Circular on Issuing the Administrative Measures for Medical Consumables for Medical Institutions (for Trial Implementation)
Circular on Issuing the Administrative Measures for Medical Consumables for Medical Institutions (for Trial Implementation)
Circular on Issuing the Administrative Measures for Medical Consumables for Medical Institutions (for Trial Implementation)
Guo Wei Yi Fa [2019] No. 43
June 6, 2019
Health commissions and traditional Chinese medicine administrations of all provinces, autonomous regions, municipalities directly under the Central Government and Xinjiang Production and Construction Corps,
With a view to regulating the management of medical consumables in medical institutions, promoting the rational and standardized use of medical consumables, and ensuring the medical quality and safety, the National Health Commission and the State Administration of Traditional Chinese Medicine organized the formulation of the Administrative Measures for Medical Consumables for Medical Institutions (for Trial Implementation) (which can be downloaded under the column of Medical Policies and Medical Administration on the website of the National Health Commission), which are hereby issued to you for your compliance and implementation.
Administrative Measures for Medical Consumables for Medical Institutions (for Trial Implementation)
Chapter I General Provisions
Article 1 These Measures are formulated in accordance with the Law on Medical Practitioners, the Administrative Regulations on Medical Institutions, the Regulations on the Supervision and Administration of Medical Devices and other laws and regulations with a view to strengthening the management of medical consumables for medical institutions, promoting the rational use of medical consumables and safeguarding the physical health of the public.
Article 2 For the purpose of these Measures, "medical consumable" refers to any consumable medical device for use with limited number of times upon approval by competent medical products administration, including disposable and reusable medical consumables.
For the purpose of these Measures, management of medical consumables or medical consumables management refers to any professional technical service that a medical institution conducts effective whole-process organization, implementation and management of procurement, storage, use, traceability, monitoring, evaluation and supervision, etc., of medical consumables with patients as the center and on the basis of medical science to promote clinically scientific and rational use of medical consumables as well as related medical consumables management work, which is an important and integral part of medical management.
Article 3 The National Health Commission and the State Administration of Traditional Chinese Medicine shall be responsible for the supervision and administration over the management of medical consumables for medical institutions nationwide.
Local health administrations and administrations of traditional Chinese medicine at the county level or above shall be responsible for the supervision and administration over the management of medical consumables for medical institutions within their respective administrative regions.
Article 4 These Measures shall apply to the management of medical consumables for hospitals of Grade II and above, while medical consumables for other medical institutions may be managed with reference to these Measures. In particular, the selection and procurement of medical consumables by non-public medical institutions may be carried out with reference to these Measures.
Article 5 A medical institution shall, designate a specific division as the medical consumables management division to be responsible for such daily management work as the selection, procurement, inspection and acceptance, storage, and distribution of medical consumables, and; designate a medical affairs management division to be responsible for the daily management of such professional technical services as the clinical use, monitoring and evaluation of medical consumables.
Article 6 Personnel engaging in the management of medical consumables in a medical institution shall possess the academic qualification in relevant major and professional technical titles commensurate with the management work or have received relevant technical training.
Personnel directly accessing medical consumables in a medical institution shall undergo the physical examination on an annual basis. No infectious disease patient, pathogen carrier and suspected infectious disease patient may engage in any work directly accessing medical consumables prior to being cured or eliminating the suspicion of relevant infectious disease.
Chapter II Institutional Management
Article 7 A hospital of Grade II or above shall establish a medical consumables management committee, and each of other medical institutions shall establish a medical consumables management organization. It is not required for any of other medical institutions such as village health offices (centers, stations), outpatient departments, clinics or medical offices to establish a medical consumables management organization, while the management of medical consumables therein shall be under the responsibility of the personnel designated by the principal thereof.
A medical consumables management committee shall consist of personnel with qualifications for senior technical positions that work in relevant clinical departments and departments of pharmacies, medical engineering, nursing, medical technology, as well as heads of divisions of hospital infection management, medical consumables management, medical affairs management, financial management, medical insurance management, information management, discipline inspection and supervision, auditing, etc.
The principal of a medical institution shall serve as the chairman of its medical consumables management committee, and the heads of the medical consumables management division and the medical affairs management division shall serve as vice chairmen of the medical consumables management committee.
Article 8 The daily work of a medical consumables management committee shall be under the responsibilities of the designated medical consumables management division and the medical affairs management division upon division of duties.
