properly clean, disinfect, or sterilize, and use or store medical equipment, devices, and supplies, not only poses risks for the person seeking health services, but also carries the risk for person-to-person transmission of infections. The Joint Commission Hospital Accreditation Standards (HAS) 4 3M 2014 All rights reserved. Patient Risks The incidence of dirty instruments showing up in the OR is increasing Wide spread problem * *iwatch News by The Center for Public Integrity Filthy surgical instruments: The hidden threat in America s operating rooms. on 2/22/2012 at: 5 3M 2014 All rights reserved. Endoscope and Instrument Reprocessing The ECRI Institute Top Ten Technology Hazards for 2014 Hazard #6: Inadequate Reprocessing of Endoscopes and Surgical Instruments Flexible endoscopes complex devices with narrow, hard-to-clean channels, that can be particularly challenging to decontaminate not the only devices subject to reprocessing failures Incidents have been reported that describe other instruments and devices (e.g., arthroscopy shoulder cannulas) that were used despite being contaminated with potentially infections biological matter ECRI Institute, Health Devices November 2013, Top 10 Technology Hazards For M 2014 All rights reserved. 2

The Joint Commission Joint Commission Online July 2011 Surveyors received in-depth training on sterilization processes through AAMI Before training cited 10% noncompliance for HLD/sterilization*

Survey to most up-to-date ANSI/AAMI ST79 Expect ANSI/AAMI ST79 to be available to employees http://apicne.org/wp-content/uploads/young.pdf Joint CommissionOnline July 20, 2011.

3 The Joint Commission Joint Commission Online July 2011 Surveyors received in-depth training on sterilization processes through AAMI Before training cited 10% noncompliance for HLD/sterilization* After training cited 40% noncompliance for HLD/sterilization* * Louise Kuhny (a TJC Surveyor) presented an AORN webinar 9/21/2011 on TJC Survey Process: Second Generation Tracers. Survey to most up-to-date ANSI/AAMI ST79 Expect ANSI/AAMI ST79 to be available to employees Joint CommissionOnline July 20, Focus on sterilization and high-level disinfection processes. Eiland, John E, Surveyor, The Joint Commission. Joint Commission presentation at IAHCSMM annual meeting in May Presentation available on flash drive provided to attendees. 7 3M 2014 All rights reserved. The Joint Commission National Patient Safety Goals NPSG Implement evidence-based practices for preventing surgical site infections Element of Performance 3 Implement policies and practices aimed at reducing the risk of surgical site infections. These policies and practices meet regulatory requirements and are aligned with evidence-based guidelines (for example, the Center for Disease Control and Prevention [CDC] and/or professional organization guidelines). The Joint Commission Hospital Accreditation Standards (HAS) 8 3M 2014 All rights reserved. Evidence-Based Guidelines Association for the Advancement of Medical Instrumentation (AAMI) Comprehensive guide to steam sterilization and sterility assurance in health care facilities ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 (Consolidated Text) Association of Perioperative Registered Nurses (AORN) Perioperative Standards and Recommended Practices (2014 Edition) Centers for Disease Control and Prevention (CDC) Guideline for Disinfection and Sterilization in Healthcare Facilities, M 2014 All rights reserved. 3

4 Regulations & Recommended Practices Establish State-of-the-Art for Sterile Processing 10 3M 2014 All rights reserved. Cleaning, Decontamination, and Sterilization Process Should Follow Recommended Practices Hospitals ASCs Clinics Doctor Offices Dental Facilities 11 3M 2014 All rights reserved. Cleaning vs. Decontamination Cleaning* Removal of foreign material using water with detergent or enzymatic products Need thorough cleaning before high-level disinfection and sterilization Decontamination** Remove, inactivate, or destroy blood-borne pathogens so not capable of transmitting infectious particles Physical or chemical means *CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 **ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Section M 2014 All rights reserved. 4

Cleaning and Decontamination Many factors influence our success Sequential nature to the steps take one out of order, skip a step altogether, or perform it inadequately any of these can lead to

requirements Environment and PPE 13 3M 2014 All rights reserved. Let s Check Your Current Knowledge True or False?

