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This series of self-study lessons on Central Service topics was developed by the International Association of Healthcare Central Service Materiel Management (IAHCSMM). The lessons are administered by Purdue University’s Continuing Education Division.

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Lesson Plan CRCST 105
Cleaning/Decontamination of Complex and Difficult-to-Clean Instrumentation [Reprinted from Communiqué: March/April 2009]

The primary goal of every sterile processing department is to effectively clean and decontaminate instruments and other medical devices¹. Processing must be done accurately and on a timely basis to ensure patient safety and customer satisfaction. Surgical instrumentation that has not been properly cleaned after use may lead to post-operative complications and infections. Central Service personnel should always follow the detailed handling and reprocessing instructions for instruments written by their Original Equipment Manufacturer (OEM).

Objective 1: Review terms required to understand the cleaning and decontamination of complex instruments.

Cleaning is the removal, usually with a detergent and water, of visible and non-visible soil (i.e., blood, protein substances, and other debris) from the surfaces, crevices, serrations, joints, and lumens (tubular shafts) of instruments, devices, and equipment.

Cleaning is the first and most important step in the sterilization process. One can clean without sterilizing, but one cannot sterilize without cleaning. Also, one can clean without disinfecting, but one cannot disinfect without cleaning. The sterilization process cannot produce a sterile device that has not first been cleaned.

Decontamination involves the use of physical or chemical procedures to remove, inactivate, or destroy blood-borne pathogens on a surface or item. The decontamination process is necessary so pathogens (organisms that can cause disease and infection) can be killed and can no longer cause infection. Then the surface or item will be safe for handling, use, or disposal.

Decontamination makes devices safe for people not wearing gloves. Some instruments are safe for handling after they have been thoroughly cleaned while others require exposure to a microbiocidal process. For example, instruments opened for inspection but never used or exposed to a patient’s body fluids must only be cleaned prior to sterilization. By contrast, instruments used in the presence of a patient and/or exposed to body fluids must be cleaned and decontaminated.

The level of decontamination required depends upon the purposes for which the item was last used and for which it will next be used. Infusion pumps and heating pads are not exposed to broken skin, and they should be safe to handle after cleaning. By contrast, complex surgical instruments have been exposed to blood and body tissue, and they must first be cleaned and then decontaminated.

The U.S. Food and Drug Administration (FDA) requires and the Association for the Advancement of Medical Instrumentation (AAMI) endorses the need for manufacturers of reusable medical devices to provide written and detailed instructions about reprocessing procedures. Ideally, Central Service managers will be involved in purchase decisions for these devices so they can review these requirements at that time.

Instructions should then be given to those who will reprocess the devices so they can be consistently and accurately followed.

Medical instrumentation can be “simple” or “complex.” Simple instruments, such as hemostats, needle holders, scissors, and hand-held retractors have few moving parts, lumens, and articulation points such as simple box locks, hinges, and slides. They can be placed in an automated cleaning and decontamination process for effective cleaning with just a few successive steps in an effective processing cycle leading to sterilization.

Complex instruments are medical devices and instruments powered by electric motors, compressed gas (pneumatic), or batteries. They also include items with difficult-to-reach lumens, crevices, multiple articulation points, and special cleaning requirements defined by the OEM. Complex instruments require multiple steps to effectively clean and disinfect. Unfortunately, simple instruments can present a complex instrument challenge if bioburden or gross soil remains and dries on a device for an extended time.

Objective 2: Provide details about steps in the cleaning and decontamination cycle for complex instruments.

The first step in the cleaning and decontamination cycle for complex instruments occurs at the point of use. The customer should take these instruments apart and wipe them to remove gross soil which, if left to dry on surgical instruments, poses a greater challenge to remove and can also damage stainless steel. Instruments that have been soiled by patient blood or protein should be scheduled into the cleaning process as soon as possible to prevent soil and bioburden from drying and adhering to them. For example, one endoscope manufacturer states that its scopes should be queued into the cleaning process within 15 to 60 minutes after use².

