The disinfection supply room is an important department for the hospital to supply various sterile instruments, dressings and supplies. The quality of their work directly affects the quality of medical care and patient safety. In order to strengthen the scientific management of the disinfection supply room, ensure medical safety, and adapt to the needs of hospital civilization construction, this standard is specially formulated.
1. Construction requirements The new construction, expansion and reconstruction of the supply room shall be based on the premise of improving work efficiency and ensuring work quality. The supply room should be close to the clinical department and can be located in the middle of the inpatient department and the outpatient department. The surrounding environment should be clean and free from pollution. A relatively independent area should be formed to facilitate the organization of internal working lines and to avoid interference from outsiders. In order to avoid the pollution of disinfection and sterilization equipment, it should be divided into pollution area, clean area, aseptic area, and the route must be forced to pass, and it is not allowed to retrograde. The supply of high pressure steam should be sufficient and convenient. Ventilation and lighting should be good. Walls and ceilings should be free of cracks, dust, and easy to clean and disinfect. The ground is smooth and has a drain. The complete supply room should have receiving, washing, special drying items, dressing production, disinfection, aseptic storage, distribution and staff locker room. Conditional hospitals should have a pyrogen monitoring room, office and bathroom.
Second, the staffing of the staffing supply room should be equipped according to the size, nature, tasks and other needs of the hospital. In principle, the head nurse (or team leader), nurses, hygienists and disinfectors should be equipped, of which more than 1/2 should have nursing majors. Technical titles are mainly for middle and young people. All other personnel need training before they can be employed. Patients with infectious diseases are not allowed to work in the supply room.
Third, the leadership system supply room has close ties with clinical departments and general affairs logistics departments, and plays an important role in the hospital. It should be guided by the head of the dean and the nursing department or the chief head nurse, or directly led by the nursing department, and the clinical Coordination and cooperation. The general affairs logistics department and other departments guarantee the equipment, installation, maintenance, and material supply.
Fourth, the necessary conditions 1. There must be regular water (tap water), hot water supply and purification (filtration) systems.
2. Distilled water supplies, filtration systems and storage equipment must be equipped with a distiller.
3. Various rinsing tools: including decontamination, pyrogen removal, detergent removal, sinks, and storage items.
4. Sterilization and sterilization equipment such as pressure steam sterilizer, gas sterilizer, acid-resistant cylinder, and corresponding ventilation and cooling equipment and net storage of closed sterile cabinets.
5. Cotton ball machine, gauze machine, drying cabinet (box), household washing machine, grinding equipment, and other dressing processing equipment and various storage equipment such as trays, aluminum boxes, glass equipment cabinets, and lower delivery equipment. And use automatic washing, processing and other equipment as much as possible to improve working conditions.
6. Labor insurance products: personal protective glasses, acid-proof clothing, rubber shoes, rubber gloves, etc.
V. Management requirements 1. Strictly implement the provisions of the "Hospital Work System" and "Disinfection Management Measures" regarding the management of supply rooms. Improve the post responsibility system, item washing, packaging, sterilization, storage, quality monitoring, material management and other systems. At present, it is necessary to strengthen the implementation of the “Infusion, Blood Transfusion, and Syringe Washing Operation Procedures†(Annex 1) “Infusion, Blood Transfusion, Syringe Washing Quality Inspection Standards†(Annex 2). Do a good job in the recovery and disinfection of disposable syringes.
2. According to the nature of the hospital, tasks and personnel, it should generally be divided into washing group, packaging group, dressing group, disinfection group, distribution group, instrument group and quality inspection group (or by the pharmacy department). Needles, syringes, infusion tubes and other various equipment, catheter compartments should be treated. The disinfected and unsterilized areas must be strictly separated.
3. Supply room personnel must establish a serious work attitude, strict concept of sterility, conscientiously implement various technical operating procedures and quality inspection standards, familiar with the performance of various instruments and equipment, disinfection methods and washing operation techniques, to achieve the application of supplies And absolutely sterile to ensure medical safety.
