Evaluation of disinfection and sterilization quality of endoscopy and minimally invasive instruments

In order to standardize the disinfection and sterilization of endoscopy in medical institutions and ensure the medical quality and medical safety of endoscopy and minimally invasive technology, this guide is formulated according to the "Disinfection Management Measures", "Nosocomial Infection Management Measures" and "Technical Operation Specifications for Cleaning and Disinfection of Endoscopy" of the Ministry of Health. This guideline is applicable to all kinds of medical institutions carrying out endoscopic diagnosis and treatment. Medical institutions carrying out endoscopic diagnosis and treatment should incorporate the disinfection and sterilization of endoscopy and minimally invasive instruments into medical quality management, and strengthen monitoring and supervision. Local health administrative departments at all levels shall be responsible for the supervision and administration of endoscopic disinfection and sterilization in medical institutions within their jurisdiction.

Chapter I Basic Requirements

1. Medical institutions carrying out endoscopic diagnosis and treatment should formulate and improve various rules and regulations for the management of endoscopic rooms, and conscientiously implement them.

2. Medical personnel engaged in endoscopic diagnosis, treatment and endoscopic disinfection and sterilization should have the knowledge of endoscopic disinfection and sterilization, regularly participate in the relevant nosocomial infection management knowledge training, and strictly abide by the relevant rules and regulations.

3. The disinfection and sterilization of endoscopy should be carried out separately from the diagnosis and treatment of endoscopy. Separate disinfection and sterilization rooms and endoscopic treatment rooms should be set up, and the disinfection and sterilization rooms should be well ventilated. The endoscopic treatment room shall be equipped with diagnosis and treatment beds, aspirators, treatment vehicles and other basic facilities.

IV. The diagnosis and treatment of endoscopy in different parts should be carried out in separate rooms; If the diagnosis and treatment of upper and lower gastrointestinal endoscopy cannot be performed in different rooms, it should be performed in different time periods. Equipment for disinfection and sterilization of endoscopy of different parts should be separated.

V. The diagnosis and treatment of the sterilized endoscope should be carried out in the area meeting the surgical standards, and be managed in accordance with the requirements of the surgical area.

6. When disinfecting and sterilizing the endoscope, the staff should wear necessary protective equipment, including working clothes, anti-penetration aprons, masks, hats, gloves, etc.

VII. According to work needs, corresponding endoscopy and disinfection and sterilization equipment shall be provided in accordance with the following requirements:

(I) Endoscopes and accessories: the number of endoscopes should be in line with the size of the hospital and the number of patients treated, so as to ensure that the instruments used can meet the corresponding requirements of disinfection and sterilization before use and ensure the safety of patients.

(2) basic disinfection sterilization equipment: including special flow water disinfection tank (four or five groove groove), negative pressure aspirator, ultrasonic cleaning machine, high-pressure spray, drying equipment, timer, ventilation facilities, corresponding to the disinfection and sterilization method adopted by the necessary disinfection and sterilization equipment, 50 ml syringe, all kinds of brush, gauze, cotton swab and other consumables.

(3) Disinfection and sterilization agent: multi-enzyme lotion, disinfectant suitable for endoscopy, 75% ethanol.

VIII. The cleaning, disinfection or sterilization of endoscopy and its accessories must follow the following principles:

(1) Endoscopes and accessories that enter human sterile tissues and organs or enter human sterile chambers through surgical incision, such as laparoscopy, arthroscopy, ventriculoscope, cystoscope, hysteroscopy, etc., must be sterilized.

(2) Endoscopic appendages that perforate mucosa, such as biopsy forceps and high-frequency electrotome, must be sterilized.

(3) Endoscopies that enter the human digestive tract and respiratory tract and contact with the mucosa, such as laryngoscopy, tracheoscope, bronchoscope, gastroscopy, colonoscopy, sigmoidoscopy and proctoscopy, shall be disinfected at a high level in accordance with the requirements of the Technical Operation Specifications for Endoscopy Caution and Disinfection. 

(4) The endoscope and accessories should be cleaned, disinfected or sterilized immediately after use.

(5) Disinfectants, disinfection instruments and other disinfection equipment used by medical institutions must conform to the provisions of the "Measures for the Administration of Disinfection".

(6) The cleaning, disinfection or sterilization time of the endoscope and its accessories should be controlled by a timer.