Immersible complex devices should be disassembled and pre-soaked in a measured amount of water and enzymatic detergent. Disassembly allows the moisture to penetrate deep into the complex device, and this is a critical step in a successful reprocessing cycle. Note: complex electric, air, and battery powered devices should never be immersed in a solution because fluid invasion will damage the instrument’s internal components.

If adequate amounts of pre-soaking solution are not available at the point-of-use or if instruments cannot be submerged, a moistened towel draped over the instruments will suffice. Do not use saline because it may pit and rust even surgical grade steel. Note: spray instrument moistening agents can also be used if large amounts of water are unavailable.

The second step in the cleaning and decontamination cycle for complex instruments is the complete disassembly and opening of hinge joints. While ideally done at point-of-use, this may be forgotten because of the haste and pressure to rapidly prepare the operating room for the next procedure. Then it must be done in the decontamination area because the serrations and lumens of instruments that are closed or assembled cannot be adequately cleaned. Examples of instruments to be disassembled include tissue retraction systems, orthopedic cutting blocks and guides, and instruments with moving parts such as trocars with valve assemblies. Instruments should be removed from their stringers and opened before processing in automatic washers, and lumens must be flushed with water and enzymatic detergent.

The third step in the cleaning and decontamination cycle for complex instruments is pre-inspection for cracks, defects, missing or broken parts, chips, holes in air hoses, exposed wires, and leakage of bearing oils, among other concerns. Those failing inspection must be removed from service and clearly tagged to prevent accidental use because they pose a significant risk to patients and staff. Note: “repair/re-sharpen” tags are available from numerous sources to identify damaged instruments. These tags must be available to the sterile field, should be recognizable by all workers, and they must be able to withstand the complete decontamination process.

The fourth step in the cleaning and decontamination cycle for complex instruments is the physical removal of any deposits that are present. Manual cleaning uses friction and an approved cleaning agent to bind and loosen bioburden and soils. Water temperature should be below 109°F (43°C). Cooler water may not activate the detergent, and water above 140°F (60°C) may coagulate (denature) the protein and destroy enzymes used to loosen protein soils.

Water hardness and temperature—and the type of soil to be removed—impact detergent effectiveness. Be sure to use the quantity of detergents and cleaning agents specified by the OEM as excessive amounts can be difficult to rinse off and will eventually begin to deteriorate instruments.

Soft, lint-free cloths and cleaning brushes are important for proper cleaning. The correct-size and type of brush must be used if permitted by the OEM. Consider, for example, the need to clean a lumen (channeled) instrument. If the brush is too large, it will not fit into the lumen. If it is too small, it will not have complete contact with the lumen walls, and it will not thoroughly clean them.

The fifth step in the cleaning and decontamination cycle for complex instruments is decontamination. Reusable brushes used to clean instruments must also be cleaned and disinfected/sterilized at the end of the shift or when they are visibly soiled to reduce the risk of cross-contamination. Those that show wear should be discarded. A cleaning process that uses reusable components, such as brushes, must include the process used to clean them.

Spray arms to dispense water and hoses with multiple-sized fittings to dispense compressed air should be readily available in decontamination rooms. Residual bioburden and moisture can be removed from complex instruments by use of cleaning techniques that meet the individual challenges posed by complex instruments. Compressed air is needed to test pneumatic instruments and hoses for leaks, but it should not be used to “blow out” lumens because of the hazards involved in doing so.

Use care to avoid splash and aerosol exposures when using these cleaning methods. Full coverage of exposed body parts, eyes, and face with personal protective equipment (PPE) is mandatory for staff safety whenever these devices are used. Hearing protection must also be provided to protect staff from repetitive use and the effects of compressed air upon the auditory senses.

Decontamination areas should be well-stocked with cotton tipped applicators, soft wash cloths, plastic syringes, and soft gauze pads to safely and effectively clean the delicate eye pieces and distal tips of endoscopic instruments. Harsh chemicals, abrasive materials, and rough handling must be avoided. Follow the OEM’s written recommendations for processing rigid and flexible scopes and instrumentation. Failure to do so could result in visibility issues, fluid invasion of electrical components, and the possible voiding of the manufacturers’ warranties.

Objective 3: Explain the use of automated washers and ultrasonic cleaners and basic manual washing procedures for complex instruments.

