The main drafters of this standard: Li Liuyi, Gong Yuxiu, Moli, Ren Wuai, Zhang Qing, Zhang Liubo, Li Xinwu, Qian Liming, Feng Xiulan, Wang Yifei, Zhong Xiuling, Wu Yinghong, Zhang Yu, Huang Jingxiong.
1 Scope
This standard specifies the hospital disinfection supply center (central sterile supply department ,CSSD) disinfection and sterilization effect monitoring requirements and methods and quality control process of recording and traceability requirements.
This standard applies to the hospital CSSD and provide disinfection and sterilization services for hospitals and social sterilization institutions. For the time being, hospitals that have not implemented centralized management of disinfection and supply work, the disinfection and supply work of their operating departments (rooms) should implement this standard.
Other medical institutions that have taken centralized sewage treatment can refer to use.
2 normative references
The following documents in the provisions of this standard through the citation of this standard and become the provisions of this standard. Where the cited documents are dated, all subsequent modifications (excluding errata) or revisions are not applicable to this standard, however, the parties to the agreement under this standard are encouraged to study whether the latest version of these documents can be used. Where the cited document is not dated, its latest version applies to this standard.
GB15982 Hospital disinfection health standard
GB 18278 Healthcare product sterilization confirmation and routine control requirements (industrial moist heat sterilization Part 1 pressure steam sterilization effect evaluation methods and criteria)
WS310.1 Hospital disinfection and supply centers Part 1: management specifications
WS 310.2 Hospital disinfection and supply Center Part 2: Cleaning, disinfection and sterilization technology practice
Disinfection technology specifications Ministry of Health
3 Terminology and definitions
The terms and definitions of WS 310.1 and WS 310.2, as well as the following terms and definitions apply to this standard.
3.1 Traceabilitytraceability
The key elements affecting the sterilization process and results are recorded, kept for reference, and made traceable.
3.2 sterilization process verification device process challenge device,PCD
The sterilization process has a predetermined resistance to the simulation device, used to evaluate the effectiveness of the sterilization process. Its internal placement of chemical indicators called chemical PCD, placed biological indicators called biological PCD.
3.3 A0 value A0value
Evaluation of the effectiveness of moist heat sterilization indicators, refers to the time (seconds) when the microbial killing effect expressed in terms of Z-value of lOK, the temperature is equivalent to 80 ℃.
3.4 Small pressure steam sterilizer table-top sterilizer
Pressure steam sterilizers with a volume of less than 60 liters.
3.5 rapid pressure steam sterilizationflash sterilization
A pressure steam sterilization process specifically designed to treat items for immediate use.
3.6 tube lumen device hollow device
Instruments containing a tube lumen with an inner diameter of ≥2 mm, and any point in the lumen is ≤1500 times its inner diameter from the opening to the outside world.
3.7 Cleaning effect test indicator test soil
An indicator used to test the cleaning effect of a washer disinfector.
4 Monitoring requirements and methods
4.1 General requirements
4.1.1 A person should be responsible for quality monitoring.
4.1.2 Regular quality checks shall be conducted on detergents, disinfectants, washing water, lubricants, packaging materials, etc., and the results of the checks shall meet the requirements of WS 310.1.
4.1.3 Regular quality checks should be carried out to monitor the material, including random checks of the Ministry of Health disinfection product health permit approvals and expiration dates, etc., the results should meet the requirements. Homemade test standard package should meet the relevant requirements of the "Technical Specification for Disinfection".
4.1.4 Maintenance and care of equipment should follow the manufacturer's instructions or guidebook for daily cleaning and inspection of the cleaner disinfector, sterilizer.
4.1.5 In accordance with the following requirements for the testing and validation of equipment:
a) cleaning and disinfecting machine should follow the manufacturer's instructions for use or guidance manual for calibration;
b) pressure steam sterilizer should be tested annually on the pressure and safety valves to verify;
c) dry heat sterilizers should be used annually with a multi-point temperature detector for the sterilization of all layers of the inside, middle and outside points of temperature. , center, and outside of the temperature at various points of physical monitoring.
d) Low-temperature sterilizers should be validated by following the manufacturer's instructions or guidebook.
