Technical Practice for Cleaning and Disinfection of Endoscopes:
Notice of the Ministry of Health on the Issuance of the Technical Practice for Cleaning and Disinfection of Endoscopes (2004 Edition)
The Department of Health of all Provinces, Autonomous Regions, and Municipalities Directly under the Central Government, and the Bureau of Health of the Xinjiang Production and Construction Corps:
For the purpose of further enhancing the work of cleaning and disinfecting of endoscopes in healthcare institutions to ensure medical quality and medical safety In order to further strengthen the work of endoscopic cleaning and disinfection in medical institutions, to protect the quality of medical care and medical safety, the Ministry of organizing the relevant experts, on the basis of investigation and research developed the "endoscopic cleaning and disinfection of technical specifications for operation (2004 edition)" (hereinafter referred to as "norms"), is issued to you, please comply with the implementation. In order to ensure the smooth implementation of the "norms", the following requirements:
All levels and types of medical institutions must attach great importance to endoscopy disinfection, endoscopy disinfection quality into the quality of medical care and medical safety management. Before the implementation of this Code, medical institutions carrying out endoscopic diagnosis and treatment business must carry out self-examination and rectification work in accordance with the requirements of the Code.
Establishment and implementation of the endoscopy disinfection of the rules and regulations, and effectively ensure the quality of disinfection, strict prevention and control of hospital infections caused by endoscopy disinfection.
Second, strengthen the study and training of the Code. Carry out endoscopic diagnosis and treatment of medical institutions, must seriously organize the study and comprehensive implementation of the "norms", the relevant hospital infection management personnel, engaged in endoscopic diagnosis and treatment of endoscopy and endoscopy cleaning and disinfection of medical personnel should receive appropriate training to correctly grasp the endoscopy of the cleaning and disinfection and sterilization techniques.
Third, health administrative departments at all levels to strengthen the supervision and management of endoscopic disinfection of medical institutions, medical institutions that do not meet the requirements of the "norms", shall not carry out the corresponding endoscopic diagnostic and therapeutic operations.
Code of Practice for Endoscopic Cleaning and Disinfecting Technology (2004 Edition)
Chapter I, General Provisions
Article I In order to regulate the work of cleaning and disinfecting endoscopes in medical institutions, to protect the quality of medical care and medical safety, the development of this specification.
The second article of this specification applies to carry out endoscopic diagnosis and treatment of medical institutions.
The third endoscopic diagnosis and treatment of medical institutions, should be cleaned and sterilized endoscopy work into the quality of medical management, strengthen the monitoring and supervision.
Article IV of the local health administrative departments at all levels are responsible for the supervision and management of the work of cleaning and disinfection of endoscopes in medical institutions under their jurisdiction.
Chapter II, the basic requirements
Article 5 to carry out endoscopic diagnosis and treatment of medical institutions should develop and improve the endoscopy room management of the rules and regulations, and conscientiously implement.
Sixth endoscopic diagnosis and treatment and endoscopic cleaning and disinfection of medical personnel, should have knowledge of endoscopic cleaning and disinfection, accept the relevant hospital infection management knowledge training, and strictly abide by the relevant rules and regulations.
Article 7 of the cleaning and disinfection of endoscopy should be carried out separately from the diagnosis and treatment of endoscopy, separate cleaning and disinfection room and endoscopy diagnosis and treatment room, cleaning and disinfection room should be guaranteed to ensure good ventilation. Endoscopic diagnosis and treatment room should be equipped with diagnosis and treatment beds, suction, treatment trolley and other basic facilities.
Article VIII of the different parts of the endoscopic diagnosis and treatment should be divided into rooms; upper gastrointestinal tract, lower gastrointestinal tract endoscopy diagnosis and treatment can not be divided into rooms, should be divided into time periods; different parts of the endoscopic cleaning and disinfection of the work of the equipment should be separated.