(7) Do not use non-flowing water to clean the endoscope.

IX. Endoscopic room shall do a good job of registration of endoscopic disinfection and sterilization. The registration content shall include the name of the patient, the number of the endoscope used, the cleaning time, the disinfection time, and the name of the operator, etc.

10. The nosocomial infection management department shall be responsible for the supervision and management of the use, disinfection and sterilization quality of endoscopy in the institution in accordance with this guideline.

The second chapter is the cleaning and disinfection of soft endoscope

11. After the use of the soft endoscope, the dirt on the outer surface should be immediately wiped with wet gauze, and repeated air and water supply should be carried out for at least 10 seconds. The endoscope should be removed, the waterproof cover should be installed, and the endoscope should be placed in an appropriate container and sent to the disinfection and sterilization room.

Cleaning steps, methods and key points include:

(1) washing

1. Put the endoscope into the cleaning tank:

(1) Rinse thoroughly under flowing water, scrub the endoscopic surface repeatedly with gauze, and clean the operating part at the same time;

(2) Remove the biopsy inlet valve, aspirator button and air and water supply button, and thoroughly scrub the aspirator pipe of the biopsy hole and light guide hose with a clean brush. When scrubbing, the brush head must be seen at both ends, and the dirt on the brush head must be washed;

(3) Install full-pipe perfusion device, pipe plug, waterproof cap and aspirator, and repeatedly suction the biopsy hole with the aspirator;

(4) The whole pipeline irrigation device is connected with a 50ml syringe to absorb water and inject it into the air and water supply pipeline;

(5) Dry the moisture of the biopsy orifice with aspirator and dry the endoscopic surface.

2. Rinse removed aspirator button, water supply and air supply button and biopsy inlet valve with clean water and dry.

3. After the use of endoscopic accessories, such as biopsy forceps, cell brush, cutting knife, guide wire, crushed stone tools, net basket, angiography catheter, foreign body forceps, etc., put them in clean water first, brush the inner surface of the forceps flap and joint with a small brush, clean them and wipe them dry.

4. The cleaning gauze should be used once and the cleaning brush should be used once and disinfected.

(2) enzymatic washing

1. The configuration and soaking time of the multi-enzyme lotion are in accordance with the product instructions.

2. The dried endoscope was placed in the enzyme washing tank, and 100 ml of the multi-enzyme lotion was aspirated with a syringe, and the air and water supply pipeline was flushed. The enzyme lotion was inhaled into the biopsy pore with an aspirator, and the operation department was wiped with the multi-enzyme lotion.

3. After drying, the accessories, all kinds of buttons and valves should be soaked in multi-enzyme lotion, and the accessories should be cleaned in the ultrasonic cleaner for 10 minutes.

4. The multi-enzyme lotion should be replaced after every cleaning of the endoscope.

(3) Cleaning

1. After the endoscope was soaked with the multi-enzyme lotion, the tubes were thoroughly flushed with a water gun or syringe to remove the multi-enzyme lotion and loose dirt in the tubes, and the outer surface of the endoscope was rinsed at the same time.

2. Use a 50 ml syringe to flush air into each pipe to drain water from the pipe so as not to dilute the disinfectant.

XII. When using chemical disinfectants to disinfect or sterilize soft endoscopy, it shall be conducted in accordance with the instructions for use, and chemical and biological monitoring shall be carried out.

13. When soaking in 2% alkaline glutaraldehyde for disinfection or sterilization, the cleaned and dried endoscope should be placed in a disinfection tank and immersed in disinfectant, and each channel should be filled with disinfectant with a syringe.

The operating part of the incomplete immersion endoscope must be wiped with water and then wiped with 75% ethanol for disinfection.

14. When the endoscope that needs disinfection is sterilized with 2% basic glutaraldehyde, the soaking time is:

(1) Immerse gastroscopy, colonoscopy and duodenoscopy for no less than 10 minutes;

(2) Bronchoscope immersion for no less than 20 minutes;

(3) Patients with special infection such as Mycobacterium tuberculosis and other mycobacteria should be soaked in endoscope for no less than 45 minutes after use.

XV. Endoscopies that need to be sterilized must be soaked for 10 hours when 2% basic glutaraldehyde is used for sterilization.

