Decontamination and Reprocessing of Medical Devices PDF

Decontamination and reprocessing Aide-memoire of medical devices for health-care facilities Background This resource is intended to provide information on...

Decontamination and reprocessing Aide-memoire of medical devices for health-care facilities Background This resource is intended to provide information on cleaning, disinfection and sterilization of reusable Decontamination of medical devices plays an important patient-care and medical equipment. It does not describe role in the prevention of health care-associated infections. endoscope reprocessing and is not applicable to cleaning It includes cleaning, disinfection and/or sterilization. and disinfection of the environment. The processes involved in decontamination are complex, require specific infrastructure and equipment, and involve several sequential steps that need to be performed correctly – from device collection and receipt by the decontamination unit to processing, storage and distribution throughout the facility. Quality control procedures (such as validation) at each step of the Single-use devices decontamination process are of the utmost importance Single-use devices should only be used as recommended to ensure the correct functioning of the equipment and by the manufacturer and should not be reused. Such items processes. have not undergone extensive testing, validation and documentation to ensure that they are safe to reprocess Important Information and reuse. Decontamination is the process of removing soil and Reuse of a single-use device may compromise its intended pathogenic micro-organisms from objects – such as function and performance. It may not withstand – or come medical devices – so that they are safe to handle, whether with instructions for – decontamination. that involves further processing (sterilization), use or disposal. Spaulding’s classification Spaulding’s classification is a system of classifying the potential risk of reusable medical equipment/devices. It recommends an appropriate method of decontamination before using the device on another patient (Table 1). Table 1. Spaulding’s classification Classification Definition Decontamination Examples method High risk (critical) Medical devices that are Sterilization Surgical instruments, delivery involved with a break in the sets, dental instruments skin or mucous membrane or enter a sterile body cavity. Intermediate risk Medical devices in contact High-level disinfection Respiratory and anaesthetic (semi-critical) with mucous membranes equipment, reusable vaginal or non-intact skin. specula, endoscopes Low risk (non-critical) Items in contact with intact Low-level disinfection Blood pressure cuffs, skin (i.e., cleaning with detergent stethoscopes, and and disinfectant). electrocardiogram lead. WHO/UHL/IHS/IPC/2022.4 © World Health Organization 2022. Some rights reserved. This work is available under the CC BY-NC-SA 3.0 IGO licence. Decontamination and reprocessing environment Staff education Water quality for decontamination and reprocessing Training should be provided to staff and should be should be soft, with low mineral and salt content. documented. It should cover: The decontamination area, where used medical devices r isk assessment, use of PPE and how to handle chemicals are received for reprocessing, should be physically safely; separated from all other work areas, with a one-way a ll aspects of the decontamination cycle; work flow from the dirty area to the clean area. It should h ow to decontaminate any new equipment purchased also be in a low-traffic area of the facility. (such as robotics or laser systems); Staff working in the decontamination area should: u se and understanding of the cycles for specific equipment (such as washer/disinfector and sterilizers); wear appropriate personal protective equipment (PPE) t he anatomy/construction of medical devices and routine when handling medical devices; maintenance; e nsure that “dirty” and “clean” activities are kept interpretation of validation tests (to ensure recognition physically separate; of failed indicator results) and record-keeping; c lean and disinfect work surfaces at least daily, o ccupational health and safety; moving from clean to dirty areas while doing so; p rovision of hepatitis B immunization (if not already u se separate cleaning equipment for clean and immunized) following exposure to blood-borne dirty areas; pathogens; c lean spills immediately, in accordance with local s harps injury prevention; guidance; P PE appropriate to the various tasks performed; k eep the environment clean, dry and dust-free. a uditing of practice for competency testing and consistency with best practice. Quality assurance Several checks need to be in place to ensure the functioning and sterility of equipment and medical instruments/devices. Policies and standard operating procedures should be in place for: a ll steps of the decontamination process; d econtamination of each device; m  anagement of damaged medical devices; p urchasing of new equipment (such as sterilizers), medical devices/equipment and products (such as disinfectants). 2  Summary of decontamination lifecycle The life cycle of decontamination illustrates the features of the decontamination process. These steps are further described as key elements below. ACQUISITION 1. Purchase 2. Loan CLEANING INSPECTION TRANSPORT HIGH-LEVEL DISINFECTION (HLD) *this step not required if performing sterilization AT ALL STAGES Location Facilities Equipment PACKAGING USE Management *this step not required if performing HLD Policies/Procedures DISPOSAL 1. Scrap 2. Return to lender STORAGE STERILIZATION *this step not required if performing HLD TRANSPORT Source: adapted from Department of Health, United Kingdom (2). For additional information, consult Decontamination and reprocessing of medical devices for health care facilities (3), Global guidelines for the prevention of surgical site infection (4) and the online OpenWHO course Decontamination and sterilization of medical devices (1). KEY ELEMENTS AT A GLANCE Receipt and transportation (dirty area) R emove gross soil and sharps at point of use to prepare instruments and equipment for transport to the decontamination and reprocessing area. T ransport contaminated equipment in clearly labelled, fully enclosed, leak and puncture-proof containers. K eep soiled instruments moist (for example, with enzymatic spray or a water- moistened towel). T o prevent damage to devices, do not soak them in saline or hypochlorite solution. 