Guidelines for The Reprocessing of Hemodialyzers
The process of reusing a used blood hemodialyzer, after a series of procedures, such as rinsing, cleaning, and disinfection to meet the specified requirements, for the same patient’s dialysis treatment is called hemodialyzer reuse.
Due to the potential risks involved in reprocessing, which may pose safety hazards to patients, there are strict operational regulations for reusing blood hemodialyzers. The operators must undergo thorough training and adhere to the operational guidelines during reprocessing.
Water Treatment System
Reprocessing must use reverse osmosis water, which must meet biological standards for water quality and meet the water demand of equipment working during peak operation. The extent of pollution caused by bacteria and endotoxins in RO water should be regularly tested. Water inspection should be done at or near the joint between the blood dialyzer and the reprocessing system. The bacterial level can not be over 200 CFU/ml, with an intervention limit of 50 CFU/ml; the endotoxin level can not be over 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. However, measures should be taken (such as disinfecting the water treatment system) to prevent further contamination. Bacteriological and endotoxin testing of water quality should be conducted once a week, and after two consecutive tests meet the requirements, bacteriological testing should be conducted monthly, and endotoxin testing should be conducted at least once every 3 months.
Reprocessing System
The reprocessing machine must ensure the following functions: putting the dialyzer in the reverse ultrafiltration state for repeated rinsing of the blood chamber and dialysate chamber; conducting performance and membrane integrity tests on the dialyzer; cleaning the blood chamber and dialysate chamber with a disinfectant solution of at least 3 times the blood chamber volume, and then filling the dialyzer with effective concentration disinfectant solution.
Wesley’s dialyzer reprocessing machine--mode W-F168-A/B is the first full-automatic dialyzer reprocessing machine in the world, with automatic rinse, clean, test, and affuse programs, which can complete dialyzer flushing, dialyzer disinfection, testing, and infusion in about 12 minutes, fully meeting the standards of reuse dialyzer processing, and print the TCV(Total Cell Volume) test result out. The automatic dialyzer reprocessing machine simplifies the work of operators and ensures the safety and effectiveness of reused blood dialyzers.
W-F168-B
Personal Protection
Every worker who may touch patients’ blood should take precautions. In dialyzer reprocessing, operators should wear protective gloves and clothing and abide by infection control prevention standards. When engaging in the procedure of known or dubitable toxicity or solution, the operators should wear masks and respirators.
In the working room, an emergent eye-washing water tap shall be set to ensure effective and timely washing once the worker is hurt by the splashing of chemical material.
Requirement for Blood Dialyzers Reprocessing
After dialysis, the dialyzer should be transported in a clean environment and handled immediately. In case of special situations, blood hemodialyzers that are not treated in 2 hours can be refrigerated after rinsing, and the disinfection and sterilization procedures for the blood dialyzer must finished in 24 hours.
●Rinsing and cleaning: Use standard RO water to rinse and clean the blood and dialysate chamber of the blood hemodialyzer, including back-flushing. Diluted hydrogen peroxide, sodium hypochlorite, peracetic acid, and other chemical reagents can be used as cleaning agents for the dialyzer. But, before adding a chemical, the previous chemical must be removed. Sodium hypochlorite should be eliminated from the cleaning solution before adding formalin and not be mixed with peracetic acid.
●TCV test of dialyzer: The TCV of the blood dialyzer should be greater than or equal to 80% of the original TCV after reprocessing.
●Dialysis membrane integrity test: A membrane rupture test, such as an air pressure test, should be conducted when reprocessing the blood hemodialyzer.
●Dialyzer disinfection and sterilization: The cleaned blood hemodialyzer must be disinfected to prevent microbial contamination. Both the blood chamber and dialysate chamber must be sterile or in a highly disinfected state, and the dialyzer should be filled with disinfectant solution, with the concentration reaching at least 90% of the regulation. The blood inlet and outlet and the dialysate inlet and outlet of the dialyzer should be disinfected and then covered with new or disinfected caps.
●Shell of dialyzer treatment: A low-concentration disinfectant solution (such as 0.05% sodium hypochlorite) that is adapted for the materials of the shell should be used to soak or clean the blood and dirt on the shell.
●Storage: The processed dialyzers should be stored in a designated area to separate from the unprocessed dialyzers in case of pollution and misuse.
External Appearance Checking after Reprocessing
(1) No blood or other stain on the outside
(2) No cranny in the shell and the port of blood or dialysate
(3) No clotting and black fiber on the surface of the hollow fiber
(4) No clotting at two terminals of the dialyzer fiber
(5) Take caps on the inlet and outlet of blood and dialysate and make sure no air leakage.
(6) The label of the patient’s information and dialyzer reprocessing information is right and clear.
Preparation before The Next Dialysis
●Flush the disinfectant: the dialyzer must be filled and flushed sufficiently with normal saline before use.
●Disinfectant residue test: residual disinfectant level in dialyzer: formalin <5 ppm (5 μg/L), peracetic acid <1 ppm (1 μg/L), Renalin <3 ppm (3 μg/L)
Post time: Aug-26-2024