5 Cleaning and Decontamination Many factors influence our success Sequential nature to the steps take one out of order, skip a step altogether, or perform it inadequately any of these can lead to unsatisfactory results Challenges: Dealing with a microscopic enemy Inventory issues and turnaround time expectations Device construction and complexity Differences in manufacturers processing requirements Environment and PPE 13 3M 2014 All rights reserved. Let s Check Your Current Knowledge True or False? The Sterile Processing Area design should promote physical separation of the receiving and processing of contaminated items from all areas in which clean or sterile items are handled or stored Workflow patterns should ensure that contamination is contained in all phases of reprocessing Air in decontamination should be under negative pressure 14 3M 2014 All rights reserved. The ECRI Health care facility needs to provide: Adequate space Equipment Trained staff Instructional materials Sufficient time to perform the reprocessing correctly ECRI Institute, Health Devices November 2013, Top 10 Technology Hazards For M 2014 All rights reserved. 5

Design Considerations Enough hand sanitizers in area Area to receive loaners Meet specific needs for instrumentation Leak tests, dental drills, robotics Location and accessibility of IFU No dietary

6 Design Considerations Enough hand sanitizers in area Area to receive loaners Meet specific needs for instrumentation Leak tests, dental drills, robotics Location and accessibility of IFU No dietary service items processed in decontamination Anti-fatigue mats Final rinse water is treated (manual and automatic) Deionized, distilled, and reverse osmosis ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Sections 3.2.2, , , , M 2014 All rights reserved. Design Considerations Ensure optimal performance of decontamination equipment Follow manufacturer s written IFU Ergonomic and preferably height adjustable tables Break out area to remove items from external shipping carton Hand hygiene facilities accessible to sterile storage Plumbed eyewashes and showers Activate weekly to ensure flushing fluid is available Verify water temperature [15ºC to 43ºC (60ºF to 100ºF)] Document routine testing ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Sections 3.2.2, , , , M 2014 All rights reserved. Functional Workflow Patterns Workflow pattern design: Separation is needed between areas in which decontamination activities occur and areas used for clean activities, such as packaging, sterilizing and storage Ensure that contaminants are contained and employee exposure to blood-borne pathogens and other disease-producing organisms is minimized Move all items progressively from being contaminated to being safe to handle ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Section M 2014 All rights reserved. 6

7 Functional Workflow Patterns Workflow pattern design: Locate elevators for transport of soiled and clean items, cart holding spaces and sorting spaces to limit environmental contamination Pass-through (between decontamination and the clean processing area) decontamination equipment is recommended A pass-through window is recommended for transport of manually processed items ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Section M 2014 All rights reserved. Traffic Control for Decontamination Always restricted to authorized persons Specify criteria in policies for authorized entry, movement through the areas and attire Rationale: Visitors and personnel increase potential for environmental contamination of the areas and it is important to also protect them from exposure to microorganisms on the dirty items ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Section M 2014 All rights reserved. Ventilation Recommendations Decontamination Ventilation system designed such that air contaminants from Decontamination do not enter clean areas Decontamination area must be under negative pressure Minimum of 10 air exchanges/hour Air exhausted to the outside via non-recirculating system ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Section M 2014 All rights reserved. 7

8 Let s Check Your Current Knowledge True or False? Items should be pre-cleaned in the OR to prevent formation of biofilm Care should be taken to transport soiled devices in enclosed bins, or leak proof bags, that are labeled contaminated In general, contaminated items should not be transported in liquids because of the risk of spills and possibility of employee injury Since one wears gloves in decontamination it is not necessary to wash your hands after removing them 22 3M 2014 All rights reserved. Immediate Handling of Contaminated Items at Point of Use Separate reusable items from waste and handle as little as possible Discard contaminated disposable items Wear personal protective equipment (PPE) Infection hazard greatest during handling and segregation of soiled, contaminated items at the point of use Contain the contaminated items in leakproof container Label contaminated items ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Sections 6.2 and M 2014 All rights reserved. Remove Gross Soil at Point of Use is the Responsibility of the OR Objective is to minimize the time between when the instruments were last used and the start of the cleaning process Remove gross soil at point of use to prevent formation of biofilm Wipe with moistened sponge (water not saline) Can use precleaning disinfectant Segregate sharps to minimize injury Place instruments open, disassembled, and arranged in an orderly fashion Place light weight instruments on top of heavy instruments Place microsurgical instruments in separate containers Protect scopes ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Sections 6.3, 6.4 AORN:2014, Care of Instruments RP, Recommendation IV 24 3M 2014 All rights reserved. 8

which could damage instruments 25 3M 2014 All rights reserved.

