【 Knowledge Popularization 】 Requirements for Validity Verification of Active Medical Device Products

Page View：   Time：2023-08-07 11:46:46 Classification： Technical Support

Abstract：1 Basic definitionActive medical device usage period: refers to the period during which the applicant registrant
1. Basic definition
Active medical device usage period: refers to the period during which the applicant/registrant for medical device registration ensures the safe and effective use of the product through risk management, and during this period, the product can maintain its scope of application.
Expiration date: refers to the end of the usage period, after which the safety and effectiveness of the medical device cannot be guaranteed. The service life of active medical devices shall be from the date of formation of the final product to the expiration date, taking into account both the time period before the device is put into use and the time period after the device is put into use.
Expected service life of active medical devices: refers to the expected period during which the applicant for medical device registration ensures the safe and effective use of the product through risk management before its launch, during which the product can maintain its scope of application.
 
2. Evaluation method
There are generally two ways for medical device registration applicants/registrants to determine the product's service life:
A method for medical device registration applicants/registrants to pre-set the usage period based on evaluation or experience, and verify the rationality of the pre-set values through one or more methods;
A method for medical device registration applicants/registrants to determine the product's service life through one or more methods without setting a predetermined deadline value.
 
3. Evaluation path
Evaluation path 1 is to directly validate the product. You can list the usage status of the product, fully analyze its clinical use, and directly conduct real-time aging tests or accelerated aging tests on the product. During the trial, reference should be made to the requirements of clinical usage frequency and intensity, as well as usage environment.
Evaluation path 2 is to evaluate by decomposing the product (system) into different subsystems/components. Firstly, a detailed analysis of the decomposition relationship should be conducted, and on this basis, the service life of the product should be determined through different decomposition methods (such as dividing the product into critical and non critical components and/or characteristic components and/or replaceable and non replaceable components and/or moving and non moving components and/or electronic and mechanical components).
 
 
4. Influencing factors
The determination of the service life of active medical devices can consider the following aspects:
Key components such as high integrity components, frequency and intensity of use, transportation, storage and usage environment, cleaning/disinfection/sterilization, maintenance and repair of components, and commercial factors. The registration applicant can determine the expected service life of the product by analyzing the above factors.
Medical device registrants should dynamically evaluate the product's lifespan through risk analysis throughout its entire lifecycle. In addition, repair, maintenance, and upkeep of the product may be necessary during its use.
 
5. Evaluation methods
When evaluating the service life of a product, the first step is to develop an evaluation plan, which includes a sampling plan for the product, including the purpose of collecting the product/component, the quantity and reason for selecting the product/component, selection criteria, and the batch to be sampled; Based on the influencing factors described in Part 6, clarify the specific evaluation and analysis methods used in the evaluation of the service life. Secondly, test according to the evaluation plan or obtain results through other processes, and finally form an analysis report.
The specific evaluation and analysis methods for the product's service life include:
（1） Conduct prospective studies using accelerated aging tests (see Appendix 1) on products/critical components, and/or validate real-time aging correlations;
（2） Summarize and study the experience of using this product or similar products, which may involve sample testing, installation and usage, maintenance rate or maintenance records, complaint history, or research on public literature;
（3） Reliability evaluation and analysis methods, simulation testing methods, or other theoretical and simulation calculation methods for products/critical components.
The above methods can be used alone or in combination. Other reasonable and scientific methods can also be used.
 
1. Testing and verification of different components
The analysis of the service life of key electronic components can be evaluated based on reliability prediction or reliability simulation analysis methods. The analysis of the service life of mechanical components can be conducted through accelerated life testing or direct clinical scenario cumulative testing. For example, if it is expected that the robotic arm will stretch and retract 100000 times within 10 years, a conclusion can be drawn by observing the status of the robotic arm after 100000 mechanical tests. The components undergoing acceleration testing need to develop a theoretical model for acceleration testing and provide a calculation method for the acceleration factor.
 
2.The principle of two analogies
Similar products or components should have similar hardware structures, materials, electrical performance indicators (voltage, power, current), similar main process flow, and similar working environment and clinical reference usage intensity.
If the service life of a product is evaluated through analogical analysis of similar products, detailed comparative information should be provided.
Basic information should include: name, model, specifications or configuration, and registrant.
Technical information should include key technical indicators and process characteristics. These technical indicators should be in line with the actual situation, such as voltage, power, current, applicable duty cycle, some performance indicators, main process names, etc.
The benchmark condition information includes: usage climate environment (temperature, humidity, air pressure), mechanical environment (vibration tolerance characteristics, collision tolerance characteristics), clinical reference usage frequency and intensity, etc.
2. If the service life of a component is evaluated through analogical analysis, in addition to the information mentioned in 1 above, the following information of the component should also be provided:
Basic information should include: name, model, specifications or configuration, and manufacturer.
Technical information should include key technical indicators and process characteristics. These technical indicators should be in line with the actual situation, such as voltage, power, current, applicable duty cycle, component performance indicators, and interface specifications.
The benchmark condition information includes: usage climate environment (temperature, humidity, air pressure), mechanical environment (vibration tolerance characteristics, collision tolerance characteristics), clinical reference usage frequency and intensity, etc.
3 Empirical data
The service life of the declared product can be inferred by analyzing the usage experience data of similar products listed domestically and internationally. When estimating the service life using existing empirical data, the following characteristics of the data should be considered:
1. Authenticity: Market data should be true and reliable;
2. Adequacy: Market data that has reached the declared usage period should be sufficient and cover a sufficiently long period of time for statistical analysis;
3. Unbiased: Market data cannot be provided with bias or selectivity;
4. Traceability: The data should be traceable and the tracking chain of the data should be reliable.
The distribution information of data with the above characteristics should be provided, and the confidence interval should be given.
 
picture Source: Guidelines for Technical Review of Registration of Service Life of Active Medical Devices
[Statement] This article is a reprinted content. If there are any copyright issues, please contact us and we will handle them immediately to protect the rights and interests of all parties.

Return