1 range
This standard specifies the requirements and methods for monitoring the disinfection and sterilization effect of CSSD, as well as the requirements for recording and traceability of the quality control process.
This standard is applicable to hospital CSSD and socialized disinfection and sterilization institutions that provide disinfection and sterilization services for hospitals. This standard should be implemented in the disinfection supply work of the hospital operating department (room) that has not yet implemented the centralized management of disinfection supply work.
Other medical institutions that adopt centralized sewage treatment can refer to it.
2 normative reference documents
The clauses in the following documents become the clauses of this standard by reference. All dated reference documents and all subsequent revisions (excluding errata) are not applicable to this standard. However, parties who have reached an agreement according to this standard are encouraged to study whether the latest versions of these documents can be used. For undated reference documents, the latest edition is applicable to this standard.
GB 15982 Hygienic standard for hospital disinfection
GB 18278 Requirements for sterilization confirmation and routine control of health care products (Methods and standards for evaluation of sterilization effect of industrial moist heat sterilization by pressure steam (Article 1))
WS3 10. 1 Hospital Disinfection Supply Center Part 1 Management Specification
WS 3 10.2 Hospital Disinfection Supply Center Part 2: Operating Specification for Cleaning, Disinfection and Sterilization Technology
Technical specification for disinfection of Ministry of Health
3 Terms and definitions
The terms and definitions in WS3 10. 1 and WS 3 10.2 and the following terms and definitions are applicable to this standard.
3. 1 traceability
Record the key factors affecting the sterilization process and results, keep them for future reference, and realize traceability.
3.2 Sterilization process verification device, PCD
A simulation device with predetermined resistance to the sterilization process is used to evaluate the effectiveness of the sterilization process. The chemical indicator placed inside is called chemical PCD, and the biological indicator is called biological PCD.
3.3 A0 value A0 value
The evaluation index of moist heat disinfection effect refers to the time (seconds) when the sterilization effect is lOK and the temperature is equivalent to 80℃ expressed by Z value.
3.4 Small pressure steam sterilizer desktop sterilizer
Pressure steam sterilizer with capacity less than 60 liters.
3.5 Rapid pressure steam sterilization
The pressure steam sterilization process is specially used to treat articles for immediate use.
3.6 Hollow device of lumen instrument
It contains an instrument with an internal diameter of ≥2mm, and the distance between any point in the cavity and its external opening is ≤ 1500 times its internal diameter.
3.7 Test indicators of cleaning effect Test soil
An indicator for detecting the cleaning effect of the cleaning and disinfecting machine.
4 Monitoring requirements and methods
4. 1 General requirements
4. 1. 1 A special person shall be appointed to be responsible for quality control.
4. 1.2 Regularly inspect the quality of cleaning agents, disinfectants, washing water, lubricants and packaging materials, and the inspection results shall meet the requirements of WS 3 10. 1.
4. 1.3 The monitoring data shall be inspected regularly, including the approval documents and validity period of disinfection products Health Permit issued by the Ministry of Health, and the inspection results shall meet the requirements. The self-made test standard package should meet the relevant requirements of Technical Specification for Disinfection.
4. 1.4 The maintenance of the equipment shall follow the manufacturer's instructions or instructions for use, and the cleaning sterilizer and sterilizer shall be cleaned and inspected daily.
4. 1.5 Test and verify the equipment according to the following requirements:
A) The cleaning sterilizer shall be calibrated according to the manufacturer's instructions or user's manual;
B) The pressure steam sterilizer shall check the pressure and safety valve every year;
C) Dry-hot sterilizers should use multi-point temperature detectors to physically monitor the temperatures inside, inside and outside the sterilizer every year.
D) The low-temperature sterilizer shall be verified according to the manufacturer's instructions or user's manual.
4.2 Monitoring of cleaning quality
4.2. 1 Monitoring of cleaning quality of instruments, appliances and articles
4.2. 1. 1 Daily monitoring should be carried out when checking the package, and the inspection should be carried out by visual inspection and/or with the help of a magnifying glass with a light source. After cleaning, the surface of the instrument, its joints and teeth should be smooth, and there should be no residual substances such as blood stains, stains, scale and rust spots.
