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Single-use medical devices and instruments shall not be reused!
2023-10-08

In the "People's Republic of China Infectious Disease Prevention and Control Law", "Medical Devices Supervision and Management Regulations", "Hospital Infection Management Measures", "Disinfection Management Measures", "Disposable Sterile Medical Devices Supervision and Management Measures", and other documents emphasize that "single-use medical devices and appliances shall not be reused."

In order to strengthen the safety management of clinical use of medical devices, reduce the risk of clinical use of medical devices, and improve the quality of medical care, the management requirements for single-use medical devices are also clarified on page 31 of the Hospital Infection Management System of the First Hospital of Qiqihar compiled by our department.

Provisions of the source
(a) Article 51 of the Law of the People's Republic of China on Prevention and Control of Infectious Diseases stipulates that "medical institutions shall sterilize medical devices used in accordance with the regulations; medical instruments used once in accordance with the regulations shall be destroyed after use".
(ii) Article 6 of the Regulations on the Supervision and Administration of Medical Devices stipulates: "The directory of single-use medical devices shall be formulated, adjusted and published by the food and drug administration department under the State Council in conjunction with the competent department of health and family planning under the State Council. Repeated use can ensure the safety and effectiveness of medical devices are not included in the catalog of single-use medical devices. For the design, production process, sterilization technology and other improvements in repeated use can ensure the safety and effectiveness of medical devices, should be adjusted out of the directory of single-use medical devices". Article 35 states: "single-use medical devices shall not be reused, the used shall be destroyed and recorded in accordance with relevant state regulations".
(c) "Disinfection Management Measures" stipulates in Article 6: "Single-use medical supplies used in medical and health institutions should be harmlessly treated in a timely manner after use".
(d) "Hospital Infection Management Measures", Article 12 provides: "Medical institutions using disinfection medicine, disposable medical equipment and appliances should be in line with the relevant provisions of the state. Disposable medical devices and instruments shall not be reused".
(e) Article 22 of the Measures for the Supervision and Administration of Disposable Sterile Medical Devices stipulates: "Medical institutions shall not reuse sterile instruments."

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