liquid at to minimize spills in transportation Keep instrument moist by adding Towel moistened with water (not saline) Foam,

biohazardous contents label Clean and sterile supplies are transported in another container/cart ANSI/AAMI ST79:2010 & A1:2010

9 What s wrong with these pictures? Poor transportation: Left: Instruments not moist; Right: liquid that is not contained Left: trays stacked on top of each other which could damage instruments 25 3M 2014 All rights reserved. Transportation Immediately contain in leak proof and puncture resistant container and transport to decontamination Discard liquid at to minimize spills in transportation Keep instrument moist by adding Towel moistened with water (not saline) Foam, spray or gel product Place large quantities of items in a transport container/cart with doors or plastic cover OSHA requires a biohazardous contents label Clean and sterile supplies are transported in another container/cart ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Section 6.4 AORN:2014, Care of Instruments RP, Recommendation V, VI 26 3M 2014 All rights reserved. Personal Protective Equipment (PPE) What s wrong with this picture? TJC and CMS surveyors will be verifying appropriate PPE 27 3M 2014 All rights reserved. 9

General Attire Clean uniforms donned at facility and laundered in the facility if contaminated AORN now says all scrub clothing should be laundered in the facility Head and facial hair covered No

to prevent injury from dropped items ANSI/AAMI ST79:2010 & A1:2010 & A2:201 & A3:2012 & A4:2013 Section 4.5.1 AORN:2014, Surgical Attire RP 28 3M 2014 All rights reserved.

10 General Attire Clean uniforms donned at facility and laundered in the facility if contaminated AORN now says all scrub clothing should be laundered in the facility Head and facial hair covered No jewelry or wrist watches Change into street clothing if traveling between buildings and leaving the campus Develop own policy for cover apparel within facility Shoes clean, non-skid soles and sturdy to prevent injury from dropped items ANSI/AAMI ST79:2010 & A1:2010 & A2:201 & A3:2012 & A4:2013 Section AORN:2014, Surgical Attire RP 28 3M 2014 All rights reserved. Personal Protective Equipment for Decontamination Wear appropriate PPE Masks Fluid-resistant to protect from splash or splatter (AAMI ST79) Cover nose and mouth Once mask donned it is considered contaminated and can spread microorganisms if worn hanging around the neck, or stuffed into a pocket, or perched on the forehead CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 pp ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Section M 2014 All rights reserved. Personal Protective Equipment for Decontamination Wear appropriate PPE Eye protection Protection against liquid splashes/ microorganisms/and chemicals Goggles or full-length face shields Still need to wear a mask if face shield is used CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 pp ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Section M 2014 All rights reserved. 10

11 Personal Protective Equipment for Decontamination Wear appropriate PPE Gowns Protect from splash and splatter Liquid-resistant covering with sleeves (ANSI/AAMI ST79) Change if gets wet or soiled Shoe coverings Liquid-resistant (ANSI/AAMI ST79) Potential for contamination or soaked with blood or other infectious material CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 pp ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Section M 2014 All rights reserved. cross- Personal Protective Equipment for Decontamination Wear appropriate PPE Gloves Prevent punctures, contact with microorganisms, decrease contamination General purpose heavy-duty, water-proof, long and cuffed Pick up sharps with forceps and discard in puncture-resistant container Still need to wash hands 32 3M 2014 All rights reserved. CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 pp ANSI/AAMI ST79:2010 & A1:2010 & A2:201 & A3:2012 & A4:2013 Section Personal Protective Equipment (PPE) Decontaminate reusable PPE at least daily and between employees Replace torn gloves immediately Remove all disposable PPE prior to leaving the decontamination area, being careful not to contaminate scrub suit or skin Wash hands prior to leaving the decontamination area ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Section M 2014 All rights reserved. 11