4.2. 1.2 check the cleanliness of all items in 3 ~ 5 packages to be sterilized regularly, at least once a month, and check the contents the same as daily monitoring, and record the monitoring results.
4.2.2 Cleaning sterilizer and its quality monitoring
4.2.2. 1 Daily monitoring The physical parameters and operation of each batch of cleaning sterilizers shall be monitored and recorded.
4.2.2.2 regularly monitors.
4.2.2.2.1The cleaning effect of the cleaning sterilizer can be monitored by the annual cleaning effect detection index. When the cleaning items or cleaning procedures change, the cleaning effect test indicators can also be used to monitor the cleaning effect.
4.2.2.2.2 The monitoring method shall follow the manufacturer's instructions or user's manual; If the monitoring result does not meet the requirements, it should be tested according to the manufacturer's instructions or instructions. Cleaning and disinfection equipment can only be used after the cleaning and disinfection quality inspection is qualified.
4.3 Monitoring of disinfection quality
4.3. 1 moist heat disinfection
4.3. 1. 1 The temperature and time of each disinfection or A0 value shall be monitored and recorded. The monitoring results shall meet the requirements of WS3 10.2.
4.3. 1.2 The main performance parameters of the cleaning sterilizer shall be tested once a year. The test results shall meet the requirements of the manufacturer's instructions or user's manual.
4.3.2 Chemical disinfection should regularly monitor the concentration, disinfection time and temperature of disinfectant according to the characteristics of disinfectant, and record the results, which should comply with the provisions of disinfectant.
4.3.3 Monitoring of disinfection effect Articles directly used after disinfection should be monitored once every quarter, and the monitoring method and results meet the requirements of GB 15982. Test 3 ~ 5 representative projects at a time.
4.4 Monitoring of sterilization quality
4.4. 1 General requirements
4.4. 1. 1 The sterilization quality should be monitored by physical, chemical and biological methods, and the monitoring results should meet the requirements of this standard.
4.4. 1.2 Sterilized articles that fail physical monitoring shall not be distributed, and the reasons shall be analyzed and improved until the monitoring results meet the requirements.
4.4. 1.3 Sterilized articles that fail in chemical monitoring outside the package shall not be distributed, and sterilized articles that fail in chemical monitoring inside the package shall not be used. The reasons should be analyzed and improved until the monitoring results meet the requirements.
4.4. 1.4 When the biological monitoring is unqualified, all unused sterilized articles after the last biological monitoring are recalled as soon as possible and reprocessed; The reasons for disqualification should be analyzed. After the improvement, the biological monitoring can only be used after three consecutive passes.
4.4. 1.5 The sterilized implantable devices shall be monitored biologically in each batch. It can only be issued after the biological monitoring is qualified.
4.4. 1.6 According to the types of sterilized articles, representative PCD can be selected to monitor the sterilization effect.
4.4.2 Monitoring of pressure steam sterilization
4.4.2. 1 Physical monitoring method: The sterilization parameters such as temperature, pressure and time during sterilization should be continuously monitored and recorded every time. The temperature fluctuation range is within +3℃, and the time meets the requirement of the shortest sterilization time. At the same time, the time, temperature and pressure values of all key points should be recorded, and the results should meet the sterilization requirements.
4.4.2.2 chemical monitoring method
4.4.2.2.1Chemical indicators inside and outside the package should be monitored. The specific requirement is that there should be a chemical indicator outside the sterilization package, and the chemical indicator inside the package should be placed in the most difficult position for sterilization. If the color change of the chemical indicator in the package can be directly observed through the packaging material, it is not necessary to place the chemical indicator outside the package. Judging whether sterilization is qualified or not by observing the color change of chemical indicator.
4.4.2.2.2 When the rapid pressure steam sterilization procedure is adopted for sterilization, a chemical indicator in the package should be placed directly next to the articles to be sterilized for chemical monitoring.
Biological monitoring methods in 4.4.2.3
4.4.2.3.1should be monitored once a week. See appendix a for monitoring methods.
