Tracing High-Level Disinfection April 26, 2019 Mary Cole, MSN, CJCP, CIC Consultant Joint Commission Resources, Inc.

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IC.02.02.01 Medical Equipment, Devices, and Supplies The hospital reduces the risk of infections associated with medical equipment, devices, and supplies – implements infection prevention and control activities

IC.02.02.01 Medical Equipment, Devices, and Supplies Low level disinfection Intermediate and high level disinfection and sterilization Disposal Storage Reprocessing single-use devices

Spaulding Classification

#1 most frequently cited clinical standard #1 issue in Immediate Threat to Life

IC.02.02.01 Medical Equipment, Devices, and Supplies EP2 Intermediate and high-level disinfection (HLD) and sterilization of medical equipment, devices and supplies, such as scopes; contamination issues

Know Where HLD Occurs Clinics Emergency Rooms OB-GYN Clinics ORs Central Sterile Processing Special Procedure Rooms Sleep Apnea Study Labs Endoscopy Rooms

HLD – Other Devices, Equipment Vaginal and rectal probes, TEE probes (Transesophageal echocardiography) Respiratory therapy equipment (CPAP masks/Sleep Study Centers)

Sleep Study Centers Masks Tubing, supplies Instructions for use Reprocessing

Include HLD in Risk Assessment

Compliance Strategies Approach to IC-related standards: Regulation Condition of participation (if deemed status) Manufacturer instructions Evidence-based standards or guidelines Consensus documents or position papers Incorporate into facility-based risk assessment and policy

Common Products For HLD Glutaraldehyde Ortho-phthalaldehyde (OPA) Hydrogen peroxide

Glutaraldehyde Advantages Numerous use studies published Relatively inexpensive Excellent material compatibility

Glutaraldehyde Disadvantages Respiratory irritation from glutaraldehyde vapor Pungent and irritating odor Relatively slow mycobactericidal activity (unless other disinfectants added such as phenolic, alcohol) Coagulates blood and fixes tissue to surfaces Allergic contact dermatitis

OPA Advantages Fast acting, high-level disinfectant No activation required Odor not significant Excellent materials compatibility claimed Does not coagulate blood or fix tissues to surfaces claimed

OPA Disadvantages Stains protein gray (e.g., skin, mucous membranes, clothing, environmental surfaces) Limited clinical experience More expensive than glutaraldehyde Eye irritation with contact Slow sporicidal activity Anaphylactic reactions to OPA in bladder cancer patients with repeated exposure to OPA through cystoscopy

Hydrogen Peroxide Advantages No activation required No odor Non-staining No special venting requirements Manual or automated applications 12-month shelf life, 14-day reuse 8 min at 20oC high-level disinfectant claim

Hydrogen Peroxide Disadvantages Material compatibility concerns (brass, zinc, copper and nickel/silver plating) both cosmetic and functional Severely irritating and corrosive to eyes, skin and gastrointestinal tract if inadequately rinsed Excessive exposure could cause irreversible tissue damage to the eyes, including blindness, inhalation of hydrogen peroxide vapors can be severely irritating to the nose, throat, and lungs

Pre-cleaning At Point of Use Scope immediately wiped down at point of use (in the procedure room) and channels flushed with enzymatic, detergent. For other instruments, follow manufacturer IFU.

Transport Scope is safely transported to the cleaning area/decontamination room in a leak-proof, puncture-resistant container/device labeled as biohazardous which is based on evidence-based guidelines, manufacturer instructions for use

Decontamination Area Scope is leak tested; if fails, finish processing, remove from service, and send for repair All accessories are removed for cleaning or discarded if disposable – following manufacturer’s instructions for use Scope and accessories immersed in measured enzymatic detergent

Decontamination Area Cleaning solution is changed after each scope is cleaned, based on manufacturer instructions for use All channels and accessories thoroughly brushed with manufacturer recommended brushes

Manual Clean High Level Disinfectant (HLD) solution and concentration monitored and documented and dated as per manufacturer instructions for use If test strip fails while checking HLD minimum effective concentration, discard & replace HLD; if problem with test strips, use different bottle – always check expiration dates

Manual Clean Test strips should be dated upon opening with the discard date as per manufacturer instructions for use, and quality control conducted per label instructions High-level disinfectant used is FDA-approved; used per label directions (contact time) all items completely submerged Temperature of the HLD meets HLD label instructions

Manual Clean Soak time meets manufacturer’s label instructions Scopes rinsed 3 times with sterile water or water as per manufacturer’s instructions for use; flushed with alcohol and compressed air after high-level disinfection

Storage Scopes thoroughly dried before storage – there should be no water-staining at the base of the storage cabinet which may reflect an inadequate drying process Scopes vertically hung in a manner that prevents contamination; scope attachments are dried and stored as per manufacturer instructions for use and evidence-based guidelines Scopes reprocessed per evidence-based guidelines, manufacturer, and organizational policy

High-level Disinfection (HLD) – Using an Automated Endoscope Reprocessor (AER) Point of use precleaning and transport to decontamination are the same as for manual cleaning

Decontamination With AER Leak test if AER doesn’t do this If fails, finish processing, remove from service, send for repair Manual cleaning, brushing is performed

Decontamination With AER HLD solution concentration is checked and documented; changed if test strip fails Test strips dated with discard date as per manufacturer instructions for use and quality control per label Scope connection instructions posted near the AER; proper connectors used

Decontamination With AER Cycle run, meets HLD contact time and temperature AER set for triple rinse in accordance with manufacturer’s IFU

Drying and Storage On completion of cycle, if AER doesn’t include a drying process, flush channels with alcohol and compressed air Scopes vertically hung in a manner that prevents contamination; scope attachments are dried and stored separately

Storage On visual inspection, do these areas look clean, free of debris, and dry? Is there a regular cleaning schedule of cabinets? Is cabinet surface intact and cleanable? Is equipment stored not touching the base of the cabinet? Are scopes stored according to manufacturer instructions for use?

