Legal analysis: (1) surgical instruments are always by the operating room is responsible for the requisition, storage and uniform provision of the use. (2) the operating room is responsible for routine surgical equipment ordering, the purchase of specialized special equipment should first be put forward by the specialist advice, after discussing with the operating room *** with the purchase. (3) The establishment of a special cabinet for surgical instruments, classified according to specialty placement, dedicated management. (4) Surgical instrument packages according to the surgery required for the combination of instruments, the establishment of surgical equipment inventory to facilitate the inventory, to avoid loss. (5) The instrument nurse prepares common and special instruments according to the operation notice one day before the operation. (6) It is strictly prohibited to take the surgical instruments out of the operating room or privately divert them for other uses or replace them. Doctors, trainees and interns are not allowed to bring surgical instruments for use in the operating room. (7) Surgical instruments shall be dried of blood after use, checked for completeness and sent to the Sterilization and Supply Center for sterilization. (8) In principle, surgical instruments are not loaned out, but when they need to be borrowed, they must be approved by the relevant departments and agreed by the head nurse of the operating room, and then loaned out with a note.
Legal basis: "supervision and management of medical devices regulations"
Article 35 The medical device registrant, the filing of the person, the commissioned manufacturer shall, in accordance with the quality management standard for the production of medical devices, the establishment and improvement of the production of medical devices and ensure the effective operation of the quality management system; strictly in accordance with the registered or filed by the technical requirements of the products to organize the production, to ensure the factory of medical devices comply with the mandatory standards and the registered or filed by the product. Medical devices comply with mandatory standards and registered or filed product technical requirements.
Medical device registrants, filers, commissioned manufacturers should be regularly on the operation of the quality management system for self-examination, and in accordance with the provisions of the State Council drug supervision and management department to submit a self-examination report.
Article 36 of the medical device production conditions change, no longer meet the requirements of the quality management system for medical devices, medical device registrants, filers, commissioned manufacturers shall immediately take corrective measures; may affect the safety and effectiveness of the medical device, shall immediately stop production activities, and report to the original production license or production filing department.
Article 37 of the medical device shall use the common name. Generic name should be consistent with the State Council drug supervision and management department to develop medical device naming rules.
Article 38 of the State according to the medical device product categories, the step-by-step implementation of the unique identification system for medical devices, medical devices to achieve traceability, the specific measures developed by the State Council drug supervision and management department in conjunction with the relevant departments of the State Council.