4.4.2.3.2 Five chemical indicators can be added to biological PCD when the implantable devices are sterilized in an emergency. Five kinds of chemical indicators can be used as a sign of early release, and the results of biological monitoring should be notified to the user department in time.
4.4.2.3.3 When using new packaging materials and methods for sterilization, biological monitoring should be carried out.
4.4.2.3.4 Because there is no standard biological monitoring package for small pressure steam sterilizers, the biological testing package or biological PCD should be made of commonly used and representative sterilizers and placed in the most difficult position of the sterilizer, and the sterilizer should be fully loaded. The biological test package or biological PCD should be placed on the side, and it can be placed flat when it is big.
4.4.2.3.5 When the rapid pressure steam sterilization procedure is adopted for sterilization, the biological indicator should be directly put into an empty sterilizer, taken out after a sterilization cycle, cultured under specified conditions, and the results observed.
4.4.2.3.6 If the biological monitoring is unqualified, it shall be implemented according to 4.4. 1.4.
4.4.2.4 B-D Test Pre-vacuum (including pulsating vacuum) pressure steam sterilizer should be tested by B-D before starting sterilization operation every day, and the sterilizer can only be used after passing the B-D test. If the B-D test is unqualified, the reason should be found in time for improvement, and the sterilizer can only be used after the monitoring is qualified.
Physical monitoring, chemical monitoring and biological monitoring should be carried out after the new installation, relocation and overhaul of sterilizers in 4.4.2.5. After the physical monitoring and chemical monitoring have passed, the biological monitoring should be continuously monitored for three times with no load, and it can only be used after it is qualified. The monitoring method shall meet the relevant requirements of GB 18278. For small pressure steam sterilizers, biological monitoring should be carried out continuously for three times at full load, and they can only be used after passing the test. Pre-vacuum (including pulsating vacuum) pressure steam sterilizer shall be tested by B-D and repeated for three times. Sterilizer can only be used after continuous monitoring is qualified.
4.4.3 Monitoring of dry heat sterilization
4.4.3. 1 Physical monitoring method: Physical monitoring is carried out for each sterilization batch. The monitoring method is to place multiple probes of multi-point temperature detectors in each layer of sterilizer, close the cupboard door, lead out the wires, and observe the temperature rise and duration from the recorder. When the temperature reaches the preset temperature within the set time, the physical monitoring is qualified.
4.4.3.2 chemical monitoring method: use the chemical indicator outside each sterilization package, and use the chemical indicator inside each sterilization package, and put it in the most difficult position for sterilization. For unpacked articles, one or more chemical indicators in the package should be used and placed near the articles to be sterilized for monitoring. Take it out after a sterilization cycle, and judge whether it meets the sterilization requirements according to its color change.
4.4.3.3 biological monitoring method should be monitored once a week, and the monitoring method is shown in Appendix B. ..
After the new installation, relocation and overhaul in 4.4.3.4, physical monitoring, chemical monitoring and biological monitoring should be carried out (repeated three times), and the sterilizer can only be used after the monitoring is qualified.
4.4.4 Monitoring of low temperature sterilization
Low temperature sterilization methods include ethylene oxide sterilization, hydrogen peroxide plasma sterilization and low temperature formaldehyde steam sterilization.
4.4.4. 1 Generally, when new installation, relocation, overhaul and sterilization fail and packaging materials or sterilized articles change, the sterilization effect should be re-evaluated, including physical monitoring, chemical monitoring and biological monitoring (repeated three times), and the sterilizer can only be used after the monitoring is qualified.
Monitoring of Ethylene Oxide Combustion Disinfection in 4.4.4.2
4.4.4.2.1Physical monitoring method: Sterilization parameters such as temperature, pressure and time should be continuously monitored and recorded for each sterilization. Sterilization parameters meet the requirements of sterilizer instructions or operation manuals.
4.4.4.2.2 Chemical monitoring method: The chemical indicator outside each package of sterilized articles should be used as the symbol of sterilization process, and the chemical indicator inside each package should be placed in the most difficult position for sterilization. By observing its color change, it can be judged whether it meets the requirements of sterilization.