XVI. When 2% basic glutaraldehyde is used for disinfection of endoscopes, such as gastroscopy, colonoscopy, duodenoscopy and bronchoscope that need to be disinfected and are no longer used on the same day, the disinfection time shall be extended to 30 minutes.

XVII. The use of other disinfectants, automatic disinfection and sterilization devices or other disinfection devices must comply with the provisions of Article 8, Paragraph 5 of this Guide, and the operation shall be conducted in strict accordance with the instructions for use.

Before using the instrument for disinfection and sterilization, the endoscope must be cleaned in accordance with the provisions of Article 11.

18. After the soft endoscope is disinfected, it should be rinsed and dried according to the following methods and steps:

(1) Before the endoscope is removed from the disinfection tank, the disinfection and sterilization personnel should change the gloves and inject air into each lumen with a syringe to remove the disinfectant.

(2) Put the endoscope into the washing tank, clean the outer surface of the endoscope with gauze under flowing water, and repeatedly suck clean water to wash each hole.

(3) Dry the outer surface of the endoscope with gauze, and clean the water in each pore. Remove all kinds of special pipes and buttons when cleaning, and replace all kinds of accessories for diagnosis and treatment before they can be used for the diagnosis and treatment of the next patient.

(4) bronchoscope after the above operation, also need to use 75% ethanol or clean compressed air and other methods for drying.

19. Endoscopies soaked in chemical disinfectants for sterilization must be thoroughly rinsed with sterile water before use to remove residual disinfectants.

20. Disinfection and sterilization methods and key points of endoscopic appendages include:

(1) Endoscopic accessories such as biopsy forceps, cell brush, incisive knife, guide wire, crushed stone tools, net basket, angiography catheter, foreign body forceps, etc., must be used and sterilized simultaneously. The preferred method is pressure steam sterilization, or ethylene oxide or 2% alkaline glutaraldehyde immersion for 10 hours for sterilization, or use disinfectants and disinfection instruments suitable for endoscopic disinfection in accordance with the provisions of Article 8, Paragraph 5 of this Guide, and the specific operation methods shall be in accordance with the instructions.

(2) The bending plate and dressing cylinder shall be sterilized by pressure steam; Non-disposable mouth ring can be disinfected with a high level of chemical disinfectants, such as 500 mg/l effective chlorine containing disinfectants or 2000 mg/l peracetic acid for 30 minutes. After disinfection, rinse the residual disinfectant thoroughly with water and dry it for use. The water bottle and connecting pipe shall be soaked and disinfected with a high level of non-corrosive chemical disinfectant. After disinfection, the residual disinfectant shall be thoroughly rinsed with sterile water and dried for later use. Fill the water bottle with sterile water and change it daily.

XXI. Sterilized accessories shall be stored in accordance with the storage requirements for sterile items.

22. After the daily diagnosis and treatment, the disinfected tubes of the endoscope should be flushed and dried with 75% ethanol, and stored in a special clean cabinet or mirror room. The mirror body should be suspended and the corner fixing button should be placed in a free position.

The inner surface of the cabinet or the wall of the mirror room should be smooth, seamless, easy to clean, clean and disinfect once a week.

23. After the daily diagnosis and treatment, the suction bottle, suction tube, cleaning tank, enzyme washing tank and washing tank must be disinfected and sterilized. The specific methods and key points include:

(1) After cleaning, the suction bottle and suction tube shall be soaked and disinfected for 30 minutes with chlorine-containing disinfectant with effective chlorine content of 500 mg/L or with peracetic acid of 2000 mg/L. Then they shall be cleaned and dried for later use.

(2) After the cleaning tank, enzyme washing tank and washing tank are thoroughly scrubbed, they shall be wiped with chlorine-containing disinfectant with an effective chlorine content of 500 mg/l or 2000 mg/l peracetic acid.

The disinfectant tank must be thoroughly scrubbed when replacing disinfectant.

24. Before the start of daily diagnosis and treatment, the disinfection endoscope to be used on that day must be disinfected again. If 2% alkaline glutaraldehyde is used to soak, the disinfection time should not be less than 20 minutes. After rinsing and drying, it can be used for patient diagnosis and treatment.

The third chapter is the disinfection and sterilization of rigid endoscope

25. The cleaning steps, methods and key points of rigid endoscope include:

(1) Immediately after use, clean thoroughly with running water to remove blood, mucus and other residual substances, and wipe dry.

