The Capabilities of Medical Equipment to Response in Public Health Events at Chongqing Market

Ziyue Sheng

doi:10.60027/ijsasr.2024.3869

Authors

Ziyue Sheng Suan Sunandha Rajabhat University, Thailand https://orcid.org/0009-0002-3149-0981

DOI:

https://doi.org/10.60027/ijsasr.2024.3869

Keywords:

Public Health; , Medical Equipment; , Safety and Reliability Capabilities; , Inspect

Abstract

Background and Aim: 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. However, medical devices cannot fully meet clinical needs due to factors such as long research and development and inspection cycles, wide applicable standards, insufficient production capacity, and cumbersome review processes. In public health emergencies, medical devices that serve as auxiliary or direct treatment play a crucial role and play an indispensable role. Therefore, whether medical devices can function safely and effectively has become a determining principle. By conducting procedural testing on a specific medical device in public health emergencies in 2022, the qualification status of such medical devices can be more clearly and intuitively analyzed, And the specific problems with unqualified medical devices, and these medical devices during this period based on the obtained data.

Materials and Methods: Safety testing of medical devices used in 8 public health events using Chinese national standards

Results: 87% of the samples meet national standards and pass the inspection

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

References

GB 9706.1—2007. (2007). Medical Electrical Equipment Part 1: General Safety Requirements. Beijing: China Standard Press.

GB 9706.1—2020. (2007). Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Basic Performance. Beijing: China Standard Press.

GB4793.1-2007. (2007). Safety of electrical equipment for measurement, control, and laboratory use. Beijing: China Standard Press.

Li, X., Liu, S., Li, B., Li, J., Yu, Z., Zhang, Y., & Yang, L. (2023). GB 9706.1-2020 Medical Electrical Equipment Revision Key Points and Medical Device Regulatory Application Analysis Commodity Inspection. China NMPA Updates Electric Medical Equipment Standards.

National Drug Administration (2020). Medical Devices According to the requirements of the "Administrative Measures for Quality Sampling Inspection. Beijing: National Drug Administration.

The State Food and Drug Administration organizes. (2009). The compilation of technical basis for medical device supervision. Beijing China Medical Science and Technology Press.

Wang, A., & Shen, W. (2023). Experience and Reflection on Improving the Emergency Approval Mechanism for Medical Devices in Public Health Emergencies in China. 8, 24-34. DOI 10.3969/j.issn.1673-5390.2020.07.003.

Wei J., Tang, M., & Hu, J. (2020). Institutional Considerations for Achieving Accessibility of Medicines and Medical Devices in Public Health and Other Emergencies, Article No. 1673-5390 (2020) 04-020-08.

Zhou, J. (2023). Improving quality control and regulatory frameworks for medical devices. Journal of Medical Device Regulation, 15(2), 112-127.