Surgical Instrument Processing Steps PDF

# Choice of Decontamination Process ## Surgical Instrument Processing Steps - Pre-Preparation (wiping & keeping moist) - Manual Cleaning - Ultrasonic Cleaning (if necessary) - Automated Washer - Instrument Care - Sterilization ## To Prevent Infection All reusable medical devices (RMDs) that come...

# Choice of Decontamination Process ## Surgical Instrument Processing Steps - Pre-Preparation (wiping & keeping moist) - Manual Cleaning - Ultrasonic Cleaning (if necessary) - Automated Washer - Instrument Care - Sterilization ## To Prevent Infection All reusable medical devices (RMDs) that come into contact with the patient or surgical field should be systematically decontaminated after each surgical procedure. ### Decontamination Processes - Must be validated - Must reprocess to a level appropriate for the intended use. - The appropriate level depends on the body sites where the device will be used and the risk associated with a particular procedure. ### Minimum Levels of Processing The minimum levels of processing are based on three risk categories of use, and are shown in the Spaulding classifications. | Patient Contact | Examples | Device Classification | Minimum Inactivation Level | |---|---|---|---| | Skin surface non-invasive | | Non-Critical | Cleaning and/or Low/Intermediate Level Disinfection | | Mucous membranes or non-intact skin | | Semi-Critical | High Level Disinfection | | Sterile areas of the body, including blood contact | | Critical | Sterilization | ### The Minimum Levels of Reprocessing For Different Types of Sites Are: #### Critical Site - Devices must be sterile at the time of use. - Devices are either single-use, steam sterilized for devices that are capable of withstanding heat or have undergone low temperature sterilization for thermo-labile devices that are not capable of withstanding heat. #### Semi-Critical Site - Devices are either single-use or sterilized after each use. - High-level disinfection is the minimum acceptable level of reprocessing. #### Non-Critical Site - Cleaning alone is generally sufficient for all noncritical items after every individual use. - Intermediate or low level disinfection may be appropriate in specific circumstances. ### Reprocessing Methods - Must provide minimum decontamination and safety standards. - Must keep up with the demands of clinical services. ## Sorting and Disassembly of Contaminated RMD As mentioned in module 4, to be effective, reusable medical device decontamination must be carried out in a timely manner. Sorting, disassembly, and cleaning facilitates timely cleaning in a way that minimizes risk to the decontamination specialist. ### Once the Containers Are Received and Unloaded - Reusable medical devices are sorted according to whether they need a manual or an automated cleaning process. - Policies and/or procedures should be developed for the handling, sorting and disassembly of all devices used within the facility, and for handling specialized items if required. - The manufacturer's instructions for cleaning are followed in order to ensure the device is not damaged and is cleaned adequately. ### Disassembly of RMD Complete the following activities to facilitate effective cleaning: - Open all reusable medical device box locks, hinges etc. - Place the medical devices in a mesh basket in a way that ensures effective cleaning of the device. - Do not place reusable medical devices on top of one another. Overloaded baskets will result in ineffective cleaning. - Arrange medical devices in an orderly fashion in mesh trays so that all surfaces are exposed to the cleaning action when using an automated cleaner. - Place each jointed medical device in the open position in the mesh basket. - If extra mesh baskets are required for cleaning a device set, a marker is placed in the extra baskets to identify the set name and number. - Place heavy retractors and other heavy medical devices on the bottom or in a separate tray. - Secure small and light items with a hold down screen or by other means to ensure they are not free to move around during the cleaning process. - Place scissors, light-weight medical devices, and microsurgical devices next. Receivers and gallipots (bowl-shaped items) must not be placed over any other reusable medical devices, as they may cause shadowing and interfere with the cleaning process. - Separate all sharp devices from general devices. This is to ensure ease of identification for personnel assembling the devices after cleaning, in order to prevent sharps injury. - For medical devices with one or more lumens (tubes), connect each lumen to the appropriate flushing system provided for that purpose. - Ensure the tips of devices align and meet at the tip, and are not hooked or snagged-items that are misaligned, damaged or worn need to be sent for repair. - Open ratcheted devices for cleaning to ensure the box joints and jaws are being cleaned thoroughly and all debris removed. - Dismantle any devices with valves, ports or multiple parts as far as possible for cleaning, following manufacturer's instructions. - Open, flush and brush taps that do not come apart, before mechanically cleaning. - Stylets are used to unblock devices