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Best Practices for High-Level Disinfection (HLD)

Mr. Anibal (Luis) AcevedoRN-MSN-CNOR

High Level Disinfection Program Manager

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ObjectivesAt the end of this training, participants will be able to:

• Explain the Spaulding Classification System for the reprocessing of reusable medical devices

• Understand the importance of effective cleaning and decontamination prior to HLD

• Identify commonly used agents for HLD

• Discuss recommended steps for the HLD of flexible endoscopes and Intra-cavity probes

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Introduction• Reports of infection in GI endoscopy gain national media coverage- CNN

headlines (Feb 2015) UCLA- contaminated EUS Scopes with the 'nightmare' superbug that contributed to 2 deaths in L.A.

• 2008 hepatitis C outbreak at a Las Vegas colonoscopy clinic was “preventable” and “costly”. The cost of the outbreak was estimated at $16.3 to $21.9 Millions.

• Veterans’ Hospitals 2008 (TN, Florida, Georgia)- June 9, 2010: 68 ASCs in three states- 28.4% failed to adhere to recommended practices regarding

• May 2010 to September 2011 Minnesota Department of Health - 7 Endoscope reprocessing breeches - 5 Healthcare facilities

• More healthcare-associated outbreaks linked to endoscopes than to any other medical device-CDC

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HLD Training Levels & Assignments 

There are three levels for assigning staff to become fully trained to perform High Level Disinfection:

• Level-1: OJT training on Cidex OPA manual & AERs (time specific to staff or area).

Competency sign-off by site super-users at the end of the OJT training.

• Level-2: Completion of Command training program & Advanced Vendor scope specific training. Vendor training arranged by department super-users.

• Level-3: Expert- Attendance at an expanded vendor provided training course. Currently the Olympus University course is the only sourced/approved expanded training available. Expert qualification would require for HLD Super-users.

• Provision of an HLD course/competency refresher to be done on a q6mo basis in October and April. The format will be planned as a 4 hour course, to include basic HLD competencies, a ‘break-out’ session to discuss scope, probe (Trophon) specific competencies, and a written exam.

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Breaches In Protocol (Why)

- High-level disinfection is personnel dependent. - Complex equipment design- Failure to follow cleaning/disinfection/sterilization guidelines

and infection control practices (Olfstead et al 43-47% of time) - Inadequate cleaning (clean all channels) - Flaws in design of endoscopes or AERs- ECRP Scopes- Inappropriate/ineffective disinfection (time exposure, perfuse

channels, test concentration, ineffective disinfectant, inappropriate disinfectant)

- Staff rushed due to high volume- supply & demand- Out of date training - Chemicals may not be used correctly

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Types of HLD at NMCSD• Automated Endoscope Reprocessor (AER)with Cidex OPA

– Medevator– Evotech – Anesthesia

• Trophon – Hydrogen Peroxide – Intracavitary probes– 8 sites (NMCSD & NBHC’s)

• Steris – Accelerated Hydrogen Peroxide (AHP)– Scopes in Urology Clinic

• Manual HLD with Cidex OPA– Cardiology, ENT, GSC, GI, PICU/GI– Some attachments (forceps)– Goal: Trying to get rid of manual reprocessing

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HLD Process Guidelines The products used for cleaning, disinfection of

endoscopes must be compatible with the equipment being used

Each health care setting in which endoscopic procedures are performed should have written detailed procedures for the cleaning and handling of endoscopes.

Reprocessing of contaminated patient equipment should be done in an area designated and dedicated for this function

Ventilation must be capable of removing toxic vapors generated by, or emitted from, cleaning or disinfectant agents, minimum of 6-12 air exchanges per hour in the reprocessing area

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Three Levels of DisinfectionThe terminology adopted by the CDC and widely used, describes disinfectants in terms of their activity as set out below. This instruction will focus on high-level disinfection (HLD)

• High-Level Disinfectant: Are chemicals sterilants, which when used for a specified exposure period will kill all microorganisms with the exception of bacterial spores.

