Principles of device management do not include random placement.
Principles of device management:
One, the principle of reasonableness
The principle of reasonableness is the basis and premise of medical device management. Rationality refers to all the processes of shopping, purchasing, using, maintaining and disposing of medical devices in hospitals must be in line with the needs of medical services, in line with the actual needs of the clinic, in line with the corresponding laws and regulations, in line with the quality and safety requirements, rather than just the pursuit of commercial interests.
Scientific principle
Scientific principle means that in the purchase, procurement, use, maintenance and disposal of medical devices must be based on the laws and principles of science, clinical practice and experience, the selection of appropriate equipment, used under the correct operation, in order to achieve good medical results and the maintenance of patient safety and comfort.
Third, the principle of normality
The principle of normality means that the management of medical devices should be strictly in accordance with the relevant national and local laws and regulations, standards and management norms, to ensure that the use of each piece of equipment is in line with the standards, norms and procedures, and to improve the quality of the management of medical devices and the level of service.
Four, safety principle
Safety principle refers to the process of medical device management must be the patient's safety and health care as the primary consideration, to ensure that the use of devices does not cause any threat to the patient's life and health.
Including the safety, reliability and stability factors of the device must be taken into account when purchasing and the safety requirements of the device and the regulations on the instruction manual must be followed when using the device to ensure that the rights and interests of the patients are fully protected.
Medical device management methods:
The state of medical devices in accordance with the degree of risk of the implementation of categorized management.
The first class of medical devices to implement product filing management, by the filer to the location of the municipal people's government food and drug supervision and management department to submit the record information.
The second and third class of medical devices to implement product registration management. Apply for Class II medical device product registration, the registration applicant shall be the location of the provincial, autonomous regions, municipalities directly under the Central People's Government of the Food and Drug Administration to submit the registration application information. Apply for Class III medical device product registration, the registration applicant shall be submitted to the State Council food and drug supervision and management department of the registration application information.
The State Food and Drug Administration is responsible for the national supervision and management of the quality of medical devices. Above the county level, the local food and drug supervision and management department is responsible for the administrative region of the quality of medical equipment supervision and management.