WS 507 -2016 ruǎn shì nèi jìng qīng xǐ xiāo dú jì shù guī fàn
2 English ReferenceRegulation for cleaning and disinfection technique of flexible endoscope
3 Basic informationICS 11.020
C 05
The People's Republic of China (PRC) Health Industry Standard WS 507-2016 Regulation for cleaning and disinfection technique of flexible endoscope is issued by the Chinese Ministry of Health. technique of flexible endoscope) was issued by the National Health and Family Planning Commission of the People's Republic of China*** and the State of China on December 27, 2016, and has been implemented since June 01, 2017.
4 Preface
4.1.1, 4.1.2, 5.2.7, 5.2.8, 5.3.3, 5.3.7, 5.3.8, 5.3.9b), 5.3.11c) 2), 5.3.11e) 2), 5.3.11f) 2),
6.1.2c), 6.1.4a) 1), 6.2.2g), 6.3.2, 6.4.5a)1), 7.1.2, 7.6.4 are recommended and the rest are mandatory.
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
The main drafting unit of this standard: the General Hospital of the Chinese People's Liberation Army, the National Institute of Hospital Management of the National Health and Family Planning Commission, the Medical Administration of the Ministry of Health of the General Logistics Department, Changhai Hospital of the Second Military Medical University, Xuanwu Hospital of the Capital Medical University, the Chinese Center for Disease Control and Prevention, Peking University First Hospital, the first hospital attached to the School of Medicine of Zhejiang University, Huazhong University of Science and Technology Tongji Medical College, the Concordia Hospital, Heilongjiang Provincial Hospital, Beijing Friendship Hospital of Capital Medical University, Nanfang Hospital of Southern Medical University, Xijing Hospital of the Fourth Military Medical University.
The main drafters of this standard: Liu Yunxi, Xing Yubin, Gong Yuxiu, Tian Xiaoli, Li Zhaoshen, Wang Lihong, Zhang Liubo, Li Liuyi, Fang Ying, Liu Feng,
Suo Jijiang, Kong Jinyan, Deng Min, Zhang Yu, Zhang Jingli, Yang Yunsheng, Chen Cuimin, Ren Xu, Zhang Shutian, Jiang Po, Guo Xuegang.
5 Standard TextTechnical specifications for cleaning and disinfection of soft endoscopes
5.1 1 ScopeThis standard specifies the management requirements, layout and facilities, equipment requirements, cleaning and disinfection procedures, monitoring and recording related to cleaning and disinfection of soft endoscopes.
This standard applies to the soft endoscopy diagnosis and treatment of medical institutions.
Note: The "endoscope" in this standard refers to soft endoscopy.
5.2 2 Normative referencesThe following documents are essential to the application of this document. Where a document is dated, only the dated version applies to this document. Where a referenced document is not dated, the latest version (including all change orders) applies to this document.
GB 5749? Hygienic Standard for Drinking Water
GB 15982? Hygienic Standard for Disinfection in Hospitals
GB 28234? Safety and Hygienic Standard for Acid Oxidation Potential Water Generator
GB 30689? Hygienic Requirements for Automatic Cleaning and Disinfecting Machines for Endoscopes
WS/T 311? Technical Specification for Isolation in Hospitals
WS/T 311?
WS/T 313? Hand hygiene standard for medical personnel
WS/T 367? Technical specification for disinfection in medical institutions
5.3 3 Terms and definitionsThe following terms and definitions are applicable to this document.
3.1
flexible endoscope? flexible endoscope
A bendable endoscope used for the diagnosis and treatment of disease.
3.2
Cleaning? cleaning
The process of removing contaminants from an endoscope using a cleaning solution.
3.3
Rinsing? rinsing
The process of rinsing residues from a cleaned endoscope with running water.
3.4
Final rinsing? final rinsing
The process of final rinsing of a sterilized endoscope with purified or sterile water.
3.5
Cleaning solution? cleaning solution
The preparation of a medical cleaning agent in accordance with product instructions by adding the appropriate amount of water to a liquid of the concentration to be used.
5.4 4 Management requirements 5.4.1 4.1 Management requirements of medical institutions4.1.1 Hospitals with the conditions are recommended to establish a centralized endoscopy diagnosis and treatment center (room), responsible for endoscopy diagnosis and treatment and cleaning and disinfection.