4.2 Monitoring of the quality of cleaning
4.2.1 Monitoring of the quality of cleaning of instruments, appliances, and articles
4.2.1.1 Routine monitoring is carried out at the time of inspection of the packaging and should be done visually and/or with the aid of a magnifying glass with a light source. The surface of the cleaned instruments and their joints and teeth shall be smooth and clean, free from residual substances such as blood stains, stains, limescale and rust spots.
4.2.1.2 Regular sampling should be at least 3 to 5 randomly selected each month to be sterilized packages of all the items in the cleaning quality, check the contents of the same daily monitoring, and record the monitoring results.
4.2.2 Monitoring of the washer disinfector and its quality
4.2.2.1 Daily monitoring shall monitor the physical parameters and operation of the washer disinfector on a batch-by-batch basis and record them.
4.2.2.2 Periodic monitoring
4.2.2.2.1 The cleaning effect of the washer-disinfector may be monitored annually using a cleaning effect test indicator. The cleaning effect may also be monitored using the cleaning effect test indicator when there is a change in cleaning items or cleaning procedures.
4.2.2.2.2 Monitoring method should follow the manufacturer's instructions or instruction manual; monitoring results do not meet the requirements, should follow the manufacturer's instructions or instruction manual for testing, cleaning and disinfection quality testing, cleaning and disinfecting before use.
4.3 Monitoring of disinfection quality
4.3.1 Moist heat disinfection
4.3.1.1 The temperature and time or A0 value of each disinfection should be monitored and recorded. The monitoring results shall comply with the requirements of WS310.2.
4.3.1.2 The main performance parameters of the cleaner disinfector should be tested annually. The test results should be in line with the manufacturer's instructions or guidebook requirements.
4.3.2 Chemical disinfection should be based on the characteristics of the type of disinfectant, the concentration of disinfectant, disinfection time and temperature during disinfection should be regularly monitored and recorded, and the results should be in line with the provisions of the disinfectant.
4.3.3 Disinfection effect monitoring disinfection of directly used items should be monitored quarterly, monitoring methods and monitoring results in line with the requirements of GB 15982. Each test 3 to 5 representative items.
4.4 Sterilization quality monitoring
4.4.1 General requirements
4.4.1.1 The quality of sterilization using physical monitoring method, chemical monitoring method and biological monitoring method, the monitoring results should meet the requirements of this standard.
4.4.1.2 Physical monitoring of unqualified sterilized items shall not be issued, and shall analyze the reasons for improvement until the monitoring results meet the requirements.
4.4.1.3 Sterilization articles with unqualified chemical monitoring outside the package shall not be issued, and sterilization articles with unqualified chemical monitoring inside the package shall not be used. And shall analyze the reasons for improvement until the monitoring results meet the requirements.
4.4.1.4 When the biological monitoring fails, all unused sterilized articles since the last qualified biological monitoring shall be recalled as soon as possible and reprocessed; and the reasons for the failure shall be analyzed and improved, and the sterilized articles shall not be used until the biological monitoring has been qualified for three consecutive times.
4.4.1.5 Sterilization of implantable devices should be biomonitoring per batch. Biological monitoring after passing, can be issued.
4.4.1.6 According to the type of sterilized loaded items, representative PCD can be selected for monitoring the sterilization effect.
4.4.2 Pressure steam sterilization monitoring
4.4.2.1 Physical monitoring method: each sterilization should be continuously monitored and recorded sterilization parameters such as temperature, pressure and time during sterilization. Temperature fluctuations within +3 ℃, time to meet the requirements of the minimum sterilization time, at the same time should be recorded at all critical points of time, temperature and pressure values, the results should be consistent with the requirements of sterilization.
4.4.2.2 Chemical monitoring method
4.4.2.2.1 should be carried out outside the package, package chemical indicator monitoring. Specific requirements for the sterilization package should be outside the package chemical indicators, highly hazardous items package should be placed inside the package chemical indicators, placed in the most difficult part of the sterilization. If through the packaging material can be directly observed through the package chemical indicator color change, it is not necessary to place the package outside the chemical indicator. Through the observation of chemical indicator color changes, determine whether to meet the sterilization requirements.
4.4.2.2.2 When using rapid pressure steam sterilization procedure sterilization, a piece of package chemical indicator should be placed directly next to the item to be sterilized for chemical monitoring.
