You Can’t See Clean · to monitor CSSD reprocessing steps. • Describe the current methods used to monitor CSSD reprocessing steps • Describe how a monitoring program can be

3M Sterile U Webinar 2.16.12

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3M™ Sterile U Network3M™ Sterile U Web Meeting – February 16, 2012

© 3M 2012. All Rights Reserved.1

You Can’t See Clean:Clean Monitoring in the CSSD

Today’s meeting times: 9:00 a.m., 11:00 a.m. and 1:00 p.m. CST

Welcome!

Topic: You Can’t See Clean: Clean Monitoring

in the CSSD.

Facilitators: Beth Fritcher, 3M

Dorothy Larson, 3M


Housekeeping• Questions

• Mute feature (*7 = unmute; *6 = mute)

• “Chat” feature

• Technical difficulties

• Post session follow-up

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

Next week, all of today’s meeting participants will be sent an email containing instructions for obtaining a CE Certificate for today’s meeting.

How do I get a CE Certificate?


The email will be sent to the email address you provided when you logged-in to today’s meeting. If there are others listening with you today who did not log-on, you may forward the CE certificate email to them.


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Speakers

David Jagrosse CRCST,CSPDT IAHCSMM Executive Board. Member AAMI WG40 Connecticut Central Service Association President


Manager Middlesex Hospital Middletown

Grace Thornhill, Ph.D.Technical Service Specialist3M Infection Prevention Division, St. Paul, [email protected]

Learning Objectives

• List the 7 current concerns for surgical instrument reprocessing.

• Describe the types of universal and specific markers used


Describe the types of universal and specific markers used to monitor CSSD reprocessing steps.

• Describe the current methods used to monitor CSSD reprocessing steps

• Describe how a monitoring program can be incorporated into an automated washer and manual cleaning verification program.

Reprocessing – What is the concern?

“Every patient undergoing a medical procedure has a basic expectation that the environment and instruments of care will be clean and safe. In recent years, that expectation has been shaken by reports of patients put at risk of


serious infection from reusable medical devices that were inadequately cleaned, sterilized, or disinfected—the domain known as reprocessing.”

AAMI. Reprocessing. 2011 Summit. Priority Issues from the AAMI/FDA Medical Device Reprocessing Summit . http://www.aami.org/reprocessing/materials.html


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Seven Clarion ThemesAAMI. Reprocessing. 2011 Summit. Priority Issues from the AAMI/FDA Medical Device Reprocessing Summit

1. “How clean is clean?”

2. Standardized, clear, repeatable instructions for reprocessing

3. When designing a new device pay early and comprehensive attention to reprocessing requirements


p p g q

4. Consideration of human factors and work environment when developing reprocessing procedures.

5. Improve information collection and sharing to increase use of best practices.

6. Competency driven via education, training, certification

7. Greater sense of urgency needed regarding consequences of inadequate reprocessing.

Concerns for Patient Safety

“Right now, it is impossible to follow manufacturers’ instructions for use.”

Linda Condon, educator, Central Sterile Processing Department The Johns Hopkins Hospital


Department, The Johns Hopkins Hospital

“As an end user, I’m just so confused about what is clean.”

A summit participantAAMI. Reprocessing. 2011 Summit. Priority Issues from the AAMI/FDA Medical Device Reprocessing Summit . http://www.aami.org/reprocessing/materials.html

Cleaning Verification

“Cleaning is a basic initial step in medical device reprocessing procedures. Yet, the importance of proper cleaning to ensure the effectiveness of


proper cleaning to ensure the effectiveness of downstream reprocessing steps such as sterilization/disinfection has been underappreciated.”

Geetha C. Jayan, Senior Science Advisor, Center for Devices and Radiological Health, FDAAAMI. Reprocessing. 2011 Summit. Priority Issues from the AAMI/FDA Medical Device Reprocessing Summit


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Cleaning…..

“Cleaning is the removal of foreign material (e.g., soil, and organic material) from objects and is normally accomplished using water with detergents or enzymatic products. Thorough cleaning is required before high-level


disinfection and sterilization because inorganic and organic materials that remain on the surfaces of instruments interfere with the effectiveness of these processes.”