4.1.2?Cleaning and disinfection of endoscopy can also be responsible for disinfection and supply centers, follow the work of this standard.
4.1.3 Endoscopy cleaning and disinfection should be included in the quality of care management, development and improvement of endoscopy diagnostic and treatment center (room) hospital infection management and endoscopy cleaning and disinfection of the various rules and regulations and implementation, and strengthen the monitoring.
4.1.4 Nursing management, personnel management, hospital infection management, equipment and logistics management and other departments should, within their respective terms of reference, the management of endoscopy diagnosis and treatment center (room) to perform the following duties:
a) According to the workload of reasonable allocation of endoscopy diagnosis and treatment center (room) staff.
b) Implementation of job training system. Endoscopic cleaning and disinfection of professional knowledge and related hospital infection prevention and control knowledge into the endoscopy diagnosis and treatment center (room) personnel continuing education program.
c) The endoscopy diagnosis and treatment center (room) cleaning, disinfection, sterilization work and quality monitoring guidance and supervision, regular inspection and evaluation.
d) In the event of suspected endoscopy-related infections, organize and coordinate the endoscopy treatment center (room) and related departments to investigate and analyze, and propose improvement measures.
e) Hygienic review of the design of new endoscopy centers (rooms), alterations and expansion; cleaning, disinfection and sterilization equipment configuration and quality indicators to put forward the views.
f)? Responsible for the audit of equipment acquisition (certificate of conformity, technical parameters); establish the quality audit and acceptance system for the installation and overhaul of manufacturers' equipment;
Specialists are responsible for the maintenance and regular overhaul of the equipment of endoscopy diagnostic and treatment centers (rooms) and the establishment of equipment files.
g) Guarantee the supply and quality of water, electricity and compressed air in the endoscopy diagnosis and treatment center (room), and carry out regular maintenance and overhaul of facilities and pipelines.
5.4.2 4.2 Management requirements of endoscopy diagnostic and treatment center (room)4.2.1 Should establish and improve job responsibilities, cleaning and disinfection operating procedures, quality management, monitoring, equipment management, device management, occupational safety and protection, continuing education and training, and other management systems and emergency response plans for emergencies.
4.2.2 There should be a relatively fixed number of specialists engaged in endoscopic cleaning and disinfection, the number of which matches the workload of the unit.
4.2.3 There should be a designated person responsible for quality monitoring individual work.
4.2.4 Staff endoscopy diagnosis and treatment or cleaning and disinfection, should follow the standard precautionary principle and the requirements of WS / T 311 good personal protection, wear the necessary protective equipment. See Appendix A for the requirements of protective clothing in different areas.
4.2.5 The staff of endoscopy center (room) should receive post training and continuing education corresponding to their duties and correctly master the following knowledge and skills:
a) knowledge and skills of cleaning, disinfection, sterilization of endoscopes and accessories;
b) knowledge of endoscopy construction and maintenance;
c) cleaning agents, disinfectants, disinfectants, disinfecting agents, disinfecting agents, disinfecting agents, disinfecting agents, disinfecting agents, disinfecting agents, disinfecting agents, disinfecting agents, disinfecting agents and disinfecting agents.
c) the use of cleaning agents, disinfectants and cleaning and disinfecting equipment;
d) the principles and methods of standard precautions and occupational safety protection;
e) the knowledge of hospital infection prevention and control.
5.5 5 Layout and facilities, equipment requirements 5.5.1 5.1 Basic requirements5.1.1 Endoscopy diagnosis and treatment center (room) should be set up in the office area, patient waiting room (area), diagnosis and treatment room (area), cleaning and disinfection room (area), endoscopes and accessory storage library (cabinet), etc., and the area should be matched with the work needs.
5.1.2 should be carried out according to the endoscopic diagnosis and treatment program to set up the appropriate diagnostic and treatment room.
5.1.3 Different systems (such as respiratory, gastrointestinal system) soft endoscopy diagnosis and treatment should be carried out in separate rooms.
5.5.2 5.2 Endoscopy clinic5.2.1 Each unit in the clinic should include a diagnostic bed, the host computer (including monitors), suction, treatment trolley and so on.