12 Let s Check Your Current Knowledge True or False? You can disinfect or sterilize a medical device without cleaning it first All medical device manufacturer s have the same instructions for cleaning and decontaminating medical devices Once cleaning is accomplished, the qualities of the final rinse are extremely important to remove the debris and detergent and prevent staining 34 3M 2014 All rights reserved. Significance of Cleaning for Sterilization Potential sterilization process failures If the medical device is not effectively cleaned, the sterilant cannot penetrate the material contaminating the item and sterilization will not occur Sterilization assurance monitors will not detect cleaning failures ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Section M 2014 All rights reserved. Steam Sterilization-Update on the Joint Commission s Position User Concerns Surveyor may, among other activities Ask for manufacturers instructions Ask staff to describe and demonstrate how instruments are cleaned and decontaminated according to those instructions Be concerned about meticulous cleaning and rinsing Want instruments cleaned the same way no matter location (CSSD/SPD, OR, ASC, Clinic) Want loaner and other instruments cleaned the same way Want rigid containers taken apart for cleaning Joint Commission Perspectives, July 2009, Vol. 29, Issue 7. Copyright 2009 Joint Commission on Accreditation of Healthcare Organizations and personal communications with hospitals that have had surveys 36 3M 2014 All rights reserved. 12

Steam Sterilization-Update on the Joint Commission s Position User Concerns Ensure you have the most up-to-date IFUs from the manufacturers of the: Medical devices (standard or extended cycles)

com, 1-800-701-3560 Joint Commission Perspectives, July 2009, Vol. 29, Issue 7.

13 Steam Sterilization-Update on the Joint Commission s Position User Concerns Ensure you have the most up-to-date IFUs from the manufacturers of the: Medical devices (standard or extended cycles) Cleaning and disinfection products and equipment Implements (brushes, cloths, etc) Have a method to keep your IFUs up-to-date onesource document site Joint Commission Perspectives, July 2009, Vol. 29, Issue 7. Copyright 2009 Joint Commission on Accreditation of Healthcare Organizations and personal communications with hospitals that have had surveys 37 3M 2014 All rights reserved. Cleaning Agents Compatible with medical device and cleaning equipment Use according to cleaning agent manufacturer s written IFU: Use within shelf life Dilute appropriately Calculate volume of cleaning agent sink or solution container TJC will be observing to see if you are correctly diluting the cleaning agent Discard cleaning solution when soiled or according to directions ANSI/AAMI ST79:2010 & A1:2010 & A2:201 & A3:2012 & A4:2013 Section M 2014 All rights reserved. Manual Cleaning Basics Manual Cleaning Process - Used for delicate or complex medical devices: Initial cold water rinse or soak in cool water and/or a soil dissolving enzymatic cleaner May need to dissolve enzyme cleaner first in warm water and then add cold water Lukewarm water/detergent solutions 27ºC to 44ºC [80ºF to 110ºF] or enzymatic cleaners (not to exceed 60ºC/140ºF) The temperature of the soaking solution should be monitored and documented Clean with soft brush under water surface ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Sections , 7.5.4, 7.5.6, Annex D 39 3M 2014 All rights reserved. 13

Manual Cleaning Basics Manual Cleaning Process Clean lumens with appropriate size brush or pipe cleaner Brush of appropriate type, size (diameter and length) (A3:2012) Bristle type and material

14 Manual Cleaning Basics Manual Cleaning Process Clean lumens with appropriate size brush or pipe cleaner Brush of appropriate type, size (diameter and length) (A3:2012) Bristle type and material (A3:2012) Soak lumens vertically or thoroughly flush to ensure complete contact with the processing chemicals Vertical Soaker ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Sections , 7.5.4, 7.5.6, Annex D 40 3M 2014 All rights reserved. Manual Cleaning Basics Manual Cleaning Process Thoroughly rinse with water recommended by medical device manufacturer to remove debris and detergent: Initial rise can be tap water Final rinse should be treated water to prevent staining and/or contamination of instrument Low endotoxin content Deionized, distilled or reverse osmosis water ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Sections , 7.5.4, M 2014 All rights reserved. Manual Cleaning Basics Manual Cleaning Process Water-soluble instrument lubricants Dry before packaging for sterilization Air or lint free cloth ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Sections , 7.5.4, M 2014 All rights reserved. 14

Manual Cleaning Basics Brushes and Other Cleaning Implements: Brushes and other cleaning implements should be single-use, disposable items and discarded after every use or, if reusable, be

A3:2012 & A4:2013 Sections 7.5.3.2, 7.5.6 43 3M 2014 All rights reserved. Let s Check Your Current Knowledge True or False?