Clean/Dirty That Is The Question Must be able to clearly differentiate clean from dirty

Space and Equipment Is there sufficient work space? Is there an appropriate hand-washing or alcohol- based hand rub station? Is there an appropriate eyewash station? Are cleaning supplies, storage areas, and other critical items clearly labeled?

Ventilation Is there negative air pressure in the decontamination room to surrounding areas? Are air exchange rates and filtration efficiencies appropriate (per your facility manager)? Is exhaust vented directly outside?

Environmental Controls Temperature AAMI: 18°C to 24°C [65°F to 75°F] Humidity AAMI: 30% to 60% Airflow © Sylvia Garcia-Houchins Physical factors such as temperature, humidity, air exchanges, ventilation exhaust, adequate space and equipment can also affect the disinfection and sterilization process. Physical properties of CSP and decentralized reprocessing areas should meet local building code requirements as well as specific requirements established by the manufacturer’s of equipment and supplies used in these locations. In the absence of local guidance the following physical areas are recommended. © Sylvia Garcia-Houchins © Sylvia Garcia-Houchins

Workflow Are staff stopped before entering the area and asked to put on PPE? Does work flow from soiled areas to clean? Does the route from the processor to the storage cabinet avoid crossing through the soiled processing area?

Separation of Clean and Dirty

In Decontamination Setting Personal Protective Equipment (PPE) is worn and includes: Hair covering/cap Face mask/shield Fluid resistant gown Gloves used should be durable to prevent tearing and leaking of chemicals and/or contaminated fluids when the user’s hands are under water Note a distinct flow and separation of dirty and clean processes that minimizes the risk of cross- contamination

Decontamination Cleaning Process Demonstrate Labeling of sinks Standard work with low/no variation Job aids Manufacturer’s instructions (temp, measurements) Training & Competency

Questions to Ask Is there an inventory list of all scopes maintained in the department? Do staff know how frequently these are maintained and how that maintenance occurs? When staff members are questioned, can they show where manufacturer instructions and evidence-based practices and guidelines are located? Do all staff have competencies on file? Who signed them off as competent?

Common Findings With HLD Not pre-cleaning at point-of-use Reusing single use brushes Reusable brushes to clean endoscopes not being cleaned or disinfected between each use or at the end of the day per evidence-based guidelines or manufacturers’ instructions for use Use of a low-level disinfectant wipe instead of a high-level disinfectant to reprocess equipment between patient use

Common Findings With HLD Lack of quality monitoring, documentation, (temperature, time, minimal effective concentration of high-level disinfectant) per manufacturers’ instructions for use or evidence-based guidelines

Clarifying Standard Requirements: High Level Disinfection

Endoscope Sheaths, AAMI ST91 Endoscope sheaths are available for use with specified endoscopes. The instructions for endoscope processing for some of these devices recommend alternative processing instructions to conventional liquid chemical sterilization/high-level disinfection when the sheath remains intact after endoscope use.

Endoscope Sheaths, AAMI ST91 For these endoscopes and sheaths, the manufacturer's written IFU should be followed. If the processing instructions from the endoscope manufacturer and the endoscope sheath manufacturer appear to differ or to conflict, personnel should contact each manufacturer to request additional information and make their own decision based on all available information

Documentation and Record Keeping, AAMI ST91 Assigned lot number, including chemical sterilizer, AER, or soaking container identification and cycle number Specific contents of the lot or load, including quantity, processing area, and a description of the items Patient’s name and unique patient identifier Procedure, physician, and, if applicable, serial number or other identification of the item

Documentation and Record Keeping, AAMI ST91 Exposure time and temperature, if not provided on the physical monitors Date and time of cycle HLD type and concentration; pH test results if required by facility policy or manufacturer's written IFU Name or initials of the operator

Documentation and Record Keeping, AAMI ST91 Results of MRC or MEC solution monitoring strip, if applicable; Results of the quality control of test strips, if applicable

Education and Competencies Upon hire Recommend at least annually Whenever new item or equipment borrowed leased purchased Whenever new policies and procedures are implemented

Education and Competencies Determine frequency of competency and training based on staff turnover, purchasing new equipment or products, or a breach in the process has been identified Random observations Who signs off on competencies? Who signed them off?

Education Principles of cleaning, disinfection and sterilization Inspection, preparation, and packaging of instruments Worker safety and use of personal protective equipment (PPE) Manufacturer’s instructions for use Quality control of processes Endoscope model specific cleaning and disinfection, if applicable

Questions or comments? Thank you! mcole@jcrinc.com