SanPiN: disinfection and sterilization of medical devices

In Russia, all medical institutions are required to work according to strict standards, among which the correct disinfection and sterilization of medical devices takes an important place.

Why comply with the standard

Today, many people, even those far from medicine, are familiar with such a term as nosocomial infection. It includes any disease that the patient either gets as a result of his request for help at a medical institution, or the organization’s personnel in the performance of their functional duties. According to statistics, in surgical hospitals the level of purulent-inflammatory complications after net operations is 12-16%, in gynecological departments complications after operations develop in 11-14% of women. After studying the structure of the incidence, it became apparent that from 7 to 14% of newborns become infected in maternity hospitals and children's wards.

Of course, such a picture can be observed far from in all medical organizations and their prevalence depends on many factors, such as the type of institution, the nature of the assistance provided, the intensity of the mechanisms of transmission of nosocomial infections, its structure. Against this background, one of the main non-specific measures to prevent the occurrence and transmission of nosocomial infections is the disinfection and sterilization of medical devices.

Regulations

In their work, all health facilities are guided by the recommendations recorded in many regulatory documents. The fundamental document is SanPiN (disinfection and sterilization of medical devices in it is highlighted in a separate section). The latest edition was approved in 2010. The following normative acts also determine the work of medical institutions.

1. Federal Law No. 52, which proclaims measures of the epidemiological safety of the population.
2. Order No. 408 (for viral hepatitis) dated 12.07.1984.
3. Order No. 720 (to combat nosocomial infections).
4. Order of September 3, 1999 (on the development of disinfection).

OST "Sterilization and disinfection of medical devices" No. 42-21-2-85 is also one of the main documents regulating the standard for processing tools. It is in his work that all medical institutions are guided.

In addition, there are a large number of guidelines (MU), the disinfection and sterilization of medical devices in which is considered from the point of view of various disinfectants allowed for this purpose. Today, due to the fact that many des are officially approved. funds, relevant guidelines are also an integral part of the documents on which the work of health facilities is based. To date , the standard for processing tools consists of three successive stages - disinfection, PSO and sterilization of medical devices.

Disinfection

A disinfection is a set of measures, as a result of which pathogenic microorganisms are destroyed on environmental objects. These include surfaces (walls, floors, windows, hard furniture, equipment surfaces), patient care items (linens, dishes, sanitary equipment), as well as biological fluids, patient discharges, etc.

In the identified foci of infection, measures are called “focal disinfection”. Its purpose is the destruction of pathogens directly in the identified focus. The following types of focal disinfection are distinguished:

• current - it is carried out in medical institutions in order to prevent the spread of infection;
• final - is carried out after the source of infection is isolated, that is, a sick person was hospitalized.

In addition, there is preventive disinfection. Her events are held constantly, regardless of the presence of an infectious focus. It includes washing hands, cleaning the surrounding surfaces with the help of agents having bactericidal additives.

Disinfection methods

Depending on the goals set, the following disinfection methods are used:

• mechanical : it directly refers to the mechanical effect on the subject - wet cleaning, shaking or knocking out bedding - it does not destroy pathogenic microorganisms, but only temporarily reduces their number;
• physical : exposure to ultraviolet, high or low temperatures - in this case, destruction occurs if the temperature regime and exposure time are strictly observed;
• chemical : destruction of pathogenic microorganisms with the help of chemicals - immersion, rubbing or irrigation of an object with a chemical solution (is the most common and effective method);
• biological - in this case, they use the antagonist of the microorganism that needs to be destroyed (most often used at specialized bacteriological stations);
• combined - combines several methods of disinfection.

OST "Sterilization and disinfection of medical devices" 42-21-2-85 states that all objects and instruments with which the patient had contact must pass through the disinfection process. Medical facilities use the physical or chemical method of disinfection. After its completion, the products, depending on their purpose, are further processed, disposed of or reused.

Pre-sterilization cleaning

Disinfection and sterilization of medical devices for reusable instruments to be sterilized also includes pre-sterilization cleaning, which takes place after the disinfection of the product. The purpose of this stage is the final mechanical removal of residual fat and protein contaminants, as well as drugs.

The new SanPiN, the disinfection and sterilization of medical devices, which is considered in sufficient detail, provides for the following stages of the PSO.

1. Within 0.5 minutes, the product is washed under running water to remove residual disinfectant solution.
2. In a washing solution, for the manufacture of which only permitted agents are used, the products are soaked with complete immersion. In the event that they consist of several parts of the product, it is necessary to disassemble and ensure that all available cavities are filled with solution. At a temperature of the washing solution of 50 °, the exposure is 15 minutes.
3. After time, each product with a ruff or gauze swab is washed for 0.5 minutes in the same solution.
4. The products are rinsed under running water . The duration of rinsing depends on the product used (“Astra”, “Lotus” - 10 minutes, “Progress” - 5, “Biolot” - 3).
5. Rinse in distilled water for 30 seconds.
6. Drying in hot air ovens.