5.2.2 The number of flexible endoscopes and accessories should match the workload.
5.2.3 Sterilized endoscopy clinic environment should at least meet the requirements of non-clean operating room.
5.2.4 Hand hygiene devices should be provided with non-touch faucets.
5.2.5 Masks, hats, gloves, goggles, or protective face shields should be provided.
5.2.6 The water in the injection bottle should be sterile and replaced daily.
5.2.7 It is desirable to use a total immersion endoscope. 5.2.8 It is desirable to use disposable suction tubes.
5.5.3 5.3 Cleaning and disinfection room5.3.1 Should be independent.
5.3.2 It should be well ventilated.
5.3.3 If mechanical ventilation, it is desirable to take the "upward and downward" way, the number of air exchanges should be ≥ 10 times / h, the minimum amount of fresh air should be up to 2 times / h.
5.3.4 cleaning and disinfection process should be done from dirty to clean, the operating procedures should be in words or pictures in the appropriate location in the cleaning and disinfection room posted. The operation procedure should be posted in words or pictures in the appropriate location of the cleaning and disinfection room.
5.3.5 Cleaning tanks for soft endoscopes of different systems (e.g., respiratory, digestive) and automatic endoscope cleaning and disinfecting machines should be set up and used separately.
5.3.6 The following facilities and equipment should be provided:
a) Cleaning tank. Manual cleaning and disinfection operations should also be equipped with rinsing tanks, disinfection tanks, final rinsing tank.
b) Full pipeline irrigator.
c) Specialized brushes for various endoscopes.
d) Pressure water gun.
e) Pressure air gun.
f) Leak detection instruments.
g) Timer.
h) Transport container for endoscopes and accessories.
i) Low-fiber flocculent, soft-textured wipes and pads.
j) Hand hygiene devices with non-touch faucets.
5.3.7 It is desirable to have a power pump (used in conjunction with a full pipeline irrigator), and an ultrasonic cleaner.
5.3.8 It is desirable to have an automatic endoscope cleaning and disinfecting machine.
5.3.9 Endoscopy automatic cleaning and disinfection machine requirements should be consistent with the provisions of GB 30689, including:
a) should have the function of cleaning, disinfection, rinsing, and self-sanitization;
b) desirable to have the function of leakage detection, water filtration, drying, and data printing.
5.3.10 Sterilization equipment: low-temperature sterilization equipment for endoscopy sterilization should be in line with relevant national regulations.
5.3.11 Cleaning and disinfection room consumables should meet the following requirements:
a) Water: there should be tap water, purified water, sterile water. Tap water quality should be consistent with the provisions of GB 5749. Purified water should be in line with the provisions of GB 5749, and should ensure that the total number of bacteria ≤ 10 CFU/100 mL; production of purified water used in the pore size of the filter membrane should be ≤ 0.2 μm, and regularly replaced. Sterile water is water treated by sterilization process. Microbiological testing of purified water or sterile water when necessary.
b) Compressed air: should be clean compressed air.
c) medical cleaning agent should meet the following requirements:
1) should be selected for soft endoscopy of the low-foaming medical cleaning agent;
2) according to the need to choose a special-purpose medical cleaning agent, such as biofilm removal of the role of medical cleaning agent.
d) medical lubricants: should be water-soluble, with good compatibility with human tissue, does not affect the penetration of the sterilization medium and the mechanical properties of the instrument.
e) Disinfectants should meet the following requirements:
1) They should be suitable for endoscopy and comply with the relevant national regulations and have low corrosiveness to endoscopy;
2) phthalaldehyde, glutaraldehyde, peroxyacetic acid, chlorine dioxide, acidic oxidized potentiometric water, chlorine-containing compounded disinfectants, or other disinfectants;
3) Some disinfectants are used as described in Appendix B;
3) Some disinfectants are used as follows:
4) The method of disinfectant is shown in Appendix B. Methods see Appendix B;
4) Acidic oxidation potential water should comply with the provisions of GB 28234.
f) Sterilizing agents should meet the following requirements:
1) should be suitable for endoscopy and in line with national regulations, and low corrosiveness to the endoscope;
2) Glutaraldehyde, peroxyacetic acid, or other sterilizing agents;
3) Part of the use of sterilizing agents, see Appendix B.
g) Sterilant concentration test paper: should be in line with national regulations. comply with relevant state regulations.
h) drying agent: should be equipped with 75% ~ 95% ethanol or isopropyl alcohol. 5.3.12 Personal protective equipment: should be equipped with waterproof apron or waterproof isolation gowns, medical surgical masks, goggles or protective masks, hats, gloves, special shoes and so on.
