Processing of endoscopic equipment
Processing of endoscopic equipment
Endoscopic examinations are increasingly used for the diagnosis and treatment of various diseases and are widely used in healthcare facilities. Endoscopes are complex optical diagnostic systems composed of various materials, including metal, plastic, fiber optics, rubber, and adhesives. They also feature several different channels and cavities, making them challenging to handle. Endoscopes, including video endoscopes, and their accessories (valves, plugs) (hereinafter referred to as endoscopes), as well as instruments for them (biopsy forceps, loops, needles, etc.) are intended for visualization of organs and tissues and for performing therapeutic and diagnostic manipulations. They are classified as medical devices that come into contact with mucous membranes and/or penetrate tissues and sterile cavities of the body and, during use, may become contaminated with various pathogenic and opportunistic microorganisms throughout their entire length (including removable parts, their connection points and the instrument channel, the sheath of the insertion part of the endoscope, the air and biopsy channels, the eyepiece, handles, and valves). Therefore, proper and thorough processing of endoscopic equipment is necessary. Since May 1, 2003, the sanitary and epidemiological rules "Prevention of infectious diseases during endoscopic manipulations" have been put into effect. SP 3.1.127-03", approved by the Chief State Sanitary Doctor of the Russian Federation on April 2, 2003, which regulate the procedure for endoscope processing. The main terms and concepts used in the sanitary rules: - Cleaning and the process of removing visible contaminants, organic and other foreign materials. Cleaning precedes disinfection and sterilization. - Disinfection (disinfection) is the destruction of pathogenic and opportunistic microorganisms, bacteria, viruses, fungi (except for bacterial spores) on medical devices, as well as in their channels and cavities. - Pre-sterilization cleaning and removal of protein, fat, mechanical contaminants and drug residues. High-level disinfection (HLD) and destruction (killing) of pathogenic and opportunistic forms of bacteria (including Mycobacterium tuberculosis), lipid and non-lipid viruses and fungi and a significant reduction in spore forms. - Sterilization and the process of destruction (killing) of microorganisms of all types, at all stages of development (including all spore forms). The process of reprocessing endoscopes that do not penetrate sterile cavities of the body consists of the following sequential stages: - Primary cleaning to remove significant contamination (preliminary cleaning); - Cleaning with special enzymatic detergents, which is always performed after checking the endoscope for leaks and is completed by rinsing the endoscope with running water (pre-sterilization cleaning, which is carried out manually or mechanically); - High-level disinfection; - Storage. For endoscopes used to penetrate sterile organs and tissues, sterilization is performed after pre-sterilization cleaning. Only chemical and physical agents permitted for these purposes in the established manner in the Russian Federation can be used as means for cleaning, disinfection and sterilization of endoscopes and their instruments. When selecting cleaning agents, consider the recommendations of the manufacturers of endoscopes and their instruments regarding the effects of specific agents on the materials of these products. When cleaning, disinfecting, and sterilizing endoscopes and their instruments, it is permissible to use equipment and materials (units, washers, containers for pre-sterilization cleaning, chemical disinfection, and sterilization, sterilizers, packaging materials, etc.) that are approved for industrial production and use (in the case of imported products and approved for use) in the Russian Federation. Pre-sterilization cleaning cannot be combined with high-level disinfection. Anti-epidemic measures must be observed during all stages of processing endoscopes and their instruments: wear protective medical clothing and gowns, a cap, mask, goggles, and a waterproof apron. The effectiveness of high-level disinfection and chemical sterilization is influenced by factors related to the object being disinfected, such as the quality of object cleaning and the extent of organic contamination, the type and intensity of microbial contamination, the physical configuration of the object, the parameters of the disinfectant solution (active ingredient concentration, temperature, and pH), and the exposure time. During manual cleaning, endoscopes and their instruments are placed in a container with the solution. Rigid endoscopes are placed disassembled. For long instruments, flexible endoscopes should be coiled for ease of placement in the container, following the manufacturer's recommendations. The instruments are completely immersed in the solution (for partially immersible endoscopes, the working part and immersion-approved parts are immersed in the solution); all channels are filled with the solution using a syringe or other device, avoiding the formation of air locks. Endoscope instruments with locking parts are immersed open, after several working movements have been made in the solution to improve the penetration of the solution into the locking area. Containers used for high-level sterilization and disinfection must contain at least 2 liters of the working solution, with a solution-to-volume ratio of at least 5:1. The solution layer above the product must be at least 1 cm thick. When using products that allow for repeated use of the working solution, carefully monitor its appearance. At the first sign of a change in appearance (color change, turbidity, etc.), the solution must be replaced immediately, even if its expiration date has not expired. To avoid excessive dilution of the solution, monitor the active ingredient concentration at least once daily using chemical analysis methods or express testing tools. To optimize the cleaning, high-level disinfection, and sterilization of endoscopes, automated washer-disinfector systems of domestic and imported manufacture can be used. When working with such systems, ensure that the endoscope is properly connected to the elements that ensure all its channels are filled. Various methods can be used to sterilize endoscopes. Endoscopes that can withstand high temperatures and humidity can be steam sterilized. Most endoscopic equipment is classified as heat-sensitive, so low-temperature (up to 60 degrees C) methods should be used for its processing. Low-temperature methods include: chemical sterilization with liquid agents; sterilization with ethylene oxide; sterilization with vapors of a solution of formaldehyde in ethyl alcohol; sterilization with low-temperature hydrogen peroxide plasma. When sterilizing with vapors of formaldehyde in ethyl alcohol (sterilization must be carried out in strict accordance with the guidelines for disinfection, pre-sterilization cleaning and sterilization of medical instruments for flexible endoscopes No. 28-6/3 dated February 9, 1988). Sterilization is carried out in packaged form in a microanaerostat or a "Minutka" pressure cooker at a temperature of 45+ - 5 degrees. With a relative humidity of 90-100%, the devices must be equipped with a vacuum gauge. Ozone sterilization cannot be used for endoscopes. The SO-01-S-P6 ozone sterilizers (AOZT MELP, St. Petersburg) are approved by the Russian Ministry of Health only for sterilizing simple-configuration medical instruments without cavities, channels, or locks, made of corrosion-resistant metals (stainless steel, titanium alloys). This sterilizer model does not have a device for removing air from the channels and cannot be used to sterilize endoscopes. Furthermore, ozone, as an active oxidizer, has a destructive effect on rubber and other polymeric materials. Each healthcare facility must have operating instructions for endoscope reprocessing, covering all processing stages and specifying the specific disinfectants used, approved by the facility's chief physician. Based on the 2004 results of the analysis of disinfectant procurement under the regional programs "To Prevent the Spread of Human Immunodeficiency Virus (HIV) and Anti-HIV/AIDS," the following disinfectant solutions can be used for high-level disinfection and chemical sterilization of endoscopes purchased by districts: Lysoformin 3000, Saidex, and Novodez Forte. Lysoformin 3000 working solution for high-level disinfection can be used once.

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