Report - APIC



MultiCare Health System

Endoscopes in Clinic Settings

Endoscope Cleaning and Disinfection in the Ambulatory Setting

Education to ensure safe and proper cleaning and sterilization of endoscopes in Ambulatory Care.

Self-Study Guide

Cleaning and Disinfection of Endoscopes

Objectives

➢ Identify the step(s) that must be taken before an instrument or scope can be disinfected or sterilized.

➢ Identify the Spaulding Classification category that applies to endoscopes.

➢ Describe the level of disinfection required for endoscopes.

➢ State three factors that may interfere with any disinfection process.

➢ State the minimum soak time for each of the two chemical germicides used to disinfect scopes.

Definitions

Cleaning

1. Removal of all visible dust, soil, other foreign material (usually takes “elbow grease”.)

2. Scopes must be physically cleaned before they can be chemically disinfected or sterilized!

Decontamination

1. Process of removing disease-producing microorganisms.

2. Renders the object safe for handling.

Disinfection

1. Process that kills or destroys most disease-producing microorganisms.

2. Rarely kills all spores.

3. Disinfectants are used on inanimate objects only.

Sterilization

1. Process that destroys all forms of microbial life (bacteria, viruses, spores, fungi.)

2. Steam heat.

3. Ethylene Oxide (“gas”.)

4. Others(Steris, Sterrad)

Detergent (Cleaning agent with:)

1. Surface wetting agent (decreases surface tension.)

2. Builder (cleaning agent.)

3. Sequestering / chelating agent (suspends soil so it can be washed away.)

Germicide

1. Chemical that will destroy microbes, but not necessarily resistant bacterial spores.

2. Can be an antiseptic or a disinfectant.

Antiseptic vs. Disinfectants

1. Antiseptic: chemical that inhibits the growth of, or destroys microorganisms on living tissue (skin.)

2. Disinfectant: chemical that kill or destroys microorganisms (except spores) on inanimate objects.

Other Definitions

1. –cidal: indicates killing or destruction.

2. –static: inhibits growth, does not kill.

Leak testing

1. A procedure to check the integrity of the channels of an endoscope.

2. It is performed after use and before cleaning.

Items to Be Cleaned and Disinfected or Sterilized

1. Instruments

2. Equipment

3. Environmental surfaces

Spaulding Classification System

Three Categories

Items are classified into one of three categories, based on the risk of infection to the patient:

1. Critical

2. Semi-critical

3. Non-critical

Critical

➢ Those entering sterile tissues or vascular system.

➢ High risk of infection.

➢ Require sterility.

➢ Example: OR instruments, cardiac catheters.

Semi-critical

➢ For items coming in contact with mucous membranes or non-intact skin.

➢ Free of microorganisms, except spores.

➢ Example: endoscopes, respiratory therapy equipment, laryngoscope blades.

Non-critical

➢ Items coming in contact with intact skin.

➢ Example: Environmental surfaces, linens, BP cuffs, furniture, etc.

Three Levels of Disinfection

Low level

Intermediate level

High level

Low level

▪ Kills most vegetative bacteria, fungi, lipid viruses. Will not kill spores, non-lipid viruses, and may be less active against some gram negative rods and Mycobacterium Tuberculosis (TB.)

▪ Used for environmental cleaning and cleaning non-critical items.

▪ Routine cleaning with hospital-grade germicide is adequate (SaniCloth, Maxima.)

▪ Follow label instructions for mixing and contact time.

Intermediate-Level Disinfection

▪ Kills vegetative bacteria, tubercle bacillus, fungi, lipid and non-lipid viruses.

▪ Does not kill resistant bacterial spores.

▪ Used for some semi-critical, non-critical items (whirlpool tanks.)

▪ Includes products such as alcohols, phenolics, iodophors.

High-Level Disinfection

▪ Kills vegetative bacteria, tubercle bacillus, some spores, fungi, lipid, non-lipid viruses.

▪ Used for items that enter non-sterile body areas or items that cannot be steamed or gassed.

▪ Usually used for semi-critical items like scopes.

▪ Soak in 0.55% ortho-phthalaldehyde (Cidex OPA.)

Scopes and instruments entering non-sterile body cavities such as the GI tract (from either end)

▪ Don’t need to be sterile. They must be free of significant organisms on/in the scope from a previous patient or environmental source, such as tap water left in a channel growing a large number of bacteria, or retained disinfectant.

Biopsy forceps that pass through the scope will penetrate tissue when obtaining a specimen, so these must be sterile, either reusable or disposable. Reusables must be sent to Central Services for reprocessing.

High-Level Disinfectant

1. Cidex OPA- 0.55% ortho-phthalaldehyde is the approved product. (Urology scopes must be reprocessed with 2% glutaraldehyde, as Cidex OPA is not approved for this use.)