15 Manual Cleaning Basics Brushes and Other Cleaning Implements: Brushes and other cleaning implements should be single-use, disposable items and discarded after every use or, if reusable, be disinfected or sterilized at least daily The device manufacturer should provide information regarding brush size and type for cleaning devices with lumens ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Sections , M 2014 All rights reserved. Let s Check Your Current Knowledge True or False? Clogged arms on washer-decontaminators or disinfectors do not affect the ability of the equipment to clean Preventive maintenance on mechanical equipment is vital to ensure that the function meets manufacturer s specifications Currently there are no validated test methods that allow users to rapidly verify inadequate cleaning in a washerdisinfector 44 3M 2014 All rights reserved. Mechanical Cleaning Equipment Mechanical cleaning equipment removes soil and microorganisms through an automated cleaning and rinsing process Some are designed to clean and/or disinfect specific kinds of medical devices, such as endoscopes Includes: Utensil and cart washers Washer-sanitizers, pasteurization equipment Washer-disinfectors, washer-decontaminators, and washersterilizers Ultrasonic cleaners ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Section M 2014 All rights reserved. 15

Mechanical Cleaning Equipment Performance Daily and preventive maintenance is vital to the proper function

pumps Check to ensure correct chemical and lubricants are being used Check the chemical feed rate and

in the decontamination area is vital to efficiency and worker safety and to the successful outcome of the

Clean out the inside of the arm and filter on end of arm 47 3M 2014 All rights reserved.

16 Mechanical Cleaning Equipment Performance Daily and preventive maintenance is vital to the proper function of all mechanical cleaning equipment: Descaling, cleaning strainer and spray arms and nozzles, checking pumps Check to ensure correct chemical and lubricants are being used Check the chemical feed rate and detergent feed lines (mark container to know use patterns) Understanding how to correctly operate equipment in the decontamination area is vital to efficiency and worker safety and to the successful outcome of the process ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Sections , M 2014 All rights reserved. Clean out the inside of the arm and filter on end of arm 47 3M 2014 All rights reserved. What s wrong with this picture? Washer-disinfector drain screen not cleaned Clean daily 48 3M 2014 All rights reserved. 16

Ultrasonic Cleaners Check cleaning solution between cycles and change immediately if it becomes heavily contaminated or at least daily If the solution is excessively contaminated, it will cause a

water and wipe chamber with alcohol or other disinfectant recommended by the equipment manufacturer and a lint free cloth AORN:2014, Care of Instruments RP, Recommendation X ANSI/AAMI ST79:2010 &

Mechanical Cleaning Equipment Performance Follow the medical device and cleaning equipment manufacturers instructions for use for: Cleaning agent Water quality Time at temperature Tray and rack

17 Ultrasonic Cleaners Check cleaning solution between cycles and change immediately if it becomes heavily contaminated or at least daily If the solution is excessively contaminated, it will cause a loss of ultrasonic cleaning power and possibly damage to your machine Clean chamber when visibly soiled and at least daily (preferably after each use to prevent TASS) Empty, clean, rinse with sterile water and wipe chamber with alcohol or other disinfectant recommended by the equipment manufacturer and a lint free cloth AORN:2014, Care of Instruments RP, Recommendation X ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Section M 2014 All rights reserved. Mechanical Cleaning Equipment Performance Follow the medical device and cleaning equipment manufacturers instructions for use for: Cleaning agent Water quality Time at temperature Tray and rack selection Loading ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Sections 7.5.2, , M 2014 All rights reserved. What s wrong with this picture? Follow manufacturer s written IFU Poor loading technique in mechanical washer need to disassemble reusable rigid containers (remove disposable filter retentions plates) so all surfaces are exposed to the cleaning process. 51 3M 2014 All rights reserved. 17

Correct Loading Procedure for Rigid Sterilization Containers in a Mechanical Washer

retention plates removed 52 3M 2014 All rights reserved.

Follow manufacturer s written IFU Poor loading technique in mechanical washer -

instrument surfaces will not come in contact with the detergent or rinse water 53 3M

Correct or Incorrect Loading of Containment Devices in a Mechanical Washer?