4. Quality Control: The head nurse or quality supervisor is responsible for the quality inspection of raw materials and regular quantitative quality monitoring of the supplied sterile medical supplies. Establish a tracking system for the causes of pyrogen reactions and a monthly reporting system for the occurrence of pyrogen reactions. In the event of a pyrogen reaction, it must be immediately reported to the drug testing department and sent to the infusion, syringe and medicine.
Attachment 1: Infusion, blood transfusion, syringe washing operation instructions Infusion, blood transfusion device (hereinafter referred to as infusion set), immediately rinse with water. The scalp needle and the syringe and needle used for puncture are immediately soaked with a disinfectant that can kill hepatitis B virus (there should be no gas in the syringe, needle hole and scalp needle), and then sent to the supply room for washing. After the supply room is recycled, it should be completely dismantled and treated separately according to the characteristics of different parts. The entire washing process should include decontamination, depyrogenation, detergent removal, and fine washing.
1. Glass part washing method: (1) Wash with normal water, wash off the residue, wash it with a suitable detergent until it is bright, and then rinse the detergent. (2) The potassium dichromate sulfuric acid washing liquid is hung on the inner wall of the bucket, the syringe is immersed in the washing liquid, and the Morphy's dropper and the needle are taken into the washing liquid for more than 4 hours, or dry heat method is used. Go to the pyrogen. (3) Wash the lotion with normal water. (4) Rinse twice with distilled water and rinse twice with fresh (non-pyrogen) filtered distilled water.
2. Cleaning method of rubber hose and rubber plug: (1) Wash the residual blood clot and liquid medicine with normal water in time, then simmer with a small amount of alkaline water, and then wash away the alkali liquid and the falling material with normal water. (2) Immerse in a 4% (g/ml) HCl solution for 12 hours. Note that there is no gas in the middle of the hose. (3) After taking out, rinse with normal water to neutral. (4) Rinse with distilled water for 2-4 times, then rinse twice with fresh filtered distilled water.
3. Cleaning method of the needle: (1) The removed needle is dipped in normal water. (2) can be placed in the ultrasound machine, add disinfectant, ultrasonic for 30 minutes, or immersed in 2-3% sodium carbonate or sodium bicarbonate solution for 15 minutes. Then, use a needle machine to rinse or use a copper wire to clean the needle hole, and use a cotton swab to wipe the needle plug to remove residual blood clots and liquid medicine. (3) Wash with normal water. (4) Rinse with distilled water and rinse with fresh filtered distilled water.
4. How to clean the scalp needle: (1) Wash the residue with normal water. (2) Injecting a disinfectant that can kill hepatitis B virus. (3) After taking out, inject a 3-5% hydrogen peroxide solution for 12 hours. (4) Wash with normal water. (5) Rinse with freshly filtered distilled water for 2-4 times.
5. The cloth should be placed in a special washing machine (or sent to the laundry room) to wash and dry. Other packaging containers should also be washed.
6. Assembly sterilization: (1) The assembly room should be spaced apart from other operations and disinfected with UV light after cleaning. (2) After assembling the above cleaned infusion set, rinse the inside and the outside with fresh filtered distilled water. (3) Wrap or box the infusion set, syringe, and put the card with the washing person, the quality person in charge, and the sterilization date. (4) High pressure steam sterilization. (5) Note: It should not exceed 1-2 hours from the last rinse with fresh filtered distilled water until sterilization begins.
7. The infusion set and syringe after sterilization should be stored in a special cabinet, and the storage date should be 1 week in dry conditions.