□ High-level disinfectant

□ Comes in 1 gallon jugs, 4 jugs per box

□ Does not need to be activated, use as is

□ Once poured, can be reused for up to 14 days, label soaking container with “mix” & expiration “exp” dates)

□ Product remaining in the jug is good for 75 days, can be poured on day 75 and used for 14 days (label jug with 75-day expiration date)

□ Unopened product is good until manufacturer’s expiration date

□ OPA stains protein and environmental surfaces- keep off skin and avoid splashing, use protective equipment

2. OPA Concentration Dipstick Test Strips: Determines concentration of product

□ Strips are good for 90 days after opening, label container with “exp” date

□ Solid dark blue/purple indicates adequate concentration

□ Follow directions on label, read at indicated time (90 seconds exactly)

□ Dipstick before each use

□ A test strip that is mottled blue in color indicates lack of potency, discard and replace product

□ Disinfectant must be discarded on day 14 regardless of test results

□ Note results in the log

3. The Infection Control Committee must approve all cleaning and disinfection products.

Scope Processing (Cleaning and High-Level Disinfection)

Processing should not be done in the procedure room.

Dirty scopes should never be placed back in the transport case.

Procedure Steps for Scope Processing

1. Immediately after the procedure, wipe off the scope with a damp cloth or 4x4 to remove any gross debris, then wrap in a clean towel and take to the soiled utility room. Always wear gloves to handle a dirty scope. Wear gown and face protection if splashing is likely.

2. Perform the leak test by connecting the scope to the leak test device. REQUIRED!

Follow manufacturer’s instructions for the procedure.

If the scope fails (is leaking, indicated by visible air bubbles) wipe it off, place in a plastic bag and contact Biomed for repair.

DO NOT use the scope again until checked by Biomed.

DO NOT put dirty scope in the case without first placing in a plastic bag.

Label as “biohazardous” and notify Biomed it has not been cleaned.

3. Perform the dipstick test on the disinfectant solution to ensure potency.

Dip and read in exactly 90 seconds.

Note results in the log.

If the test fails, discard the solution and replace with fresh solution, retest.

4. Don additional protective equipment, generally gown/apron and a mask with eye protection.

5. Mix enzymatic detergent per label directions in a sink or basin.

Mark sink or basin at the 1, 2, or 3 gallon level.

Label enzymatic cleaner jug with exactly the amount to be added to the appropriate water level.

Have the correct measuring device available.

6. Follow the posted instructions for the particular scope you’re cleaning.

Manufacturer’s cleaning instructions for each scope MUST be posted in the cleaning area!

Immerse the scope in the enzymatic cleaner.

Flush all channels with enzymatic cleaner.

Soak for 10-15 minutes if time allows.

Thoroughly brush all channels or lumens with the correct size cleaning brush.

Brushes must retain their shape and stiffness, and must be replaced before they get too soft to use.

All items must be completely submerged.

If the brush will not go the full length of the channel, send the scope to Biomed for repair.

Clean all ports, lenses, and accessories per manufacturer’s instructions.

7. When cleaning is complete, thoroughly rinse to remove any debris and/or enzymatic cleaner. Discard enzymatic cleaner.

8. Dry with a clean, non-linting towel. Blow channels with compressed air or suction to dry.

9. Place in the high level disinfectant- Cidex OPA.

Coil loosely, don’t bend or kink as it will damage the scope.

Be sure channels are filled per manufacturer’s instructions.

Brushes must be cleaned and soaked with the scope each time they are used, or discarded if disposable.

Keep the cover on the disinfectant container at all times except when putting in or removing items.

OR Place in automatic endoscope reprocessor

Ensure appropriate connectors are available

Connect to scope properly to the reprocessor

Ensure machine settings are correct for soak time and triple rinsing

Go to Step 13

10. Set the timer for the correct soak time.

12 minutes for Cidex OPA, minimum temperature 20(C/68(F. DO NOT EXCEED 15 MINUTES!

Timing begins when the last item is submerged.

If additional items are added after the soak cycle has begun, restart the timer.

11. When the soak cycle is completed, don PPE (gown, gloves, mask, eye protection) and remove the scope from the solution.

12. Rinse by immersion in at least 2 gallons of tap water and flushing each lumen with at least 100 ml of water. Discard the rinse water. Repeat this two more times, for a total of 3 rinses.

13. Aspirate 70% isopropyl alcohol through the ports to help drying and blow with compressed air. (Required for all scope processing, whether the scope is to be reused or stored.)

14. Dry with clean, lint-free cloth such as a hand towel, not terrycloth.

15. Store by hanging.

Other considerations

DO NOT allow used scopes to dry out. Wipe, rinse and immerse in enzymatic detergent solution to prevent debris from becoming crusted and difficult or impossible to remove.

Solution may become diluted if items are not towel dried prior to immersion, or precipitate from hard water may form. Replace solution if precipitate is observed.

Disinfection cannot occur unless items are completely submerged.

Trapped air bubbles will interfere with the disinfection process.

12 minutes minimum soak time per manufacturer’s label is required.

Spills of Cidex OPA can be neutralized with glycine (25 g per gallon of OPA for one hour) and the debris rinsed down the drain or placed in the regular trash.

Cidex OPA and glutaraldehyde must be neutralized with glycine prior to disposal.

Reference:

CDC Guideline for Disinfection and Sterilization in Healthcare Settings, 2008.



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