(2) After drying, the endoscope was soaked in multi-enzyme lotion, and the time was according to the instructions.

(3) 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 an ultrasonic cleaner should be used to clean it for 10 minutes.

(4) The shaft section of the instrument, the bending part and the tube cavity shall be thoroughly cleaned with a soft brush, and attention shall be paid to avoid scratching the mirror surface when cleaning.

XXVI. Disinfection or sterilization methods and key points of rigid endoscope include:

(I) Endoscopes or endoscopic parts that are suitable for sterilization by pressure steam should be sterilized by pressure steam, and attention should be paid to selecting the temperature and time according to the instructions of endoscopy.

(2) Ethylene oxide sterilization method is suitable for the sterilization of various endoscopes and accessories.

(3) Endoscopes and accessories that cannot be sterilized by pressure steam can be sterilized by soaking in 2% basic glutaraldehyde for 10 hours.

(4) Hard endoscopy that meets the disinfection requirements, such as laryngoscope and colposcope, can be sterilized by boiling for 20 minutes.

(5) When disinfecting and sterilizing the instrument with shaft joint, the shaft joint of the instrument with tube cavity shall be fully opened, and the instrument cavity with tube cavity shall be fully injected with disinfectant.

(VI) The use of other disinfectants and disinfection devices must comply with the provisions of Article 8, Paragraph 5 of this Guide, and the specific operation methods shall follow the instructions.

27. Rigid endoscopy soaked in chemical disinfectants should be rinsed with running water after disinfection, and then dried with sterile gauze.

Rigid endoscopy soaked in chemical disinfectants should be thoroughly rinsed with sterile water after sterilization, and then dried with sterile gauze.

XXVIII. Sterilized endoscopy and accessories shall be stored in accordance with the storage requirements of sterile articles.

Chapter 4 Monitoring the effect of endoscopic disinfection and sterilization

29. The concentration of disinfectant must be monitored and recorded regularly every day to ensure the disinfection effect.

The time of use of disinfectant shall not exceed the period of use specified in the product manual.

30. After disinfection, biological monitoring should be carried out quarterly and monitoring records should be made.

After sterilization, biological monitoring should be carried out on a monthly basis and monitoring records should be made.

The qualified standard of endoscopy after disinfection was: total number of bacteria < 20CFU (number of colonies)/piece, can not detect pathogenic bacteria; After sterilization, the qualified standard of endoscopy was: qualified for asepsis test.

31. The following methods are used to monitor the disinfection effect of endoscopy:

(I) Sampling method: the monitoring sampling site is the endoscopic lumen surface. 10 ml of buffer solution containing the corresponding neutralizer was extracted with a sterile syringe and injected through the endoscopic biopsy mouth to be examined. The buffer solution was collected from the biopsy exit with a 15ml sterile test tube and sent for examination in time for detection within 2 hours.

(2) Count of colonies: Take 0.5 ml of the solution and add it to 2 sterile plates with a diameter of 90 mm. Add 15 ml of melted nutrient AGAR at 45¡æ to each plate and shake it well while pouring. The AGAR is solidified and cultured at 35¡æ for 48 hours before counting.

Results: The number of colonies/mirror = the mean number of colonies of 2 plates ¡Á20.

(III) Detection of pathogenic bacteria: The solution was fully shaken with a swirl, and 0.2ml of the solution was inoculated into 90mm blood platen, Chinese blue platen and SS platen respectively, evenly coated, and cultured at 35¡æ for 48 hours to observe the growth of pathogenic bacteria.

Chapter V Other

32. If a medical institution has an endoscopic diagnosis and treatment center, its construction area shall match the scale and function of the medical institution, and the patient waiting room (area), examination room, disinfection and sterilization room, endoscopic storage room, etc., shall be set up.

Each diagnosis and treatment unit in the diagnosis and treatment room shall include: 1 diagnosis and treatment bed, main engine (including monitor), suction device, treatment vehicle, etc. The net usable area of each medical unit shall not be less than 20 square meters. The operating room should be equipped with endoscopic operating room, cleaning room, instrument preparation room, disinfection and sterilization room.

33. Medical institutions or endoscopic diagnosis and treatment centers equipped with automatic cleaning and disinfection machines should operate correctly in strict accordance with the instructions, and thoroughly clean manually before being put into the automatic cleaning and disinfection machines for disinfection.