On February 4, the National Health Commission issued an interpretation of the “Measures for the Management of Clinical Use of Medical Devices”.
The safe and effective use of medical devices is directly related to the quality and safety of medical care and the health of the people. According to the relevant provisions of the “Regulations on the Supervision and Administration of Medical Devices” (hereinafter referred to as the “Regulations”), the health authorities shall supervise and manage the use of medical devices in accordance with their responsibilities. In 2010, the then Ministry of Health formulated and released the “Safety Management Standards for Clinical Use of Medical Devices (Trial)”. Since the implementation of this management standard, it has played a very good role in strengthening the standardized management of clinical use of medical devices, and has accumulated a lot of effective experience in improving the management system of medical device use in medical institutions and clarifying the management requirements for different aspects of clinical use of medical devices.
In order to further implement the relevant provisions of the “Regulations”, upgrade the effective experience in the clinical use management of medical devices into departmental regulations, strengthen the management of clinical use of medical devices in medical institutions, and ensure the safe and effective clinical use of medical devices, these Measures are formulated in conjunction with the responsibilities of the health authorities.
The main contents are as follows:
The “Measures for the Management of Clinical Use of Medical Devices” is divided into eight chapters, namely: general principles, organizational structure and responsibilities, clinical use management, guarantee and maintenance management, handling of safe use incidents, supervision and management, legal responsibilities, and supplementary provisions, totaling 51 chapters.
(1) About general provisions. The clear purpose of the legislation is to strengthen the management of clinical use of medical devices and ensure the safety and effectiveness of clinical use of medical devices. Clarify the division of responsibilities between the national health and health authorities and local health and health authorities for the supervision and management of medical devices. It is clarified that the principal person in charge of a medical institution is the first person responsible for the clinical use management of medical devices in the institution. Medical institutions are required to establish and improve the clinical use management system of medical devices in the institution and implement classified management of medical devices.
(2) About organizational structure and responsibilities. Clearly define the responsibilities of health authorities and medical institutions in terms of organizational structure building. Clarify the responsibilities of relevant departments, departments and personnel of medical institutions in the management of clinical use of medical devices, and stipulate the qualifications of professionals staffed by medical institutions, the qualifications of relevant professionals, and the responsibilities of the departments using them. It stipulates the responsibilities of medical institutions in organizing continuing education and training on clinical use management of medical devices, strengthening information management, and conducting self-examination, assessment, and evaluation.
(3) Regarding clinical use management. Clarify the responsibilities of medical institutions in the evaluation, purchase, installation and acceptance of medical devices, and require medical institutions to establish a medical device acceptance verification system. Clarify the principles, specifications and precautions for clinical use of medical devices by medical institutions and their medical staff. Medical institutions are required to establish a risk management system for the clinical use of medical devices, implement a use safety monitoring and reporting system for key medical devices such as life support, record medical records for large medical devices and implantable and interventional medical devices, conduct clinical use evaluation of medical devices, and immediately stop using medical devices with safety hazards and notify them for maintenance.
(4) Regarding guarantee, maintenance and management. It is clarified that the maintenance and management of medical devices should focus on testing and preventive maintenance. Medical institutions should record and analyze maintenance and repair records. At the same time, they should have storage locations and conditions suitable for the variety and quantity of medical devices.
(5) Regarding use of security incident handling. It clarifies the principle of reporting suspected and timely reporting of medical device safety incidents; stipulates different handling procedures according to the different degrees of damage caused by medical device safety incidents; for those with greater impact, local health authorities at or above the county level can take risk warnings and suspend the use of medical devices of the same batch and specification model by medical institutions within their jurisdiction to effectively reduce risks.
(6) Regarding supervision and management, legal responsibilities and supplementary provisions. It is clarified that local health authorities at or above the county level should strengthen the supervision and management of the clinical use of medical devices in medical institutions and clarify the relevant responsibilities that they have the authority to exercise; it stipulates that local health authorities at or above the county level should organize regular or irregular spot checks on the clinical use and management of medical devices in medical institutions. Corresponding penalties are provided for illegal acts that violate the provisions of these Measures. The concept and adjustment scope of safety events in the use of medical devices are clarified in the appendix. The concept of safety incidents in the use of medical devices is defined in the supplementary provisions; the scope of adjustment of the Measures is clarified.