Recent signals show that large medical equipment is becoming the focus of medical devices in addition to high-value consumables, IVD, another focus of standardized management. Management methods in addition to configuration permits, the use of supervision, as well as centralized procurement.
The State Council is clear: a national guard Planning Commission in large equipment
Recently, the State Council issued the 13th Five-Year deepening the reform of medical care system planning , formally proposed to carry out large-scale medical equipment procurement. It happens that there is a similar case。 Recently, the general office of the State Council issued the central budget unit 2017 – 2018 centralized procurement catalog and standards. According to the document, the next two years, must by the State Planning Commission to centralized procurement projects include: 1, contraceptives, including copper IUD, medicated IUD, condoms, contraceptive tablet, pill, pill, pill injection suppository gel, contraceptive film and contraceptive implants; 2, large medical equipment, including positron emission tomography (PET\/CT), positron emission magnetic resonance imaging system (PET\/MR), endoscopic surgical instrument control system (robot), gamma ray stereotactic head emission treatment system (gamma knife), stereotactic radiation therapy system, helical tomotherapy system the high-end medical linear accelerator, electron cyclotron treatment system, proton therapy system, 306 MEG etc..
Compared with the previous two years, the central budget unit 2015-2016 centralized procurement catalog and standards, the State Council made a major adjustment of the National Health Planning Commission centralized procurement projects.
As described above, in 2017-2018 years, the State Planning Commission’s centralized procurement project added a large medical equipment. In addition, the Catalogue will also be the government procurement of goods and services to the public tender amount increased from 1 million 200 thousand yuan to 2 million yuan, the goods and services of the decentralized procurement quota increased from 500 thousand yuan to 1 million yuan. In fact, the State Planning Commission as early as a few years ago for a centralized procurement of large equipment, and this is explicitly written into the Guozihao document. The international exchange and cooperation center of the State Planning Commission as the guardian Planning Commission a large equipment Jicai to undertake specific institutions, in the 5 years ending in November 2014, 29 provinces (autonomous regions and municipalities) in the 148 medical institutions of large medical equipment 192 sets a total turnover of nearly 2 billion 600 million yuan. According to the Department statistics, centralized procurement price effect is obvious, for the medical institutions to save 28% of the procurement budget funds. The future, with the 13th Five-Year health care reform plan and Guozihao document strong blessing, centralized procurement of large medical equipment category will continue, while group B large equipment, or there will be more provinces such as Anhui as the implementation of the provincial centralized procurement. Expensive large medical equipment, lower prices and low selection has become a major trend.
Large medical equipment configuration permit, toward legalization
The same is the latest news, according to the National Health Planning Commission website January 10th announcement, the State Planning Commission approved the day before the Shanxi Provincial Planning Commission on the issue of licensing medical radiation from, said the configuration of large medical equipment has been licensed by non administrative licensing adjustment for administrative licensing, Planning Commission is fulfilling the new licensing procedures, in the meantime the configuration of the license suspended for large medical equipment. Over the years, the State Planning Commission has been in the name non administrative license, issued for large medical equipment configuration of a license issued by the Provincial Planning Commission is responsible for the group B large medical equipment configuration permits. However, the non administrative license has been considered to be unclear, there is a huge controversy in the legal profession, is regarded as a gray area. After the new government came to power, Premier Li Keqiang pushing the reform of the examination and approval, cancel all non administrative licensing matters. This once sparked concern in the industry, large medical equipment configuration management will go? Fully liberalized or further specification? National Guard Planning Commission latest approval shows that the allocation of large medical equipment configuration issued by non administrative license changed to administrative license. That is, by the Wei Planning Commission since the strong retention of the unreasonable outside the law, the change in order to legitimate and reasonable Ying Youzhi measures. Get rid of the awkward position after the embarrassment, Wei Planning Commission on the allocation of large medical equipment management, it will be easier to start.
Hospital unauthorized disposition of large equipment, or will be fine
In fact, the future, Wei Planning Commission for large medical equipment configuration management will not only continue to be standardized, it is likely to be more stringent. May 2016, the State Council Legislative Affairs Office on the Regulations on the supervision and administration of medical devices amendment (Draft) for public comment. According to the draft regulations, medical overhaul, and the main contents of the amendments is to increase a lot, the allocation of medical institutions use of large medical equipment regulations. Large scale medical equipment allocation. The allocation of medical institutions of large medical equipment, should have the basic technical conditions, guarantee the quality and safety of medical professional personnel, facilities and equipment, and in accordance with the planning, made above the provincial health administrative department issued a permit allocation. The unauthorized use of the configuration of large medical equipment, using improper means to obtain large medical equipment configuration permits, can not guarantee the quality and safety of medical not to stop the use of large medical equipment and other acts of illegal situations draft also clear the medical institution shall bear the legal responsibility of the administrative punishment and the corresponding content. For example, increased stipulates: the unauthorized use of the configuration of large medical equipment, by the people’s governments at or above the county level health administrative departments to give a warning, ordered to stop using, confiscate the illegal income; the illegal income is less than 10 thousand yuan, 10 thousand yuan but not more than 50 thousand yuan fine; the illegal income of more than 10 thousand yuan, and the illegal the 5 times more than 10 times the fine; if the circumstances are serious, large medical equipment configuration permits responsible person and medical devices used to apply for acceptance within 5 years. The main purpose of this revision, one is the configuration of the license management of large medical equipment legalization, second is to avoid the blind pursuit of high-end equipment, medical institutions to fight equipment, prevent from the hospital to take the medicine to fill in the medicine.
Source: Blue Saibo instrument
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