2 English reference specification for cleaning and disinfection technology of flexible endoscope
3 basic information ICS 1 1.020
C 05
People's Republic of China (PRC) (PRC) health industry standard WS 507-20 16 "Technical Specification for Cleaning and Disinfection of Flexible Endoscopes" was issued by the National Health and Family Planning Commission of the People's Republic of China on February 27th, 20th16th, and since June 27th, 20th17th,
4 Prefaces of this standard are 4. 1. 1, 4. 1.2, 5.2.7, 5.3.3, 5.3.7, 5.3.8, 5.3.9b) and 5.3.
6. 1.2c)、6. 1.4a) 1)、6.2.2g)、6.3.2、6.4.5a) 1)、7. 1.2、7.6.6。
This standard was drafted according to GB/T1.1-2009.
The main drafting units of this standard are: General Hospital of Chinese People's Liberation Army, Hospital Management Institute of National Health and Family Planning Commission, Medical Administration Bureau of Ministry of Health of General Logistics Department, Changhai Hospital of Second Military Medical University, xuanwu hospital of Capital Medical University, China Center for Disease Control and Prevention, Peking University First Hospital, First Affiliated Hospital of Zhejiang University Medical College, Union Hospital of Tongji Medical College of Huazhong University of Science and Technology, Heilongjiang Provincial Hospital, Beijing Friendship Hospital affiliated to Capital Medical University, Nanfang Hospital affiliated to Southern Medical University and Xijing Hospital of Fourth Military Medical University.
Main drafters of this standard: Liu Yunxi, Xing Yubin, Gong, Tian Xiaoli, Li, Zhang Liubo, Li,, Liu Feng.
Suo Jijiang, Kong, Zhang Yu, Chen, Chen, jiang bo, Guo Xuegang.
Technical specification for cleaning and disinfection of standard text soft endoscope
5. 1 1 Scope This standard specifies the management requirements, layout and facilities, equipment requirements, cleaning and disinfection operation procedures, monitoring and records related to soft endoscope cleaning and disinfection.
This standard is applicable to medical institutions that carry out soft endoscopic diagnosis and treatment.
Note: "Endoscope" in this standard refers to soft endoscope.
5.2 2 Normative reference documents The following documents are very important for the application of this document. For dated reference documents, only dated version is applicable to this document. For undated reference documents, the latest version (including all revisions) is applicable to this document.
GB 5749？ Drinking water quality standard
GB 15982？ Hygienic standard for hospital disinfection
GB 28234？ Safety and Hygienic Standard for Acidic Oxidation Potential Water Generator
GB 30689？ Hygienic requirements of automatic cleaning and disinfection machine for endoscope
WS/T 3 1 1？ Technical specification for hospital isolation
WS/T 3 13？ Hand hygiene standard for medical staff
WS/T 367？ Technical specification for disinfection of medical institutions
5.3 3 Terms and Definitions The following terms and definitions apply to this document.
3. 1
Soft endoscope? Flexible endoscope
Flexible endoscope for disease diagnosis and treatment.
3.2
Cleaning? clean
The process of removing contaminants attached to an endoscope with a cleaning solution.
3.3
Hey? clean water
The process of washing the residue on the endoscope with running water.
3.4
Final rinse? Final rinse
The final process of washing and disinfecting the endoscope with purified water or sterile water.
3.5
Cleaning solution? cleaning solution
According to the product instructions, the medical cleaning agent is added with appropriate amount of water to prepare a liquid with use concentration.
5.4 4 Management Requirements 5.4. 1 4. 1 Management Requirements of Medical Institutions 4. 1. 1 Conditional hospitals should establish centralized endoscopic diagnosis and treatment centers (rooms) to be responsible for endoscopic diagnosis and treatment, cleaning and disinfection.
4. 1.2? Endoscope cleaning and disinfection can also be carried out by disinfection supply center in accordance with this standard.
4. 1.3 Endoscopic cleaning and disinfection should be included in medical quality management, and various rules and regulations on hospital infection management and endoscopic cleaning and disinfection in endoscopic diagnosis and treatment center (room) should be formulated and implemented, and monitoring should be strengthened.
