Recently, the State Council amended the regulations on the supervision and administration of medical devices and established an administrative license for the allocations of large-scale medical equipment. Further standardize and strengthen the management of the allocations and use of large-scale medical equipment, ensure medical quality and safety, and promote the rational allocations of medical resources.
On May 4, Premier Li Keqiang signed order No. 680 of the State Council and promulgated the decision of the State Council on Amending the regulations on the supervision and administration of medical devices, which shall go into effect as of the date of promulgation.
That is, from today on, the regulations on the supervision and administration of medical devices have been updated. Both large hospitals and small clinics "contribute" money every year because of the non-standard management of medical devices. In addition to neglecting the device management, most of them don't know which behaviors are illegal. Through the change of the regulations on the administration of medical devices, let's see what management regulations have been added and learn which behaviors in the use and management of devices will be punished by the regulatory authorities:
one
The use of large-scale medical equipment shall be approved by the hospital
The latest regulations on the supervision and administration of medical devices merge the first and second paragraphs of Article 34, As the first paragraph: "the user of medical devices shall have storage places and conditions suitable for the variety and quantity of medical devices in use. The user of medical devices shall strengthen the technical training of staff and use medical devices in accordance with the requirements of product instructions and technical operation specifications."
Add a paragraph, As paragraph 2: "The allocations of large-scale medical equipment by the user of medical devices shall comply with the allocations plan of large-scale medical equipment formulated by the competent department of health and family planning under the State Council, adapt to its functional positioning and clinical service needs, have corresponding technical conditions, supporting facilities and professional technicians with corresponding qualifications and capabilities, and be approved by the competent department of health and family planning under the people's government at or above the provincial level , obtain the configuration license of large-scale medical equipment. "
One paragraph is added as the third paragraph: "the measures for the administration of the allocations of large-scale medical equipment shall be formulated by the competent department of health and family planning under the State Council in conjunction with the relevant departments under the State Council. The catalogue of large-scale medical equipment shall be proposed by the competent department of health and family planning under the State Council in consultation with the relevant departments under the State Council and implemented after being approved by the State Council."
two
Track large medical equipment: strictly investigate excessive examination and treatment
Merge the first and second paragraphs of Article 56, As paragraph 1: "The food and drug supervision and administration department shall strengthen the spot check and inspection of the medical devices produced, operated and used by the medical device production and operation enterprises and users. The spot check and inspection shall not charge inspection fees and any other fees, and the required fees shall be included in the budget of the government at the same level. The food and drug supervision and Administration Department of the people's government at or above the provincial level shall timely release the medical devices according to the spot check and inspection conclusions Device quality announcement. "
One paragraph is added as the second paragraph: "the competent health and family planning department shall supervise and evalsuate the use of large-scale medical equipment; in case of illegal use and excessive inspection and treatment related to large-scale medical equipment, it shall be corrected immediately and dealt with according to law."
three
Unauthorized allocations and use of large-scale medical equipment shall be punished
Add a paragraph to Article 63, As paragraph 3: "Whoever configures and uses large-scale medical equipment without permission shall be ordered by the competent health and family planning department of the people's government at or above the county level to stop using it, give a warning and confiscate the illegal income; if the illegal income is less than 10000 yuan, he shall also be fined not less than 10000 yuan but not more than 50000 yuan; if the illegal income is more than 10000 yuan, he shall also be fined not less than 5 times but not more than 10 times the illegal income; if the circumstances are serious, he shall not be punished within five years Handle the application for configuration license of large-scale medical equipment submitted by relevant responsible persons and units. "
From the above changes, we can see that the changes in the regulations on the supervision and administration of medical devices not only restrict large hospitals from purchasing large equipment, but also indirectly restrict large hospitals from obtaining inspection fees from large equipment and restrict the expansion of large hospitals.