Ministry of Health on X-ray computed tomography device CT and other large medical equipment configuration and application of management implementation rules

Chapter I Configuration Management Article I Ministry of Health to develop X-ray computed tomography device (CT), magnetic **** vibration imaging device (MRI), Acme knife (X-knife), gamma knife (γ-knife) four items of large-scale medical equipment configuration planning and annual distribution plan. Article II of the people's governments of provinces, autonomous regions and municipalities directly under the Central People's Government health administrative departments to develop large-scale medical equipment regional configuration plan is based on:

Annual distribution plan issued by the Ministry of Health and the region's medical and health care institutions set up planning (planning, including the configuration of large-scale medical equipment);

Second, the medium- and long-term goals of medical and health care services;

Third, the primary The completion of primary health care tasks;

four, the state of economic development, the total population, age composition and epidemiological statistics;

five, has been configured with the number of large-scale medical equipment and its distribution;

four, the applicant health care institutions have been assessed by the level of its related equipment and the configuration of the medical and technical personnel. Article III application for the configuration of large medical equipment, medical and health institutions must have been included in the regional configuration plan, in line with the following conditions, and according to the hospital level configuration of the corresponding models.

Application for the configuration of CT medical and health institutions, must have routine X-ray inspection equipment and the corresponding personnel, technology and other conditions.

Second, apply for the configuration of MRI medical and health institutions, must be configured and use CT for more than two years.

Three, apply for the configuration of X-knife medical and health institutions, must be configured and used linear gas pedal for more than one year.

Four, applying for the configuration of γ - knife medical and health institutions must have neurosurgery specialized equipment and technical conditions.

V. CT, MRI models are divided into three types: clinical research, clinical application, clinical utility.

Sixth, has been rated third-class hospitals can be equipped with: CT, MRI one of the three models; X-knife or γ-knife.

Seven, has been rated second-class hospitals can be equipped with: CT, MRI clinical application or clinical utility model. Article IV application for the configuration of large-scale medical equipment for medical and health institutions, must have already obtained the "large-scale medical equipment on board personnel technical qualification certificate" of physicians and technicians. Article V application for the configuration of CT procedures:

One of the CT configuration conditions by the medical and health institutions to the province, autonomous region, municipalities directly under the Central People's Government of the health administrative department to apply, and fill out the "large medical equipment configuration application form" (Annex I).

Second, the provinces, autonomous regions, municipalities directly under the Central People's Government of the health administrative department according to the Ministry of Health approved the annual CT configuration plan and published annual guidance equipment model unified approval, and summary reported to the Ministry of Health, receive "large medical equipment configuration license" (Annex II). If the declared model is inconsistent with the annual guidance equipment model announced by the Ministry of Health, it shall be reported to the Ministry of Health for approval. Article VI application for the configuration of MRI, X-knife, γ-knife procedures:

One, in line with the conditions of MRI, X-knife, γ-knife configuration of medical and health institutions to the provincial, autonomous regions, municipalities directly under the Central People's Government of the health administrative department to apply, and fill out the "large-scale medical equipment configuration application form".

Second, the provinces, autonomous regions, municipalities directly under the Central People's Government of the health administrative department of the Ministry of Health approved MRI, X-knife, γ-knife annual configuration plan for preliminary examination, summary, and then submitted to the Ministry of Health for approval. Article VII of the provincial, autonomous regions, municipalities directly under the Central People's Government health administrative departments in the first quarter of each year will be the previous year's large-scale medical equipment contracts and other materials reported to the Ministry of Health for the record. Article VIII of the Ministry of Health organization of professional and technical academic group, the technical performance of large medical equipment, price and after-sales service for comprehensive evaluation, the annual periodic announcement of the national guide to equipment models. Acquisition work to promote public bidding, centralized purchasing. Article IX where any form of cooperation with any unit or individual configuration of large medical equipment, must be reported to the Ministry of Health for approval. Article X has obtained a "large medical equipment configuration license" of health care institutions, large medical equipment should be updated to fill out the "large medical equipment update application form" (Annex III), apply for a new license. Chapter II Application Management Article XI of the Ministry of Health to develop and recognize the application of large medical equipment safety, health protection, application of quality management standards. Article XII of the Ministry of Health set up a "national application of large medical equipment technology review committee" (hereinafter referred to as "assessment committee"), responsible for the application of large-scale medical equipment safety, health protection, technical quality management and other day-to-day assessment work.

"Jury" set up an office, the organization coordinates the work of large medical equipment professional groups. Article XIII of the people's governments of provinces, autonomous regions and municipalities directly under the Central Health Administration can set up a "national large medical equipment application technology review committee" (hereinafter referred to as "assessment committee") is responsible for the application of large-scale medical equipment within the administrative region of the review of technology. Work. "Evaluation Committee" on the "assessment committee subcommittee" work to provide business guidance. Article 14 Before large-scale medical equipment is put into use, it shall be assessed by the "assessment committee" for the application of technology. Review should be carried out in accordance with the following procedures:

One, fifteen days before the review, by the use of institutions to the provincial, autonomous regions and municipalities directly under the Central People's Government of the health administrative department to review the application, and show the "configuration of large-scale medical equipment licenses" and "large-scale medical equipment, technical qualification certificate of personnel;

Two, provinces, autonomous regions and municipalities directly under the Central People's Government of the health administrative department receives the use of institutions The evaluation application, after checking the above two certificates should be timely entrusted to the "jury branch" to send a person to carry out the evaluation on schedule;

Three, the evaluation should be strictly in accordance with the "jury" to develop the project, procedures and methods; equipment performance must be To achieve the technical parameters specified in the ordering contract; equipment supporting must include basic testing tools for quality control;

4, the results of the review into the technical file, as the basis for equipment review data; and this review into the hospital review, the results of the review as a key indicator of the hospital's review;

5, the review of qualified, and then issued to the "large-scale medical equipment application Quality Certificate" (Annex IV).

The "Jury Branch" can invite the "Jury" **** with the review.