4. 1.4 Nursing management, personnel management, hospital infection management, equipment and logistics management and other departments shall perform the following duties within their respective functions and powers:
A) Reasonably allocate the personnel of the endoscopic diagnosis and treatment center (room) according to the workload.
B) Implement on-the-job training system. Incorporate the professional knowledge of endoscopic cleaning and disinfection and the related knowledge of hospital infection prevention and control into the continuing education plan for the staff of endoscopic diagnosis and treatment center (room).
C) Guide and supervise the cleaning, disinfection, sterilization and quality control of the endoscopic diagnosis and treatment center (room), and conduct regular inspection and evaluation.
D) when suspicious endoscope-related infection occurs, organize and coordinate the endoscopic diagnosis and treatment center (room) and relevant departments to conduct investigation and analysis, and put forward suggestions for improvement? Measures.
E) Hygienic review of the design scheme for new construction, reconstruction and expansion of the endoscopic diagnosis and treatment center (room); Cleaning, disinfection and sterilization equipment? Suggestions on the structure and quality index of ….
f)？ Responsible for the review of equipment procurement (certificate of approval, technical parameters); Establish quality audit and acceptance system for the installation and maintenance of manufacturer's equipment;
The special person shall be responsible for the maintenance and regular overhaul of the equipment in the endoscopic diagnosis and treatment center (room), and the equipment files shall be established.
G) Ensure the supply and quality of water, electricity and compressed air in the endoscopic diagnosis and treatment center (room), and conduct regular maintenance and overhaul of facilities and pipelines.
5.4.2 4.2 Management Requirements of Endoscopic Diagnosis and Treatment Center (room) 4.2. 1 Management systems such as job responsibilities, cleaning and disinfection operation procedures, quality management, monitoring, equipment management, instrument management, occupational safety protection, continuing education and training, and emergency plans should be established and improved.
4.2.2 There should be relatively fixed personnel engaged in endoscope cleaning and disinfection, and the number should match the workload of the unit.
4.2.3 A special person shall be appointed to be responsible for quality control.
4.2.4 When carrying out endoscopic diagnosis and treatment or cleaning and disinfection, the staff should follow the standard prevention principle and the requirements of WS/T 3 1 1 to do personal protection and wear necessary protective articles. See appendix a for the requirements of protective clothing for personnel in different areas.
4.2.5 The staff of the endoscopic diagnosis and treatment center (room) should receive on-the-job training and continuing education corresponding to their job responsibilities, and correctly master the following knowledge and skills:
A) Knowledge and skills of cleaning, disinfection and sterilization of endoscopes and accessories;
B) Knowledge of endoscope structure and maintenance;
C) Cleaning agents, disinfectants and methods of using cleaning and disinfection equipment;
D) Principles and methods of standard prevention and occupational safety protection;
E) Relevant knowledge of hospital infection prevention and control.
5.5 5 Layout, facilities and equipment requirements 5.5. 1 5. 1 Basic requirements 5. 1. 1 Endoscopic diagnosis and treatment center (room) should be equipped with office area, patient waiting room (area), consulting room (area), cleaning and disinfection room (area), and.
5. 1.2 corresponding consultation rooms should be set up according to the endoscopic diagnosis and treatment items.
5. 1.3 The diagnosis and treatment of different systems (such as respiratory system and digestive system) by soft endoscopy should be carried out in different rooms.
5.5.2 5.2 Endoscopic outpatient service 5.2. 1 Each outpatient service in the outpatient service shall include 1 beds, mainframe (including monitors), aspirator, therapeutic vehicle, etc.
5.2.2 The number of flexible endoscopes and accessories should match the workload of diagnosis and treatment.
5.2.3 The diagnosis and treatment environment of sterile endoscope should at least meet the requirements of clean operating room.
5.2.4 Hand hygiene equipment shall be provided and non-contact faucets shall be adopted.
5.2.5 Masks, hats, gloves, goggles or protective masks shall be provided.
5.2.6 The water in the water needle bottle should be sterile water, which should be changed every day.
5.2.7 Full immersion endoscope should be adopted. 5.2.8 Disposable straws should be used.
5.5.3 5.3? 5.3. 1 Cleaning and disinfection rooms shall be set up independently.
