Release date: 2008-07-21

Issues to be paid attention to in the registration of disposable dialyzers. Evaluation by the Center for Medical Device Evaluation of the State Food and Drug Administration: Wang Yongqing, Deng Jie, Zhang Shiqing In recent years, with the rapid development of the domestic blood purification-related medical industry, the registration of hemodialyzers The number of declarations also showed a rapid growth trend. Although it is a one-time use, it is a high-risk product because it has direct contact with the patient's blood, has a long cumulative action time, and requires complicated production processes. In the process of product registration and declaration, in order to ensure a comprehensive and scientific evaluation of the safety and effectiveness of products, producers need to provide comprehensive technical support materials to facilitate more scientific and accurate evaluation of product risks and benefits, and thus improve products. The efficiency of registration declaration.
Based on the recent experience in reviewing such products, the problems that need to be paid attention to during the one-time use of the hemodialyzer registration process are explained. I hope that it will be helpful to the applicants.
1. The technical report of the product shall systematically and comprehensively discuss the research, design, production and processing process of the declared product, and provide technical documents on the intended use, technical characteristics, risk analysis, safety and effectiveness evaluation and application of the domestic and foreign applications. Among them, we need to focus on the following:
1. Clarify the material composition, chemical name, production qualification of raw material manufacturers, biological properties of materials and research reports. Raw materials are an important factor in the final quality control of products. Manufacturers should try to select raw materials with relevant application history, and focus on providing evaluation materials for dialysis membranes, outer casings, sealing adhesives and other raw materials. 2. Data and research reports on membrane structure and performance. The structure and performance of the dialysis membrane, such as the size, number, thickness and pore size distribution of the membrane, are the key technical indicators that ultimately determine the product performance and clinical application effect. The enterprise should provide product research, design, clinical application correlation and production processing. Argument data on aspects. 3. Data and research data on product process control and residual solvent evaluation. The company shall submit the production and processing of the product, including various processing techniques, the use of various processing aids, and the control of residual monomers, binders and solvents. Product safety evaluation should include the toxicity evaluation of components such as adhesives and solvents, control and demonstration of residual amount indicators, detection methods and test data. 4. Report the relevant materials and verification report of the product validity period and packaging material safety evaluation. 5. The standard should clarify the sterilization method and technical requirements, and provide the product sterilization verification report. 6. The pyrogen reaction is one of the most serious adverse reactions of dialyzers. It must be ensured from the production process and process control to prevent pyrogens from intruding into the product. At the same time, the batch test method should be used to detect possible pyrogens. 7. The dialysis method of the dialyzer and the safety evaluation of the residue are extremely important. Not only different materials need to adopt different sterilization methods, but also the residues after sterilization are different, and biological evaluation is required. 8. The reporting enterprise shall provide a biological evaluation report of the product according to the requirements of GB/T16886.1 and GB/T16886.4, and the report shall consider its cumulative effect.
2. The registered product standard shall be based on the requirements of relevant laws and regulations, the implementation of national standards or industry standards, and the technical requirements for ensuring the safety and effectiveness of the products and the controllable quality according to the characteristics of the products, the technical requirements of the registered product standards and Test methods should be verified. The registration standards for disposable dialyzer products should pay attention to the following aspects:
1. The new version of the dialyzer standard "Cardiovascular implants and artificial organs hemodialyzers, hemodiafiltration filters, hemofilters and blood concentrators" (YY 0053-2008) has been released, the reporting companies should pay attention to the new standard Changes in content, registered product standards requirements should not be lower than industry standards. 2. There are many varieties of dialyzers. The product standard should clearly define the material composition of each part of the product, and classify the product according to the technical characteristics such as membrane structure parameters and blood chamber capacity. 3. Product performance testing, including structural adhesion, solute clearance, ultrafiltration rate, blood chamber capacity, fluid resistance, pressure drop, etc. Due to the diversity of dialyzers and their clinical application methods, the specific standards of the products are not specified in the new standards. Enterprises should formulate corresponding performance indicators according to their own characteristics. In the new standard, the solute removal filter and ultrafiltration rate adopt the internationally common expression method, and the test conditions have also changed. Enterprises should pay special attention.
Third, the clinical trial data in addition to strictly in accordance with the requirements of the "Medical Device Clinical Trials Regulations", also need to pay attention to the following aspects:
1. Selection of test subjects. The test subject should in principle be a patient with chronic renal failure; the test subject should be representative; if the test subject has anemia and other symptoms that are not suitable for the test, it should be excluded.
2. Test protocol. Multi-center study, and each center program must be consistent; sufficient sample size, in line with statistical requirements; control group and test group should be distributed according to random principle; there are clear evaluation indicators, such as ultrafiltration rate, solute clearance rate, blood biochemical examination , biocompatibility, membrane rupture, residual blood volume, blood chamber volume, etc.; clinical observation and follow-up time of the experimental group and the control group should be the same; using classical, recognized statistical methods, calculation formulas, statistical software.
3. Clinical trial report. The clinical trial report should be consistent with the clinical trial plan; whether all cases have been followed up, whether the completed follow-up cases are included in the statistics, and the reasons for the loss of follow-up should be clearly identified; the results of the evaluation and safety evaluation are included in the statistical process. Raw data; report the time, cause, and consequences of all adverse reactions and adverse events and the relationship with the test equipment, and the treatment measures to be taken must be clarified.
The above points are based on the actual situation of the current technical review of the disposable hemodialyzer, and the staged summary of the key problems on the basis of the submitted materials submitted by the enterprise. It is impossible to cover all the problems and only prepare for the producers. Refer to the information when filing. It should be noted that the above is only some current understanding of dialyzer products, not mandatory requirements. (China Medical News)

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