To prepare the washing solution, use 5 g of SMS (Progress, Astra, Lotus, Biolot), 33% perhydrol - 16 g, or 27.5% - 17 g. 6% (85 g) is also allowed ) and 3% (170 g) of hydrogen peroxide, drinking water - up to 1 liter.

Modern means used for disinfection allow combining disinfection and PSO processes. In this case, after the end of the exposure directly to the des. the solution is roughened with tools and then - all subsequent steps of the PSO.

Quality control

Joint ventures, disinfection and sterilization of medical devices in which they are painted literally step by step, pay great attention to the quality control of each stage of processing. To do this, tests are carried out to monitor the absence of blood, other protein compounds on the processed product, as well as the quality of washing off detergents. Control subject to one percent of the processed tools.

The phenolphthalein sample allows you to evaluate how thoroughly the detergents that were used in the pre-sterilization cleaning were removed from the products. To place it on a tampon, apply a small amount of the prepared 1% phenolphthalein solution and then wipe those products that you want to check. If pink staining appears, the quality of washing off detergents is considered insufficient.

Disinfection and sterilization of medical devices require monitoring at each stage, and another test that allows you to evaluate how well the first stages were carried out is an azopyram test. She assesses the presence or absence of blood and drug substances on them. For its implementation, you will need a solution of azopyram, which in prepared form can be stored for 2 months in the refrigerator (at room temperature this period is reduced to one month). Some turbidity of the reagent in the absence of sediment does not affect its quality.

For the sample immediately before its conduct, the same amount of azopyram and 3% hydrogen peroxide are mixed and applied to the blood stain for verification. The appearance of violet staining means that the reagent is working - you can start the test. To do this, the swab is moistened with the prepared reagent and the surfaces of the tools and equipment are wiped. In products having hollow channels, a few drops of the reagent are placed inside and after 1 minute the result is evaluated, paying particular attention to the joints. In the event that a violet color appears, gradually turning into a pink-lilac color, the presence of blood is ascertained. Brownish color indicates the presence of rust, and purple - chlorine-containing substances.

To properly evaluate the results of an azopyram test, several points must be taken into account:

• a positive test is considered only if the staining appeared within the first minute after applying the reagent;
• working solution can be used only during the first two hours after preparation;
• products should be at room temperature (the sample will not be informative on a hot surface);
• regardless of the results, the products on which the test was carried out are washed with water and again subjected to pre-sterilization cleaning.

In the case of obtaining positive results after the samples, the entire batch is re-processed until a negative result is obtained.

Sterilization

Sterilization is the final step in the processing of those products that have contact with the wound surface, mucous membrane or blood, as well as injection drugs. In this case, there is a complete destruction of all forms of microorganisms, both vegetative and spore. At the same time, all manipulations are regulated in detail by such a normative document of the Ministry of Health as an order. Sterilization and disinfection of medical devices are carried out according to the specifics of the medical institution and their purpose. Sterilized products, depending on the packaging, can be stored from day to six months.

Sterilization methods

The methods of disinfection and sterilization of medical devices are somewhat different from each other. Sterilization is carried out by the following methods:

• thermal - air, steam, glasperlen;
• chemical - gas or in solutions of chemicals;
• plasma or ozone;
• radiation.

In medical facilities, they usually use steam, air or chemical methods. In this case, the most important component of the sterilization process is the careful observance of the established modes (time, temperature, pressure). The mode of disinfection and sterilization of medical devices is selected depending on the material from which the processed product is made.

Air method

In this way, medical instruments, parts of apparatuses and devices made of metal, glass and silicone rubber are sterilized . Before the sterilization cycle, the products must be thoroughly dried.

The maximum deviation from the temperature regime with this sterilization method should not exceed 3 ° C.

Steam method

The steam method is by far the most widely used, due to the short cycle, the possibility of using it to sterilize products made from non-heat-resistant materials (underwear, suture and dressings, products from rubber, plastic, latex). Sterility with this method is achieved through the use of steam supplied under excess pressure. This happens in a steam sterilizer or in an autoclave.

Deviations in pressure conditions are allowed up to 2 kg / m², and temperature conditions - 1-2 °.

Glasperlen sterilization

The technical support of medical institutions in recent years has improved significantly and this is noted in recent joint ventures (disinfection and sterilization of medical devices). A new sterilization method that has become widely used in healthcare facilities is the glacial sterilization. It consists in immersing the tools in an environment of glass granules heated to 190 - 330 °. The sterilization process takes minutes, and after the instrumentation is ready for use. The disadvantage of this method is that only small tools can be protected with it, so it is used mainly in dental departments.

Disinfection, pre-sterilization cleaning, sterilization of medical devices are the most important elements in the work of modern healthcare facilities. The health of both patients and medical personnel will depend on how carefully all measures that are enshrined in regulatory acts approved by the Ministry of Health of the Russian Federation are implemented.