3  Cleaning (dirty area) If a device has not been cleaned, it cannot be disinfected or sterilized. M  anual cleaning is necessary to remove visible soil from devices prior to placing it in a mechanical washer, if used (such as an ultrasonic cleaner, automated washer or washer-disinfector). U  se clean, lint-free cloths, soft bristle brushes, spray guns and flushing devices. U  se appropriate PPE: wear long, heavy-duty gloves (or nitrile gloves), waterproof aprons or gowns, facial protection for mucous membranes (such as a mask with visor, face mask with goggles or full visor) and closed-toe shoes or boots. D  isassemble the device to facilitate the cleaning of all surfaces.  se a detergent solution compatible with the instrument/device to facilitate U cleaning. P repare detergent according to the manufacturer’s instructions. Immerse devices below the level of the detergent solution when brushing, to limit splashes/sprays when cleaning surfaces and lumens. Inspect medical devices during cleaning to ensure that all soil has been removed. R inse instruments/equipment with tap water and dry (mechanically, by air or by or W hand with lint-free cloth, depending on the instrument/device design).  here possible, clean devices by mechanical means to: – clean difficult-to-reach areas; – achieve the required exposure; – reduce potential risks to staff. Cleaning Process This cleaning process figure describes the key components required for effective cleaning. Mechanical action: Chemical action: mechanical action Solvent water: water alone is not is essential to availability an effective cleanser; cleaning. This is best of good-quality water a detergent accomplished by using is essential; (see section below) soft nylon brushes, the water should be soft that attracts and holds which do not damage (with low mineral and salt organic matter equipment surfaces. content). Water-softening is necessary. Be sure Use wiping, flushing, systems are available. to use a detergent that brushing and spraying is recommended for use actions. with medical devices. Contact time: the recommended Temperature: heat improves detergent contact time for detergent to interact performance, but not at temperatures over 45 °C. with the various surfaces must be Make sure the temperature is not too high, adhered to. Do not rush. or materials with protein will coagulate. Source: OpenWHO course Decontamination and sterilization of medical devices (1) 4 Inspection, assembly and packaging (clean area) C hange PPE worn while working in the cleaning area prior to entering the inspection, assembly and packaging area. P erform hand hygiene prior to handling clean devices. Inspect instruments for cleanliness, damage and function. A ssemble instruments prior to packaging if recommended by the manufacturer’s instructions. P ack instruments to allow penetration of sterilant, maintain sterility of the device and facilitate removal of instruments using an aseptic technique. P lace an internal chemical indicator inside the package so that it will be visible for inspection when the pack is opened. U  se an external chemical indicator to differentiate between clean and sterile instruments. L abel the package with contents, expiry date and/or sterilization date and load number. High-level disinfection or sterilization When undertaking high-level disinfection: p erform a risk assessment when handling chemicals; w  ear PPE in accordance with risk assessment and the manufacturer’s instructions; mmerse all surfaces in the disinfectant, adhering to the recommended contact i time, and document this; t est the concentration of the disinfectant daily, and document the results. Note – instruments do not require high-level disinfection and sterilization. When undertaking sterilization: u se steam sterilization (preferred) for heat-stable devices; u se low-temperature (ethylene oxide, gas plasma, hydrogen peroxide) and dry-heat methods if steam is not an option because of the material and design of the medical device; t o promote contact with steam, don’t overload the sterilizer/autoclave; inspect packages for chemical indicator change, damage and moisture when unloading the sterilizer; p lace packs or racks to allow air circulation and facilitate cooling; v alidate sterilization by monitoring and documentation of process indicators – for example: –d ocument physical parameters (time, temperature and pressure) for each cycle; –m onitor internal and external chemical indicators for each package; –p erform biological indicator test and document results each day the sterilizer runs and with each different cycle. Storage S tore instruments in a dry, clean, dust-free environment, with no water tapping or drain points. P ackages should be stored off the floor and should not touch the walls or ceiling. Ideally, room temperature should be in the range 15–25°C, with humidity between 40% and 50%. C heck expiry dates regularly. 5 References 1. D  econtamination and reprocessing of medical devices for health-care facilities. Geneva: World Health Organization; 2016 (https://apps.who.int/iris/handle/10665/250232, accessed 15 July 2022). 2. H  ealth Technical Memorandum 01-01: management and decontamination of surgical instruments (medical devices) used in acute care. Part A: management and provision. London: Department of Health; 2016. © Crown copyright 2016. 3. D  econtamination and sterilization of medical devices. In: Infection Prevention and Control [online course series]. Geneva: World Health Organization; 2016 (https://openwho.org/courses/ipc, accessed 15 July 2022). 4. G  lobal Guidelines for the Prevention of Surgical Site Infection. Geneva: World Health Organization; 2016. (https://apps.who.int/iris/handle/10665/250680, accessed 15 July 2022). 6