CDC: Guideline for Disinfection and Sterilization in Healthcare Facilities 2008. W. Rutala, D. Weber and HICPAC. p.36-37

Cleaning (definition #2)

• “Removal of contamination from an item to the extent necessary for further processing or for the intended use”

AAMI TIR30:2011. A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices


Cleaning Validation vs Cleaning Verification

Validation – “If I clean the device this way, will it be acceptable for use?”• Performed by device manufacturers


Verification - “Did I clean the device to the acceptable level?• Performed by end-user


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The CDC has a wish….

“Although the effectiveness of high-level disinfection and sterilization mandates effective cleaning, no “real-time” tests exist that can be employed in a clinical setting to


p y gverify cleaning. If such tests were commercially available they could be used to ensure an adequate level of cleaning.”

CDC: Guideline for Disinfection and Sterilization in Healthcare Facilities 2008. W. Rutala, D. Weber and HICPAC. p.36-37

What can you do now to address some of these issues?


• to ensure compliance to established protocols

• to define what “clean” means in your facility

• to ensure your process is under control

• to drive process improvement

• to ensure staff competency

• as a part of staff training

How do you monitor the efficacy of cleaning processes?

• Measure markers that are present in soil

• CSSD focus – soils that carry pathogens• Environmental soils


• Soils on surgical instruments and medical devices

• Components of soils• Human cells, tissues, fluids, excretions

• Microbial cells, spores

• Biofilms

• Bioorganic grit, grime (non-living)


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Cleanliness markers

• Allow you to assess level of cleanliness by measuring indicators called markers

• Visual assessment is most common method


Familiar Visual markers

Dust bunnies Shiny surfaces

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


Universal Markers

A marker that is present in all types of soils


Current Candidates: Found in all soils derived from living organisms• ATP (adenosine tri-phosphate)

• Protein


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Protein

• Commercialized assays to monitor cleanliness of surgical instruments, endoscopes and washer disinfectors

• Advantages: • Universal marker – present everywhere, produced by living

i


organisms

• Well known detection chemistry

• Disadvantages• Present everywhere – how much has to be on surface in order to

be considered a clinical risk?

• Rapid assessment methods are qualitative, colorimetric

• Microbial protein might not be measured by some assays

• Does not measure insoluble proteins left behind by processing

Protein Tests – How do they work?

• Sample site of interest: flush, brush or swab

• Measure protein levels


Measure protein levels

using colorimetric methods

• Results are qualitative

• Ex. Purple color = presence of protein

• Can be semi-quantitative

ATP Bioluminescence Technology

• Commercialized to monitor cleanliness• Food Safety application for past 30 years

• Monitors Cleanliness of Environmental Surfaces

Surgical Instruments, Flexible Endoscopes

• Universal Marker

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• Advantages• Present everywhere, produced by living cells

• ATP bioluminescence measurements are real-time (15 sec.)

• Quantitative – provides numerical assessment of efficacy of cleaning

• Disadvantages• Present everywhere - what levels are clinically relevant?


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ATP – How does it work?

• Sampling – swab, flush or brush

exterior surfaces and interior lumens

• Measure ATP levels of sample


• Measure ATP levels of sample.

• ATP is converted to a light signal and is measured by a hand-held luminometer.

Why are surgical instruments and medical devices difficult to reprocess?

• Complex design

• Multiple, long, narrow, channels that are difficult to clean

• Lack of consistent effective


• Lack of consistent effective training

• Lack of time and resources for adequate reprocessing

• Visual inspection not adequate to monitor efficacy of reprocessing.

Practical Applications


David Jagrosse


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There are resources out there!

• Look at current monitoring options for manual and automated washing steps

• What are the recommendations?


• Review data from a monitoring study?

• What do I do when I discover a problem?

• What does a comprehensive monitoring program look like?

