march 2016 sterile u webinar...

10/03/2016

1

3M Health Care AcademySM

© 3M 2016. All Rights Reserved


The Cleaning Challenge:Best Practices and Verification Methods

March 17, 2016

Sue Klacik



Welcome!Topic: The Cleaning Challenge:

Best Practices and Verification MethodsFacilitators: Christophe de Campeau, 3M Susan Flynn, 3M

Speaker: Sue Klacik BS, CRCST, CIS, FCS

For more information: www.3M.com/3MSterileU

© 3M 2016. All Rights Reserved 3

House Keeping

From the GoToWebinar page:• Click on the orange box with a

white arrow to expand your control panel (upper right-hand corner of your screen).

• Type a question in the question box and click send.

10/03/2016

2


House Keeping

Continuing EducationEach 1 hour web meeting is approved by IAHCSMM, CBSPD and is 3M Health Care Provider approved by the California Board of Registered Nurses CEP 5770 for one contact hour.

Post webinar email• Link to Course Evaluation• CS Tech CE Certificate Included• Forward eMail to others in attendance


Disclosure

Sue Klacik BS, CRCST, CIS, FCS

Educational Consultant to 3M Healthcare


Learning Objectives

1. Describe the best practices for cleaning anddecontamination

2. Discuss cleaning methods 3. Discuss challenges that can affect cleaning

outcomes 4. List the different methods of cleaning verification

10/03/2016

3


© 3M 2016. All Rights Reserved© 3M 2016. All Rights Reserved3M Health Care AcademySM

7

Describe the best practices for cleaning and decontamination


Best Practices

• Centers for Disease Control and Prevention and the Healthcare Infection Control Practices Advisory Committee (HICPAC). Guideline for disinfection and sterilization in healthcare facilities.

• AORN 2016 Guideline for Cleaning and Care of Surgical Instruments

• AORN 2016 Guideline for Processing Flexible Endoscopes


Best Practices

AAMI• ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 &

A4:2013 Comprehensive guide to steam sterilization and sterility assurance in health care facilities

• ANSI/AAMI ST91:2015 Flexible and semi-rigid endoscope processing in health care facilities

• AAMI TIR63:2014 Management of loaned critical and semi-critical medical devices that require sterilization or high-level disinfection

10/03/2016

4


The Joint Commission BoosterPak

• Leadership• Risk Assessment• Sterilization• Environment of Care• High-level Disinfection• Competency & Training

http://www.jointcommission.org/standards_booster_paks/


Joint Commission BoosterPak

Checklist Point-of-use• O.R. removes body fluids • Disposes of single use items• Use of foam, gel spray solution or moist towel

during transport



Transport to Decontamination Area• Items are contained• Items are to be kept moist during transport • Containers must be leak-proof, puncture-proof, and

labeled as biohazardous

10/03/2016

5



• Instruments should not be left unattended in corridors

• Instruments should not be left soaking in containers in de-centralized locations for extended periods of time

• Staff must wear PPE in decontam• One-way flow & separation of dirty to clean



Decontamination • Hinged items are opened • Cleaning based on manufacturer’s instructions for use

and evidence-based guidelines • Manual or performed by hand• Mechanical or automated process• Combination of manual and automated based on

manufacturer’s instructions for use and evidence-based guidelines


CDC & FDA Health Update (October/2015)

CDC & FDA alert to healthcare facilities to properly maintain, clean, & disinfect or sterilize reusable medical devices

Why? “Recent infection control lapses due to non-compliance with recommended reprocessing procedures highlight a critical gap in patient safety.”

http://emergency.cdc.gov/han/han00383.asp

10/03/2016

6


CDC & FDA Health Update Recommendations

Have an expert/consultant asses reprocessing procedures to assure:• Reprocessing is performed correctly• Adequate time is allowed/taken• All steps from the IFU are followed



CDC/FDA Health Update (October/2015)

Recommendations• Training• Audit & Feedback• Infection Control Policies & Procedures



Polling Question

Which of the following competencies was given at your facility last year?Flexible endoscope processingSteam sterilizationWasher disinfectorUltrasonic cleanerCleaning laparoscopic instruments

10/03/2016

7



19

Discuss cleaning methods


Cleaning Considerations

• Water quality• Detergent• Rinsing• Washing method• Preparation

• Cleaning equipment• Drying• Operator performance• Preparation• Load capacity

ANSI/AAMI ST79:2010 & A1:2010 & A 2:2011 & A3:2012 & A4:2013


Point of Use

To prevent formation of biofilm• Wipe gross soil from

instruments w/ sponge moistened w/ water

• Place moistened towel over instruments

• Use of pretreatment spray

ANSI/AAMI ST79:2010 & A1:2010 & A 2:2011 & A3:2012 & A4:2013

10/03/2016

8


Contain for transport

Contain • Carts• Containers• Devices• Bag if no sharpsDenote Biohazard

ANSI/AAMI ST79:2010 & A1:2010 & A 2:2011 & A3:2012 & A4:2013


Dress for Success

PPE• General-purpose utility gloves • Liquid-resistant covering with sleeves • Liquid-resistant shoe covers • Fluid-resistant face mask • Eye protection could include goggles, full-

length face shields, or other devices that prevent exposure to splash from all angles