Article IX sterilization endoscopy diagnosis and treatment should be carried out in the area to meet the surgical standards, and in accordance with the requirements of the surgical area for management.
Article X staff cleaning and disinfecting endoscopes should wear the necessary protective equipment, including coveralls, impermeable aprons, masks, hats, gloves and so on.
Article XI according to the needs of the work, in accordance with the following requirements are equipped with the appropriate endoscopy and cleaning and disinfection equipment:
One, endoscopes and accessories: the number of hospitals should be adapted to the size and the number of patients in order to ensure that the use of the device can be used to achieve the appropriate disinfection before use, sterilization qualified requirements, to protect the safety of patients.
Two, the basic cleaning and disinfection equipment: including special flow of water cleaning and disinfection tank (four or five tanks), negative pressure suction, ultrasonic cleaner, high-pressure water gun, drying equipment, timer, ventilation facilities, and the method of disinfection, sterilization methods used in the necessary disinfection, sterilization instruments, 50 ml syringes, a variety of brushes, gauzes, cotton swabs and other consumables.
Third, cleaning and disinfecting agents: multi-enzyme lotion, disinfectant suitable for endoscopy, 75% ethanol.
Article XII of the endoscopy and accessories cleaning, disinfection or sterilization must comply with the following principles:
I. All into the human body's sterile tissues, organs, or through a surgical incision into the human body's sterile chamber endoscopy and accessories, such as laparoscopy, arthroscopy, ventriculoscopy, cystoscopy, hysteroscopy, etc., must be sterilized.
Second, all endoscopic accessories that penetrate the mucous membrane, such as biopsy forceps, high-frequency electrosurgical knife, etc., must be sterilized.
Third, where the human digestive tract, respiratory tract and other endoscopes in contact with mucous membranes, such as laryngoscopes, bronchoscopes, bronchoscopes, gastroscopes, intestinal scopes, sigmoidoscopes, proctoscopes and so on, should be sterilized in accordance with the "sterilization specifications," the requirement for a high level of disinfection.
Four, endoscopes and accessories should be cleaned, disinfected or sterilized immediately after use.
V. Disinfectants, disinfecting instruments or other disinfecting equipment used in medical institutions must comply with the provisions of the Administrative Measures for Disinfection.
VI, endoscopy and accessories cleaning, disinfection or sterilization time should be controlled using a timer.
VII. Prohibit the use of non-flowing water for cleaning endoscopes.
Article XIII of the endoscopy room should do a good job of endoscopy cleaning and disinfection of the registration, registration should include, the patient's name, the use of endoscopy number, cleaning time, disinfection time, and the operator's name and other matters.
Article XIV of the hospital infection management department should be in accordance with these norms, is responsible for the institution of endoscopy use and cleaning and disinfection of quality supervision and management.
Chapter III cleaning and disinfection of soft endoscopy
Article XV of the soft endoscopy should be used immediately after the use of wet gauze to wipe off the external surface dirt, and repeatedly send gas and water for at least 10 seconds, remove the endoscope and install the waterproof cover, placed in a suitable container to send cleaning and disinfection room.
Cleaning steps, methods and points include:
I. Water washing
(1) Put the endoscope into the cleaning tank:
1. Rinse thoroughly under flowing water, scrub the mirror body with gauze repeatedly, and clean the operation part at the same time;
2. Remove the biopsy inlet valve, the suction device button and the button of sending air and water, and brush the biopsy orifice and the guide thoroughly with a clean brush. Brush the biopsy orifice and the attractor pipe of the light-guiding hose thoroughly with a clean brush, the brush must be seen at both ends of the brush head, and wash the dirt on the brush head;
3, install the full pipeline irrigator, the pipeline plug, the waterproof cap and the attractor, and repeatedly suction the biopsy orifice with the attractor;
4, the full pipeline irrigator is connected to the 50ml syringe, and the water is sucked and injected into the air supply and water supply pipeline;
5, suck the biopsy orifice dry with the suction to dry the biopsy orifice and dry the mirror.
