1, the implementation of effective and feasible medical equipment renewal system is to ensure the normal operation of hospitals and improve the quality of medical care is a key measure.
2, medical equipment renewal life, can be determined according to its performance, durability, quality, frequency of use.
3, the tentative renewal life of medical equipment: electronic and optical instruments for 8 years, mechanical medical appliances for 10 years, radiological equipment and other durable equipment for 15 years, fiber endoscopes for 5,000 times.
4, the Department of Instruments is responsible for the hospital's valuable medical instruments and equipment, file management, record the purchase of the machine, installation time, use of time, failure and maintenance of the situation, for the update of the equipment to accumulate information based on.
5, each department should fill out the machine in a timely manner to use and maintenance records, equipment maintenance personnel to regularly check the use of machine operation, fill out the maintenance records.
The degree of equipment needs to be updated:
1, has reached or exceeded the specified age and no repair value of the use of instruments and equipment.
2, the structure of the old, backward performance, a serious loss of precision, can not meet the requirements of use and can not be repaired instruments and equipment.
3, a serious impact on safety, continue to use will cause accidents, and is not easy to repair the modification. The patient is also a hazard.
4, a serious waste of energy, causing serious harm, due to accidents or disasters caused serious damage to the instruments and equipment.
In summary, the applicant for registration of medical devices should specify the use period of the product in the registration data and provide relevant verification information, the use period of the active medical device refers to the period of time by the applicant for registration of medical devices to ensure the safe and effective use of the product through the management of risk, in which the product is able to maintain its scope of application.
Legal basis:
"Chinese People's Republic of China*** and the State Regulations on the Supervision and Administration of Medical Devices"
Article 39
Medical devices should have instructions, labeling. The content of the instruction manual, labeling should be consistent with the registered or filed by the relevant content, to ensure that the true and accurate.
Medical devices instructions, labels shall indicate the following matters:
(a) generic name, model, specifications;
(b) medical device registrant, filer, the name and address of the commissioned manufacturer, and contact information;
(c) the date of manufacture, the use of the period or the date of expiration;
(d) the performance of the product, Main structure, scope of application;
(E) contraindications, precautions and other needs to be warned or prompted content;
(F) installation and use of instructions or illustrations;
(G) maintenance and maintenance methods, special transportation, storage conditions, methods;
(H) technical requirements of the product should be marked with other content.
The second class, Class III medical devices should also be marked medical device registration number.
Personal use by consumers of medical devices should also have a safe use of special instructions.