during use. Remove them and flush and brush the devices prior to mechanical cleaning. Stylets need to be checked for correct fit and function. ## Automated Cleaning (Including Pre-Cleaning) As we have learned, cleaning is an essential prerequisite for all effective disinfection and sterilization processes, as organic residue may prevent the disinfectant or sterilants from contacting the surfaces of the item being processed and may also bind and inactivate chemical disinfectants. In other words - if the item can't be cleaned, it can't be disinfected or sterilized. ### Cleaning is the Initial and Most Crucial Step - Today it is globally accepted that cleaning is the initial and most crucial step in breaking the chain of disease transmission. - The use of mechanical cleaners such as washer-disinfectors and ultrasonic cleaners is preferred to the manual cleaning of items. ### The Advantage of Using Automated Cleaning Equipment Is that it provides an efficient, validated, reproducible process which is more easily controlled than manual methods. #### Examples - A simple example is the temperature of the water at <40C for pre-cleaning. - Controlling tap water temperature is less accurate than controlling the washer-disinfector temperature-even if you have a thermometer. - Recent research advises changing the sink water for every tray - so in the busy CSSD's of today - that would be an exhaustive process. - Another consideration is the human factor. Some people work better or worse, depending on the day. The machine, if maintained and tested regularly, always reproduces the same result. ### Automated Processes Are Generally More Convenient - Provide protection for the user in reducing exposure to contaminated devices and chemicals. - Ideally, manual cleaning should be used only where no pre-treatment has been carried out by the user, and gross soiling remains on the device. - All soiling must be removed before automated cleaning takes place. ## Washer-Disinfectors All washer-disinfectors used for decontamination of reusable medical devices conform to the Medicines & Healthcare Products regulatory Authority (MHRA) requirements. - Are compliant with EU legislation and have CE Marking. - Are approved by the US Food and Drug Administration (FDA) or an equivalent competent authority. - The water for the final rinse stage is purified water (prepared by reverse osmosis or deionization) giving the lowest levels of process residuals. ### Questions to Consider When determining if the device is compatible with the washer-disinfector include: - What does the manufacturer's IFU indicate? - Is it water submersible. - What is the maximum operating temperature? - Will mechanical damage occur from the impact of the water jets or other items in the load? - Is the device compatible with the process chemicals? ## When Ready to Load the Reusable Medical Devices - Ensure the washer-disinfector and all services are operational. - The washer-disinfector should not start if any anomalies are present including blocked or occluded spray arms (Figure M5-11). - Wearing PPE, load the rack or machine ensuring that the arrangement of devices does not get in the way of the cleaning process, and the rotary spray arms can rotate. - Use the load carrier and racks for items they were designed to hold (Figure M5-9 and Figure M5-10). - Keep a record of each device and device set processed in each washer-disinfector, and each cycle in order to trace them through the decontamination process. - Load the load carrier into the washer-disinfector (Figure M5-11). - Secure the door (if fitted), and select and start the appropriate cycle. - When the cycle is done, make sure that all stages and parameters have been achieved. - When the automated cleaning process is complete, inspect the processed devices. ## Ultrasonic Cleaners The ultrasonic cleaner is used to remove fine soil from surgical devices after they have been manually cleaned and before they are sterilized. The equipment works by converting high-frequency sound waves into mechanical vibrations that free soil from the surface of devices. - The high-frequency energy causes microscopic bubbles to form on the surface of the devices and as the bubbles implode, minute vacuum areas are created, drawing out the tiniest particles of debris from the crevices of the devices. - This process is called cavitation. - Plastics and other similar materials cannot be successfully processed by this method. - Cemented glass syringes and lenses will be damaged if repeatedly subjected to this process. ### Consult The Manufacturer's IFU - To see if ultrasonic cleaning is suitable for the device. ## General Guidelines - Follow the manufacturer's IFUs and standard operating procedures (SOP). - Older machines - de-gas time is between 5 and 15 minutes (de-gas is the removal of air from the water to allow the ultrasonic waves to pass more freely). - Cycle time depends on the machine, cycle program and how much soil is on the medical device. - Water temperature is usually <35C. - Thermal disinfection option - temperatures between 80C - 93C with holding time >20 seconds to 10 minutes. - Document, scan and record all cycles and processes - preferably using automated track