5.3.2 Good ventilation should be maintained.
5.3.3 If mechanical ventilation is adopted, it is advisable to adopt the mode of "upper delivery and lower exhaust", the air exchange rate should be ≥ 10 times /h, and the minimum fresh air volume should reach 2 times/h. ..
5.3.4 The cleaning and disinfection process should be from dirty to clean, and the operation procedures should be posted in the proper position of the cleaning and disinfection room in the form of words or pictures.
5.3.5 Different systems (such as respiratory system and digestive system) should set up and use the cleaning tank and automatic cleaning and disinfection machine of soft endoscope respectively.
5.3.6 The following facilities and equipment shall be provided:
A) clean the fuel tank. Manual cleaning and disinfection operation should also be equipped with rinsing tank, disinfection tank and final rinsing tank.
B) Full-pipeline perfusion device.
C) Various special brushes for endoscopes.
D) pressure water gun.
E) pressure air gun.
F) leak detector.
G) timer
H) transport containers for endoscopes and accessories.
I) Wipes and mats with low fiber floc and soft texture.
J) Hand hygiene device, using non-contact faucet.
5.3.7 Power pump (used together with the whole pipeline perfusion device) and ultrasonic cleaner shall be provided.
5.3.8 An automatic cleaning and disinfecting machine for endoscope shall be equipped.
5.3.9 Relevant requirements of automatic cleaning and disinfecting machine for endoscope shall comply with the provisions of GB 30689, mainly including:
A) It has the functions of cleaning, disinfection, washing and self-disinfection;
B) It shall have the functions of leak detection, water filtration, drying and data printing.
5.3. 10 sterilization equipment: the low-temperature sterilization equipment used for endoscope sterilization shall comply with relevant national regulations.
5.3. 1 1 The consumables in the cleaning and disinfection room shall meet the following requirements:
A) Water: tap water, purified water and sterile water should be available. The water quality of tap water should comply with the provisions of GB 5749. Purified water shall comply with the provisions of GB 5749, and ensure that the total number of bacteria is ≤10cfu/100ml; The pore size of the filter membrane used in the production of purified water should be ≤0.2μm, and it should be replaced regularly. Sterile water is sterilized water. When necessary, carry out microbial detection on pure water or sterile water.
B) Compressed air: it should be clean compressed air.
C) Medical cleaning agents shall meet the following requirements:
1) low-foaming medical cleaning agent suitable for flexible endoscope should be selected;
2) Special medical cleaning agents can be selected as required, such as medical cleaning agents with biofilm removal function.
D) Medical lubricant: it should be water-soluble and have good compatibility with human tissues, and it will not affect the permeability of sterilization medium and the mechanism of instruments. Mechanical properties.
E) Disinfectant shall meet the following requirements:
1) should be suitable for endoscopes, comply with relevant national regulations, and have low corrosiveness to endoscopes;
2) O-phthalaldehyde, glutaraldehyde, peracetic acid, chlorine dioxide, acidic oxidation potential water, chlorine-containing compound disinfectant or other disinfectants can be selected;
3) See Appendix B for the usage of some disinfectants;
4) Acidic oxidation potential water shall comply with the provisions of GB 28234.
F) Disinfectant shall meet the following requirements:
1) should be suitable for endoscopes, comply with relevant national regulations, and have low corrosiveness to endoscopes;
2) Disinfectants such as glutaraldehyde and peracetic acid can be selected;
3) See Appendix B for the usage of some disinfectants.
G) disinfectant concentration test paper: it shall comply with relevant national regulations.
H) Desiccant: 75% ~ 95% ethanol or isopropanol shall be provided. 5.3. 12 personal protective equipment: waterproof apron or waterproof isolation gown, medical surgical mask, goggles or protective mask, hat, gloves, special shoes, etc.
5.5.4 5.4 The inner surface of the storage room (cabinet) for endoscopes and accessories shall be smooth and seamless for cleaning and disinfection. Endoscope and accessory storage (cabinet) should be well ventilated and kept dry.