5.5.4 5.4 Endoscopy and accessory storage (cabinet)The inner surface should be smooth, no gaps, easy to clean and disinfect, and accessory storage (cabinet) should be well ventilated and kept dry.
5.6 6 Cleaning and disinfection operation procedures 5.6.1 6.1 Basic principles6.1.1 All soft endoscopes should be thoroughly cleaned and disinfected or sterilized at a high level after each use.
6.1.2 Soft endoscopes and reusable accessories and diagnostic and therapeutic supplies should be classified and handled according to the following principles:
a) Soft endoscopes and accessories that enter sterile human tissues and organs, or that come into contact with broken skin or broken mucous membranes, should be sterilized;
b) Soft endoscopes that come in contact with intact mucous membranes and do not enter sterile human tissues and organs, or come into contact with broken skin or broken mucous membranes should be sterilized;
c) Soft endoscopes that do not come into contact with intact mucous membranes should be sterilized.
6.1.3 The following process should be followed for endoscope cleaning and disinfection (see Figure 1).
Figure 1 Process for cleaning and disinfection of soft endoscopes
6.1.4 Precautions are as follows:
a) Leak detection should be performed after endoscopy use as follows:
1) It is appropriate to perform leak detection before each cleaning;
2) Leak detection should be performed at least once a day when the conditions do not permit.
b) Endoscopes should be thoroughly cleaned before disinfection or sterilization.
c) The duration of action of cleaning agents and disinfectants should follow product instructions. The duration of disinfection of endoscopes and accessories that have been used by patients with confirmed or suspected mycobacterial infection should follow the product instructions.
d) Disinfected endoscopes should be subjected to final rinsing with purified or sterile water, and endoscopes sterilized by immersion should be subjected to final rinsing with sterile water.
e) Endoscopes should be stored in a clean, dry environment.
f) Before the start of each day's treatment, the sterilized endoscopes to be used on that day should be re-sterilized, final rinsed and dried before they are used for patient treatment.
5.6.2 6.2 Manual procedure6.2.1 The pre-processing procedure is as follows:
a) Immediately after the endoscope is removed from the patient's body, and before it is detached from the light source and the video processor, the dirt on the external surface should be wiped off with a wet towel or a wet gauze that contains a cleaning solution, and the wipes should be disposable;
b) Repeatedly deliver gas and water for at least 10 s;
c) Repeatedly deliver gas and water for at least 10 s;
d) Repeat the procedure for the endoscope.c) Place the apex of the endoscope into the container with cleaning solution, start the suction function, and pump the cleaning solution until it flows into the suction tube;
d) Cover the waterproof cover of the endoscope;
e) Put it into the delivery container and send it to the cleaning and disinfection room.
6.2.2 Leak detection process is as follows:
a) Remove all kinds of buttons and valves;
b) Connect the leak detection device and inject the pressure;
c) Submerge the endoscopy in water, and use a syringe to inject water into the tubes in order to expel the gas in the tubes;
d) Bend the apex of the endoscopy in all directions to see if there are bubbles coming out; then see if there is any gas coming out. d) First, bend the apex of the endoscope in all directions and observe whether there are bubbles; then observe whether there are bubbles in the insertion part, operation part and connection part;
e) If leakage is found, it should be guaranteed and sent for inspection;
f) Leakage detection should be recorded;
g) Other effective leakage detection methods can also be used.
6.2.3 The cleaning process is as follows:
a) Prepare the cleaning solution in the cleaning tank, and completely submerge the endoscopes, buttons and valves in the cleaning solution.
b) Repeatedly scrub the body of the mirror with a wiping cloth, and should focus on scrubbing the insertion and operation parts. The wipes should be replaced every time they are used.
c) Scrub all the tubes of the soft endoscope, with the brush head visible at both ends, and wash the dirt from the brush head; repeat the scrubbing until there is no visible contamination.
d) Connect the full tube irrigator and use a power pump or syringe to fill the tubes with cleaning solution; the soak time should follow the product instructions.
e) Brush buttons and valves suitable for ultrasonic cleaning should be ultrasonically cleaned according to the manufacturer's instructions.
f) The cleaning solution should be changed after every 1 endoscope cleaning.
g) Clean the scrubbing brush, sterilize it at a high level and prepare it for use.
