Module 8 Decontamination Point of Use Preparation and Transport PDF

Module 8 DECONTAMINATION POINT OF USE PRAPARATION AND TRANSPORT Introduction THIS ZONE PROVIDES AN OVERVIEW OF THE DECONTAMINATION ZONE AND THE EQUIPMENT AND PROCESSES NEEDED TO ACCOMPLISH THOROUGH CLEANING Choice of Decontamination Process To prevent infection, all RMDs that come into contact wit...

Module 8 DECONTAMINATION POINT OF USE PRAPARATION AND TRANSPORT Introduction THIS ZONE PROVIDES AN OVERVIEW OF THE DECONTAMINATION ZONE AND THE EQUIPMENT AND PROCESSES NEEDED TO ACCOMPLISH THOROUGH CLEANING Choice of Decontamination Process To prevent infection, all RMDs that come into contact with the patient or surgical field should be systematically decontaminated after each surgical procedure, giving attention to all potential sources of contamination. All decontamination processes must be validated and the reusable medical devices reprocessed to a level appropriate for their intended use. The appropriate level depends on the body sites where the device will be used and the risk associated with a particular procedure. The minimum levels of processing, based on three risk categories of use, are shown in a classification system called the Spaulding classifications (Figure M5–2). For example, non-critical would be a stethoscope, semi-critical would be a Parkes retractor and critical would be a Travers retractor. 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 Sterilisation Figure M5–1 Surgical device processing steps Figure M5–2 Surgical Instrument Processing Steps Must follow established department protocol In/Near 1. Pre-Preparation (wiping & keeping moist) OR SPD Dirty side SPD Clean side 2. Manual Cleaning 3. Ultrasonic Cleaning (if necessary) 5. Instrument Care 6. Sterilization 4. Automated Washer Decontamination Book.indb 112 27/02/2018 16:33 Medical Device Reprocessing (Decontamination Specialist) 113 The minimum levels of reprocessing for different types of sites are: Critical site – devices must be sterile at the time of use. This means 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. If this is not possible, high level disinfection is the minimum acceptable level of reprocessing. Non-critical site – cleaning alone is generally sufficient 215 for all noncritical items after every individual use, although either intermediate or low- level disinfection may be appropriate in specific circumstances. Later in the module, when we learn about procurement or acquisition of new devices, we will discuss choosing decontamination processes based on compatibility with the reusable medical device. Reprocessing methods must provide minimum decontamination and safety standards, while keeping 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 and in a way that minimizes risk to you, the decontamination specialist. Once the containers are received and unloaded from the transport carts you learned about in module 4, the reusable medical devices are sorted— usually 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, hi nges 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 (Figure M5–3c). 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 (Figure M5–4). Receivers and gallipots (bowlshaped items) must not be placed Figure M5—3a Overloaded baskets result in ineffective cleaning Figure M5—3b Poor Arrangement Figure M5—3c Better Arrangement Decontamination Book.indb 114 27/02/2018 16:33 Medical Device Reprocessing (Decontamination Specialist) 115 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 (Figure M5–5). 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 (Figure M5–6). 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 (Figure M5–7). Stylets need to be checked for correct fit and function. Figure M5–4 Hold-down screen for small or light items Figure M5–6 Flush tubes for Lumens Figure M5–5 RMD with Lumens attached to flushing system Figure M5–7 Cleaning 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 218 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 nondamaging 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 Figure M5–13 Figure M5–14 Decontamination Book.indb 121 27/02/2018 16:33 122 Cleaning and disinfection 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 (module 2) 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 8.0–11.5). 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). Figure M5–15 Three cleaning sinks washing, potable or tap water rinse, and purified water rinse Decontamination Book.indb 122 27/02/2018 16:33 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. 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 washerdisinfector. 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. In order to know if chemical disinfection processes were adequate, 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 semicritical 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. Decontamination Book.indb 124 27/02/2018 16:33 Medical Device Reprocessing (Decontamination Specialist) 125 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. Figure M5–18 Decontamination Book.indb 125 27/02/2018 16:33 126 Cleaning and disinfection According to the Association for the Advancement of Medical Instrumentation (AAMI) the characteristics of process chemicals are at minimum: Non-abrasive 222 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. Figure M5–19 Cleaning and disinfection Type of DETERGENT Quality of WATER Type of INSTRUMENT Type of WASHER Decontamination Book.indb 126 27/02/2018 16:33 Medical Device Reprocessing (Decontamination Specialist) 127 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 Ionic 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: a. Daily Spray arm rotation Spray nozzles Removes and clean strainers and filters b. Weekly Automatic control test Safety checks Water hardness Water conductivity Cleaning efficacy test (residual soil detection—see below). c. Quarterly Automatic control test Calibration verification of RMD Thermometric test for thermal disinfection Cleaning efficacy test by assessment of soil removal d. 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 reprocessing 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). Figure M5–20 Further Reading Detailed descriptions of each step are available in HTM 01-01 Part D from the NHS website http://www.wales.nhs.uk/sites3/docopen. cfm?orgid=254&id=223475 Decontamination Book.indb 128 27/02/2018 16:33 Medical Device Reprocessing (Decontamination Specialist) 129 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: a. Daily Remove and clean strainers and filters Visual inspection of device post-cycle, i.e., look for visible soils or lack of cleaning when you remove items from the washer. If items are soiled then the load is rejected. b. Weekly Automatic control test (if using an automated ultrasonic cleaner)  Safety checks Cleaning efficacy test (residual soil detection) c. Quarterly Automatic control test Verification of calibration of RMD Ultrasonic activity test Cleaning efficacy test d. 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 Figure M5–21 Cart washer Cart Washers Clean carts and other transportation vehicles and containers routinely to remove dust and spillage. Most cartwashers 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. Cleaning and disinfection Load carriers Air quality Cleaning efficacy Chamber wall and load carrier temperature test Over-temperature cut-out test Thermometric test for thermal disinfection Load dryness test Test for ultrasonic activity Sound pressure test 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 in order 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 Brownes 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 Exercises and Checklists Exercise 1 Demonstrate and discuss examples of simple hinged devices, cannulated medical devices, multipart devices, and difficult to clean RMD. Write your findings in your log book. Exercise 2 In your CSSD what factors do you think affect the efficacy of disinfection? Write your findings in your log book. Exercise 3 Discuss the daily/weekly validation methods in your C.S.S.D. Which do you think is the most effective? Write your findings in your log book. Exercise 4 Go to your log book and complete the Decontamination Wash Room Competency Checklist Exercise 5 Go to your log book and complete the relevant unit Equipment Competency Checklists for a washer disinfector, ultrasonic washer and cart washer Endoscope module 9 plus rigid scope