• Intermediate-Level Disinfection: May kill mycobacteria, vegetative bacteria, most viruses and most fungi but not necessarily bacterial spores.

• Low-Level Disinfection: May kill most vegetative bacteria, some fungi and some viruses.

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Spaulding Classification of Medical Devices

BASED ON RISK OF INFECTION

• Critical devices-Enter normally sterile body tissue: e.g., surgical instruments- Sterilization

• Semi-critical devices-Contact mucous membranes: e.g., flexible endoscopes-Sterilization, if not feasible- Minimally high level disinfection

• Non- critical devices-Contact intact skin: e.g., stethoscopes, electrocardiogram electrodes- Intermediate or Low level disinfection

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Spaulding Classification of Medical Devices

• Critical items are medical devices that enter sterile tissue or the vascular system

• These items should be sterile when used

• Examples include, but are not limited to: - surgical instruments - endoscopes used in sterile body cavities - cardiac, vascular or urinary catheters - implants, needles used in the sterile body cavities.

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Spaulding Classification of Medical Devices• Semi-critical items are medical devices that come into contact

with non-intact skin or mucosal membranes

• These items should be high level disinfected when used

• Examples include, but are limited to: - vaginal and rectal probes - anesthesia equipment - Bronchoscopes - gastrointestinal endoscopes (and accessories)

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Spaulding Classification of Medical Devices• Non-critical items are medical devices that come into contact with

only intact skin

• These items should receive intermediate level disinfection, low level disinfection or cleaning

• Intact skin is considered an effective barrier to most organisms

• Examples of non-critical items include, but are limited to: - Tourniquets - Blood pressure cuffs - Lines - Bed pans - Stethoscopes

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Professional Society Guidelines-recommends gowns, gloves, and protective eye wear when handling HLD.

It’s the law – Occupational Safety & Heath Administration (OSHA)

Gowns – impervious to fluid, long sleeves that fit snugly around the wrist, and wrap to cover as much of the body as possible.

Gloves – inspect for tears or holes before use. Gloves should be long enough to extend up the arm to protect the forearm or clothing from splashes or seepage. To prevent cross-contamination, change gloves and wash hands whenever moving from a dirty to clean task or environment

Eye and/or face protection are necessary – contact lenses are not sufficient eye protection. A face shield is recommended.

Personal Protective Equipment

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Transportation & Handling of Contaminated Endoscopes

Covered and closed containers with easily cleanable surfaces should be used for handling and transporting soiled endoscopes

Containers used to transport soiled endoscopes should be cleaned after each use

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Minimal Effective ConcentrationMEC

MEC is routinely done to ensure the minimum effective concentration of the active ingredient (Cidex OPA)

Check the solution prior to each use and document the results

Document on HLD log If the chemical indicator shows that the

concentration is less than the minimal effective concentration, the solution should be discarded

Perform MEC monitor strip QC each time a new bottle of monitoring strips is opened

Document on QC log

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Endoscopes Reprocessing Steps

1. Pre-clean

2. Leak Test

3. Manual Clean

4. Rinse

5. High Level Disinfection

6. Rinse

7. Dry

8. Store

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Pre-Cleaning Performed at point of use before

bio-burden has an opportunity to dry

Follow manufacturer’s instructions

Transport the soiled endoscope to reprocessing area in a manner that prevents exposure of staff, patients or the environment to the potentially infectious organisms

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DELAYED REPROCESSING • One hour delay between pre-cleaning and manual cleaning –

Cleaning validation studies recommend:

• Delayed reprocessing (Olympus America) If there is one hour delay from Pre-cleaning to manual

cleaning Soak until hardened debris is loosened Follow Manufacturer’s delayed reprocessing

instructions 10 hour soak – depends on length of the scope- Not

intended for routine reprocessing

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Leak Testing

Detects damage to the interior or exterior of the endoscope

Begin leak test in a dry surface before immersion of the endoscope in reprocessing solutions after each case

Manual Leak Testing

Fresh, clear water

Computerized Leak test

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Leak Test Failure

If a leak is detected, the endoscope must be repaired. Follow manufacturer’s instructions