Attachment 2: Infusion, blood transfusion, syringe washing quality inspection standards This standard infusion, blood transfusion device (hereinafter referred to as infusion device) refers to the open or closed clinical use for infusion, blood transfusion after washing and sterilizing in the medical unit supply room. Infusion set. A syringe is a variety of different sizes of glass syringes that are clinically used for injection or dosing after being sterilized by a medical unit supply chamber. In order to ensure the safety of the patient's clinical infusion medication, the infusion set and syringe after washing and sterilizing should be inspected in accordance with the provisions of this standard.
The open infusion set includes a bucket and a pipe connected thereto (a hose, a Morphite dropper, a glass connector, a tee, a needle, a scalp needle).
Closed infusion sets include hoses, Morphy's droppers, glass adapters, tees, needles, and scalp needles.
The syringe includes a needle for use with it.
Both the infusion set and the syringe are packaged in a suitable wrap or other suitable container.
[Appearance] The cloth or container should be complete, clean, dry and odorless. There should be signs such as the washer, sterilizer or quality person in charge and the storage (effective) period.
All parts of the infusion set should be completely matched, and the connection should be tight, firm and free of adhesion. The cap does not fall off foreign objects. The glass part should be smooth and clean, and the water will not hang water drops. The hose part is not sticky or aging. The needle should not be removed from the foreign object.
〔an examination〕
The clarification open infusion set is filled with 5 ml of sterile water for injection, and the closed infusion set is filled with 2.5 ml of sterile water for injection. After fully washing the infusion set (be careful not to knead the hose), the water is concentrated in the Morphy's dropper. Check with the inspection method for the clarity of the injection.
The syringes are connected well, and the syringe is inhaled with sterile water for injection (2 ml for syringes of 20 ml or more and 1 ml for syringes of 10 ml or less). After thoroughly rinsing the inner wall of the syringe, check the method for checking the clarity of the injection.
The above tests should not be turbid.
Bacterial endotoxin The above-mentioned infusion set or syringe filled or inhaled with sterile water for injection is placed in an incubator or a dry box and kept at 50 ° C ± 5 ° C for half an hour. During this time, the infusion set is subjected to two kneading and buckets of the hose. Rotate so that the sterile water for injection is in full contact with the inner wall of the infusion set. A 0.1 ml of water was taken for bacterial endotoxin test. The syringe was washed twice, and 0.1 ml of water was taken for bacterial endotoxin test. The scalp needle is first filled with sterile water for injection, and after being insulated under the same conditions as the infusion set, 0.1 ml of water is taken for bacterial endotoxin test.
The bacterial endotoxin test was performed using the sputum test method and the results were not positive.
Sterilization quality should be qualified by S-BI autoclave bio-indicator inspection. That is, the indicator is sterilized at the same time as the article to be inspected, and the result is judged according to the regulations.
After checking the bacterial endotoxin in the chloride infusion device, 1 ml of residual water is placed in a small test tube, and 1 drop of the acid silver test solution is added, and no turbidity may occur (only the silicone tube is used as a pipe infusion set). Take 0.5 ml of residual water after checking the bacterial endotoxin in the syringe, place it in a small test tube, add 1 drop of silver nitrate test solution, and do not turbid.
The acid remaining in the infusion set or syringe to check the residual water after bacterial endotoxin is dripped on a wide range of pH test paper, and the pH should be 5-7.
With reagent test paper 1. Sterilized water for injection should meet the following quality requirements:
Chloride is checked according to the inspection method under the distilled water (Chinese Pharmacopoeia 1985 edition, page 583).
Bacterial endotoxins are examined by the sputum test and should not be positive. Other items should be in accordance with the provisions of sterile water for injection (Chinese Pharmacopoeia 1985 edition, second 263 pages).
2. The silver nitrate test solution is the same as the Chinese Pharmacopoeia 1985 edition.
3. pH 1 - 14 specifications for a wide range of pH test strips.
4. The sputum reagent sensitivity is 1 ng/ml.
Hygienic specification for manufacturers of disinfection products
Chapter I General Provisions Article 1 In order to strengthen the sanitation management of disinfection products manufacturing enterprises and ensure the sanitary quality of disinfection products and the safety of consumers, this hygienic standard is formulated.
