Warning 1 Hospitals and doctors must realize that reusing disposable consumables is a criminal offense
The Regulations for the Supervision and Administration of Medical Devices clearly stipulate that single-use medical devices shall not be reused, and used ones shall be destroyed and recorded in accordance with relevant state regulations. Single-use medical devices directory by the State Council drug supervision and management departments in conjunction with the State Council health departments to develop, adjust and publish. Included in the catalog of single-use medical devices, should have sufficient evidence of the reasons why they can not be reused. Reuse can ensure the safety and effectiveness of medical devices, not included in the catalog of single-use medical devices. Due to 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 catalog of single-use medical devices, allowing repeated use.
Warning 2 hospital procurement, the use of single-use medical devices must strictly adhere to the rules
Supervision and Management of Medical Devices Regulations" provides that the use of medical devices units should be purchased from a legally qualified medical device registrant, record holder, manufacturer and operator of medical devices. The purchase of medical devices, should check the qualifications of the supplier and medical equipment qualification documents, the establishment of the purchase inspection records system.
Medical device units should strengthen the technical training of staff, in accordance with product instructions, technical specifications and other requirements for the use of medical devices. Reusable medical devices, medical equipment units shall be disinfected and managed in accordance with the provisions of the competent health departments of the State Council.
Single-use medical devices shall not be reused, the used shall be destroyed and recorded in accordance with relevant state regulations. The need for regular inspection, testing, calibration, maintenance, maintenance of medical devices, medical devices should be used in accordance with the requirements of the product manual inspection, testing, calibration, maintenance, maintenance and be recorded, timely analysis, evaluation, to ensure that medical devices in good condition, to protect the quality of use; the use of large medical devices for a long period of time, should be used to establish a unit-by-unit file, record its use, maintenance The use of large medical devices for a long period of time, should be established on a case-by-case basis to record their use, maintenance, transfer, actual use of time and other matters. Record-keeping period shall not be less than 5 years after the termination of the specified period of use of medical devices.