Do not disconnect scope from leak tester

Contact your supply Petty Officer

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Manual Cleaning Necessary prior to automated or

manual disinfection

Most important step in removing the microbial burden from the endoscope

Retained debris may inactivate or interfere with the capability of the high Level disinfectant

If scope sits dirty for an undetermined amount of time, it needs to be soaked in enzymatic solution per MFG’s

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Manual Cleaning- Detergent

Medical-grade, low-foaming, neutral pH Clearly visualize scope Excessive foaming can inhibit

good fluid contact with device surfaces

Freshly prepared detergent solution for each endoscope to prevent cross-contamination.

Dilute and use according to detergent manufacturer’s instructions. Amount per gallon of H20 Submersion time Temperature

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Manual Cleaning

Follow endoscope MFGs

Use small, soft brushes to clean all removable parts, including under the suction valve, air/water valve, and biopsy port cover and openings

Use brush sizes compatible with each channel

After each passage, rinse the brush in detergent and reinsert into channel until brush is free of debris when removed

Discard disposable brushes

Reprocess reusable brushes between each case

Automated pumps eliminate manual flush (Scope buddy)

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ERCP Scopes

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Cidex OPA High Level Disinfection• After cleaning and decontamination is completed-place scope

in Cidex OPA bucket or AER• Test Cidex solution (MEC) before placing devise in AER or

Cidex OPA bucket• Soak device for 12 minutes-Manual Cidex OPA• After soaking for 12 minutes, rinse, dry and store scope per

MFG’s• Medical device manufacture's guidelines are required to be

readily available provide health care facilities with valid reprocessing instructions for use (IFU)

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Rinse after Manual CleaningRinsing prevents exposure and potential injury of skin and mucus membranes from HLD residue

Thoroughly rinse endoscope and all removable parts with clean water to remove residual debris and detergent

Prevent dilution of the HLD used in subsequent steps

Purge water from all channels using forced air

If using AER this step may be included with initiation of AER

Dry exterior of the scope

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DryingNote: AER May be equipped with alcohol flushing

and purging cycles

Drying is as important to the prevention of disease transmission and nosocomial infection as cleaning and high level disinfection

Purge all channels with air until dry Flush all channels, including accessory channels, with 70%

isopropyl alcohol until the alcohol can be see exiting the opposite end of the channel

Alcohol mixes with remaining water to encourage evaporation Purge all channels with air Dry exterior of the endoscope with a soft, lint-free towel

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Storage Stored in a manner that will protect

the endoscope from contamination

Hang Scopes with all accessories removed

Hang scopes vertically (not touching the wall or bottom shelve)

Storage area should be clean, well ventilated and dust free

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Storage Interval

The interval of storage after which endoscopes should be reprocessed before use has had limited investigation and warrants further data and research http://www.asge.org/uploadedFiles/Public_E-Blast_PDFs/ReprocessingEndoscopes.pdf

AORN Advises 5 days, APIC advises 7 days The American Society For Gastrointestinal Endoscopy

(ASGE-2012) states reuse within 10-14 days

Per guideline may be advisable, particularly for instruments:

Used infrequently because of low volumes or specialty applications

Used in patients at high-risk of infection such as those whose immune systems are suppressed by medications or disease

Used in procedures with anticipated entry to otherwise sterile regions such as the biliary tree, pancreas or peritoneal space

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Disinfection Logs Maintain a log for each procedure to assist in an

outbreak investigation Monitor and Document

Patient’s DoD numberHLD TempChemical Strips expiration ateSoak timeMEC resultExpiration dateDate of reprocessing Scope serial number

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Documentation

Link patient to device:

Approved NMCSD Logs for Trophon & Cidex OPA-Scopes

GI & GSC use Endo-works changing to (Endopro-IQ from Pentax)

DoD number

ETR# (ED)

Accession # (Radiology)

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Training Requirements for HLD- Scopes

Initial Training is done by each area super-user

Two to three weeks of hands-on supervise by super-users

Individuals performing HLD will have full understanding and demonstrated competency on all HLD processes.

