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Are the electromagnetic waves emitted by ultrasound devices safe? Is the oxygen concentration of the oxygen generator up to standard and the noise exceeding the standard? Does the mask have a particle filtration efficiency of more than 95%? Is the "one bar" and "two bars" of in vitro diagnostic reagent test results accurate?
Before a medical device can be marketed, its function and safety need to be tested. Efficient and responsible testing helps to protect the life and health safety of the people, and also helps qualified medical device products to be launched as soon as possible to benefit patients. A few days ago, the reporter came to the Sichuan Provincial Medical Device Testing Center, and under the leadership of Lan Wanling, vice president of the Sichuan Provincial Institute for Drug Control (Sichuan Medical Device Testing Center), he visited the testing process of some medical devices.
It is worth mentioning that at present, the Sichuan Provincial Food and Drug Review and Evaluation and Safety Monitoring Center has set up sub-centers in Chengdu Medical City and other medical and health industrial parks, and the professionals stationed can intervene and serve enterprises as early as possible, so that enterprises can avoid detours in the process of declaration and certification, and effectively promote the development of Chengdu's pharmaceutical and health industry.
Visit one by one, how to test the oxygen concentrator mask test strip
Walking into the Sichuan Provincial Institute for Drug Control (Sichuan Medical Device Testing Center), the "Active Device Testing Institute" is conducting performance experiments on oxygen concentrators, and testing engineer Zhou Meiling and her colleagues have built a set of experimental devices including monitoring pressure, flow, oxygen concentration and simulating human respiratory air resistance to test the oxygen concentration index of the oxygen concentrator.
When the air duct is plugged in, the number on the oxygen concentration monitor rises as oxygen is output. "The national standard for oxygen concentration is 93% ±3%, and at present, the oxygen concentration of this machine reaches 94.83%, which meets the requirements of the standard." Zhou Meiling said.
Next, the experimenters carried out a noise test of the oxygen concentrator, and the decibel meter showed that the noise index was 45.8 decibels. "The noise of the oxygen generator is not higher than 60 decibels, and the noise of the oxygen generator is also up to standard after testing." Zhou Meiling said.
Then she added, "This is only a small part of the performance test of the oxygen concentrator, and the oxygen concentrator must be tested for electrical safety, electronic compatibility and many physical and chemical indicators before it is listed, and it can only be marketed after all the standards are met." ”
Subsequently, the reporter came to the "Passive Device Testing Institute", in the mask performance testing laboratory, the inspector spread the mask on professional equipment, and its particle filtration efficiency can be quickly displayed. The inspector specially placed a failed mask at the test port, only to see that the equipment showed that its particle filtration efficiency was only 82%. "For qualified masks, the particle filtration efficiency should reach more than 95%, and this sample is an obvious unqualified product." Said the inspector.
In the in vitro diagnostic reagent laboratory, the inspector took out two test cards, took the negative and positive samples to be tested respectively, added them dropwise to the sample addition hole of the test card, and after standing for 10 minutes, the two test cards showed "one bar" and "two bars" respectively, indicating that this batch of products is qualified. ”
There are many indicators in the whole detection process
"In order to let ordinary readers feel the detection effect, several detection scenarios that we will visit this time are relatively intuitive and simple." Lan Wanling said, but in fact, the whole detection process is more complicated, taking the familiar B ultrasound as an example, B ultrasound should have a certain detection function, this function may need to be controlled by multiple indicators, such as detection depth, resolution, geometric position accuracy, etc., B ultrasound will produce a certain thermal effect when working, and the emitted electromagnetic waves may also cause electromagnetic interference to the environment or other equipment, which needs to be controlled to ensure that the product meets safety requirements.
"The testing center is mainly engaged in the inspection and testing of medical device products, one is pre-market testing, called 'registration inspection', and the other is post-marketing regulatory testing, called 'supervision inspection'. The testing center can complete the testing of many products such as passive and active medical device products, and more than 90% of the medical device products in Sichuan Province can be tested here. Lan Wanling said.
The "sub-center" is set up in the industrial park to help enterprises quickly obtain certificates
"Medical devices can only be produced and sold after obtaining a product registration certificate, and inspection and testing is an important part of this process, but the entire review and approval process is a very complex system engineering, and some companies lack understanding of this process, which may delay enterprises to obtain certificates in a timely manner." Zhou Jianjun, who was dispatched by the Wenjiang District Market Supervision Bureau and served as the person in charge of the Chengdu Medical City Branch of the Sichuan Provincial Food and Drug Review and Evaluation and Safety Monitoring Center (hereinafter referred to as the "Provincial Evaluation Center"), introduced that in June 2023, the Chengdu Medical City Branch of the Provincial Evaluation Center was established, which is committed to serving pharmaceutical and medical device enterprises in Chengdu Medical City to quickly obtain product registration certificates, help open priority approval channels, and shorten the approval time.
Regarding the progress of the listing of the products of related medical device companies in Chengdu Medical City, Zhou Jianjun is like a treasure. Over the past year, together with Huang Ming from the Chengdu Medical City Workstation of the Sichuan Provincial Drug Administration, he has gone deep into many enterprises in Chengdu Medical City and given them "one-to-one" professional guidance. "From the pre-examination of the registration and application materials, system documents, production sites, product inspection and testing and other review and approval requirements of medical device manufacturers, to the establishment and improvement of enterprise accounts, we can provide enterprises with guidance and services for the whole chain." Zhou Jianjun said.
Chengdu Daily Jinguan News Reporter/Picture/Video Li Juan Li Keyu Editor-in-charge Liu Yang Editor Liu Chunchun