2. Scope: all departments of the institution.
3. Content:
3.1 The legal representative of the medical institution, the person in charge should be familiar with the relevant national laws, rules and regulations on the management of medical devices, the use of medical equipment, management of leadership responsibility.
3.2 medical institutions should strengthen the management of medical devices in the unit. According to the food and drug supervision and management departments, health administrative departments, combined with the actual situation of the unit to develop appropriate management system; where medical equipment involved in the department, to establish the management system of medical equipment, the implementation of the management of the responsibility.
3.3 medical institutions should be based on the functions, tasks, scale of the organization, set up the appropriate medical device management department or full-time management personnel, responsible for the relevant day-to-day management.
3.4 The legal representative or person in charge of medical institutions, medical device management department or the person in charge of full-time quality management personnel, as well as the use of medical devices, should be clearly defined responsibilities, the formation of medical device quality management assurance system.
3.5 medical institutions in accordance with the actual needs of medical care, scientific research, in order to ensure the quality of medical devices as a prerequisite for the procurement of medical devices from units with legal qualifications.
3.6 medical institutions should establish a medical device procurement system, acceptance and registration system.
3.7 medical institutions should have the appropriate conditions for the storage of medical equipment, and the establishment of a corresponding management system. Special storage conditions require medical devices, should be equipped with appropriate equipment and facilities.
3.8 medical institutions in the purchase and acceptance, storage and other aspects of the suspected unqualified medical devices, should be confirmed and dealt with, has been confirmed unqualified medical devices, shall not be used without authorization, should be reported in accordance with the management procedures, and record the relevant content, in accordance with the relevant provisions of the relevant local administrative departments.
3.9 Medical devices should be used to establish the use of medical devices management system and operational standards, designate a person to manage, specify the scope of use and the responsibility of managers. Strictly prohibited for non-medical and non-scientific needs of diagnosis and examination.
3.10 single-use sterile medical devices before use, should carefully check the single-use sterile medical device packaging. For direct contact with the medical device product packaging is broken or exceed the expiration date and other circumstances, should stop using, according to the provisions of the treatment.
3.11 medical institutions should establish a one-time use of sterile medical devices after use destruction system. Used single-use sterile medical devices must be destroyed according to the provisions of the parts and components should no longer have the use of function, disinfection and harmless treatment and make a record. Medical institutions shall not reuse single-use sterile medical devices.
3.12 on orthopedic internal fixation devices, pacemakers, intravascular catheters, stents and other implanted medical devices, should establish the appropriate management system and keep detailed records of use.
3.13 medical institutions should be in use equipment class medical devices to establish a file, and develop repair, maintenance system, by full-time or part-time personnel responsible for the implementation.
3.14 medical institutions should establish medical device adverse event monitoring and reporting system.
3.15 medical institutions in accordance with the clinical needs of the unit, can develop medical devices, under the guidance of a licensed physician in the use of the unit. Medical institutions to develop the second class of medical devices, should be reported to the provincial food and drug supervision and management department for review and approval; medical institutions to develop the third class of medical devices, should be reported to the State Council food and drug supervision and management department for review and approval.
3.16 the management of medical devices, the use of medical devices, maintenance of accidents in the work, should be dealt with in a timely manner, by the medical device management department to put forward processing advice, reported to the unit in charge of the approval of the leadership of the implementation.
3.17 the use of medical devices in the process of causing personal injury, death or economic loss of more than 100,000 yuan of major accidents, should be promptly reported to the administrative department.
3.18 Where the violation of the relevant provisions of the state and the collective caused significant losses, the parties and the persons concerned shall be held responsible.