(ii) Rinse the removed suction button, water and air delivery button, and biopsy inlet valve with water and wipe them dry.
(iii) After use, endoscopic accessories such as biopsy forceps, cytobrush, incisional knife, guidewire, lithotripter, mesh basket, contrast catheter, and foreign body forceps, etc., are placed in clean water, and the inner surfaces of the flap and the joints are cleaned with a small brush, rinsed, and wiped dry.
(d) Cleaning gauze should be used in a single-use manner, and the cleaning brush should be sterilized once used.
II. Enzymatic washing
(I) The configuration and soaking time of the multi-enzyme washing solution is in accordance with the product instructions.
(B) the dry endoscope in the enzyme wash tank, syringe suction multi-enzyme wash solution 100 ml, rinse the air and water pipeline, with the suction device will contain enzyme wash solution into the biopsy orifice, the operation of the Department of multi-enzymatic wash with a wipe.
(C) after wiping dry the accessories, all kinds of buttons and valves soaked with multi-enzyme wash solution, accessories also need to be cleaned in the ultrasonic cleaner for 5 to 10 minutes.
(iv) The multi-enzyme wash solution should be replaced after every 1 endoscope is cleaned.
III. Cleaning
(I) After soaking the endoscope in the multi-enzyme wash solution, thoroughly rinse the tubes with a water pistol or syringe to remove the multi-enzyme wash solution and loose dirt from the tubes, and rinse the outer surface of the endoscope at the same time.
(ii) Flush each tube with a 50-mL syringe to expel water from the tube to avoid diluting the disinfectant.
Article XVI of the soft endoscopes using chemical disinfectants for disinfection or sterilization, should be carried out in accordance with the instructions for use, and chemical monitoring and biological monitoring.
Article XVII of the use of 2% alkaline glutaraldehyde immersion disinfection or sterilization, should be cleaned and wiped dry endoscopes placed in the disinfection tank and all submerged in disinfectant, each orifice with a syringe filled with disinfectant. The operating section of the non-totally immersed endoscope must be wiped with water and then wiped with 75% ethanol for disinfection.
Article 18 needs to be sterilized endoscopes using 2% alkaline glutaraldehyde sterilization, the immersion time is:
(a) gastroscopy, enteroscopy, duodenoscopy immersion of not less than 10 minutes;
(b) bronchoscopes immersion of not less than 20 minutes;
(c) mycobacterium tuberculosis, other mycobacteria, and other special infections such as patients with special infections after the use of the endoscopes immersed not less than 45 minutes. than 45 minutes.
Article 19 requires sterilization of endoscopes using 2% alkaline glutaraldehyde sterilization, must be immersed for 10 hours.
Article 20 of the day no longer continue to use the gastroscope, enteroscopy, duodenoscopy, bronchoscopy and other endoscopes need to be sterilized using 2% alkaline glutaraldehyde sterilization, should be extended disinfection time to 30 minutes.
Article 21 of the use of other disinfectants, automatic cleaning and disinfection equipment or other disinfection equipment, must comply with the provisions of Article 12, paragraph 5 of these norms, and in strict accordance with the instructions for use.
Before using the instruments for cleaning and disinfection, the endoscope must first be cleaned in accordance with the provisions of Article XV.
Article 22 after disinfection of soft endoscopes, should be rinsed and dried in accordance with the following methods and steps:
I. Before the endoscope is removed from the disinfection tank, the cleaning and disinfecting personnel should change gloves and inject air into the lumen of each tube with a syringe to remove the disinfectant.
Two, the endoscope is placed in the rinsing tank, and the outer surface of the endoscope is cleaned with gauze under flowing water, and the orifices are repeatedly pumped with water to rinse them.
Third, dry the outer surface of the endoscope with gauze, and pump the water from each orifice clean. Remove all kinds of special pipes and buttons for cleaning, and replace them with all kinds of accessories for diagnosis and treatment before they can be used for the diagnosis and treatment of the next patient.
