Directive No. 01/2003/CT-BYT on Strengthening the Management of Medical Equipment

DIRECTIVE

ON STRENGTHENING THE MANAGEMENT OF MEDICAL EQUIPMENT

Medical equipment at present is one of the important factors determining the effectiveness and quality of health care services for the people. To implement the National Policy on Medical Equipment for the period 2002-2010 approved by the Prime Minister under Decision No. 130/2002/QĐ-TTg dated October 4, 2002, the Minister of Health instructs the Director of the Department of Medical Equipment and Health Facilities, heads of other departments, directors of bureaus, chief of the Office, chief of the Inspectorate of the Ministry of Health, heads of units directly under the Ministry of Health, directors of provincial health services, heads of health sectors of ministries and agencies, and directors of medical equipment production and business establishments to fulfill the following requirements:

I. AT THE MINISTRY OF HEALTH:

1. Establish a steering committee to implement the National Policy on Medical Equipment, with the participation of relevant ministries and agencies. The central-level steering committee shall be headed by the Deputy Minister of Health responsible for medical equipment, with the secretariat located at the Department of Medical Equipment and Health Facilities of the Ministry of Health. The steering committee shall be responsible for developing a plan to implement the National Policy on Medical Equipment for the period 2002-2010 to be submitted to the Minister of Health for approval.

2. In 2003, the Department of Medical Equipment and Health Facilities shall cooperate with the Legal Affairs Department to review and systematize legal documents related to medical equipment, or those related to medical equipment, to identify valid legal documents, expired legal documents, those requiring amendment and supplementation, and propose new legal documents to be issued to create a legal basis for implementing the general and specific goals of the National Policy on Medical Equipment for the period 2002-2010.

II. AT UNITS UNDER THE MINISTRY AND LOCALITIES:

1. Provincial health services, health sectors of ministries and agencies (hereinafter referred to as provincial health services), and units directly under the Ministry must fulfill the following requirements:

a) Provincial health services need to strengthen the department managing medical equipment to better advise leadership.

b) Strengthen the medical equipment supply room of general hospitals, specialized hospitals of Class I and II, and research institutes, and the medical equipment section within the planning and material management department of Class III hospitals, and the teaching materials room of universities, colleges, and secondary health schools. Gradually supplement staff trained in medical equipment technology, enhance specialized measuring devices and other necessary tools to effectively advise the head of the unit on: investment planning, procurement procedures, management and inspection of medical equipment, maintenance and repair of existing medical equipment in the unit.

c) Procurement of medical equipment must start from usage needs, based on the scientific and technical council's opinion of the institution, using the list of medical equipment for hospital levels issued by the Ministry of Health. Tendering must be conducted according to current regulations, prioritizing domestically produced medical equipment that has been granted circulation permits by the Ministry of Health.

d) Regularly calibrate medical equipment in use at healthcare facilities in accordance with laws on radiation safety and measurement.

e) Units may use up to 5-7% of their annual regular budget for fixed asset procurement activities to carry out calibration, maintenance, and repair of medical equipment.

g) For projects involving high-tech equipment being introduced for the first time, invite leading experts and qualified consulting agencies to participate in building the equipment list, technical configuration, and budget estimates, and report to the competent authority for examination and approval. To ensure investment efficiency, units need to have plans to train staff to operate and maintain the equipment.

h) Provincial health services should create favorable conditions for local medical equipment production and business establishments to expand production, business operations, and scientific research, applying new technologies to improve product quality.

i) Create opportunities for students and trainees from training institutions to intern at units.

2. For institutions with functions of training, scientific research, and technical consultation and service provision for medical equipment:

a) Improve the quality of training, scale of practical laboratories, focusing on training closely aligned with the actual needs of healthcare facilities, so that graduates can master the medical equipment currently in use in the healthcare sector.

b) Focus on researching and producing medical equipment that Vietnam can produce and ensure product quality, meeting the usage requirements of the healthcare sector.

c) Integrate training, scientific research, and technological development with medical equipment production.

d) Technical consultation activities must be scientifically sound and appropriate to the management level of each unit.

Technical service work, repair, and maintenance of medical equipment must meet quality standards and comply with legal provisions.

3. For medical equipment production and business establishments:

a) All domestically produced medical equipment products are only allowed to circulate after obtaining a circulation permit from the Ministry of Health in accordance with Circular No. 07/2002/TT-BYT dated May 30, 2002.

b) Imported medical equipment must be approved by the Ministry of Health in accordance with Decision No. 46/2001/QĐ-TTg dated April 4, 2001 of the Prime Minister on the management of import and export, and Circular No. 06/2002/TT-BYT dated May 30, 2002 guiding the import and export of medical equipment.

c) Must focus on training technical staff to install, guide usage, and provide post-sales technical services.

d) Have the responsibility to promptly provide replacement parts and consumables to customers for at least five years after installation of the equipment.

e) Have the responsibility to sign maintenance contracts after warranty for medical equipment sold when healthcare facilities request.

g) Need to concentrate on investing in research and development departments to continuously improve product quality and aim for exports.

Upon receipt of this Directive, the Heads of Departments, Directors of Bureaus, Chief Inspectors of Health Inspection, Chief of the Office of the Ministry of Health, Heads of units under the Ministry, directors of provincial health services, Heads of health departments of Ministries and Sectors, and directors of establishments producing and trading in medical supplies shall be responsible for promptly organizing and implementing it.

In the course of implementation, if there are difficulties or obstacles, the units and localities shall report to the Ministry of Health (Department of Medical Equipment and Health Works) for timely research and resolution.

The Minister of Health assigns the Head of the Department of Medical Equipment and Health Works to coordinate with the Inspectorate of the Ministry of Health and relevant Departments and Bureaus to organize inspections, audits, compile the situation of implementation, and report the results of implementing this Directive to the leadership of the Ministry.