and trace systems. ## Manual Cleaning The use of automated cleaning methods may be contra-indicated for washing certain delicate or complex devices, for example when: - Medical devices cannot be immersed in water e.g., certain power tools (Figure M5-13). - Medical devices have an operating temperature lower than is achieved in automated washing. - Mechanical damage may result from the impact of the water jets or other items in the load. ### Carefully Wash and Rinse These Devices - According to the manufacturer's instructions. - Non-immersion manual cleaning methods are appropriate for certain devices like electrical tools that may be compromised by soaking in wet solutions. ## Immersion Method Essential Requirements - Sink (not a hand hygiene sink), or a receptacle which will hold enough water and detergent to fully immerse the item to be cleaned. - Detergent and a validated method of dispensing a measured quantity, following manufacturers' instructions for dilution and temperature of warm detergent solution. - Temperature control in the wash and rinse sinks (usually <40C), thermostatic mixer taps are preferred. - Brushes a selection of non-damaging brushes in a range of diameters and lengths for cleaning both the external surfaces and the internal surfaces of devices (Figure M5-14). Single use is desirable. If not using single use, there must be a protocol in place to decontaminate the brushes at least daily. The manufacturer should provide information regarding the appropriate brush size. Always use brushes under water to avoid splashing and aerosols. - After cleaning, dry the manually washed devices that are not to be further processed through the washer-disinfector. Place devices in a drying cabinet (Figure M5-17). Where a drying cabinet is not available use a clean, disposable lint-free, absorbent wipe to dry the devices. ### To Ensure Effective Manual Cleaning - Follow written procedures (including wearing PPE at all times while handling contaminated devices). - Fill the sink with water to a predetermined level, at the specified temperature and with the appropriate amount of detergent (as per manufacturers' instructions). - Use the sink solely for the cleaning of devices and not for any other purpose. - It is recommended to use three sinks-washing, potable or tap water rinse, and purified water rinse (Figure M5-15). ### Use Detergents Specifically Designed to Clean RMD - Household soap must never be used. - A mild detergent is preferred for manual cleaning (pH range 8.0-6.0). - Follow the manufacturer's instructions and local policies and procedures for detergent dilution and water temperature. - Consider the use of an enzymatic detergent to facilitate the cleaning of devices with channels or complex parts. #### Immerse the Item - Carefully, in the solution in order to displace trapped air - it is important to ensure that the cleaning solution reaches all surfaces including those of lumened (tubed) devices. - Remove all visible soiling, including lumens and valves. - Remove stubborn staining by using inside non-abrasive scouring pad or soaking in an approved stain-removing solution. - Flush all lumened devices with a jet-gun (discharge under water to avoid splashing and aerosols) (Figure M5-16). - Rinse the item finally in warm-to-hot water (unless contra-indicated). #### Dry Mechanically in a Drying Cabinet - Or hand dry with a clean, lint-free cloth. - Note: items should not be left to dry in ambient air (Figure M5-17). - Inspect devices and equipment to establish that they are clean before further processing or storage. ### Ideally, Use Single-Use Brushes - Or identify cleaning brushes as for cleaning only, and wash, thermally disinfect, and store them dry. ### Keep a Record of Each Device - Which has manually cleaned. The records should contain, at a minimum: - Name of device or device set - Name of processor - Date - Type of cleaning - Type of detergent and detergent dilution used ## Disinfection There are two types of disinfection - thermal and chemical. ### Thermal Disinfection - Can be achieved in a thermal washer-disinfector by choosing the appropriate cycle. - It is the simplest, most efficient and cost-effective disinfection method. - Thermal disinfection equipment should allow you to monitor or record the length of time it was at a specific temperature, to make sure the microbes were killed. ### Chemical Disinfection - The effectiveness of chemical disinfection depends on a number of factors, including the initial number of microbes present, temperature, pH, and concentration. - It can be achieved with a compatible RMD-grade disinfectant of the required level, used alone or with a chemical washer-disinfector. - Rarely used in a CSSD setting, it can be seen regularly in areas that reprocess ultrasound probes and is the main disinfectant of choice in endoscopy units. #### Validation - The processes are validated microbiologically, defining the concentration, contact time and minimum/maximum temperatures for adequate disinfection. ### Disinfection Eliminates Many or All Pathogenic - Micro-Organisms on Inanimate Objects - With the exception of bacterial spores. - It makes infectious agents inactive, using either thermal (moist or dry