Fourth, the bronchoscope after the above operation, but also need to use 75% ethanol or clean compressed air and other methods for drying.
Article 23 of the endoscopes sterilized by chemical disinfectant immersion, must be thoroughly rinsed with sterile water before use to remove residual disinfectant.
Article 24 of the endoscopic accessories disinfection and sterilization methods and points include:
I. Biopsy forceps, cytobrush, incision knife, guidewire, lithotripter, mesh basket, contrast catheter, foreign body forceps and other endoscopic accessories must be sterilized once used. The preferred method is pressure steam sterilization, can also be used ethylene oxide, 2% alkaline glutaraldehyde immersion 10 hours of sterilization, or choose to comply with the provisions of the fifth paragraph of Article XII of these norms applicable to the disinfection of endoscopy disinfectant, disinfectant equipment for sterilization, the specific methods of operation in accordance with the instructions for use.
Two, curved trays, dressing cylinders, etc. should be used pressure steam sterilization; non-disposable mouth ring can be used to high-level chemical disinfectant disinfection, such as effective chlorine content of 500 mg / L chlorine disinfectant or 2000 mg / L of peroxyacetic acid immersion disinfection for 30 minutes. After disinfection, rinse the residual disinfectant thoroughly with water and dry it for spare; the water injection bottle and connecting tube are disinfected by soaking in non-corrosive chemical disinfectant at a high level or above, and after disinfection, the residual disinfectant is rinsed thoroughly with aseptic water and dried for spare. The water in the injection bottle should be sterile water, replaced daily.
Article 25 of the sterilized accessories should be stored in accordance with the requirements for the storage of sterile goods.
Article 26 of the daily diagnosis and treatment work is over, with 75% ethanol on the sterilized endoscopy of the various pipelines for rinsing, drying, stored in a special clean cabinet or mirror room. The mirror body should be hung, and the bent angle fixing knob should be placed in the free position. The inner surface of the storage cabinet or the inner surface of the wall of the mirror room should be smooth, no gaps, easy to clean, clean and disinfected once a week.
Article 27 of the end of the daily diagnosis and treatment work, must be attracted to the bottle, suction tube, cleaning tank, enzyme wash tank, rinse tank cleaning and disinfection, specific methods and points include:
A, attracted to the bottle, suction tube after cleaning, the effective chlorine content of 500mg/L chlorine-containing disinfectant or 2000 mg/L peroxyacetic acid disinfectant immersion for 30 minutes, brushing, clean, dry and spare. Dry and spare.
Second, cleaning tank, enzyme washing tank, rinse tank after sufficient scrubbing, with effective chlorine content of 500mg / L of chlorine disinfectant or 2000 mg / L of peroxyacetic acid wipe. Disinfectant tanks must be thoroughly scrubbed when replacing the disinfectant.
Article 28 before the start of the daily diagnosis and treatment work, the disinfectant type endoscopes to be used on that day must be disinfected again. If 2% alkaline glutaraldehyde immersion, disinfection time of not less than 20 minutes, rinsing, drying, before being used for patient consultation.
Chapter IV Cleaning and Disinfection of Rigid Endoscopy
Article 29 of the cleaning steps, methods and key points of rigid endoscopy include:
I. Thoroughly cleaned with running water immediately after use to remove blood, mucus, and other residual substances, and wipe dry.
Two, the endoscope after drying is placed in the multi-enzyme washing solution to soak for the time according to the instructions for use.
Third, thoroughly clean all parts of the endoscope, the lumen should be thoroughly rinsed with a high-pressure water gun, the removable part must be disassembled and cleaned, and ultrasonic cleaner for 5 to 10 minutes.
Fourth, the axial section of the instrument, the curved part, the lumen of the tube with a soft brush thoroughly scrubbing, scrubbing care to avoid scratching the mirror surface.