5.6 6 Operating Procedures for Cleaning and Disinfection 5.6. 1 6. 1 Basic Principle 6. 1. 1 All soft endoscopes should be thoroughly cleaned and disinfected or sterilized at a high level after each use.
6. 1.2 Soft endoscopes, reusable accessories and medical supplies shall be classified according to the following principles:
A) Flexible endoscopes and accessories that enter sterile tissues and organs of human body or contact with damaged skin and mucosa shall be disinfected;
B) Flexible endoscope that contacts with intact mucosa, but does not enter sterile tissues and organs of human body, and does not contact with damaged skin and mucosa, and? Accessories and appliances should be disinfected at a high level;
C) Articles that come into contact with intact skin but not mucous membrane should be disinfected or cleaned with low degree.
6. 1.3 Cleaning and disinfection of endoscope should follow the following process (see figure 1).
Figure 1 Cleaning and disinfection process of flexible endoscope
6. 1.4 Precautions are as follows:
A) After use, the endoscope shall be tested for leakage according to the following requirements:
1) Leak test shall be conducted before each cleaning;
2) Leak detection shall be carried out at least 1 time every day if conditions do not permit.
B) Thoroughly clean the endoscope before disinfection or sterilization.
C) The action time of cleaning agents and disinfectants should follow the product instructions. Disinfection time of endoscopes and accessories used by patients with confirmed or suspected mycobacterial infection should follow the product instructions.
D) The disinfected endoscope should be washed with purified water or sterile water, and the soaked and disinfected endoscope should be washed with sterile water.
E) Endoscopes should be stored in a clean and dry environment.
F) Before daily diagnosis and treatment, the disinfection endoscope used that day should be disinfected, rinsed and dried again before it can be used for patient diagnosis and treatment.
5.6.2 6.2 Manual Operation Process 6.2. 1 Pretreatment Process is as follows:
A) After the endoscope is taken out of the patient, use a wet towel or wet yarn containing cleaning solution immediately before it is detached from the light source and video processor? Wipe the dirt on the outer surface with a cloth, and the wiping articles should be used once;
B) Repeat gas supply and water supply for at least 10 second; ;
C) putting the tip of the endoscope into a container filled with cleaning liquid, starting the suction function, and sucking the cleaning liquid until it flows into the suction pipe;
D) Cover the waterproof cover of the endoscope;
E) Put it into a transport container and send it to the cleaning and disinfection room.
6.2.2 The leakage detection process is as follows:
A) Remove various buttons and valves;
B) Connect the leak detector and inject pressure;
C) completely immerse that endoscope in water, inject water into each pipeline with a syringe, and exhausting the gas in the pipeline;
D) First, bend the tip of the endoscope in all directions and observe whether bubbles appear; Then observe whether there are bubbles emerging from the insertion part, operation part, connection part and other parts;
E) If leakage is found, it shall be submitted for inspection in time;
F) Leak detection shall be recorded;
G) Other effective leak detection methods can also be adopted.
6.2.3 The cleaning process is as follows:
A) Prepare the cleaning liquid in the cleaning tank, and completely immerse the endoscope, buttons and valves in the cleaning liquid.
B) Wash the mirror body repeatedly with a rag, especially the insertion part and the operation part. The rag should be replaced once.
C) Brush all the tubes of the endoscope. When brushing your teeth, you should see both ends of the brush head and wash off the dirt on the brush head; Brush repeatedly until you can't see it? Contaminants.
D) Connect the whole pipeline perfusion device, and inject the cleaning liquid into each pipeline with a power pump or syringe. The soaking time should follow the product instructions.
E) Brush buttons and valves. Buttons and valves suitable for ultrasonic cleaning shall be ultrasonically cleaned according to the manufacturer's instructions.
F) After cleaning 1 endoscope, the cleaning solution should be replaced.
G) Clean the brush and use it after advanced disinfection.