4.4.2.3 Biological monitoring method
4.4.2.3.1 Should be monitored once a week, the monitoring method is described in Appendix A.
4.4.2.3.2 When emergency sterilization implantable devices, can be added to the biological PCD in the 5 types of chemical indicators. 5 types of chemical indicators qualified can be used as a sign of early release, the results of biological monitoring should be promptly The results of biomonitoring should be communicated to the using department in a timely manner.
4.4.2.3.3 Biological monitoring should be performed when new packaging materials and methods are used for sterilization.
4.4.2.3.4 Small pressure steam sterilizers because there is generally no standard biomonitoring kit, should be selected for the sterilizer commonly used, representative of the sterilizing production of biotest kits or biological PCD, placed in the most difficult to sterilize parts of the sterilizer, and the sterilizer should be in a state of full capacity. Biological test kit or biological PCD should be placed on the side, when the volume is large can be placed flat.
4.4.2.3.5 When sterilized using the rapid pressure steam sterilization procedure, a bioindicator should be placed directly in an unloaded sterilizer, removed after one sterilization cycle, and incubated under the specified conditions to observe the results.
4.4.2.3.6 When biomonitoring fails, the provisions of 4.4.1.4 shall be followed.
4.4.2.4 B-D test pre-vacuum (including pulsating vacuum) pressure steam sterilizer should be daily before the start of sterilization operation B-D test, B-D test pass, the sterilizer can be used. B-D test failure, should promptly find the reasons for improvement, monitoring and passing, the sterilizer can be used.
4.4.2.5 Sterilizer monitoring after new installation, relocation and overhaul should be physical monitoring, chemical monitoring and biological monitoring. Physical monitoring, chemical monitoring through, biological monitoring should be unloaded three consecutive monitoring, qualified sterilizer can be used, monitoring methods should be consistent with the relevant requirements of GB 18278. For small pressure steam sterilizer, biological monitoring should be full continuous monitoring three times, qualified sterilizer can be used. Pre-vacuum (including pulsating vacuum) pressure steam sterilizer should be B-D test and repeat three times, after passing the continuous monitoring, the sterilizer can be used.
4.4.3 Dry heat sterilization monitoring
4.4.3.1 Physical monitoring method: each sterilization batch should be physically monitored. Monitoring method for the multi-point temperature detector multiple probes were placed in the sterilizer in each layer, in and out of each point, close the cabinet door, lead wire, by the recorder to observe the temperature rise and duration. Temperature in the set time have reached the preset temperature, the physical monitoring is qualified.
4.4.3.2 Chemical monitoring method: each sterilization package should be used outside the package of chemical indicators, each sterilization package should be used inside the package of chemical indicators, and placed in the most difficult to sterilize parts. For unpackaged items, one or more in-package chemical indicators should be used and placed near the item to be sterilized for monitoring. After a sterilization cycle removed, according to its color change to determine whether the sterilization requirements.
4.4.3.3 Biological monitoring method should be monitored once a week, the monitoring method is shown in Appendix B.
4.4.3.4 After the new installation, relocation and overhaul, the physical monitoring method, chemical monitoring method and biological monitoring method should be carried out to monitor (repeated three times), after the monitoring of qualified, the sterilizer can be used.
4.4.4 Low-temperature sterilization monitoring
Low-temperature sterilization methods include ethylene oxide sterilization, hydrogen peroxide plasma sterilization and low-temperature formaldehyde steam sterilization.
4.4.4.1 General requirements New installation, relocation, overhaul, sterilization failure, packaging materials or sterilized items change, the sterilization effect should be reevaluated, including the use of physical monitoring method, chemical monitoring method and biomonitoring method of monitoring (repeated three times), after passing the monitoring, the sterilizer can be used.
4.4.4.2 Epoxy ethylene burn sterilization monitoring
4.4.4.2. 1 Physical monitoring method: each sterilization should be continuously monitored and recorded sterilization parameters such as temperature, pressure and time during sterilization. Sterilization parameters are in accordance with the requirements of the sterilizer's instructions or operation manual.
4.4.4.2.2 Chemical monitoring method: each sterilized items outside the package should be used outside the package of chemical indicators, as a sign of the sterilization process, each package of the most difficult to sterilize the location of the package placed in the chemical indicators, through the observation of its color changes, to determine whether it is to meet the requirements of sterilization.