6.2.4 The rinsing process is as follows:
a) Move the cleaned endoscopes into the rinsing tank along with the full tube irrigators, buttons, and valves;
b) Fully rinse the tubes of the endoscopes with a power pump or pressure air gun to leave no residue of the cleaning solution;
c) Rinse the outer surfaces of the endoscopes, buttons, and valves with flowing water;
d) Inflate the tubes with a power pump or pressure air gun for at least 30 s to remove water from the tubes;
e) Dry the outer surface of the endoscope, buttons and valves with a wipe, which should be replaced every time it is used.
6.2.5 The disinfection (sterilization) process is as follows:
a) Move the endoscope, together with the full-tube irrigator, as well as the buttons and valves, into the disinfection tank, and submerge them all in disinfectant solution;
b) Use a power pump or syringe to fill each tube with disinfectant solution, and the disinfection method and time should follow the product instruction manual;
c) Change the gloves and inflate each tubes for at least 30 s to remove the disinfectant solution from the tubes;
d) When sterilizing soft endoscopes using sterilization equipment, follow the instructions for the equipment.
6.2.6 The final rinsing process is as follows:
a) Move the endoscope with the full tube irrigator, as well as the buttons and valves, into the final rinsing tank;
b) Using a power pump or a pressure water gun, rinse the tubes of the endoscope for at least 2 minutes with purified or sterile water until there is no disinfectant residue;
c) Rinse the outer surface, buttons and valves of the endoscope with purified or sterile water;
d) Follow the instructions of the equipment when using sterilization equipment for soft endoscopes. external surfaces, buttons and valves with purified or sterile water;
d) Endoscopes sterilized by immersion should be subjected to final rinsing with sterile water in a special final rinsing tank;
e) Remove the whole tube irrigator.
6.2.7 The drying process is as follows:
a) Place the endoscopes, buttons, and valves on a dedicated drying table lined with sterile towels. The sterile towel should be changed every 4h.
b) Fill all tubes with 75% to 95% ethanol or isopropanol.
c) Using a pressure air gun, inflate all tubes with clean compressed air for at least 30 s until they are completely dry.
d) Dry the external surfaces of the endoscope, buttons and valves with a sterile wipe and pressure air gun.
e) Install the buttons and valves.
5.6.3 6.3 Endoscope Cleaning and Disinfecting Machine Operating Procedures6.3.1 Pre-treatment, leak detection, cleaning, and rinsing of endoscopes should be performed before using the endoscope cleaning and disinfecting machine by following 6.2.1, 6.2.2, 6.2.3, and 6.2.4.
6.3.2 Cleaning and rinsing may be performed in the same cleaning tank.
6.3.3 The use of the endoscope cleaning and disinfecting machine should follow the instructions for use of the product.
6.3.4 Endoscope cleaning and disinfecting machines without a drying function should be dried in accordance with 6.2.7.
5.6.4 6.4 Cleaning, disinfection, and sterilization of reusable accessories6.4.1 Accessories should be promptly immersed in a cleaning solution or moisturized with a humectant after use, and in the case of luminal accessories should be injected into the lumen with a cleaning solution.
6.4.2 The internal and external surfaces and joints of the accessory should be carefully brushed until they are free of visible contaminants.
6.4.3 Accessories that are ultrasonically cleaned should be ultrasonically cleaned using a medical cleaning agent following the product instructions for the accessory. After cleaning, rinse with running water and dry.
6.4.4 Lubrication of accessories should follow the manufacturer's instructions.
6.4.5 Selection of disinfection or sterilization methods according to 6.1.2:
a) Disinfection of moisture- and heat-resistant accessories:
1) Thermal disinfection can be used, or disinfectant can be used for disinfection;
2) The method of disinfectant should follow the instructions of the product;
3) After disinfection with disinfectant, it should be used with purified water or Rinse with sterile water, dry and spare.
b) moisture-resistant, heat-resistant accessories preferred pressure steam sterilization; heat-resistant accessories should be used low-temperature sterilization equipment or chemical sterilant immersion sterilization, chemical sterilant immersion sterilization should be used after the use of sterile water rinsing, dry and spare.
5.6.5 6.5 Storage6.5.1 After drying, endoscopes should be stored in the endoscopy and accessory storage (cabinet), the mirror body should be hung, the corner of the fixed knob should be placed in the free position, and will be removed from all types of buttons and valves stored separately.
6.5.2 Endoscopy and accessory storage (cabinet) should be cleaned and disinfected once a week, in case of contamination should be cleaned and disinfected at any time.