18 Correct Loading Procedure for Rigid Sterilization Containers in a Mechanical Washer Follow manufacturer s written instructions Rigid containers disassembled Filter retention plates removed 52 3M 2014 All rights reserved. What s wrong with this picture? Follow manufacturer s written IFU Poor loading technique in mechanical washer - instruments cannot be cleaned in a covered reusable rigid container because the instrument surfaces will not come in contact with the detergent or rinse water 53 3M 2014 All rights reserved. Correct or Incorrect Loading of Containment Devices in a Mechanical Washer? Follow manufacturer s written IFUs Incorrect loading procedure in mechanical washer: Lids removed but instruments not removed from container bottoms because not enough mechanical washers to load as required by IFU 54 3M 2014 All rights reserved. 18

Correct or Incorrect Loading of Containment Devices in a Mechanical

Lid removed, top layer of instruments removed, bottom layer of

instruments removed from bottom of container Correct loading

containment devices No mats placed in the bottom of the

19 Correct or Incorrect Loading of Containment Devices in a Mechanical Washer? Lid removed, top layer of instruments removed, bottom layer of instruments attached to bottom of container remain Lid removed, instruments removed from bottom of container Correct loading procedure in mechanical washer according to manufacturer s written IFU 55 3M 2014 All rights reserved. Correct Loading in a Mechanical Washer Removed baskets from containment devices No mats placed in the bottom of the baskets/trays 56 3M 2014 All rights reserved. Correct Loading in a Mechanical Washer Close Up Instruments not piled on top of each other Instruments open 57 3M 2014 All rights reserved. 19

20 Monitoring of Mechanical Cleaning Equipment Mechanical cleaning equipment should be tested Upon installation, Weekly (preferably daily) during routine use After major repairs ANSI/AAMI ST79:2010 & A1:2010 & A 2:2011 & A3:2012 & A4:2013 Sections , M 2014 All rights reserved. Monitoring of Mechanical Cleaning Equipment Mechanical cleaning equipment should be tested When evaluating or changing to a new type of cleaning chemistry Test all cycles to ensure cleaning chemistry and cleaning action are effective ANSI/AAMI ST79:2010 & A1:2010 &A 2:2011 & A3:2012 & A4:2013 Sections , M 2014 All rights reserved. Monitoring of Mechanical Cleaning Equipment A major repair is a repair that is outside the scope of routine preventive maintenance and that significantly affect the performance of the equipment Examples include replacement of: Water pump(s) Detergent delivery system Heating system Water delivery system Water treatment system Computer control Upgrade of software ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Sections , M 2014 All rights reserved. 20

Monitoring of Mechanical Cleaning Equipment Review and initial each cycle printout Document results

ANSI/AAMI ST79:2010 & A1:2010 & A 2:2011 & A3:2012 & A4:2013 Sections 7.5.3.3, 10.

In-use tests available to assess efficacy of washerdisinfectors used for medical device reprocessing

2) Test Method Soil Component Tested Limitations Coagulated blood test.

and protein Water-insoluble protein with properties similar to blood Valuable as a QA indicator for

trademark of Pereg GmbH ANSI/AAMI ST79:2010 & A1:2010 & A 2:2011 & A3:2012 & A4:2013, Annex D 62 3M

21 Monitoring of Mechanical Cleaning Equipment Review and initial each cycle printout Document results Ideally, cleaned medical devices should be traceable to the patients on whom they are used. ANSI/AAMI ST79:2010 & A1:2010 & A 2:2011 & A3:2012 & A4:2013 Sections , M 2014 All rights reserved. In-use tests available to assess efficacy of washerdisinfectors used for medical device reprocessing (extracted from AAMI ST79 Table D.2) Test Method Soil Component Tested Limitations Coagulated blood test. Metal coupon with strip of coagulated blood soil Blood test soil preapplied to thin metal coupon Blood and protein Water-insoluble protein with properties similar to blood Valuable as a QA indicator for washer functionality Valuable as a QA indicator of washer functionality TOSI TOSI is a registered trademark of Pereg GmbH ANSI/AAMI ST79:2010 & A1:2010 & A 2:2011 & A3:2012 & A4:2013, Annex D 62 3M 2014 All rights reserved. Monitoring of Mechanical Disinfectors and Decontaminators *Verify efficacy of equipment Verify sonic activity or effective cavitation Verify ability of irrigators to clean lumens *ANSI/AAMI ST79:2010 & A1:2010 & A 2:2011 & A3:2012 & A4:2013 Section M 2014 All rights reserved. 21

