The Problems and Difficulties of Medical Devices in Chongqing in Response to Public Health Incidents in 2022

Abstract

Background and Aim: In the face of emergencies such as large-scale infectious diseases, some medical device manufacturers either do not have enough practical research and development experience in related epidemic prevention medical devices or use cheaper raw materials to reduce product quality in the research and development stage to save costs and increase profits. purpose, and even use various channels and means to bypass market supervision and produce problematic medical devices from the very beginning. Or, to take advantage of the public's panic about unknown infectious diseases, some unscrupulous merchants falsely advertise products that do not meet medical requirements, confusing the masses without certain professional cognitive ability, blindly believing and following them, and causing sudden large-scale infectious diseases. It cannot effectively reduce and contain the spread of diseases or other public health events. Infectious diseases spread rapidly in various cities. This is the problem with the quality supervision of medical devices under public health emergencies. From this new crown pneumonia epidemic, it can be found that the existing system is still unable to meet the needs of emergencies such as public health. It is necessary to do a good job of system reserves for the accessibility of drugs and medical devices from the level of laws and regulations. This needs to be sorted out to achieve accessibility. The existing regulations and systems should be improved to meet the needs of medical device use in public health and other emergencies. Materials and Methods: Safety testing of medical devices used in 26 public health events using Chinese national standards Results: The histogram of sample scores in the operation link reveals a complex landscape with an increased sample size. This data accentuates the intricate scoring dynamics and intricate qualification rates within the operation link, showcasing variations even among identical products from the same manufacturer. The case of "LFR20B" and "LFR30B" infrared forehead thermometers exemplifies how subtle factors, such as the weighting of specific performance indicators, contribute to scoring distinctions. Despite the "LFR20B" model achieving a higher score, it falls short of the category's passing threshold, underscoring the intricate nature of sample evaluations. However, it is noteworthy that 58% of the samples successfully meet national standards and pass the inspection, indicating a substantial portion complying with regulatory requirements. Conclusion: Laws and regulations need to be improved, there are hidden dangers in regulation, the ability of regulatory teams needs to be improved, medical device enterprises have problems, medical devices should strictly follow national standards, and the public should actively participate in medical device regulation.