CRCST
Technical Continuing Education (TCE)
SELF-STUDY PLANS

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 93
Cleaning and Decontamination of Medical Devices
[Reprinted from Communiqué: March/April 2007]

Objective 1: Explain the importance of effective cleaning and decontamination.

The cleaning of instruments and medical devices after they have been used on patients is a core function of every Central Service department. Proper cleaning is a critical step in decontamination, and it must be done effectively and in a timely manner to ensure patient safety and customer satisfaction.

Surgical instrumentation that has not been properly cleaned after use can lead to post-operative complications, including infection. The old saying, "If it's not clean, it cannot be sterile," is true. Bioburden (the presence of microorganisms) on surgical instrumentation creates a physical barrier that hinders steam contact with organisms and allows them to survive the sterilization process.

In addition to concerns about patient safety, improper cleaning erodes customer confidence in the Central Service department, and will lead to down-time when instruments must be re-cleaned. No operating room can afford lost time due to inadequate cleaning of medical devices, which can lead to delays in patient care.

Reprocessing instructions, including those for cleaning, should be provided by the device manufacturer, should be readily available to staff, and should be followed accurately and consistently. Decontamination of all reusable medical devices is of primary importance in the reprocessing process. The safety of the staff and their ability to freely handle used medical devices depends upon the critical step of reducing potentially-deadly microorganisms to non-pathogenic levels.

Objective 2: Discuss and define the terms, "cleaning," "disinfection," and "decontamination."

Cleaning involves the removal-usually with a detergent and water-of both visible and non-visible soil (such as blood, protein substances, and other debris) from the surfaces, crevices, serrations, joints, and lumens of instruments, devices, and equipment. Gross soil should be removed as soon as possible to:

• reduce the number of microorganisms on the item
• minimize the nutrient material that can support microbial growth
• lessen the potential for environmental contamination by aerosolization or
  spillage, and
• minimize damage to devices from blood and other substances.

Manual or mechanical processes can be used to prepare items for safe handling or further decontamination.

Cleaning is the first and most important step in the sterilization process. One can clean without sterilizing, but cannot sterilize without cleaning, and one can clean without disinfecting, but cannot disinfect without cleaning. The sterilization process cannot produce a sterile device unless it has first been cleaned and then disinfected. Dead organisms in soil or organic debris left on medical devices can cause pyrogenic (fever-producing) or foreign body reactions, and create a breeding place for an infection, if the device is used for an invasive procedure. Also, residual debris can affect an instrument's ability to function properly. For example, hemostats, ronguers, and other instruments may not close properly if debris is present on them.

Disinfection, the next step in the process, kills or reduces the number of pathogenic microorganisms on the surface of inanimate surfaces. Disinfectants are formulated based on their intended use and the level of disinfection required. High-level disinfection is the minimum treatment recommended by the CDC (Centers for Disease Control) if it is not possible to sterilize the medical device.

Decontamination involves the use of physical or chemical procedures to remove, inactivate, or destroy blood-borne pathogens on a surface or item. This is necessary so microorganisms can no longer cause infection, and to assure that the surface or item is considered safe for handling, use, or disposal.

The purpose of decontamination is to make devices safe for people who are not wearing gloves. Some instruments are safe for handling after they have been thoroughly cleaned; others, however, require exposure to a microbicidal (microbe killing) process. The level of decontamination required depends upon the purpose for which the item was last used, and the purpose for which it will next be used. For example, infusion pumps and heating pads are not exposed to broken skin, and so should be safe to handle after cleaning. By contrast, surgical instruments are exposed to blood and body tissue. They pose a greater risk of exposure for personnel in the preparation and packaging areas who may be assembling sets without wearing gloves.

Objective 3: Outline steps in the cleaning and decontamination cycle.

The first step in the cleaning and decontamination cycle for the surgical instruments and medical devices is at the customer's point of use. Instruments that have been soiled by patient blood and protein should be put into the cleaning process as soon as possible. Ideally, they should be transported to the decontamination area within 15 to 60 minutes after use. Soil and protein left to dry on surgical instruments are more difficult to remove and can damage stainless steel.

Your customers, then, are part of the reprocessing team. As with all Central Service staff, they should be instructed to add moisture to the soiled instruments by pre-soaking them in a bath of water and enzymatic detergent. If an adequate amount of water is not available, or if it is difficult to completely submerge the instruments, a moistened operating room towel draped over the instruments will suffice. Do not use saline because it can pit and cause rust, even on surgical grade steel. Several companies now offer spray-on instrument moistening agents that provide alternatives to using large amounts of water.

The second step in cleaning and decontamination is the complete disassembly and opening the hinge joints of the surgical instruments being reprocessed. While these tasks should, ideally, be done at the point of use, they may be forgotten or remain undone in the haste to prepare the operating room for the next surgical procedure. If this step has not been completed, Central Service technicians must do so in the decontamination area. Otherwise, the serrations and lumens of instruments that remain closed, or are left assembled, may not be cleaned adequately. Instruments that must be disassembled, such as tissue retraction systems, should be removed from their stringers and opened for processing in automatic washers. Lumens must be flushed with water and enzymatic detergent.