4.4.4.2.3 Biological monitoring method: each sterilization batch should be biomonitoring, the monitoring method is shown in Appendix C.
4.4.4.3 Hydrogen peroxide plasma sterilization monitoring
4.4.4.3.1 Physical monitoring method: each sterilization should be continuously monitored and recorded for each cycle of the sterilization of the critical parameters, such as chamber pressure, temperature, hydrogen peroxide concentration, power input and sterilization time. Sterilization parameters such as chamber pressure, temperature, hydrogen peroxide concentration, power input and sterilization time should be continuously monitored and recorded for each sterilization cycle. Sterilization parameters are in accordance with the requirements of the sterilizer instructions or operating manual.
4.4.4.3.2 Chemical monitoring method: each sterilized article package should be used outside the package of chemical indicators, as a sign of the sterilization process; each package of the most difficult to sterilize the location of the package placed in the chemical indicators, through the observation of its color change, to determine whether it has reached the sterilization requirements.
4.4.4.3.3 Biological monitoring method: should be at least once a day to carry out biological monitoring of the sterilization cycle, the monitoring method should be consistent with the relevant provisions of the state.
4.4.4.4 Monitoring of low-temperature formic acid steam sterilization
4.4.4.4.1 Physical monitoring method: physical monitoring should be carried out for each sterilization batch. Record in detail the parameters of the sterilization process, including sterilization temperature, humidity, pressure and time. Sterilization parameters are in accordance with the requirements of the sterilizer's instructions or operation manual.
4.4.4.4.2 Chemical monitoring method: each sterilized article package should be used outside the package of chemical indicators, as a sign of the sterilization process; each package of the most difficult to sterilize the location of the package placed in the chemical indicators, through the observation of its color changes, to determine whether it is to meet the requirements of sterilization.
4.4.4.4.3 Biological monitoring method: should be monitored once a week, the monitoring method should be consistent with the relevant provisions of the state.
4.4.4.5 Other low-temperature sterilization method of monitoring requirements and methods should be consistent with the provisions of the relevant national standards.
5 Quality control process records and traceability requirements
5.1 Process records of cleaning, disinfection and sterilization operations should be established, including:
a) Printed information or records of the operating parameters of the cleaner and disinfector and sterilizer should be retained.
b) shall record each operation of the sterilizer, including the date of sterilization, sterilizer number, batch number, the main items loaded, sterilization program number, the main operating parameters, the operator's signature or code name, and the results of the monitoring of the quality of sterilization, etc., and archived.
5.2 Daily and periodic monitoring of cleaning, disinfection, and sterilization quality shall be recorded.
5.3 Records should be traceable, cleaning, disinfection monitoring information and records should be retained for ≥ 6 months, sterilization quality monitoring information and records should be retained for ≥ 3 years.
5.4 Requirements for sterilization marking
5.4.1 Sterilization packages should be marked, including the name of the item, check the packer's name or number, sterilizer number, batch number, sterilization date and expiration date.
5.4.2 The user should check and confirm that the package chemical indicators are qualified, instruments dry, clean, etc., qualified before use. At the same time, the outside of the bag identification will be retained or recorded on the surgical care record sheet.
5.5 A continuous quality improvement system and measures should be established, problems should be found and dealt with in a timely manner, and a recall system for sterilized items should be established.
5.5.1 Biological monitoring failed, should notify the use of the department to stop using, and recall all the sterilized items that have not been used since the last monitoring qualified. At the same time, it should be reported in writing to the relevant management department, explaining the reasons for the recall.
5.5.2 The relevant management department shall notify the using department to closely observe the patients who have used the sterile articles during that period.
5.5.3 Check the various aspects of the sterilization process, find possible reasons for sterilization failure, and take appropriate improvement measures, and then re-examine the biological monitoring, qualified the sterilizer can be used normally.
5.5.4 The handling of the incident should be summarized and reported to the relevant management.
Appendix A
(Normative Appendix)
Bio-monitoring method of pressure steam sterilization
A.l In accordance with the provisions of the "Sterilization Technical Specification", the thermophilic lipophilic Bacillus bacillus slices are made into the standard bio-testing kits or biological PCDs, or the use of disposable standard bio-testing kits, the quality of sterilization of the sterilizer is biomonitored. The standard biomonitoring kit is placed above the sterilizer exhaust port or at the most difficult to sterilize site in the sterilizer as recommended by the manufacturer, with a positive control and a negative control. If biomonitoring is performed multiple times in one day and the bioindicator is of the same batch number, only one positive control is sufficient.
