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Some national laws and regulations on disposable medical devices

Release time:

2020-08-13

Shijiazhuang, May 16, Xinhua (reporter Li Junyi, Rao Yajie) Article 27 of the regulations on the supervision and administration of medical devices (Order No. 276 of the State Council of the People's Republic of China), which came into effect on April 1, 2000, stipulates that medical institutions shall not reuse medical devices for one-time use; if they have been used, they shall be destroyed in accordance with the relevant provisions of the state and recorded.

Some national laws and regulations on disposable medical devices

 

Shijiazhuang, May 16, Xinhua (reporter Li Junyi, Rao Yajie) Article 27 of the regulations on the supervision and administration of medical devices (Order No. 276 of the State Council of the People's Republic of China), which came into effect on April 1, 2000, stipulates that medical institutions shall not reuse medical devices for one-time use; if they have been used, they shall be destroyed in accordance with the relevant provisions of the state and recorded.

Article 22 of the "Measures for the Supervision and Administration of Disposable Sterile Medical Devices" (Order No. 24 of the Director) officially implemented in October 2000 stipulates that medical institutions shall establish a system for the destruction of sterile devices after use. Used sterile instruments must be destroyed in accordance with the provisions, so that their parts no longer have the function of use, after disinfection and harmless treatment, and make records. Medical institutions shall not reuse sterile instruments. Article 6 of the Interpretation of the Supreme People's Court and the Supreme People's Procuratorate on Several Issues Concerning the Specific Application of Laws in Handling Criminal Cases Concerning the Production and Sale of Fake and Inferior Commodities, which came into effect on April 10, 2001, stipulates that the production and sale of substandard medical devices and medical hygiene materials that cause minor injuries or other serious consequences shall be deemed as "causing serious harm to human health" as stipulated in Article 145 of the Criminal Law "; the production and sale of medical devices and medical and sanitary materials that do not meet the standards, causing infection with viral hepatitis and other incurable diseases, serious injuries to more than one person, minor injuries to more than three people or other serious consequences, shall be deemed as" particularly serious consequences "; Production and sale of medical devices and medical and sanitary materials that do not meet the standards, those who cause death, serious disability, AIDS infection, serious injury to more than three people, minor injury to more than ten people or other particularly serious consequences shall be deemed as" particularly bad circumstances "; medical institutions or individuals, who know or should know that they do not meet the national standards and industry standards for the protection of human health, purchase and use of medical devices and medical hygiene materials, causing serious harm to human health, conviction and punishment for the crime of selling medical equipment that does not meet the standards.

The "Hospital Infection Management Regulations (Trial)" issued by the Ministry of Health in November 2001 stipulates that after the use of disposable sterile medical supplies, they must be disinfected, destroyed, and treated innocuously in accordance with the regulations of the local health administrative department. Reuse and return to society. (END)

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