Annex D User verification of cleaning processes Cleaning efficacy tests

equipment No frequency recommended ANSI/AAMI ST79:2010 & A1:2010 & A

Verify sonic activity or effective cavitation Verify ability of

thermometer or remote sensing equipment *ANSI/AAMI ST79:2010 & A1:2010 &

22 Annex D User verification of cleaning processes Cleaning efficacy tests Monitor water temperature Irreversible thermometer Remote sensing equipment No frequency recommended ANSI/AAMI ST79:2010 & A1:2010 & A 2:2011 & A3:2012 & A4:2013 Sections , Annex D M 2014 All rights reserved. Monitoring of Ultrasonic Cleaners * Verify efficacy of cleaning equipment Verify sonic activity or effective cavitation Verify ability of irrigators to clean lumens Verify temperature using an irreversible thermometer or remote sensing equipment *ANSI/AAMI ST79:2010 & A1:2010 & A 2:2011 & A3:2012 & A4:2013 Section M 2014 All rights reserved. Verifying that Instruments are Clean Visual Inspection? 66 3M 2014 All rights reserved. 22

Monitoring of Manual Cleaning Manual cleaning should be evaluated When new types of instruments are reprocessed Periodically, at intervals determined by the health

A4:2013, Annex D.1 68 3M 2014 All rights reserved.

23 Just because it looks clean. does not mean it is clean You can t see biofilm or microbes You can t see biological residues You can t see inside narrow lumens 67 3M 2014 All rights reserved. Monitoring of Manual Cleaning Manual cleaning should be evaluated When new types of instruments are reprocessed Periodically, at intervals determined by the health care organization Evaluates personnel performance AORN:2014, Care of Instruments RP, Recommendation XXll ANSI/AAMI ST79:2010 & A1:2010 & A 2:2011 & A3:2012 & A4:2013, Annex D M 2014 All rights reserved. Annex D User verification of cleaning processes Cleaning efficacy tests Visual inspection is still most common: Does not work for inner components that have lumens or are tubular (flexible endoscopes, biopsy forceps) Add another verification method to measure levels of organic soil and microbial contamination ANSI/AAMI ST79:2010 & A1:2010 & A 2:2011 & A3:2012 & A4:2013, Annex D M 2014 All rights reserved. 23

Soil Component Tested ATP (present in eukaryotic cells and live bacteria) Protein Limitations - Need instrumentation to read test Not applicable to lumens Length of test 30 seconds minutes ANSI/AAMI

24 In-use tests available to assess efficacy of cleaning of medical devices (extracted from AAMI ST79 Table D.1) Test Method ATP Swab device, extract ATP from swab, and determine ATP Protein Swab device, immerse in reagent and assess for color development 70 3M 2014 All rights reserved. Soil Component Tested ATP (present in eukaryotic cells and live bacteria) Protein Limitations - Need instrumentation to read test Not applicable to lumens Length of test 30 seconds minutes ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Annex D Routine Monitoring of Cleanliness of Individual Instruments Use a test listed in ANSI/AAMI ST79, Annex D, Table D.1 Follow test manufacturer s IFU Verify cleanliness after Manual washing Sonication Or mechanical cleaning Identify failures in system Take corrective action 71 3M 2014 All rights reserved. Adenosine Tri-phosphate (ATP) Bioluminescence ATP is present in all living organisms animal, plant, microorganisms, human secretions and excretions Contaminated surfaces show high levels of ATP, clean surfaces show low ATP levels The surface is swabbed collecting the ATP present on a surface. ATP on the swab is converted to a light signal which is measured using a luminometer. Results are quantitative: ATP bioluminescence is measured in Relative Light Units Benchmark RLU levels used to define clean 72 3M 2014 All rights reserved. 24

method to assess cleaning efficacy. 73 3M 2014 All rights reserved.

25 Protein Test Can be used to detect protein residues left on surgical instruments due to inefficient cleaning. Where does protein come from? Blood, tissue, body fluids, microbes Several different methods: Biuret, Ninhydrin Qualitative or semi-quantitative colorimetric Not real time Recommended by ISO Washer-Disinfector as a method to assess cleaning efficacy. 73 3M 2014 All rights reserved. Monitoring of Manual Cleaning Monitor and document Water/cleaning agent temperature Soaking time Monitors temperature and results recorded and accessed using PC ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section Photos provided by Healthmark Industries 74 3M 2014 All rights reserved. Documentation of Entire Cleaning Process Documentation should include maintaining records of the cleaning of instruments including, but not limited to: date time instruments method of cleaning number or identifier of mechanical decontaminator name of person performing the cleaning lot numbers of chemicals used testing results on mechanical instrument washers testing results on insulated electrical instruments disposition of defective equipment AORN:2014, Care of Instruments RP, Recommendation XX.a. 75 3M 2014 All rights reserved. 25