Automatic washers have been available for many years to effectively clean instrumentation, instrument containers, basins, bowls, pitchers, and related items. Automated mechanical washers are contraindicated (should not be used) for washing electrical, battery, or pneumatic devices which must be washed manually by carefully following the OEM’s written instructions.

Washers remove bioburden by impingement: the spray-force action of pressurized water against the instruments. They can also disinfect instruments using thermal action (heat). Enzymatic detergent cleaning agents can be used with washers to improve cleaning effectiveness. Note: detergents used in automatic washers must be approved for use in automated devices and must be selected for effectiveness based upon the instrumentation to be cleaned.

Some complex instruments can be carefully pre-cleaned manually with follow-up automated processing. For example, cannulated reamers may be considered “simple” devices, yet they are also “complex” because of the many steps and processes needed to clean and disinfect them. These devices are used to cut bone and create a channel for placement of prosthesis or nail to stabilize a bone fracture. They slide over a guide rod and are connected to a rotary power source. After use, the reamer’s inner lumen will contain significant amounts of bone chips, blood, and tissue.

Personnel at the point-of-use can only place this device in water and enzymatic pre-soak solution because it is impossible to remove the soil from the instrument’s inner channels during surgery. When the reamer enters the decontamination area, it must be flushed with clear water and an enzymatic detergent, and then a heavy-duty properly-sized brush is needed to dislodge impacted bone and debris. Several successive flushing and brushing procedures followed by processing for ten minutes in an ultrasonic washer should effectively remove the residual soil.

Automatic washer manufacturers may offer a special rack to hold the reamers during a final cleaning phase in which components are exposed to a minimum of four cycles: high-pressure, detergent wash, rinse, and thermal. After processing the reamer through these successive steps, a thorough after-cleaning inspection is required before sterilization. Note: bioburden left in a reamer after sterilization will appear as dark flakes or residual bone chips that will be dislodged during the next use.

Flexible scopes are exceptionally difficult-to-process devices, and they require delicate and expert handling. Many manufacturers offer extensive training modules for Central Service personnel which are recommended educational resources for safe practice. Visual aids and training manuals should be available for use by processing staff.

The use of specially designed brushes, flushing pumps, and scope processors by dedicated and expertly trained staff will limit cleaning failures. Leak testing of flexible scopes is an important step required after every use to validate that the internal channels, seals, and insertion tubes are intact. Cracked and split channels and tubes allow contaminates to remain inside the scope after cleaning, and they may expose the next patient to a potentially fatal disease. Bending rubbers and optics should be inspected and cleaned with soft materials specified by the OEM. The use of the incorrect connections during automated processing is another potential source of processing failure, and the OEM’s detailed guidelines must always be followed to produce a safe result.

Objective 4: Note the need to plan and implement quality controls for cleaning complex instruments.

The most common method of verifying the cleaning process is careful visual inspection after cleaning is completed. This is the responsibility of all Central Service staff and must be performed before sterilization. Sites in complex instruments where soil can be located make this difficult, and OEMs must provide inspection and process verification instructions.

Failure to perform quality assurance checks and to monitor the cleaning process may lead to sterilization failures, and the decontamination team must be properly supervised, trained, and in-serviced about cleaning processes.

In Conclusion

Quality control can be summarized:

Q – Queue the instruments into the decontamination process as early as possible after patient use.
U – Use the OEM’S written guidelines when reprocessing instruments.
A – Ask the OEM to provide in-service resources for cleaning, assembly, and sterilization.
L – Learning must be a continual process.
I – Instruments should be inspected to measure cleaning effectiveness.
T – Time is required to effectively clean and disinfect instruments.
Y – You and all Central Service personnel are responsible for the quality control process.

Endnotes:

1 Basic cleaning and decontamination procedures are discussed in: Central Service Technical Manual. Seventh Edition. Chicago, IL. International Association of Healthcare Central Service Material Management. 2007 (see Chapter Nine). Also see Lesson # 93 in this series (March, 2007).

2 The Olympus America, Inc. Olympus University.™ Guidelines on endoscope reprocessing. 2008.

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