Article 2 This Code is formulated in accordance with the relevant provisions of the Law of the People's Republic of China on the Prevention and Control of Infectious Diseases and its Implementation Measures and Measures for the Administration of Disinfection.
Article 3 The disinfection products covered by this specification include disinfectants, disinfection devices, disposable medical and sanitary products, and indicating equipment for evaluating the effects of disinfection and sterilization.
Article 4 Enterprises engaged in the production of disinfection products must abide by this Code.
Article 5 The local health administrative departments of the people's governments at various levels shall supervise the implementation of this Code.
Chapter II Production Environment and Layout Article 6 The production enterprise shall be built in a clean area without water, no weeds, no garbage, no mosquitoes and insects.
A disposable medical product manufacturing enterprise shall be greened 500 meters away from the pollution source that affects the sanitary quality of the product.
Article 7 The layout of a production enterprise shall be reasonable and shall comply with the corresponding sanitary requirements. The production area and non-production area shall be set up to ensure continuity of production and shall not be reversed.
Article 8 The production layout must conform to the production process, and the raw materials, production workshops, finished products, quality inspection departments, etc. should be set up, and the production process should be connected reasonably.
Article 9 If any toxic, harmful, flammable or explosive materials are used or produced during the production process, they must have corresponding health and safety facilities and comply with the relevant national health and safety regulations.
Article 10 Auxiliary buildings and facilities such as power, heating, air-conditioning equipment rooms, water supply and drainage systems, and treatment systems for wastewater, waste gas, and waste slag shall not affect production hygiene.
Chapter III Hygienic Requirements for Production Areas Article 11 The production area must have a dressing room. The indoors should have locker facilities such as wardrobes and shoe racks, and be equipped with mobile water washing and disinfection facilities.
Article 12 Toilets in the production area must be flushed and kept clean and hygienic.
Article 13 The floor, wall surface, top surface and work surface of the production workshop shall be easy to clean and disinfect. The interior decoration of the purification workshop should be made of non-dusting materials.
Article 14 A production enterprise must have equipment suitable for the production characteristics of the product, meeting the production needs, and ensuring the sanitary quality of the product.
Article 15 A production enterprise shall adopt disinfection measures for the workshop environment according to the sanitary requirements for product production.
Article 16 Production equipment, tools, containers, places and work clothes, hats and shoes shall be cleaned and disinfected before use according to the characteristics of the products.
Article 17 The quality of production water should meet the requirements of the production process.
Sterile water should be used for contact lens care solutions and for production water with special hygiene requirements.
Disinfectant production water should meet the sanitary standards for drinking water.
The production of flushing water for disposable medical supplies shall comply with the standards for deionized water and water for injection.
Article 18 The production and disassembly of disposable medical supplies, contact lens care solutions and disinfection products with special hygiene requirements that enter the human body aseptic tissues and organs must be carried out in a purification workshop above 100,000 class cleanliness.
Article 19 The hygiene requirements of the production workshop of disinfection products shall be implemented in accordance with the provisions of GB 15979, GB 15980 and relevant national health standards.
Chapter IV Requirements for Raw Materials, Product Packaging and Storage Sanitation Article 20 The raw materials used for the production of disposable medical and sanitary products must be non-toxic, harmless and non-polluting, and have corresponding inspection reports or certification materials. Article 21 Raw materials and finished products must be stored separately and with obvious signs. The warehouse shall have ventilation, dustproof, rodent-proof, insect-proof and other facilities. The storage shall be kept dry, clean and tidy, and shall meet the corresponding storage requirements of the product.
Disposable medical and sanitary products should be placed at a distance of not less than 10 cm from the wall and not less than 50 cm from the top.
Article 22 Products to be inspected, qualified products, and unqualified products shall be stored separately and clearly marked with easy identification. The product should be registered and accepted, and recorded for future reference.