The third step in the cleaning and decontamination process is pre-inspection. This is performed during the second step, prior to placing instruments in the automated washer. Instruments should be inspected for sharps, such as surgical needles and blades, which must be removed due to the significant exposure risk they pose.

Ideally, sharps should be removed at point of use. Should customers fail to perform this step, Central Service staff should remind them to do so, which will help improve the process. Instruments that are damaged or missing must be identified and dealt with. The use of "repair/re-sharpen" tags can help to identify damaged instruments.

Objective 4: Describe basic manual cleaning methods.

The purpose of manual cleaning is to use friction to physically remove deposits that were only softened, and not removed during pre-soaking. Manual cleaning may be done:

• prior to mechanical cleaning
• when the decontamination area does not have an ultrasonic cleaner or washer sterilizer-washer decontaminator
• for delicate or complex instruments that cannot be processed in mechanical equipment
• to clean equipment that cannot be immersed in water, or
• for instruments with lumens

For ease of cleaning, the water temperature should be below 109ºF (43ºC). Cooler water may not activate the detergent, and water that is hotter than 140ºF (60ºC) may coagulate (denature) the protein.

Water hardness, temperature, and the type of soil to be removed can all affect the effectiveness of detergents. Excessive amounts of detergent can be difficult to rinse off and will eventually begin to deteriorate the instrument, so it is important to use the correct amount, as specified by the detergent manufacturer. Note: If detergents are used, they will bind the soil that is to be removed. Using detergent will not eliminate the need for manual cleaning.

When cleaning aluminum or stainless steel, a back-and-forth motion in the direction of the grain should be used, rather than a circular motion, to avoid scratching the surface of the item. All instruments should be in a wide-open position during cleaning to properly clean the box lock or hinged areas. Using steel bristle brushes is an effective way to remove bioburden from instrument jaw serrations
and box hinges. Submerge instruments in the water during brushing to prevent
aerosol contamination.

Always use the correct-sized brush. When cleaning a lumen, for example, a brush that is too large will not fit into the lumen. If the brush is too small, it will not have complete contact with the lumen walls, and will not thoroughly clean it.

Reusable brushes used to decontaminate instruments and devices must themselves be cleaned and disinfected/sterilized at the end of the shift, or whenever they are heavily soiled. Those showing wear should be discarded. Prompt cleaning of brushes and cleaning tools reduces or eliminates biofilm-forming microorganisms. When using reusable cleaning brushes, remember that there is a risk of cross-contamination from one medical device to another. A cleaning process that uses reusable components-such as brushes-must include cleaning of these components.

Objective 5: Review the use of automated washers.

Automated washers have been used in Central Service for many years, and they are effective for cleaning instrumentation, instrument containers, basins, bowls, and pitchers. They should not, however, be used to wash electrical, battery-operated, or pneumatic devices. These devices must be cleaned manually by following the written instructions of the equipment manufacturer.

Washers work on the principle of impingement, the spray-force action of pressurized water against the instruments being processed, which physically removes bioburden. Washers effectively disinfect instruments through thermal action, and clean effectively because of the enzymatic detergents used in them. Detergents used in automated washers must be approved for this use, and must be selected for effectiveness based upon the instrumentation to be cleaned.
Washer racks should never be over-loaded, and they should be inspected daily. Spray arms should move freely during operation. Instruments that are sticking up and out of their perforated baskets should rest below the path of the spray arm. Trays or sets with multiple levels should be opened and spread out over the various rack levels. Delicate instruments may be dislodged from the racks due to the force of the spray, and so should be confined in small perforated baskets, with lids or hold-downs.

Routine cleaning of washers should include inspection and cleaning of spray arms and washer jets. Mineral build-up will impede spray action and disrupt cleaning effectiveness. Washer traps should be inspected daily for debris and cleared of accumulated debris.

Objective 6: Explain the importance of quality controls for the cleaning process.

The most common method of verifying the cleaning process is a meticulous visual inspection after cleaning is completed. This visual verification process must be performed prior to sterilization and it is the responsibility of all Central Service staff. In complex devices, it may be difficult to see where soil is located. Therefore, device manufacturers have a responsibility to provide instructions for inspecting and verifying the process.

Failing to perform quality assurance checks and monitor the cleaning process may eventually lead to sterilization failures. Establishing and using standardized cleaning practices is an effective method to minimize cleaning errors. By communicating these practices to the decontamination team through training and educational in-services-using visual aids, checklists, and flow graphs-your Central Service department can effectively minimize cleaning errors.

Endnotes

This lesson is adapted from:

Narance, D. Cleaning and Decontamination. Chapter 9 in: Central Service Technical Manual. Seventh Edition. Chicago. IL. International Association of Healthcare Central Service Materiel Management. In process.