ANSI/AAMI ST79:2010 & A1:2010 & A 2:2011 & A3:2012 & A4:2013


AAMI TIR34:2014Water for the reprocessing of medical devices

10/03/2016

9


Water Quality

Use critical water (e.g., deionized, distilled, or RO water) as the final rinse to prevent:• Instrument staining and contamination• Residues that can affect disinfection and sterilization

efficacy • Residues that can cause adverse patient reaction


AAMI TIR34, Annex GTypical presentation of water quality issues during the reprocessing of medical devicesTroubleshooting potential problems

Observed problemExamples of causesRecommendations

Reprinted with permission from AAMI TIR34:2014, Water for the reprocessing of medical devices. Copyright AAMI. Further reproduction prohibited


Manual Cleaning

• Follow Instructions for use (IFU)

• Follow Best Practices• AAMI

• AORN

10/03/2016

10


Policies & Procedures

• Have for all methods of decontamination for all reusable items

• Process audits to monitor compliance

ANSI/AAMI ST79:2010 & A1:2010 & A 2:2011 & A3:2012 & A4:2013


New and repaired instruments

New and repaired instruments require cleaning before sterilization

ANSI/AAMI ST79:2010 & A1:2010 & A 2:2011 & A3:2012 & A4:2013


Cleaning SolutionManual & Mechanical• Temperature• Correct dilution• Clean solution

ANSI/AAMI ST79:2010 & A1:2010 & A 2:2011 & A3:2012 & A4:2013

10/03/2016

11


Manual Cleaning

• Perform prior to mechanical cleaning• For delicate or complex

instrumentation• For power equipment• Lumened instruments• Cleaning solution changed frequently


Vertical Soaking

• Lumened instruments soaked vertically• Ensures complete internal contact • Solution should be changed frequently

best if changed after each set.

32


Ultrasonic Cleaning

• Cleans by cavitation, ultrasonic waves passing through a cleaning solution

• Used after gross debris is removed• Removes debris from cracks &

crevices that brushes cannot reach• Use low foaming detergent

Cavitation

10/03/2016

12


Ultrasonic Cleaning

Degas prior to useItems placed in basketsFollow IFUsUse only validated accessoriesChange solution frequentlyPerform verification solution

ANSI/AAMI ST79:2010 & A1:2010 & A 2:2011 & A3:2012 & A4:2013


Ultrasonic Cleaning

Instruments are rinsed after sonic cleaning to remove:• Scum • Sediment• Detergents

Photo courtesy of Ultra Clean Systems, Inc.


Care of lumens

• Use the correct brush type & size

• Clean brushes• Flush

ANSI/AAMI ST79:2010 & A1:2010 & A 2:2011 & A3:2012 & A4:2013

10/03/2016

13


Drying

Clean low linting cloths Medical grade/Instrument air


Washer Disinfector

• Clean by impingement• Typical cycles

• Clean

• Rinse

• Lubrication

• Dry

• Uses thermal disinfection


Preparation for Washer/Disinfector

• Disassemble multi-part pieces• Jointed instruments should be

open to make sure that all surfaces are effectively cleaned.

ANSI/AAMI ST79:2010 & A1:2010 & A 2:2011 & A3:2012 & A4:2013

10/03/2016

14


Washer Disinfector

Check washer arms Load to allow exposure


Sterilization Containers

• Containers should be cleaned carefully before sterilization

• Disassembled• All disposables removed• Follow container IFU• Interior basket removed

ANSI/AAMI ST79:2010 & A1:2010 & A 2:2011 & A3:2012 & A4:2013


Polling Question

• How often do loaner reps provide in-services to your CSS department?Hardly everOnce a yearTwice a yearThree or more times a yearWe don’t reprocess loaner instruments

10/03/2016

15


AAMI TIR63 Management of loaned critical and semi-critical medical devices that requiresterilization or high-level disinfection


Processing Time

The loaner(s) should arrive at the time agreed upon The healthcare facility should not accept loaner(s) if they do not arrive in sufficient time to follow its procedures (except in an emergency)

AAMI TIR63:2014 Management of loaned critical and semi-critical medical devices that require sterilization or high-level disinfection


Receiving

Prior to use, all loaned medical devices should be reprocessed according to the manufacturer's written IFU and in accordance with the facility's policy and procedures.

AAMI TIR63:2014 Management of loaned critical and semi-critical medical devices that requiresterilization or high-level disinfection

10/03/2016

16


Transporting Used Endoscopes

• Each endoscope should be transported with its components in its own closed system

• To avoid puncture and penetration damage to the endoscope, forceps and wires used in the procedure should be transported in their own containers.

