1 Scope
This specification describes the basic elements of rational reuse of hemodialyzers, and its purpose is to ensure the safety and effectiveness of reused hemodialyzers.
1.1 This specification applies only to clearly labeled reusable hemodialyzers approved by law.
1.2 The physician in charge of hemodialysis with knowledge of reuse and related medicine shall decide to reuse hemodialyzer, and the medical unit shall be responsible for regulating the reuse of hemodialyzer.
1.3 All unpredictable risk factors that may be encountered during reuse may not be covered by this Code.
1.4 This Code does not cover the first use of hemodialyzers.
2 Medical issues to be clarified
2.l The significance of reuse and the unforeseen hazards that may be encountered should be explained to the patient or his/her client prior to reuse, with the option to choose whether to reuse or not to reuse and to sign an informed consent form.
2.2 Hemodialyzers that have been used by patients with positive hepatitis B virus markers cannot be reused;
Hemodialyzers that have been used by patients with positive hepatitis C virus markers should be segregated from hemodialyzers used by other patients when reused.
2.3 Hemodialyzers used by HIV carriers or AIDS patients cannot be reused.
2.4 Hemodialyzers that have been used by patients with other potentially blood-borne infectious diseases cannot be reused.
2.5 Hemodialyzers used by patients who are allergic to the disinfectants used in the reuse process cannot be reused.
3 Records of reuse All records of reuse should be in accordance with the standards for medical records and should be dated and signed.
3.1 Hemodialyzer reuse manual: each hemodialysis medical unit shall set up a hemodialyzer reuse manual according to this specification, and the hemodialyzer reuse manual shall include the relevant regulations, reuse procedures, and description of reuse equipment.
3.2 Record of reuse: including patient's name, gender, case number, hemodialyzer model, date and time of each reuse, number of times of reuse, signature or number of reuse staff, and results of hemodialyzer function and safety test.
3.3 Event record: Record of events related to reuse, including causes and side effects of hemodialyzer failure.
4 Qualifications and Training of Re-users
4.1 Qualifications: Personnel engaged in the re-use of hemodialyzers must be nurses, technicians, or trained specialists. The reusers have sufficient training and continuing education to understand each aspect of reuse and its significance, to be able to follow each procedure, and to meet the qualification requirements for reuse technology.
4.2 Training content: basic principles of dialysis, performance and evaluation of hemodialyzers, physical and chemical properties of disinfectants, storage, use, side effects caused by residual disinfectants, standards and monitoring of dialysis water, adequacy of dialysis, impact of reuse on hemodialyzers, and criteria for evaluating whether hemodialyzers can be reused.
4.3 Training Information File: A record of the content of the training, including the title, the names of the participants, the date and time of the training, and the results of the assessment.
4.4 The person in charge of the hemodialysis treatment unit is responsible for the technical qualifications of the reusers.
5 Duplication equipment and water requirements Duplication equipment must be reasonably designed and tested to perform the intended task.
5.1 Reverse osmosis water should be used for reuse in the water treatment system. For reuse of reverse osmosis water must meet the biological standards of water quality, a certain pressure and flow rate, must meet the peak operating conditions of the equipment water requirements.
5.1.1 Disinfection: The water treatment system should be designed for easy cleaning and disinfection of the entire system, and the disinfection process should include flushing all parts of the system to ensure that disinfectant residuals are kept within the limits allowed by safety standards.
5.1.2 Water Quality Requirements: The level of bacterial and endotoxin contamination of reused water should be tested regularly.
Water quality testing should be performed at or as close as possible to the point where the hemodialyzer is connected to the reuse system.
Bacterial levels should not exceed 200 CFU/ml, with an intervention limit of 50 CFU/ml, and endotoxin levels should not exceed 2 EU/ml, with an intervention limit of 1 EU/ml.When the intervention limit is reached, continued use of the water treatment system is acceptable, but measures should be taken (e.g., disinfecting the water treatment system) to prevent further system contamination.
5.1.3 Timing of bacteriological and endotoxin testing of water quality: initially, testing should be done once a week, and after 2 consecutive test results meet the requirements, bacteriological testing should be done once a month, and endotoxin testing should be done at least once every 3 months.
5.2 Multipurpose system 5.2.1 Multipurpose equipment: The multipurpose equipment must ensure the following functions: to make the hemodialyzer in the state of anti-superfluous can repeatedly flush the blood chamber and dialysate chamber; can complete the performance of the hemodialyzer and the integrity of the membrane test; with at least 3 times the volume of blood chamber disinfectant to flush the hemodialyzer blood chamber and the dialysate chamber, can be used to fill up with standard disinfectant, in order to ensure that the hemodialyzer After rinsing the hemodialyzer blood and dialysate chambers with at least 3 times the volume of the blood chamber, the chambers can be filled with standard disinfectant solution to ensure that the disinfectant in the hemodialyzer reaches an effective concentration.