heat) or chemicals. - The level of disinfection achieved depends on the temperature, exposure time and/or type of chemical disinfectant used. - High-level disinfection (example used for thermo-labile endoscopes which you will learn about later) is the minimum treatment recommended for reprocessing medical devices that cannot be sterilized. - These medical devices are used in semi-critical sites or when there are specific concerns regarding contamination of surfaces. - Low-level disinfection is the minimum treatment recommended for reprocessing non-invasive medical devices for use in non-critical sites. ## Drying Drying minimizes rusting, and staining and reduces the risk of recontamination during inspection and assembly of RMD. Residual moisture interferes with the sterilization process. Place RMDs in a drying cabinet (Figure M5-18) and apply the following key considerations: - Use a clean disposable lint-free, absorbent wipe when a drying cabinet is not available. - Take care not to exceed the temperature tolerances advised by the manufacturer. - Dry the RMD in a sloping position to facilitate drainage. - Do not use alcohol or other flammable liquids as drying agents, other than in automated equipment designed for this purpose, for example, some endoscope washer-disinfectors. ## Process Chemicals We now know that thorough cleaning of used surgical devices prior to sterilization is critical. The main agent that affects cleaning is the process chemical used in the wash area of the CSSD. ### Chemicals Such as Detergents and Disinfectants - May have hazardous properties associated with them (may be irritant, corrosive, flammable), for example bleach and ammonia if mixed will release lethal chlorine gas. *Process chemicals are potentially hazardous as they may cause irritation to the skin, eyes, respiratory tract and mucous membranes.* - Things to think about when dealing with process chemicals are: - Choice of process chemicals - The controls required - Safety data sheets and labeling ### Choice of Process Chemicals - Choose process chemicals that are compatible with: - The medical device - The decontamination equipment to be used and the intended use of the device ### Choose The Least Hazardous Chemical - That will fulfil the process requirement. #### According to the Association for the Advancement of Medical Instrumentation (AAMI) - The characteristics of process chemicals are at minimum: - Non-abrasive - Low foaming - Free rinsing - Biodegradable - Non-toxic - Able to dissolve/disperse soil easily - Economical #### Dosage of Process Chemicals or Detergent - Should be determined by Manufacturer IFU and validated during commissioning. ## Control of Process Chemicals - Use defined, written procedures and methods for handling and storage of process chemicals. - Clearly identify chemicals that should not be stored together. - Store chemicals below shoulder height. - Make sure Safety Data Sheets (SDS) and labels are available to all staff in designated areas at all times, so that appropriate action can be taken in case of exposure to a hazardous substance. - Read and follow the precautions and instructions given on the SDS and on the label prior to handling and use. - Train all personnel who handle chemicals e.g., detergents, rinse aids, disinfectants, etc.. ## Water Quality The quality of water used at all stages in the cleaning process is critical to the successful outcome of the process, as the water is the last thing to make contact with the RMD prior to the user procedure. #### Unfavorable water compositions - Can have an adverse effect on the reprocessing process and on the devices themselves. - At each stage in the cleaning process the water quality should be compatible with the: - Washer-disinfector (WD) construction materials - Medical devices to be processed - Process chemical to be used - Process requirements of that particular stage. ### Other Factors to Take Into Consideration are: - pH and hardness-dissolved salts (lime scale) - Temperature - Iionic contaminants - heavy metals, phosphates and silicates leading to corrosion - Microbial population - Bacterial endotoxins ## Routine Testing of Decontamination Equipment ### Washer-Disinfector - After validation and when the washer-disinfector has been passed for use, it is subject to a schedule of periodic tests at daily, weekly, quarterly and yearly intervals. - The daily, weekly and quarterly tests supply evidence that the washer-disinfector is still operating within the limits established during commissioning. #### Periodic Tests Consist of the Following: - **Daily** - Spray arm rotation - Spray nozzles - Removes and clean strainers and filters - **Weekly** - Automatic control test - Safety checks - Water hardness - Water conductivity - Cleaning efficacy test (residual soil detection-see below). - **Quarterly** - Automatic control test - Calibration verification of RMD - Thermometric test for thermal disinfection - Cleaning efficacy test by assessment of soil removal - **Annually** - Automatic control test - Calibration verification of RMD - Water system - Drainage - Doors - Door interlocks - Fault interlocks - Water vapor discharge - Aerosol discharge - Chemical additive dosing - Load