In vitro diagnostic instruments usually refer to a type of medical device that detects or processes human samples outside the body to obtain clinical diagnostic information, and thus diagnose diseases or body functions. In vitro diagnostic instruments generally need to be used in conjunction with other instruments or reagent kits to achieve the purpose of in vitro diagnosis. With the rapid development of the in vitro diagnostic industry, in vitro diagnostic equipment has also become an important part of today's medical means. n vitro diagnostic instruments are not only a hot topic in current applications, but also a key issue of concern for manufacturers and even the industry, on how to ensure their safety and effectiveness.
One of the requirements for in vitro diagnostic equipment is to conduct clinical project analysis performance research, unlike other medical devices. Taking into account the situation of the detected substances and the main functions (such as quantitative/qualitative analysis, different detection methods/modes, etc.), representative projects should be selected for research and should be repeated multiple times including confirmation and validation processes for different types of analyzed substances and equipment functions. Research projects generally include accuracy, repeatability, linearity, stability, carry-over contamination, and so on.
Safety indicators mainly include electrical safety indicators and electromagnetic compatibility indicators. Applicants can conduct research on the above items by themselves or through commissioning inspections for validation. If the design structure differences of the products have no significant impact on safety and effectiveness, the typical model products in the same registration unit can be selected for electrical safety performance testing, but the electromagnetic compatibility performance between different model products often cannot be covered. In addition, the performance of each component module should also be evaluated.
The usage conditions and deadlines of the product should be determined and clearly stated in the instruction manual. There are many methods to determine the validity period of this type of product, such as multiplying the single-cycle life of key components and the maximum replaceable times as the effective period of the instrument, or determining the validity period through fatigue or accelerated testing.
Because human samples are used, corresponding measures need to be taken in the product design and user instructions to reduce the risk of pathogen transmission. Research and validation should be conducted on cleaning/disinfection methods, with clearly confirmed cleaning/disinfection agents, programs and cycles, etc. The cleaning and disinfection methods should be able to achieve the expected effect (such as resistance to pathogenic microorganisms) and not affect the main performance of the instrument.
In vitro diagnostic equipment generally needs to be tested and researched together with supporting reagent kits, and attention should be paid to whether the name of the supporting reagent kit is consistent with the instruction manual. Clinical research is basically the same as other medical devices and can refer to the requirements of relevant guidance principles.
It should be compiled according to regulations, including product name, product model/specification and its division description, performance indicators, inspection methods and basic safety feature appendix, etc. Sometimes, specific analysis performance, such as accuracy, precision, sensitivity, conformity rate, etc., also need to be included. The appendix part should be clear about the following four aspects: environmental conditions, equipment category, power supply, and insulation.
With a wide variety and range of expected uses, in the product evaluation process, in vitro diagnostic equipment should be more comprehensively and scientifically evaluated by considering the characteristics of the product, with reference to relevant standards, documents, and guidance principles, and focusing on key technical issues to ensure better safety and effectiveness.