6.2.4 The flushing process is as follows:
A) Move the cleaned endoscope, the whole pipeline injector, buttons and valves into a flushing tank;
B) Fully flush all the pipelines of the endoscope with a power pump or a pressure water gun until there is no residual cleaning solution;
C) Cleaning the outer surface, buttons and valves of the endoscope with flowing water;
D) Use a power pump or a pressure air gun to inflate each pipeline for at least 30 s to remove moisture in the pipeline;
E) Dry the outer surface, buttons and valves of the endoscope with a rag. The rag should be replaced after use.
6.2.5 The disinfection (sterilization) process is as follows:
A) Move the endoscope, the whole pipeline perfusion device, buttons and valves into a disinfection tank and completely immerse them in disinfectant;
B) Inject disinfectant into each pipeline with power pump or syringe, and the disinfection method and time should follow the product instructions;
C) Replace gloves, inflate each pipeline for at least 30 s, and remove disinfectants in the pipeline;
D) When using sterilization equipment to sterilize the flexible endoscope, the user manual of the equipment shall be followed.
6.2.6 The final flushing process is as follows:
A) moving the endoscope, the whole pipeline perfusion device, buttons and valves into a terminal flushing tank;
B) Using a power pump or a pressure water gun, rinse the endoscope pipeline with purified water or sterile water for at least 2 minutes until there is no disinfectant residue;
C) Cleaning the outer surface, buttons and valves of the endoscope with pure water or sterile water;
D) The endoscope disinfected by immersion shall be finally rinsed with sterile water in a special final rinsing tank;
E) Dismantle the whole pipeline perfusion device.
6.2.7 The drying process is as follows:
A) Put the endoscope, buttons and valves on a special drying table for placing sterile towels. Sterile towels should be replaced every 4h 1 time.
B) Fill all pipelines with 75% ~ 95% ethanol or isopropanol.
C) Use a compressed air gun to fill all the pipes with clean compressed air for at least 30 seconds until the pipes are completely dry.
D) Dry the external surfaces of endoscopes, buttons and valves with sterile rags and pressure air guns.
E) Install buttons and valves.
5.6.3 6.3 Operation Process of Endoscope Cleaning and Disinfecting Machine 6.3. 1 Before the endoscope cleaning and disinfecting machine is used, the endoscope should be pretreated, leak-detected, cleaned and rinsed according to the provisions of 6.2. 1, 6.2.2, 6.2.3 and 6.2.4.
6.3.2 Cleaning and rinsing can be carried out in the same cleaning tank.
6.3.3 The use of the endoscope cleaning and disinfecting machine should follow the product instructions.
6.3.4 The endoscope cleaning and disinfecting machine without drying function shall be dried according to the provisions of 6.2.7.
5.6.4 6.4 Cleaning, Disinfection and Sterilization of Reusable Accessories 6.4. 1 Accessories should be soaked in cleaning solution or moisturized with humectant in time after use. For the inner cavity accessories, the cleaning solution should be injected into the inner cavity.
6.4.2 The internal and external surfaces and joints of accessories shall be carefully scrubbed until there are no visible pollutants.
6.4.3 Ultrasonic cleaned accessories shall be cleaned with medical cleaning agent according to the product description of the accessories. Rinse with running water and dry after cleaning.
6.4.4 Lubrication of accessories shall follow the manufacturer's instructions.
6.4.5 Select disinfection or sterilization method according to 6. 1.2:
A) Disinfection of moisture-proof and heat-resistant accessories:
1) thermal disinfection can be selected, and disinfectant can also be used for disinfection;
2) The use method of disinfectant should follow the product instructions;
3) After disinfection with disinfectant, it should be washed with purified water or sterile water and dried for later use.
B) Pressure steam sterilization is the first choice for sterilization of moisture-resistant and heat-resistant fittings; Heat-labile accessories should be soaked in low-temperature sterilization equipment or chemical sterilization agent? Soak and sterilize, soak with chemical sterilizing agent, rinse with sterile water, and air dry for later use.
5.6.5 6.5 Storage 6.5. 1 After the endoscope is dried, it should be stored in the storage room (cabinet) of endoscope and accessories, the mirror body should be hung, the corner fixing buttons should be placed in the free position, and the removed buttons and valves should be stored separately.
6.5.2 The storage (cabinet) of endoscopes and accessories shall be cleaned and disinfected once a week 1 time. If there is any pollution, it shall be cleaned and disinfected at any time.