4.4.4.2.3 Biological monitoring method: biological monitoring is carried out for each sterilization batch. See appendix c for monitoring methods.
Monitoring of hydrogen peroxide plasma sterilization in 4.4.4.3
4.4.4.3.1Physical monitoring method: The key parameters of each sterilization cycle, such as cabin pressure, temperature, hydrogen peroxide concentration, power input and sterilization time, should be continuously monitored and recorded. Sterilization parameters meet the requirements of sterilizer instructions or operation manuals.
4.4.4.3.2 Chemical monitoring method: the chemical index outside the package of each sterilized article should be used as the symbol of the sterilization process; The chemical indicator in each package is placed in the most difficult position to sterilize, and whether it meets the sterilization qualification requirements can be judged by observing its color change.
4.4.4.3.3 Biological monitoring method: Biological monitoring of sterilization cycle shall be conducted at least once a day, and the monitoring method shall comply with relevant national regulations.
Monitoring of Low Temperature Steam Sterilization of Formic Acid in 4.4.4.4
4.4.4.4.1Physical monitoring method: Physical monitoring is carried out for each sterilization batch. Record the parameters of sterilization process in detail, including sterilization temperature, humidity, pressure and time. Sterilization parameters meet the requirements of sterilizer instructions or operation manuals.
4.4.4.4.2 Chemical monitoring method: the chemical index outside the package of each sterilized article should be used as the symbol of the sterilization process; The chemical indicator in each package is placed in the most difficult position to sterilize, and whether it meets the sterilization qualification requirements can be judged by observing its color change.
4.4.4.4.3 Biological monitoring method: it should be monitored once a week, and the monitoring method should comply with relevant national regulations.
The monitoring requirements and methods of other low-temperature sterilization methods in 4.4.4.5 should meet the relevant national standards.
5 Quality control process records and traceability requirements
5. 1 Process records of cleaning, disinfection and sterilization operations shall be established, including:
A) Print data or records of cleaning sterilizer and operation parameters of sterilizer shall be kept.
B) Every operation of sterilizer shall be recorded, including sterilization date, sterilizer number, batch number, main items loaded, sterilization program number, main operating parameters, operator's signature or code, sterilization quality monitoring results, etc. , and archive.
5.2 Daily monitoring and regular monitoring of cleaning, disinfection and sterilization quality shall be recorded.
5.3 Records shall be traceable, and the retention period of monitoring data and records for cleaning and disinfection shall be ≥6 months, and the retention period of monitoring data and records for sterilization quality shall be ≥3 years.
5.4 Requirements for sterilization identification
5.4. 1 The sterilization package shall be marked, including the name of the article, the name or number of the packager, the number of the sterilizer, the batch number, the sterilization date and the expiration date.
5.4.2 The user should check and confirm whether the chemical indicator in the package is qualified and whether the instrument is dry and clean. It can only be used after it is qualified. At the same time, keep or record labels on the surgical care record sheet.
5.5 Establish systems and measures for continuous quality improvement, handle problems in time when found, and establish a recall system for sterilized articles.
5.5. 1 If the biological monitoring is unqualified, notify the user department to stop using it, and recall all sterilized articles that have not been used since the last monitoring was qualified. At the same time, it shall submit a written report to the relevant administrative department, explaining the reasons for the recall.
5.5.2 The relevant administrative department shall notify the user department to closely observe the patients who have used sterile articles during this period.
5.5.3 Check all links in the sterilization process, find out the possible causes of sterilization failure, and take corresponding improvement measures, and then conduct biological monitoring again, and it can be used normally only after it is qualified.
5.5.4 The handling of this incident shall be summarized and reported to relevant management departments.
Appendix a
(normative appendix)
Biological monitoring method of pressure steam sterilization
A.l Make thermophilic Bacillus slices into standard biological detection kit or biological PCD according to Technical Specification for Disinfection, or monitor the sterilization quality of sterilizer with disposable standard biological detection kit. The standard biological monitoring package is placed above the exhaust port of the sterilizer or at the most difficult position in the sterilizer recommended by the manufacturer, with positive control and negative control. If biological monitoring is carried out many times in one day and the biological indicators are the same batch number, only one positive quality control can be set.