Article 9 The main responsibilities of a medical consumables management committee include:
1. implementing relevant laws, regulations and rules on medical and health as well as medical consumables management, formulating upon review rules and regulations of the institution on the management of medical consumables, and supervising the implementation thereof;
2.
......
Guo Wei Yi Fa [2019] No. 43
June 6, 2019
Health commissions and traditional Chinese medicine administrations of all provinces, autonomous regions, municipalities directly under the Central Government and Xinjiang Production and Construction Corps,
With a view to regulating the management of medical consumables in medical institutions, promoting the rational and standardized use of medical consumables, and ensuring the medical quality and safety, the National Health Commission and the State Administration of Traditional Chinese Medicine organized the formulation of the Administrative Measures for Medical Consumables for Medical Institutions (for Trial Implementation) (which can be downloaded under the column of Medical Policies and Medical Administration on the website of the National Health Commission), which are hereby issued to you for your compliance and implementation.
Administrative Measures for Medical Consumables for Medical Institutions (for Trial Implementation)
Chapter I General Provisions
Article 1 These Measures are formulated in accordance with the Law on Medical Practitioners, the Administrative Regulations on Medical Institutions, the Regulations on the Supervision and Administration of Medical Devices and other laws and regulations with a view to strengthening the management of medical consumables for medical institutions, promoting the rational use of medical consumables and safeguarding the physical health of the public.
Article 2 For the purpose of these Measures, "medical consumable" refers to any consumable medical device for use with limited number of times upon approval by competent medical products administration, including disposable and reusable medical consumables.
For the purpose of these Measures, management of medical consumables or medical consumables management refers to any professional technical service that a medical institution conducts effective whole-process organization, implementation and management of procurement, storage, use, traceability, monitoring, evaluation and supervision, etc., of medical consumables with patients as the center and on the basis of medical science to promote clinically scientific and rational use of medical consumables as well as related medical consumables management work, which is an important and integral part of medical management.
Article 3 The National Health Commission and the State Administration of Traditional Chinese Medicine shall be responsible for the supervision and administration over the management of medical consumables for medical institutions nationwide.
Local health administrations and administrations of traditional Chinese medicine at the county level or above shall be responsible for the supervision and administration over the management of medical consumables for medical institutions within their respective administrative regions.
Article 4 These Measures shall apply to the management of medical consumables for hospitals of Grade II and above, while medical consumables for other medical institutions may be managed with reference to these Measures. In particular, the selection and procurement of medical consumables by non-public medical institutions may be carried out with reference to these Measures.
Article 5 A medical institution shall, designate a specific division as the medical consumables management division to be responsible for such daily management work as the selection, procurement, inspection and acceptance, storage, and distribution of medical consumables, and; designate a medical affairs management division to be responsible for the daily management of such professional technical services as the clinical use, monitoring and evaluation of medical consumables.
Article 6 Personnel engaging in the management of medical consumables in a medical institution shall possess the academic qualification in relevant major and professional technical titles commensurate with the management work or have received relevant technical training.
Personnel directly accessing medical consumables in a medical institution shall undergo the physical examination on an annual basis. No infectious disease patient, pathogen carrier and suspected infectious disease patient may engage in any work directly accessing medical consumables prior to being cured or eliminating the suspicion of relevant infectious disease.
Chapter II Institutional Management
Article 7 A hospital of Grade II or above shall establish a medical consumables management committee, and each of other medical institutions shall establish a medical consumables management organization. It is not required for any of other medical institutions such as village health offices (centers, stations), outpatient departments, clinics or medical offices to establish a medical consumables management organization, while the management of medical consumables therein shall be under the responsibility of the personnel designated by the principal thereof.
A medical consumables management committee shall consist of personnel with qualifications for senior technical positions that work in relevant clinical departments and departments of pharmacies, medical engineering, nursing, medical technology, as well as heads of divisions of hospital infection management, medical consumables management, medical affairs management, financial management, medical insurance management, information management, discipline inspection and supervision, auditing, etc.
The principal of a medical institution shall serve as the chairman of its medical consumables management committee, and the heads of the medical consumables management division and the medical affairs management division shall serve as vice chairmen of the medical consumables management committee.
Article 8 The daily work of a medical consumables management committee shall be under the responsibilities of the designated medical consumables management division and the medical affairs management division upon division of duties.
Article 9 The main responsibilities of a medical consumables management committee include:
1. implementing relevant laws, regulations and rules on medical and health as well as medical consumables management, formulating upon review rules and regulations of the institution on the management of medical consumables, and supervising the implementation thereof;
2.
......