We can now verify the following:

SonicationEfficacy Water Temperature


Washer-Disinfector Function Cleaning Lumens

ALSO:ALSO:

Flexible Lumens Blood Residue


ATP


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AAMI ST79:2011 AAMI ST79:2011 Sections 7.5 and 10.2Sections 7.5 and 10.2

Section 10: Quality Control: Cleaning Verification10.2 Monitoring of mechanical cleaning equipment


Frequency of testing• Upon installation• Weekly (preferably daily) during routine use• After major repairs

Review and initial mechanical washer cycle printoutsDocument results

AAMI ST79:2010:A1:2011AAMI ST79:2010:A1:2011Annex D UserAnnex D User--verification of cleaning processesverification of cleaning processes

Table D.1 Tests to assess efficacy of cleaning medical devices

ATP, Protein, Hydrogen Peroxide, Endotoxin


Table D.2 Tests to assess efficacy of washer disinfectors

Metal coupon with pre-applied blood test soil

Peroxidase swab to test for blood

AORN Perioperative Standards and Recommended Practices (2012)Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment, Recommendation XXII.a

Cleaning VerificationTest mechanical instrument washers:• Before initial use


• Weekly during service

• After major maintenance

Evaluate manual cleaningWhen new instruments are reprocessed

and periodically


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Considerations….

• These are physical monitoring tools for mechanical processes. They are not a substitute for inadequate training and inexperienced CSSD technicians.

• The basic fundamentals of proper cleaning of instruments


The basic fundamentals of proper cleaning of instruments begins with:

the staff being properly trained,

having the adequate resources to do their jobs

having the most up to date and available instructions for use on how to clean devices.

3M™ Clean-Trace™Hospital Studies

• Hospital CSSD Studies• Visit 3 hospital CSSDs to trial Clean-Trace procedures• Hospitals chosen for baseline study are considered to be

premier hospitals with very proficient CSSDsObjective was to demonstrate applicability


• Objective was to demonstrate applicability

• Chose instrument sets suggested by hospital personnel as hard to clean

• Chose instrument subsets based on difficulty to clean and amount of visible (heavy to light soil levels)

Data: Hospital 1

*

110

1001000

10000100000

1000000Precleaning RLU

Enzyme Cleaning/ Handwashing RLUWasher-Disinfector RLU*


*Note: the screwdriver and broach appeared visibly clean after the enzyme/hand washing step; however, Clean-Trace results indicated that these items may still be dirty using an RLU cut-off of 250 RLU

1Background


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Data: Hospital 2

1

10100

1000

10000100000

1000000Precleaning RLU

Enzyme Cleaning/ Handwashing RLUWasher-Disinfector RLU


Background

*Note: worker skipped the hand wash of the mallet and L-shaped spreader; Clean-Trace™ was able to detect the missed step.

Data: Hospital 3

10100

1,00010,000

100,0001,000,000

10,000,000Precleaning RLU

Enzyme Cleaning/Handwashing RLU

Sonication RLU

Washer-Disinfector RLU


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Background

Key Learnings from 3M CSSD Studies

• Initial hospital trials demonstrate that Clean-Trace™ can be used as a clean monitor in CSSD

• The 3 hospitals generated similar data that was consistent


• Clean-Trace™ demonstrated the effectiveness of the manual wash process and was able to detect when cleaning procedures were not followed.


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When there is a problem: Monitoring after Manual cleaning

People• Observe for improper cleaning

technique.• Monitor technician that is

working and look for trends in

Process

• Is IFU being followed?

• Does CSSD have proper tools for the job (Brushes,Sonics,etc)


working and look for trends in poor technique.

• Was training adequate? Retrain technician if needed

• Rewash item under observation, monitor to determine if better results are achieved.

When there is a problem:Monitoring after Automated Washer-Disinfector

People

• Monitor technician that is working and look for trends in poor technique.

Automated Washers

• Is there a washer verification program in place?

• Check mechanical monitoring


• Rewash item under observation and determine if better results are achieved.

• Was training adequate? Retrain technician if needed

tools for poor result

• Check enzymatics

• Observe for improper loading technique of washer.

A Comprehensive Monitoring SolutionThree Inter-related Components

PeopleTraining, Competency, Observations, IFUs, Tools

Manual Cleaning


Manual CleaningMonitoring program, Lumened instruments, Endoscopes

Items that don’t go thru the wash

MechanicalSonics, Automated Washers

Monitoring Program, Temperature, Detergent, Proper loading


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Questions?


Questions?

Next 3M™ Sterile U Web Meeting• March 22, 2012

• Think Sterile Processing Organizationally, Act Sterile Processing Organizationally

Thank you!


Register at www.3m.com/SterileU/WebMeetings

Documents

You Can’t See Clean · to monitor CSSD reprocessing steps. • Describe the current methods used to monitor CSSD reprocessing steps • Describe how a monitoring program can be