Medical network - on January 11, recent signals shows that large medical equipment is becoming a medical instrument field except high-value consumables, IVD another key object of standardization management. Permission management in addition to the configuration, use, supervision and centralized purchasing.
Under the state council shall be clear: a class of large equipment, the state development planning commission in
Recently, the state council issued the "much starker choices-and graver consequences-in" deepening the reform of medical health system planning ", formally proposed to carry out large medical equipment centralized purchasing.
Similarly. Recently, the state council general office issued the 2017 central budget units - in 2018 the government centralized procurement catalogue and standard ".
According to the file, the next two years, must by the state development planning commission to a centralized procurement of project including:
1, contraceptives, including copper intrauterine device, medicated intrauterine device, condoms, contraceptive pill, contraceptive injection, suppositories, contraceptive gel, contraception and birth control pills subcutaneous preparetions contraceptive, etc.;
Type 2, large medical equipment, including positron emission tomography (PET/CT), positron emission (PET/MR) magnetic resonance imaging system, endoscopic surgical instrument control system (surgical robot), gamma stereotactic surgery system launch head (head gamma knife), X-ray stereotactic radiation therapy system, spiral CT radiation therapy system, high-end electronic cyclotron, medical linear accelerator treatment system, proton therapy, and 306 magnetoencephalography does, etc.
With the first two years of the 2015 central budget units - 2016 government centralized procurement catalogue and standard ", compared to the state council to the state development planning commission of centralized purchasing project made a big adjustment.
As above, in the 2017-2018, the state development planning commission of centralized purchasing in the project group has added a large medical equipment.
In addition, the catalogue of the public bidding of the government procurement of goods, services, project amount standard from the original 1.2 million yuan to 2 million yuan, the spread of goods and services procurement quota standard from the original 500000 yuan to 1 million yuan.
In fact, the national health development planning commission began as early as a few years ago is in charge of a class of large equipment centralized purchasing, and this is clearly written into the "state" file.
National center for health development planning commission international communication and cooperation as a group who planning commission a large equipment in the concrete institutions, in the five years in November 2014, 29 provinces (autonomous regions and municipalities) 148 medical institutions in the 192 class a large medical equipment, the total volume of nearly 2.6 billion yuan. According to the department of statistics, the centralized purchasing price effect is obvious, for medical institutions to save as much as 28% of the purchasing budget.
In the future, have much starker choices-and graver consequences-in reform plan and we should file a powerful blessing, a class of large-scale medical equipment of centralized purchasing will continue, and b large equipment, or there will be more provinces such as anhui provincial centralized purchasing. Reduction of large medical equipment is expensive, and choose the low use has become a trend.
The license of the large medical equipment configuration to legalize
Also is the latest news, according to the national health development planning commission web site announcement on January 10, the national health development planning commission has approved health development planning commission of Shanxi Province on the relevant issues of radiological diagnosis and license issuing instruct ", said the large medical equipment allocation permission has been changed from non-executive licensing for the administrative licensing, health development planning commission is to perform a new licensing procedures, in the meantime license suspended for large medical equipment configuration.
Over the years, the national health development planning commission has been in the name of "non-executive licensing", in charge of a class of large-scale medical equipment configuration permit issued by the provincial health planning department is responsible for the b class of large medical equipment configuration permit issuance.
Non-executive permission was thought to be not clear, however, chu, also there is a huge controversial in law, is regarded as gray areas.
After a new government came to power, prime minister li keqiang, promote reform of examination and approval, cancel all non-executive licensing issues. This caused the industry attention, configuration management of large medical equipment will evolve? Up or further specification?
National health development planning commission, according to the latest approved "large medical equipment allocation license issued by the" from "non-executive permission" to "administrative licensing". Namely, by the strong health development planning commission reserved the unreasonable land of "method", change for the measures of reasonable and lawful.
To get rid of is not clear not chu after the awkward position of health development planning commission of configuration management of large medical equipment, will also make it easier to lay hands on.
Hospital configuration of large equipment without authorization, or will be fined
In fact, in the future, planning for large medical equipment configuration management will not only continue to give specification, also is likely to be more strict.
In May 2016, the state council legislative affairs office once before the amendment of regulations on the supervision and administration of medical devices (SongShenGao) for public opinion.
YiXie regulations, as the SongShenGao, overhaul, and revision of the main content is increased a lot of configuration of medical institutions regulations on the use of large medical equipment.
SongShenGao set large medical equipment allocation permission. Configuration of large medical equipment, medical institutions should have the technical requirement of guarantee medical quality and safety, professional personnel, facilities, equipment, etc, and in line with the configuration planning, made at or above the provincial level configuration permit issued by the health administrative departments of family planning.
Allocation of unauthorized use of large medical equipment, by improper means licensing the large medical equipment configuration, can't not stop using the large-scale medical equipment, medical quality and safety of behavior, such as SongShenGao also made clear a medical institution shall bear the legal liability of the illegal cases and the corresponding administrative penalty.
, for example, added: "without the permission of use of large medical equipment configuration, the family planning departments of health under the people's government at or above the county level shall give warning, shall be ordered to stop the use, confiscate the illegal income; the illegal income of less than 10000 yuan, and be fined between RMB 10000 yuan and 10000 yuan; the illegal income of 10000 yuan of above, and be fined five times more than 10 times the illegal income; if the circumstances are serious, don't accept those responsible within five years of large medical equipment and medical instruments use unit configuration licensing applications".
Such modification of the main purposes, one is the large medical equipment configuration permission management legalization, the other is to prevent blind pursuit of high-end equipment, medical institutions compete to spell equipment, from "medicine for the medical" to prevent hospital "to the machinery repair cure". |