6.5.3 Sterilized endoscopes, accessories and related items should be stored in accordance with the requirements for the storage of sterile goods.
5.6.6 6.6 Cleaning and disinfection of facilities, equipment and environment6.6.1 At the end of the daily cleaning and disinfection work, cleaning tanks, rinsing tanks, etc. should be thoroughly brushed and disinfected with chlorine-containing disinfectants, peracetic acid, or other disinfectants that comply with the relevant national regulations.
6.6.2 Each time the disinfectant is replaced, the disinfection tank should be thoroughly brushed.
6.6.3 The environment of the endoscopy treatment center (room) should be cleaned and disinfected after the daily treatment and cleaning and disinfection.
5.7 7 Monitoring and Recording 5.7.1 7.1 Endoscopy Cleaning Quality Monitoring7.1.1 Each endoscope and its accessories shall be inspected by visual inspection. The surface of the endoscope and its accessories shall be clean and free of stains. If the cleaning quality is not satisfactory, it should be reprocessed.
7.1.2 Methods such as protein residue determination and ATP biofluorimetry may be used to monitor the cleaning effect of endoscopes on a regular basis.
5.7.2 7.2 In-Use Disinfectant or Sterilant Monitoring 5.7.2.1 7.2.1 Concentration Monitoring7.2.1.1 Concentration monitoring should be performed following the product instructions for use.
7.2.1.2 If the product instructions do not state the frequency of concentration monitoring, single-use disinfectants or sterilizing agents should be monitored for concentration per batch; repeated use of disinfectants or sterilizing agents should be measured once after preparation of the concentration of the disinfectant or sterilizing agent, and monitoring should be carried out prior to each use; and the disinfection of endoscopes after the number of disinfected endoscopes reaches half of the specified number should be measured prior to the disinfection of each endoscopic strip.
7.2.1.3 Acid oxidation potential water should be used before each use, should be used at the site of acid oxidation potential water outlet, respectively, to determine the pH and effective chlorine concentration.
5.7.2.2 7.2.2 Bacterial contamination monitoringQuarterly monitoring should be 1 time, the monitoring method should follow the provisions of WS/T 367.
5.7.3 7.3 Endoscopic disinfection quality monitoring7.3.1 Disinfected endoscopes should be quarterly biological monitoring. Monitoring is done by rotational sampling at 25% each time. The number of endoscopes less than or equal to 5, should be all monitored each time; more than 5, the number of each monitoring should not be less than 5.
7.3.2 The monitoring method should follow the provisions of GB 15982, disinfection qualification standards: total colony count ≤ 20 CFU / piece.
7.3.3 When hospital-acquired infections are suspected to be related to endoscopic diagnostic and treatment operations, pathogenic microorganisms should be tested, and the method should follow the provisions of GB 15982.
5.7.4 7.4 Endoscopic cleaning and disinfection machine monitoring7.4.1 Endoscopic cleaning and disinfection machine new installation or maintenance, should be cleaned and disinfected endoscopes for biological monitoring, monitoring qualified before use.
7.4.2 Other monitoring of endoscopic cleaning and disinfecting machines should follow the relevant national regulations.
5.7.5 7.5 Hand hygiene and environmental disinfection quality monitoring7.5.1 Quarterly monitoring of the effect of hand disinfection of medical personnel should be carried out, and the monitoring method should follow the provisions of WS/T 313.
7.5.2 Quarterly should be diagnosis and treatment rooms, cleaning and disinfection room environmental disinfection effect monitoring, monitoring methods should follow the provisions of WS/T 367.
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5.7.6 7.6 Records and Traceability Requirements for Quality Control Processes7.6.1 Records should be kept of the use and cleaning and disinfection of each endoscope, including: the date of diagnosis and treatment, the patient's identification and the number of endoscopes (which should be unique), the starting and ending times of cleaning and disinfection, and the name of the operator.
7.6.2 The results of the monitoring of the concentration of disinfectant and the amount of bacteria in use should be recorded.
7.6.3 The results of biological monitoring of endoscopes should be recorded.
7.6.4 It is desirable to retain a printout of the operating parameters of the endoscope cleaning and disinfecting machine.
7.6.5 The results of quality monitoring of hand hygiene and environmental disinfection should be recorded.
7.6.6 Records should be traceable, disinfectant concentration monitoring records should be retained for ≥ 6 months, and other monitoring information should be retained for ≥ 3 years.