Article 30 of the rigid endoscopy disinfection or sterilization methods and points include:
I. Suitable for pressure steam sterilization of endoscopes or endoscopic components should be used for pressure steam sterilization, pay attention to the requirements of the endoscopy manual to select the temperature and time.
Second, ethylene oxide sterilization method is suitable for sterilization of various endoscopes and accessories.
Three, can not be used to pressure steam sterilization of endoscopes and accessories can be used 2% alkaline glutaraldehyde immersion 10 hours sterilization.
Four, to meet the sterilization requirements of hard endoscopes, such as laryngoscopes, colposcopes, etc., can be used to boil sterilization for 20 minutes.
V. When disinfecting and sterilizing with disinfectant solution, instruments with axial joints should be fully opened axial joints, and the lumen of instruments with lumen should be fully injected with disinfectant solution.
Sixth, the use of other disinfectants, disinfection of instruments must comply with the provisions of the fifth paragraph of Article 12 of these norms, the specific methods of operation in accordance with the instructions for use.
Article 31 of the use of chemical disinfectant immersion disinfection of rigid endoscopy, disinfection should be rinsed with flowing water, and then dried with sterile gauze.
The use of chemical disinfectant immersion sterilization of rigid endoscopes, sterilization should be thoroughly rinsed with sterile water, and then dried with sterile gauze.
Article 32 after sterilization of endoscopes and accessories shall be stored in accordance with the requirements for the storage of sterile articles.
Chapter V monitoring the effect of endoscopic disinfection and sterilization
Article 33 of the disinfectant concentration must be regularly monitored and recorded on a daily basis to ensure the effect of disinfection.
The disinfectant must not be used for longer than the period of use specified in the product specification.
Article 34 of the sterilized endoscopes should be quarterly biological monitoring and make a good record of monitoring.
Sterilization of endoscopes should be monthly biological monitoring and monitoring records.
Sterilization of endoscopes after qualifying standards for: total bacteria & lt; 20cfu / piece, can not detect pathogenic bacteria; sterilized endoscopes after qualifying standards for: sterility test pass.
Article 35 of the sterilization effect of endoscopy monitoring using the following methods:
(a) sampling method: monitoring the sampling site for the internal cavity surface of the endoscope. With a sterile syringe, 10ml of buffer containing the corresponding neutralizing agent is drawn and injected from the biopsy port of the endoscope to be examined, and collected from the biopsy outlet with a 15ml sterile test tube, and sent for examination in time to be detected within 2 hours.
(ii) colony counting: send the liquid with vortexer fully shaken, take 0.5ml, add 2 diameter 90mm sterile petri dishes, each petri dish were added to have melted 45 ℃ -48 ℃ nutrient agar 15 ml-18ml, pouring while shaking, wait for the agar to solidify, and then cultured at 35 ℃ for 48 hours after counting.
Results judgment: the number of colonies/mirror = the average of the number of colonies of 2 dishes × 20.
(C) pathogenic bacteria detection: the delivery of the liquid with a vortexer to fully shake, take 0.2ml were inoculated with 90mm blood dishes, Chinese Orchid Petri dishes and SS Petri dishes, evenly coated, cultured at 35 ℃ for 48 hours, to observe the presence or absence of pathogenic bacteria growth.
Chapter VI Annex
Article 36 of the medical institutions with endoscopy diagnosis and treatment center, its floor space should be matched with the size and function of the medical institutions, the establishment of patient waiting room (area), diagnostic and treatment rooms, cleaning and disinfection room, endoscopy storage room.
Diagnosis and treatment room of each diagnostic and treatment unit should include: 1 diagnostic and treatment beds, host (including monitors), suction, treatment carts, etc., each diagnostic and treatment unit shall not be less than 20 square meters of net usable area.
Thirty-seven this specification since June 1, 2004 shall come into force.
The original "Hospital Infection Management Code (Trial)" Chapter VI, Section XI "endoscopy room of the hospital infection management" is repealed at the same time, other inconsistent with the provisions of this specification shall prevail.