A.2 Specific monitoring method: the bioindicator will be placed in the center of the standard test kit, which is made of 16 cotton surgical towels of 41cm x 66cm. Production method: the long side of each surgical towel is first folded into 3 layers, the short side is folded into 2 layers, and then stacked, made of 23cm × 23cm × 15cm size of the test kit. After a sterilization cycle, take out the standard test packet of indicator bacteria pieces under sterile conditions, put them into bromocresol purple glucose peptone water medium, and incubate them at 56℃±1℃ for 7d (self-contained bioindicators are executed according to the product specification), and observe the results of the incubation.
A.3 Result determination: positive control group culture positive, negative control group culture negative, test group culture negative, determined as sterilization qualified. Positive control group culture positive, negative control group culture negative, the test group culture positive, the sterilization failed; at the same time should be further identified as a test group of positive bacteria whether the indicator bacteria or contamination caused.
Appendix B
(normative appendix)
Bio-monitoring method of dry heat sterilization
B.1 In accordance with the provisions of the "Disinfection Technical Specification", the use of Bacillus subtilis black variant spore slices, made into a standard bio-test kit, placed in the most difficult parts of the sterilizer sterilizer, the sterilizer sterilization quality of bio-monitoring and the establishment of positive control and negative control. Positive control and negative control.
B.2 The specific monitoring method is as follows: Botrytis cinerea budding bacterial slices are filled into sterile test tubes respectively (1 slice/tube). Sterilizer and each level of the door handle diagonal within the line, the outer corner of the test tube placed 2 containing bacterial tablets, test tube cap placed next to the test tube, close the cabinet door, after a sterilization cycle, to be the temperature dropped to 80 ° C, add the test tube cap and then remove the test tube. Under aseptic conditions, add normal nutrient broth medium (5ml/tube), incubate at 36℃±1℃ for 48h, observe the preliminary results, and continue to incubate the sterile growth tubes until the 7th day.
B.3 Judgment of results: positive control group culture positive, negative control group culture negative, if each indicator slice inoculated broth tubes are clarified, it is judged as sterilization qualified; if the positive control group culture positive, negative control group culture negative, and one of the indicator slice inoculated broth tubes turbid, it is judged as unqualified; on the difficult to determine the broth tubes, O.lml inoculated on the nutrient agar plate, with a sterilized L stick or inoculation ring. Sterilized L stick or inoculation ring coated, placed in 36 ℃ ± l ℃ culture 48h, observe the colony morphology, and do smear staining microscopy, to determine whether the growth of indicator bacteria, if there is an indicator of bacterial growth, judged to be unqualified for sterilization; if there is no indicator of bacterial growth, judged to be qualified for sterilization.
Appendix C
(normative appendix)
Biological monitoring method of ethylene oxide sterilization
C.l The black variant spores of Bacillus subtilis were placed in the routine biological test kit to monitor the sterilization quality of the sterilizer. The routine biotest kit is placed in the most difficult part of the sterilizer to sterilize (the center of the entire loaded sterilization kit). Immediately after the completion of the sterilization cycle the bioindicator should be removed from the sterilized article and incubated at 36°C ± l°C for 7d (self-contained bioindicators should follow the product instructions), observing the change in the color of the medium. A positive control and a negative control are set up at the same time.
C.2 Preparation of routine bio-test kit: take a 20ml sterile syringe, remove the needle, pull out the spigot, put the bio-indicator into the syringe, the plastic cap with holes should be facing the needle, and then insert the spigot of the syringe back into the syringe (be careful not to touch the bio-indicator), and then after that wrap it in two layers of a small cotton towel, put it into a paper-plastic packing bag and encapsulate it.
C. 3 Result determination: positive control group culture positive, negative control group culture negative, test group culture negative, judged as sterilization qualified. Positive culture of the positive control group, negative culture of the negative control group, positive culture of the test group, the sterilization failed; at the same time, should be further identified as a positive test group of bacteria is the indicator bacteria or due to contamination.