5.2.2 Maintenance: Maintenance of hemodialyzer multiplexing equipment should follow the recommendations of the manufacturer and seller of the multiplexing equipment, with whom written repair procedures and maintenance schedules have been established. It is the responsibility of the manufacturer and seller to promise that the equipment will operate properly under properly installed conditions.
5.2.3 Hemodialysis units may use automatic multiplexing or semi-automatic multiplexing equipment according to their own conditions.
6 Safety requirements for the environment of the multiplexing room
6.1 Environment of the multiplexing room: the multiplexing room should be kept clean and hygienic, with ventilation and exhaust facilities, well ventilated and with sufficient drainage capacity.
6.2 Storage area: the treated hemodialyzer should be stored in the designated area, and should be placed separately from the hemodialyzer to be treated to prevent confusion leading to contamination or even misuse.
6.3 Personal protection: every staff member who may come into contact with the patient's blood should take measures to prevent infection. Operators should wear protective gloves and gowns during reuse, should comply with infection control prevention standards, and should wear face masks and face shields when engaged in steps that are known or suspected to be toxic or contaminant splash.
6.4 Emergency eye rinse taps should be provided in the reuse room to ensure immediate and effective rinsing of reuse staff in the event of injury from chemical splashes.
7 Hemodialyzer labeling
7.1 Requirements: hemodialyzer reuse can only be used for the same patient, the label must be able to confirm the use of the hemodialyzer patient, reuse and dialysis after the handwriting should be unaffected, hemodialyzer labels should not be obscured product model, batch number, blood and dialysate flow direction and other related information.
7.2 Content: the label should be labeled with the patient's name, medical record number, the number of times it is used, the date and time of each reuse.
8 Hemodialyzer reuse Hemodialyzer must be labeled before reuse, and then operated according to the reuse procedure, see Appendix 1 "Hemodialyzer Semi-Automatic Reuse Procedure" and Appendix 2 "Hemodialyzer Automatic Reuse Procedure".
8.1 Transportation and Disposal: Hemodialyzers should be transported in a clean and hygienic environment and disposed of immediately after dialysis. In exceptional cases, hemodialyzers not ready for disposal within 2 hours may be refrigerated after rinsing, but the procedure for disinfecting and sterilizing hemodialyzers must be completed within 24 hours.
8.2 Rinsing and Cleaning: The blood and dialysate chambers of the hemodialyzer are rinsed and cleaned using water that meets the criteria in Section 5.1.2, including reverse ultrafiltration rinsing. Diluted hydrogen peroxide, sodium hypochlorite, peracetic acid and other chemicals may be used as cleaning agents for hemodialyzers.
Note: A previous chemical must be removed before adding it. Sodium hypochlorite must be removed before adding formalin. Sodium hypochlorite cannot be mixed with peracetic acid.
8.3 Total Cell Volume (TCV) test: Test the TCV of the hemodialyzer, after reuse, the TCV should be greater than or equal to 80% of the original TCV. 8.4 Dialysis membrane integrity test: hemodialyzer reuse should be broken membrane test, such as air pressure test.
8.5 Disinfection and Sterilization: The hemodialyzer must be disinfected after cleaning to prevent microbial contamination. The blood and dialysate chambers of the hemodialyzer must be sterile or achieve a high level of disinfection, and the hemodialyzer should be filled with disinfectant, which should be at least 90% of the specified concentration. The blood inlet and outlet of the hemodialyzer and the dialysate inlet and outlet of the hemodialyzer shall be sterilized and then covered with new or sterilized caps.
Note: The sterilization procedure must not compromise the integrity of the hemodialyzer. To prevent membrane damage, do not mix substances that react with each other, such as sodium hypochlorite and formalin, in the hemodialyzer.
8.6 Hemodialyzer shell treatment: Blood and dirt on the exterior of the hemodialyzer should be soaked or cleaned with a low concentration of disinfectant (e.g., 0.05% sodium hypochlorite) that is compatible with the exterior material of the hemodialyzer.
Note: Repeated disinfection using certain low concentration disinfectant solutions may cause the plastic shell of the hemodialyzer to break.
8.7 Disposal of discarded hemodialyzers: discarded hemodialyzers should be disfigured and disposed of in accordance with the provisions of medical waste disposal.
8.8 Storage of reused hemodialyzers: after reused hemodialyzers are tested for performance and meet the test standards for multiple use, they should be stored in the designated area to prevent confusion with the hemodialyzers to be reused or discarded hemodialyzers.
8.9 Appearance inspection after reuse:
8.9.1. The exterior is free of blood and other dirt.
8.9.2. No cracks in the housing, blood and dialysate ports.
8.9.3. no blackened, coagulated fibers on the surface of the hollow fiber.