Each staff will provide a full demonstration and be signed off by the super-users.

Complete training video provided by Nanosonics

Mr. Acevedo will verify competency by observing a full demonstration of the HLD process.

Re-training will take place if demonstration is unsuccessful.

HLD Process - Trophon• PPE for cleaning• Transportation - Containers closed and labeled as dirty• Chemical cartridges & indicators

– Expiration dates documented• Pre-cleaning

– Debris removed; cord cleaned; probe dried• HLD

– Chemical indicator placed; probe in machine; cycle started; indicator checked at end of cycle

• Storage– Hung vertically; covered with disposable sheaths

• Documentation• Training Requirement

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Training Requirements for HLD - Trophon

Initial Training is done by each area super-user

Two to three weeks of hands-on supervise by super-users

Individuals performing HLD will have full understanding and demonstrated competency on all HLD processes.

Each staff will provide a full demonstration and be signed off by the super-users.

Complete training video provided by Nanosonics

Mr. Acevedo will verify competency by observing a full demonstration of the HLD process.

Re-training will take place if demonstration is unsuccessful.

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Conclusion

• Expecting that TJC will be scrutinizing the entire Command HLD process

• Read and follow instructions for use (IFU) that should accompany all medical devices

• Follow recognized industry Guidelines and Standards of Practice, AORN, AAMI, SGNA, CDC

• Stay current and competent- HLD dashboard has lots of current evidence based information on HLD

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References:

 

BUMED INSTRUCTION 6220.9B- HEALTH CARE-ASSOCIATED INFECTION PREVENTION AND CONTROL PROGRAM Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes. Society of gastroenterology Nurses An Associates, Inc (2012). http://www.cdc.gov/hicpac/disinfection_sterilization/20_00reference.htmlANSI/AAMI: ST58:2013 Chemical sterilization and high-level disinfection in health care facilities AORN Recommended Practices for Cleaning and Processing Flexible Endoscopes and Endoscope Accessories. Published online March 9, 2012, doi: 10.6015/ psrp.12.01.0499. http://www.aornstandards.org/content/1/SEC38.extract

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  Primary HLD Method Automated? Cidex OPA? Jan-15 Feb-15 Mar-15 Apr-15 May-15 Jun-15 Jul-15 Aug-15 Sep-15 Oct-15 Nov-15 Dec-15

 

Cardiology ManualNo. AER purchased; pending placement following renovation

Yes           

           

ENT Manual

No. No AER for rigid scopes.

Other scopes too widely varied

Yes          

 

           

Anesthesia EvotechPartially. Evotech not

compatible with glidoscopes

Yes                        

Adult Gastroenterology Medevator Yes. Manual HLD for accessories Yes          

            

PICU: GI Scopes Medevator Yes. PICU staff does full procedure in GI No          

            

General Surgery Medevator Yes. Manual HLD for accessories Yes          

            

Pulmonology Medevator Yes No           

           

Adult ICU: Respiratory Therapy Medevator Yes No          

            

PICU: Respiratory Therapy

(split responsibility with Adult ICU RT)

MedevatorYes. Adult RT staff does

AER processing in Pulmonology clinic

No          

 

           

Urology Steris: scopes

Trophon: probes

Yes No          

 

           

Emergency Department Trophon Yes No           

           

Fetal Assessment Unit Trophon Yes No           

           

Labor and Delivery Trophon Yes No           

           

Miramar OB/GYN Trophon Yes No                        

NMCSD OB/GYN Trophon Yes No           

           

NTC OB/GYN Trophon Yes No           

           

Radiology Trophon Yes No                        

Radiation Oncology Trophon Yes No           

           

    PERCENT COMPLIANT (% GREEN)                        

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POC: Mr. Anibal (Luis) Acevedo, RN, MSN, CNOR NMCSD Infection Control Nurse ConsultantHigh Level Disinfection Program Manager

anibal.l.acevedo.civ@mail.mil(619) 532-7486