• The system should be marked with a biohazard label

• The system should be large enough to accommodate a single endoscope without the need to over-coil the insertion or light guide tubes

ANSI/AAMI ST91:2015 Flexible and semi-rigid endoscope processing in health care facilities


Polling Question

What is the average time flexible endoscopes sit in the decontam room before they are processed?Less than 10 minutesBetween 10 and 30 minutesBetween 30 and 60 minutesMore than 60 minutes


Manual Cleaning

• Should be conducted as soon as possible after use to prevent soil from drying on the device

• Scopes must be thoroughly cleaned to effectively kill or inactivate microorganisms and may allow for biofilm development

• If it is not possible to start the cleaning process immediately after use, the endoscope manufacturer’s written IFU for delayed reprocessing of endoscopes should be followed.


10/03/2016

17


Flexible Endoscope Manual Cleaning• Fresh cleaning solution for each scope• Monitor the cleaning solution for IFU i.e., dose & temperature• Place endoscope completely within the solution • Use single use lint-free cloth or sponge• Clean all parts & scope with cleaning brushes of the length, width,

and material designated in the endoscope manufacturer's written IFU

• Flush with solution following IFUs



Flexible Endoscope Manual RinsingThe endoscope and accessories should be thoroughly rinsed with copious amounts of water. • Rinse all channels with adequate flow of water • Rinse all exterior endoscope surfaces with freely flowing potable water • Rinse all valves and other removable components according to the

manufacturer's written IFU • After cleaning, all detachable valves should be kept together with the same

endoscope as a unique set



Flexible Endoscope Manual Drying

• Purge channels with air to remove residual rinse water

• Dry the exterior of the endoscope with a clean lint-free cloth or sponge

• Dry the detachable parts and keep with the same endoscope as a unique set


10/03/2016

18


Reprocessing of endoscope accessories

• All accessories removed• Thoroughly cleaned• The water bottle is manually cleaned, HLD or

sterilized according to manufacturer's written IFU, or at least daily.




53

Discuss challenges that can affect cleaning outcomes


Design of devices for processingPhysical and material design characteristics can have a significant impact on medical device reprocessing

10/03/2016

19


Current Issues Affecting CleaningComplex Designs


Current Issues Affecting Cleaning

Confusing or incomplete IFUs Effective training


Human FactorsDecontam Environment

CongestionConstant Interruptions

Demand for quick turns

Communication difficult

Hot PPEsNoisy

10/03/2016

20


Human Factors

• Ergonomics• Lack of tactile feel• Noisy• Constant interruptions• Pressure to turn quickly


Human Factors PPE

Limited dexterity Insufficient vision



60

List the different methods of cleaning verification

10/03/2016

21


Just because it looks clean….does not mean it is cleanYou can’t see biofilm or microbes

You can’t see biological residues

You can’t see inside narrow lumens


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 Sections 7.5.3.3 and 10.2


Polling Question

• During routine use, how frequently does your facility perform verification tests on mechanical cleaning equipment?

• Never• Weekly• Daily• Daily for each cycle type used• Every cycle

10/03/2016

22


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 7.5.3.3


• “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 7.5.3.3, 10.2

Monitoring of Mechanical Cleaning Equipment


• 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:2016, Guideline for Cleaning and Care of Surgical Instruments, Recommendation XVllANSI/AAMI ST79:2010 & A1:2010 & A 2:2011 & A3:2012 & A4:2013, Annex D.1

Monitoring of Manual Cleaning

10/03/2016

23


Adenosine Triphosphate (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”


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 15883-1:2006 Washer-

Disinfector as a method to assess cleaning efficacy




Additional Questions?

10/03/2016

24



Next Live Webinar

Date: Thursday April 14, 2016

Title: How do you define clean? A tale of flexible endoscope reprocessing

Register: www.mmm.com/IPEd


References

• ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Comprehensive guide to steam sterilization and sterility assurance in health care facilities

• ANSI/AAMI ST91:2015 Flexible and semi-rigid endoscope processing in health care facilities

• AAMI TIR63:2014 Management of loaned critical and semi-critical medical devices that require sterilization or high-level disinfection


References

• Centers for Disease Control and Prevention and the Healthcare Infection Control Practices Advisory Committee (HICPAC). Guideline for disinfection and sterilization in healthcare facilities.

• AORN 2016 Guideline for Cleaning and Care of Surgical Instruments

• AORN 2016 Guideline for Processing Flexible Endoscopes

10/03/2016

25


References• International Association of Healthcare Central Service

Materiel Management. Central service technical manual. 7th ed. Chicago: IAHCSMM, 2007.

• The Joint Commission. High-Level Disinfection (HLD) and Sterilization BoosterPak.http://www.jointcommission.org/standards_booster_paks/

• CDC/FDA Health Update about the Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfecting, and Sterilizing Reusable Medical Deviceshttp://emergency.cdc.gov/han/han00383.asp



Thank you

march 2016 sterile u webinar...

Documents