8.9.4. Hemodialyzer fiber ends free of blood clots.
8.9.5. Blood and dialysate inlets and outlets are capped and free of leakage.
8.9.6. labels are correctly labeled and legible.
8.10 Reuse times: should be based on the hemodialyzer TCV, membrane integrity test and the appearance of the inspection to determine whether the hemodialyzer can be reused, any one of the three does not meet the requirements, the hemodialyzer will be discarded. Adopting semi-automatic reuse procedure, the reuse times of low flux hemodialyzer should be no more than 5 times, and the reuse times of high flux hemodialyzer should be no more than 10 times. With the automatic reuse program, the recommended reuse times for low-flux hemodialyzers should be no more than 10 times, and the recommended reuse times for high-flux hemodialyzers should be no more than 20 times.
9 For the test of hemodialyzer before use, refer to Appendix 1 "Semi-Automatic Reuse Procedure of Hemodialyzer" and Appendix 2 "Automatic Reuse Procedure of Hemodialyzer".
9.1 Appearance inspection:
9.1.1 The label is clearly written.
9.1.2 The hemodialyzer is free from structural damage and clogging.
9.1.3 The hemodialyzer port is well closed, filled with disinfectant (confirmed by the color of the hemodialyzer, with test paper or chemical reagents that the hemodialyzer has been disinfected and treated with a disinfectant solution of effective concentration), and free of leaks.
9.1.4 Stored for the specified period.
9.1.5 The hemodialyzer has a normal appearance.
9.2 Verify patient information: Ensure that the name on the hemodialyzer is consistent with the identifying information in the patient's record, and that the label on the hemodialyzer and the patient's treatment record are correct.
9.3 Flushing of disinfectant: The flushing procedure should be validated to ensure that the concentration of disinfectant filling the blood and dialysate chambers is reduced to a safe level.
9.4 Disinfectant Residue Testing: Sensitive methods (e.g., test paper method, etc.) can be used to test for disinfectant residue according to the disinfectant manufacturer's instructions to ensure that the disinfectant residue is below the maximum permissible limit.
Note: Dialysis should be started within 15 minutes of the disinfectant residual test to prevent possible rebound in disinfectant concentration. If the wait for dialysis is too long, the disinfectant residual should be re-cleaned, rinsed, and measured to bring it below the maximum allowable limit.
10 In-use monitoring of hemodialyzers
10.1 In-dialysis monitoring: the patient's clinical condition at each dialysis session should be observed and documented to identify possible complications arising from the reuse of hemodialyzers.
10.2 Syndromes associated with reuse:
10.2.1 Fever and chills: a temperature higher than 37.5°C or the presence of chills should be reported to the physician.
Unexplained fever and/or chills often occur at the start of dialysis and should be tested for endotoxin levels and disinfectant residuals in dialysis or reuse water.
10.2.2 Other Syndromes: If pain in the upper extremity on the vascular access side occurs at the start of dialysis, the physician should analyze whether the pain is due to residual disinfectant in the reused hemodialyzer. If residual disinfectant is suspected to be the cause of the reaction, the flushing procedure should be reassessed and the amount of disinfectant residual tested.
10.3 Principles for handling hemodialyzer failure: If the hemodialyzer membrane breaks or the ultrafiltration volume in dialysis deviates too much from the set value, the reuse procedure should be evaluated and adjusted; if the patient experiences a deterioration of the clinical condition, including progressive or unexplained elevation of serum creatinine level, and decrease in urea reduction rate (URR) or Kt/V (K: urea clearance rate of hemodialyzer, t: time on dialysis, and V: volume of urea distribution in the body), the patient should be evaluated and adjusted. volume of urea distribution) is decreased, dialysis operating procedures, including reuse procedures, should be examined.
10.4 Clinical monitoring: periodic testing of URR or Kt/V should be analyzed and evaluated if the results do not meet the requirements of the dialysis prescription.
11 Post-dialysis treatment backwash procedure: backwash saline to return residual blood from the hemodialyzer to the patient; air should not be used to backwash blood. After the patient is removed from the dialysis line, the hemodialyzer is flushed with the remaining saline in repeated cycles for several minutes.
12 QUALITY CONTROL
12.1 QUALITY CONTROL STANDARDS: Staff should monitor all reuse items, reuse materials, reuse procedures, reuse operations, and results.
12.2 Records: Records documenting results regarding study analyses, observations, and quality control checks, thereby providing information for objective analysis. Clinical information is the most important indicator of the quality of the multiplexing procedure, and records are used to further improve multiplexing practices.
12.3 The hemodialysis treatment unit shall accept the supervision and inspection of the hemodialyzer reuse process and quality control by the relevant organizations.