Detailed rules for the implementation of configuration and application management of large medical equipment such as X-ray computed tomography device CT of the Ministry of Health

Chapter I Configuration Management Article 1 The Ministry of Health shall formulate the configuration plans and annual configuration plans for four types of large medical equipment: X-ray computed tomography (CT), magnetic resonance imaging (MRI), X-knife and gamma knife. Article 2 The health administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall formulate regional allocation plans for large-scale medical equipment, mainly on the basis of:

First, the annual distribution plan issued by the Ministry of Health and the establishment plan of medical and health institutions in the region (including the configuration of large medical equipment in the plan);

Second, the long-term goal of medical and health services;

Three, the completion of primary health care tasks;

Four, economic development, total population, age composition and epidemiological statistics;

Five, the number and distribution of large medical equipment has been configured;

Six, the application of medical and health institutions have passed the grade review and equipped with relevant equipment and medical technicians. Article 3 Medical and health institutions applying for the allocation of large-scale medical equipment must be included in the regional allocation plan, meet the following conditions, and allocate corresponding models according to the hospital level.

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

Two, medical and health institutions to apply for magnetic resonance imaging, must configure and use CT for more than two years.

Three, the medical and health institutions applying for X- knife configuration, must configure and use the linear accelerator for more than one year.

Four, the medical and health institutions applying for the configuration of gamma knife must have the professional equipment and technical conditions of neurosurgery.

Five, CT and MRI models are divided into three types: clinical research type, clinical application type and clinical practical type.

Sixth, the hospital was rated as a third-class equipment: one of the three major models of CT and MRI; X knife or γ knife

Seven, has been rated as a second-class hospital equipment: CT, MRI clinical application or clinical practice. Article 4 Medical and health institutions applying for the allocation of large-scale medical equipment must have doctors and technicians who have obtained the technical qualification certificates of employees of large-scale medical equipment. Article 5 Procedures for applying for configuring CT:

First, medical and health institutions that meet the requirements of CT configuration apply to the health administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government and fill out the Application Form for Configuration of Large Medical Equipment (Annex I).

Second, the health administrative departments of the people's governments of all provinces, autonomous regions and municipalities directly under the Central Government shall conduct unified examination and approval according to the annual ct configuration plan approved by the Ministry of Health and the annual guidance equipment model announced, and report to the Ministry of Health for the configuration license of large medical equipment (Annex II). If the declared model is inconsistent with the annual guidance equipment model published by the Ministry of Health, it shall be reported to the Ministry of Health for approval. Article 6 Procedures for applying for configuration of magnetic resonance, X-knife and γ-knife:

First, medical and health institutions that meet the requirements of magnetic resonance, X-knife and γ-knife configuration apply to the health administrative department of the people's government of the province, autonomous region or municipality directly under the Central Government where they are located, and fill in the application form for large-scale medical equipment configuration.

Two, the health administrative departments of the people's governments of all provinces, autonomous regions and municipalities directly under the central government shall conduct preliminary examination according to the annual allocation plan of magnetic resonance, X-knife and γ-knife approved by the Ministry of Health, and report to the Ministry of Health for approval. Article 7 The health administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall submit the materials such as the trading contracts of large-scale medical equipment in the previous year to the Ministry of Health for the record in the first quarter of each year. Article 8 The Ministry of Health shall organize a professional and technical academic group to comprehensively evaluate the technical performance, price and after-sales service of large-scale medical equipment, and regularly publish the model of national guidance equipment every year. Public bidding and centralized procurement are advocated in procurement. Ninth whoever cooperates with any unit or individual in any form to configure large-scale medical equipment must report to the Ministry of Health for approval. Article 10 Medical and health institutions that have obtained the Configuration License for Large Medical Equipment shall fill in the Application Form for Updating Large Medical Equipment (Annex 3) and apply for a new license when updating large medical equipment. Chapter II Application Management Article 11 The application safety, health protection and application quality management standards for large medical equipment formulated and recognized by the Ministry of Health. Article 12 The Ministry of Health shall set up the National Evaluation Committee for the Application Technology of Large-scale Medical Equipment (hereinafter referred to as the "Evaluation Committee") to be responsible for the daily evaluation of the application safety, health protection and technical quality management of large-scale medical equipment.

The "jury" has an office to organize and coordinate the work of large-scale medical device professional groups. Article 13 The health administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government may set up a "Sub-committee of the National Evaluation Committee for the Application Technology of Large-scale Medical Equipment" (hereinafter referred to as the "Sub-committee") to be responsible for the application technology evaluation of large-scale medical equipment within their respective administrative areas. The "jury" gives professional guidance to the work of the "jury branch". Fourteenth large medical equipment before it is put into use, the "judge department" shall carry out the application technology review. The review shall be conducted according to the following procedures:

1. Before the review 15, the user shall apply to the health administrative department of the people's government of the province, autonomous region or municipality directly under the Central Government for a review, and present the License for Configuration of Large Medical Equipment and the technical certificate of the post personnel of large medical equipment;

Two, the health administrative departments of the people's governments of all provinces, autonomous regions and municipalities directly under the central government shall, after receiving the application for evaluation of the use of institutions, promptly entrust the "judges' branch" to send special personnel to conduct evaluation on schedule;

Three, the evaluation work should be carried out in strict accordance with the "jury" to develop projects, procedures and methods; The performance of the equipment must meet the technical parameters specified in the order contract; Supporting equipment must include basic testing tools for quality control;

Four, the results of the review in the technical file, as the basic information of equipment review; And the evaluation will be included in the hospital evaluation, and its evaluation results will be used as the key indicators of hospital evaluation;

Five, after passing the examination, issued a "large medical equipment application qualification certificate" (Annex four).

The "judges' branch" may invite the "judges' committee" to review together.