carriers - Air quality - Cleaning efficacy - Over-temperature cut-out - Thermometric tests for thermal disinfection - Load dryness test - Process residues **Other Washer-Disinfectors** #### Tunnel Washers - Tunnel-washers are the CSSD version of a mini car-wash! - The main advantage of these units is that most of them allow totally hands-free re-processing of the used medical devices. - Surgical instruments that have been disassembled and prepped for cleaning in the OR are placed in perforated or mesh-bottom trays and come directly from the OR or other department and placed into the tunnel washer without any further handling or arranging. - Inside, the surgical instruments are subjected to cycles of pre-rinse, washing, ultrasonic, rinse, and drying (Figure M5-20). ## Cart Washers - Clean carts and other transportation vehicles and containers - routinely to remove dust and spillage. - Most cart-washers have wash, rinse, steam and drying cycles. - Place carts in the washer in a tilted position to enable water to drain out and prevent restriction of any moving parts within the washer. - Items removed from this type of washer are very hot and must be allowed to cool before they are handled. - Thoroughly dry carts before they have contact with clean or sterile supplies. ## Ultrasonic Cleaners - After validation and when the ultrasonic cleaner has been passed for use, it is subject to a schedule of periodic checks and tests at daily, weekly, quarterly and yearly intervals depending on what standards you are following, for example EN ISO 15883 (International Organization for Standardization) or HTM 2030 (Health Technical Memorandum). - The tests supply evidence that the ultrasonic cleaner is still operating within the limits established during commissioning. - Annual tests (revalidation procedures) prove that the data collected during commissioning and performance qualification are still valid. - Revalidation may also be required under certain circumstances. #### Checks and Tests at a Minimum Include: - **Daily** - Remove and clean strainers and filters - Visual inspection of device post-cycle - **Weekly** - Automatic control test (if using an automated ultrasonic cleaner) - Safety checks - Cleaning efficacy test (residual soil detection) - **Quarterly** - Automatic control test - Verification of calibration of RMD - Ultrasonic activity test - Cleaning efficacy test - **Annually** - Weekly safety checks - Automatic control test - Verification of calibration of RMD - Water system - Drainage, doors and door interlocks - Fault interlock - Aerosol discharge - Chemical additive dosing - Load carriers - Air quality - Cleaning efficacy - Over-temperature cut-out - Thermometric tests for thermal disinfection - Load dryness test - Process residues ## Cleaning Efficacy Tests Soil removal and detection tests ensure that the cycle is able to adequately clean a heavily soiled load. The cycle must remove the soil from a strip coated with an artificial soil to pass the test. - It is important to use the correct test soil or process challenge device (PCD) for your machine as recommended by the manufacturer. Using the wrong cleaning efficacy test or PCD may provide misleading results. - Some examples of these commercially available tests are: - TOSI-protein detection test - Hemo-check - protein detection test - Browne's soil test - visual test - Ninhydrin test - protein detection test - Foil test - ultrasonic cleaner ## Disposal An important consideration during the device life cycle is the disposal of RMD. - Disposal means either returning the RMD to a third party or scrapping it. - Do not underestimate the importance of documentation at this disposal stage. - Consult the manufacturer's IFU to see if details are included on any unusual risks related to the disposal of the RMD. - Decontaminate all RMD before disposal and include a certificate stating the decontamination method. - Transport and destroy devices that are being scrapped by known, reliable contractors who certify their destruction. ## Acquisition Before ordering any medical or surgical device, obtain the written instructions for reprocessing. - This information includes detailed information on disassembly, cleaning (including equipment and detergents to be used), testing, packaging and methodologies. - RMD must be accompanied by the manufacturer's IFU. - Consult these IFU for specific guidance on cleaning, handling, inspection and decontamination and to determine whether the RMD will tolerate immersion. - Always verify that your facility has the recommended equipment to clean and sterilize the reusable medical devices and the recommended chemicals for cleaning and disinfection. - If not, either do not purchase the device, or get approval to purchase the needed equipment to process the device. ## All RMD and Accessories Must Comply with Applicable EU Legislative Standards - Must be CE marked by the manufacturer. - The manufacturer's instructions provide direction for care, cleaning and handling of RMD and powered equipment. - If the instructions for cleaning and sterilization are correctly followed, the device should be reusable, without causing injury to the patient or staff that are using the RMD (ISO, 17664).