Excessive inspection and treatment of large equipment
It goes without saying that the safety, effectiveness and economy of medical devices are directly related to the people's health, vital interests and social harmony and stability, and are a major people's livelihood and public security issue.
According to the draft submitted for review, large-scale medical equipment refers to large-scale medical equipment that has complex technology, large capital investment, high operating costs, a large impact on medical expenses, and is included in national management items."
In the supervision of medical devices, the problem of large equipment has become increasingly prominent in recent years. It is understood that the use of large equipment has high risks and safety hazards, and the existing management measures are not restrictive and targeted enough. At the same time, large-scale equipment that is expensive, technically complex, and risky is constantly being put into use. Many of these equipment are technically immature, have poor economic efficiency, and have low cost-effectiveness. Some medical institutions equipped with large-scale equipment do not have the professional and technical skills to use them safely.
In addition, the use of large equipment is not standardized and reasonable, and there are excessive inspections and treatments, and even abuse and misuse. The resulting health damage is often lagging, delayed, and difficult to remedy. And health information security protection is not enough. There is an urgent need to further improve regulations, strengthen supervision of the use of large equipment, ensure medical quality and safety, and ensure the rational and effective use of resources.
Hospitals rely more on equipment for inspection and treatment
In the new round of deepening the reform of the medical and health system, the necessity of regulating large-scale equipment has become even more prominent.
Deepening the reform of the medical and health care system requires controlling the unreasonable and rapid increase in medical expenses, effectively reducing the burden of medical expenses on residents, and promoting the rational allocation of medical resources. The rational use of large-scale medical equipment is an important measure to control the unreasonable and rapid growth of medical expenses. At this stage, it is urgent to improve the legal system and strengthen rigid constraints to guide and standardize the use of equipment in medical institutions.
One of the profound implications of this revision is to prevent the shift from "supporting medicine with medicine" to "supplementing medicine with equipment." With the implementation of policies such as zero margin for drugs, and a reasonable compensation mechanism has not yet been established, the income of medical institutions will be more dependent on equipment inspection and treatment, and there is a tendency to induce demand.
This revision also targets the competition among medical institutions to equip large-scale medical equipment. Healthy and orderly competition among medical institutions should be reflected in improving operational efficiency, service levels and quality, rather than "fighting for equipment", which leads to duplication of a large amount of resources and waste.
According to reports, the purpose of this revision is also to control the disorderly expansion of public hospitals. Medical institutions generally have the urge to expand bed capacity and large-scale medical equipment. If effective measures are not taken, it will aggravate the unscientific layout and unreasonable structure of medical resources, strengthen the siphon effect of large hospitals, and reduce the effects of established policies such as "strengthening the grassroots" .
Unauthorized allocation of 10 times the maximum illegal income
The draft submitted for review still contains eight chapters and eighty articles, and the overall structure and chapters remain unchanged.
The draft for review adds requirements for the configuration and use of large-scale medical equipment in medical institutions. Implement the concept of ladder configuration and solve the problem of unrealistic and blind pursuit of high-end equipment in medical institutions. It puts forward principled requirements that the configuration and use of large-scale medical equipment in medical institutions should be consistent with its functional positioning, technical level and other factors. Clarify the basic system for the configuration and management of large medical equipment. The state formulates configuration plans for large-scale medical equipment and implements hierarchical management according to categories.
It is worth noting that the draft submitted for review sets the configuration permission for large medical equipment. When medical institutions configure large-scale medical equipment, they must have the technical conditions, professionals, supporting facilities and equipment to ensure medical quality and safety, comply with the configuration plan, and obtain a configuration license issued by the health and family planning administrative department at or above the provincial level.
The draft submitted for review clearly clarifies the supervision and management of the configuration and use of large medical equipment. Strengthen the tracking and evaluation of usage status and standardize usage behavior. Clarify the illegal situations and corresponding administrative penalties that should bear legal responsibility, such as deploying and using large medical equipment without permission, obtaining large medical equipment configuration permission by improper means, failing to ensure the quality and safety of medical care and failing to stop using large medical equipment.
For example, a provision was added: "Anyone who configures and uses large-scale medical equipment without permission shall be given a warning and ordered to stop using it by the health and family planning department of the people's government at or above the county level, and the illegal income will be confiscated; if the illegal income is less than 1 million yuan, a fine of 0 + A fine of not less than RMB 10,000 but not more than RMB 50,000; if the illegal income is RMB 1 RMB 0,000, a fine of not less than 5 times but not more than 0 times of the illegal income shall be imposed; if the circumstances are serious, the case filed by the relevant responsible person and the medical device user unit will not be accepted within 5 years. "Application for configuration license of large medical equipment".
The draft for review also stipulates the responsibilities of the health and family planning administrative departments in the management of the configuration, use and use of large-scale medical equipment. First, implement configuration licensing in accordance with the law, and formulate specific rules in accordance with the Administrative Licensing Law and regulations. The second is to carry out use evaluation, supervision and management of large-scale medical equipment in accordance with the law. The third is to punish according to law.