Chapter V Hygienic Quality Control Article 23 An enterprise shall establish and improve the sanitary quality assurance system for product production. The sanitary indicators and inspection methods in product enterprise standards or quality standards shall comply with the relevant national health standards and technical specifications.
Article 24 An enterprise shall establish a self-inspection system and have corresponding inspection instruments and equipment. The measuring instruments used for production and inspection shall be periodically verified as required and recorded for future reference.
Article 25 Personnel engaged in sanitary quality inspection must pass the examination of the provincial health administrative department and obtain the employment certificate.
Article 26 Every batch of products must be tested for sanitary quality before being placed on the market.
Article 27 An enterprise shall carry out self-inspection of self-inspection of workshop environmental sanitation and product hygiene quality according to product characteristics, and self-inspection items of different product manufacturers:
(1) The disinfection device manufacturer shall test the intensity of the disinfection factor of each product or the physical and chemical indicators related to the disinfection and sterilization effect;
(2) The disinfectant production enterprise shall test the physical and chemical indicators of each batch of raw materials and products produced by each team. Products without specific effective content detection methods, such as plants, biological extracts and other products should establish corresponding technical parameters, testing indicators and methods to ensure the quality of the product;
(3) The indicating equipment for evaluating the disinfection and sterilization effect shall establish corresponding technical parameters, testing indicators and methods to ensure the quality of the product;
(4) The one-time use medical product manufacturing enterprise shall conduct microbiological index testing on the products produced in each shift;
(5) The sanitary product manufacturing enterprise shall carry out microbiological index testing on the products produced by each feeding batch;
Article 28 The product quality inspection records and reports shall be complete and shall not be altered or used at random.
Article 29 The original records of the production process shall be properly kept for a period of three months after the expiration date of the product.
Chapter VI Personnel Requirements Article 30 Enterprises must be equipped with professionally trained full-time or part-time health management personnel. The list of management personnel shall be reported to the provincial health administrative department for the record.
Article 31 Operators who are directly engaged in the production of disinfection products must conduct a physical examination before going to work and every year, and obtain a certificate of preventive health examination before they can be employed.
Patients with active tuberculosis, viral hepatitis, intestinal infectious diseases and pathogen carriers, and infectious diseases such as suppurative or chronic exudative skin diseases shall not engage in the production of disposable medical and sanitary products.
Article 32 Production personnel must be trained in disinfection and hygiene knowledge and relevant health standards before they are employed, and they must obtain a health training certificate before they can be employed.
Article 33 The overalls of the staff members shall be neatly dressed and cleaned and disinfected according to the hygiene requirements of the products before operation.
Practitioners engaged in disposable medical and hygiene products are not allowed to wear jewelry, watches, nails and long nails during the production process.
Article 34 Staff members shall not engage in activities such as smoking or eating that affect the sanitary quality of products during the production process.
Chapter VII Supplementary Provisions Article 35 The meanings of the following terms in this Code:
Product batch: The product is finally disinfected and sterilized, and the disinfection and sterilization batch is used as the product batch; the other products are the same batch of raw materials and the products produced under the same production conditions are one batch. 100,000-level cleanliness purification workshop: According to the strict division design of the control area and the clean area, the indoor environment and appliances are made of materials that are free of dust, easy to clean and disinfect. The physical filtration and dust removal and directional ventilation make the indoor microclimate meet the following requirements: temperature 18-28°C, relative humidity 50-65%, air inlet speed is not less than 0.25m/s, indoor and outdoor pressure difference is not less than 4.9Pa, air ≥0.5цm particle number is not more than 3500/L, air bacterial colony is not More than 500 cfu/m3, the number of bacterial colonies on the surface of the object is not more than 10 cfu/cm2.
Article 36 The Ministry of Health is responsible for the interpretation of this Code.
Article 37 This Code shall be implemented as of January 1, 2001.
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