6.5.3 Sterile endoscopes, accessories and related articles shall be stored according to the storage requirements of sterile articles.
5.6.6 6.6 Cleaning and disinfection of facilities, equipment and environment 6.6. 1 After daily cleaning and disinfection, the cleaning tank and rinsing tank should be thoroughly scrubbed and disinfected with chlorine-containing disinfectant, peracetic acid or other disinfectants in line with relevant national regulations.
6.6.2 Every time the disinfectant is changed, the disinfection tank should be thoroughly scrubbed.
6.6.3 After the daily diagnosis and treatment, cleaning and disinfection, the environment of the endoscopic diagnosis and treatment center (room) should be cleaned and disinfected.
5.7 7 Monitoring and recording 5.7. 1 7. 1 Endoscope cleaning quality monitoring 7. 1. 1 Each endoscope and its accessories shall be visually inspected. The surface of the endoscope and its accessories should be clean and free of stains. If the cleaning quality is unqualified, it should be reworked.
7. 1.2 methods such as protein residue determination and ATP bioluminescence determination can be used to monitor the cleaning effect of endoscope regularly.
5.7.2 7.2 Monitoring of disinfectants or sterilizers in use 5.7.2. 1 7.2. 1 concentration monitoring 7.2. 1 concentration monitoring shall be carried out according to the product instructions.
7.2. 1.2 If the frequency of concentration monitoring is not specified in the product manual, the concentration of disposable disinfectants or disinfectants shall be monitored in each batch; Repeated use of disinfectant or disinfectant concentration should be determined once after preparation and monitored before each use; After the number of disinfected endoscopes reaches half of the specified number, it should be determined before disinfection of each endoscope.
7.2. 1.3 Before each use, the pH value and available chlorine concentration of the acid oxidation potential water should be measured at the outlet of the acid oxidation potential water at the use site.
7.2.2 The monitoring of bacterial pollution in 5.7.2.2 should be every quarter 1 time, and the monitoring method should follow the provisions of WS/T 367.
5.7.3 7.3 Monitoring of disinfection quality of endoscopes 7.3. 1 Biological monitoring should be carried out on disinfected endoscopes every quarter. The rotation sampling method is adopted for monitoring, and the sampling rate is 25% each time. If the number of endoscopes is less than or equal to 5, all endoscopes should be monitored at a time; If more than five, the number of each monitoring should be not less than five.
7.3.2 The monitoring method should follow the provisions of GB 15982, and the disinfection qualification standard: the total number of colonies ≤20 CFU/ piece.
7.3.3 When it is suspected that hospital infection is related to endoscopic diagnosis and treatment, pathogenic microorganisms should be detected, and the method should follow the provisions of GB 15982.
5.7.4 7.4 Monitoring of Endoscope Cleaning and Disinfection Machine 7.4. 1 Newly installed or maintained endoscope cleaning and disinfection machine, the cleaned and disinfected endoscope should be biologically monitored, and it can only be used after it is qualified.
7.4.2 Other monitoring of the endoscope cleaning and disinfecting machine shall be carried out in accordance with relevant state regulations.
5.7.5 7.5 Monitoring of hand hygiene and environmental disinfection quality 7.5. 1 The hand disinfection effect of medical staff should be monitored every quarter, and the monitoring method should follow the provisions of WS/T 3 13.
7.5.2 The environmental disinfection effect of consulting room and cleaning and disinfection room should be monitored every quarter, and the monitoring method should follow the provisions of WS/T 367.
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5.7.6 7.6 Requirements for recording and traceability of quality control process 7.6. 1 The use, cleaning and disinfection of each endoscope shall be recorded, including the date of diagnosis and treatment, the patient's identity and endoscope number (which should be unique), the start and end time of cleaning and disinfection, the name of the operator, etc.
7.6.2 Monitoring results of disinfectant concentration and bacterial contamination in use shall be recorded.
7.6.3 The biological monitoring results of the endoscope shall be recorded.
7.6.4 It is suggested to keep the printed data of the operating parameters of the endoscope cleaning and disinfection machine.