6 Appendix 6.1 Appendix A (normative appendix) endoscopy center (room) different areas of personnel protective clothing requirementsendoscopy center (room) different areas of personnel protective clothing requirements are shown in Table A.1.
Table A.1 endoscopy center (room) different areas of personnel protective clothing requirements
area
Protective clothing
Work clothes
Surgical cap
Mask
Gloves
Goggles or mask
Waterproof apron or waterproof isolation gown
Specialized shoes
Diagnostic room
√
√
√
√
√
△
< p>Cleaning and disinfection room
√
√
√
√
√
√
√
Note: √ should be used, △ is appropriate.
6.2 Appendix B (normative appendix) Partial disinfectant (sterilizing) agent usePartial disinfectant (sterilizing) agent use is shown in Table B.1.
Table B.1 Partial disinfectant (sterilizing) agent use
Disinfectant (sterilizing) agent
High level disinfecting and sterilizing parameter
Usage
Precautions <
o-Phthalaldehyde
(OPA)
Concentration: 0.55% (0.5% to 0.6%)
Time: Disinfection ≥ 5 min
1. Endoscopic cleaning and disinfection machine.
2. Manual operation: disinfectant should be filled with each pipe, immersion disinfection
1. Easy to stain clothes, skin, instruments and so on.
2. Contact with steam may *** respiratory tract and eyes
Glutaraldehyde
(GA)
Concentration: ≥ 2% (alkaline)
Time: bronchoscopy disinfection immersion time of ≥ 20 min; other endoscopy disinfection of ≥ 10 min; mycobacterium tuberculosis, other mycobacteria, and other special infections such as patients after the use of the endoscopy immersion ≥ 15 min; sterilization ≥ 10 h
1. Endoscope cleaning and disinfection machine.
2. Manual operation: disinfectant should be filled with each tube, immersion disinfection
1. To the skin, eyes and respiratory sensitization and ***, and can cause dermatitis, conjunctivitis, nasal inflammation and occupational asthma, it is appropriate to use in endoscopy cleaning and disinfection machine.
2. easy to form hard substances on the endoscope and cleaning and disinfection equipment
Peroxyacetic acid
(PAA)
Concentration: 0.2% to 0.35% (v/v)
Time: disinfection ≥ 5 min, sterilization ≥ 10 min
Endoscopy disinfector
******** on the skin, eyes and respiratory tract. Respiratory tract has *** sex
Chlorine dioxide
Concentration: 100 mg/L ~ 500 mg/L
Time: disinfection 3 min ~ 5 min
1. endoscopy cleaning and disinfection machine.
2. Manual operation: the disinfectant should be filled with each pipe and immersed for disinfection
The activation rate is low when it produces a large *** odor, which is suitable to be used in endoscope cleaning and disinfecting machine
Acidic Oxidation Potential Water (AEOW)
Main indexes:
Effective chlorine concentration of 60 mg/L±10 mg/L;
pH 2.5 mg/L±10 mg/L;
Concentration of 100 mg/L~500 mg/L;
Time: 3 min~5 min
1. Endoscope cleaning and disinfecting machine. p>
pH 2.0 ~ 3.0;
Redox potential ≥ 1100 mV;
Residual chlorine ions <1000 mg/L.
Time: Disinfection 3 min ~ 5 min
1. Acidic Oxidation Potential Water Endoscopy Cleaning and Disinfection Machine.
2. Manual operation: the use of a special connector will be acidic oxidation potential water outlet and endoscopy of each orifice connected to the flow of immersion disinfection
1. In the presence of organic substances, the disinfection effect will be sharply reduced, disinfection should be thoroughly cleaned before. Especially for serious contamination, not easy to clean endoscopy (such as enteroscopy, etc.), should increase the number of brushing, extend the cleaning time, to ensure the quality of cleaning.
2. Flow immersion should be used to disinfect.
3. After disinfection, purified water or sterile water rinse 30 s
Note 1: The disinfectant (sterilizing) agents listed in the table, the specific conditions of use and precautions to follow the product instructions.
Note 2: The table is not listed in the same or other disinfectants (sterilizing) agents, their use and precautions to follow the product instructions.
Note 2: The use of similar or other disinfectants (sterilizers) not listed in the table should follow the instructions for use.