26 Key Learnings 1 Cleaning and decontamination are critical steps in instrument reprocessing 2 Follow manufacturers IFUs Medical Device, Rigid Containers, Cleaning Agents, Mechanical Cleaning Equipment 3 Protect yourself - wear your PPE Test mechanical cleaning equipment weekly, preferably daily, 4 during routine use, when changing cleaning chemistries and after major repairs 76 3M 2014 All rights reserved. Questions? 77 3M All rights reserved. References 78 3M All rights reserved. 26

References The Joint Commission. 2014 Hospital Accreditation Standards (HAS) Stephen Kovach, Improving the Performance of Your Medical Automatic Washer, Managing Infection Control, Feb 2007 Stephen M.

27 References The Joint Commission Hospital Accreditation Standards (HAS) Stephen Kovach, Improving the Performance of Your Medical Automatic Washer, Managing Infection Control, Feb 2007 Stephen M. Kovach. Understanding the Sonic Cleaning Process. healthvie.com, June Available at: n/3msterileu/home/inservicearticles/ 79 3M 2014 All rights reserved. References AAMI Horizons Sterilization and Reprocessing a Matter of Patient Safety Spring M 2014 All rights reserved. Reference iwatch News by The Center for Public Integrity Filthy surgical instruments: The hidden threat in America s operating rooms. Accessed on 12/05/2012 at: M 2014 All rights reserved. 27

28 References Martha Young. Are You Taking Risks when Cleaning Reusable Medical Devices. 3M Sterile U, Jan 2013 Available at: n/3msterileu/home/inservicearticles/ 82 3M 2014 All rights reserved. Evidence-Based Guidelines Association of perioperative Registered Nurses (AORN) Perioperative Standards and Recommended Practices (2014) Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment Recommended Practices for Surgical Attire 83 3M 2014 All rights reserved. How to Purchase AORN Standards for Your Reference Library AORN Standards can be purchased through AORN using the following options: Internet: Call: x 1 or x 1 (Monday-Friday, 8AM to 4:30PM mountain standard time) Fax: By mail: AORN, Inc., Customer Service/Book Orders, 2170 South Parker Road, Suite 300, Denver, CO , USA 84 3M 2014 All rights reserved. 28

29 Evidence-Based Guidelines Association for the Advancement of Medical Instrumentation (AAMI) Comprehensive guide to steam sterilization and sterility assurance in health care facilities, ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 (Consolidated Text) 85 3M 2014 All rights reserved. How to Purchase AAMI Standards for Your Reference Library AAMI documents can be purchased through AAMI by credit card using the following four options: Internet: Call: Fax: Mail: AAMI Publications, P.O. Box 0211, Annapolis Junction, MD M 2014 All rights reserved. How to Purchase AAMI Guidelines for Your Reference Library Associations for the Advancement of Medical Instrumentation. Comprehensive guide to steam sterilization and sterility assurance in health care facilities, ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 (Consolidated Text). Also available to order through AORN and IAHCSMM at AAMI membership prices A free PDF of A3:2012 and future amendment(s) may be downloaded by visiting which also includes information on how to update your copy of ST79 when free amendments are available. Print and save to your hard drive 87 3M 2014 All rights reserved. 29

30 ANSI/AAMI ST79 Recommended Practice If You Have This AAMI Document ANSI/AAMI ST79: 2006 ANSI/AAMI ST79:2006 and A1:2008 & A2:2009 What To Purchase Purchase ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Purchase ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 What To Download Free 88 3M 2014 All rights reserved. ANSI/AAMI ST79 Recommended Practice If You Have This AAMI Document ANSI/AAMI ST79:2010 & A1:2010 (Consolidated Text) ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 (Consolidated Text) What To Purchase What To Download Free Download A2:2011 PDF and replace pages Then download A3:2012 and replace pages Then download A4:2013 and replace pages Download A3:2012 PDF and replace pages Then download A4:2013 and replace pages ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4: (Consolidated 3M 2014 All rights reserved. Text) Most up-to-date to purchase Evidence-Based Guidelines Centers for Disease Control and Prevention (CDC) Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 Available free at: M 2014 All rights reserved. 30

Of Critical Importance: Infection Prevention Strategies for Environmental Management of the CSSD. Study Points

Of Critical Importance: Infection Prevention Strategies for Environmental Management of the CSSD I. Introduction Study Points Management of the CSSD environment is vital to preventing surgical site infections.