7.6.5 Monitoring results of hand hygiene and environmental disinfection quality shall be recorded.
7.6.6 Records shall be traceable. The storage period of disinfectant concentration monitoring records should be ≥6 months, and other monitoring data should be ≥3 years.
6 Appendix 6. 1 Appendix A (normative appendix) Requirements of protective clothing for personnel in different areas of endoscopic clinic center (room) See Table A. 1 for requirements of protective clothing for personnel in different areas of endoscopic clinic center (room).
Table A. 1 Requirements for personal protective clothing in different areas of endoscopic consultation room (room)
region
protective gowns
work clothes
Surgical cap
surgical mask
gloves
Goggles or masks
Waterproof apron or waterproof isolation gown.
Special shoes
consulting room
√
√
√
√
△
Clean and disinfect the room
√
√
√
√
√
√
√
Note: √ To be used, △ to be used.
6.2 Appendix B (normative appendix) Usage of some disinfection (sterilization) agents See Table B. 1 for usage of some disinfection (sterilization) agents.
Table b. 1 Usage of local disinfectants (sterilizers)
Disinfecting (sterilizing) agent
High level disinfection and sterilization parameters
usage mode
Matters needing attention
Phthalaldehyde
(OPA)
Concentration: 0.55% (0.5% ~ 0.6%)
Time: disinfection ≥5 minutes.
1. Endoscope cleaning and disinfecting machine.
2. Manual operation: each pipeline should be filled with disinfectant and soaked for disinfection.
1. Easy to dye clothes, skin, equipment, etc.
2. Contact with steam may cause respiratory tract and eyes.
glutaric dialdehyde
(GA)
Concentration: ≥2% (alkaline)
Time: Bronchoscope disinfection soaking time ≥ 20min; Other endoscopic disinfection ≥10 min; Patients with special mycobacterial infection such as tuberculosis were soaked in endoscope ≥15 min after use; Sterilization ≥ 10 hour
1. Endoscope cleaning and disinfecting machine.
2. Manual operation: each pipeline should be filled with disinfectant and soaked for disinfection.
1. allergic to skin, eyes and breathing, which can cause dermatitis, conjunctivitis, nasal inflammation and occupational asthma. Suitable for endoscope cleaning and disinfection machine.
2. It is easy to form induration substances on endoscopes and cleaning and disinfection equipment.
peroxyacetic acid
(PAA)
Concentration: 0.2% ~ 0.35% (volume fraction)
Time: disinfection ≥5 min, sterilization ≥ 10 min.
Endoscope cleaning and disinfecting machine
* * * On the skin, eyes and respiratory tract.
chlorine dioxide
Concentration: 100 mg/l ~ 500 mg/l.
Time: disinfection for 3 min~5 min.
1. Endoscope cleaning and disinfecting machine.
2. Manual operation: each pipeline should be filled with disinfectant and soaked for disinfection.
When the activation rate is low, it will produce a strong smell and should be used in the endoscope cleaning and disinfection machine.
Acidic oxidation potential water
(AEOW)
Main indicators:
The concentration of available chlorine is 60mg/l10mg/l;
pH 2.0 ~ 3.0
Redox potential ≥11100mv;
Residual chloride ion
Time: disinfection for 3 min~5 min.
1. acidic oxidation potential water endoscope cleaning and disinfection machine.
2. Manual operation: connect the acidic oxidation potential water outlet with each channel of the endoscope with a special connector, and then flow and soak for disinfection.
1. In the presence of organic matter, the disinfection effect will drop sharply, and it should be thoroughly cleaned before disinfection. Especially for endoscopes that are seriously polluted and difficult to clean (such as colonoscopy, etc.). ), to increase the number of brushing, extend the cleaning time, to ensure the cleaning quality.
2. Mobile immersion disinfection should be adopted.
3. Rinse with purified water or sterile water for 30 s after disinfection.
Note 1: The disinfectants (disinfectants) listed in the table, the specific use conditions and precautions shall be implemented according to the product instruction manual.
Note 2: For similar or other disinfectants (disinfectants) not listed in the table, their usage methods and precautions should follow the product instruction manual.
7 standard full text