A.2 The specific monitoring method is: place the biological indicator in the center of the standard test bag, which is made of 4 1.6 cotton surgical towel 4 1cm×66cm. Manufacturing method: Fold the long side of each surgical towel into three layers, and fold the short side into two layers, and then stack them together to make a test bag with a size of 23cm×23cm× 15cm. After a sterilization cycle, the indicator tablets of the standard test package were taken out under aseptic conditions, put into bromocresol purple glucose peptone water culture medium, and cultured at 56℃ 65438 0℃ for 7 days (self-provided biological indicators were implemented according to the product instructions), and the culture results were observed.
A.3 Result judgment: the positive control group is positive, the negative control group is negative, and the experimental group is negative, so it is judged as qualified sterilization. The positive control group was positive, the negative control group was negative, and the experimental group was positive, so the sterilization was unqualified; At the same time, it is necessary to further identify whether the positive bacteria in the experimental group are caused by indicator bacteria or pollution.
Appendix b
(normative appendix)
Biological monitoring method of dry heat sterilization
B. 1 According to the Technical Specification for Disinfection, the standard biological test package consists of Bacillus subtilis var. Niger tablets were placed in the most difficult position of the sterilizer to monitor the sterilization quality of the sterilizer biologically, with positive and negative controls.
B.2 The specific monitoring method is as follows: Put the budded pieces of Bacillus subtilis in sterile test tubes (1 piece/tube) respectively. Two test tubes containing bacterial slices are placed in the diagonal inner corner and outer corner between the sterilizer and the door handle on each floor. The test tube cover is placed next to the test tube, and the cabinet door is closed. After a sterilization cycle, when the temperature drops to 80℃, take out the test tube after capping. Under aseptic conditions, ordinary nutrient broth medium (5ml/ tube) was added and cultured at 36℃ 65438 0℃ for 48h. The preliminary results were observed, and the sterile growth tube continued to be cultured until the seventh day.
B.3 result judgment: the positive control group is positive and the negative control group is negative. If the broth tube inoculated with each indicator piece is clarified, it is judged as qualified sterilization; If the culture of the positive control group is positive and the culture of the negative control group is negative, and the broth tube inoculated with one of the indicator tablets is turbid, it is judged as unqualified; O.lml was inoculated on nutrient agar plate in broth tube which was difficult to determine, coated evenly with sterilized L rod or inoculation ring, and cultured at 36℃1℃ for 48 hours. Observe the colony morphology, do smear staining and microscopic examination to determine whether there is indicator bacteria growth. If there is indicator bacteria growth, it is judged that sterilization is unqualified. If the growth of bacteria is not indicated, it is judged that sterilization is qualified.
Appendix c
(normative appendix)
Biological monitoring method of ethylene oxide sterilization
Bacillus subtilis var. spores. Niger is placed in a routine biological test package to monitor the sterilization quality of sterilizers. The conventional biological test package is placed in the most difficult part of the sterilizer (the central part of the whole loading sterilization package). After the sterilization cycle is completed, the biological indicator should be taken out from the sterilized articles immediately, and cultured at 36℃1℃ for 7 days (the self-provided biological indicator should follow the product instructions), and the color change of the culture medium should be observed. At the same time, set positive control and negative control.
C.2 Preparation of routine biological test package: Take a 20ml sterile syringe, unplug the needle and the needle plug, put the biological indicator into the syringe with the plastic cap with hole facing the needle, then insert the needle plug of the syringe back into the syringe (be careful not to touch the biological indicator), then wrap it in a cotton towel for two layers, put it into a paper-plastic packaging bag, and pack it.
C.3 Result determination: the positive control group is positive, the negative control group is negative, and the experimental group is negative, and it is determined that sterilization is qualified. The positive control group was positive, the negative control group was negative, and the experimental group was positive, so the sterilization was unqualified; At the same time, it is necessary to further identify whether the positive bacteria in the experimental group are caused by indicator bacteria or pollution.