I. Legislation Background
The safe and effective use of medical devices is directly related to medical quality and safety and people's health. In accordance with Regulations on the Supervision and Administration of Medical Devices (hereinafter referred to as "Regulations"), the competent health department supervises and administrates the use of medical device according to the responsibilities. In 2010, the original Ministry of Health (now National Health Commission) formulated and issued the Safety Management Standard for Clinical Use of Medical Devices (Trial) (WYGF [2010] No. 4) Since the implementation of the Management Standard, it has played a key role in strengthening the standardized management of clinical use of medical devices, and 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 links of clinical use of medical devices, etc. The Measures are hereby formulated based on the responsibilities of the competent health departments to further implement the relevant provisions of the Regulations, upgrade the effective experience in the management of clinical use of medical devices to departmental rules, strengthen the management of clinical use of medical devices in medical institutions, and ensure the safe and effective clinical use of medical devices.
II. Main Contents
Management Measures for Clinical Use of Medical Devices includes eight chapters: General Provisions, Organizations and Responsibilities, Management of Clinical Use, Support Maintenance Management, Handling of Use Safety Incidents, Supervision Management, Legal Responsibilities and Supplementary Provisions, a total of 51 articles.
(I) General Provisions. The Measures clarify that legislation is to strengthen the management of clinical use of medical devices, ensure the safety and effectiveness of clinical use of medical devices. The Measures define the division of responsibilities of the national competent health departments and local competent health departments for supervision and management of medical devices; clarify that the person chiefly in charge of the medical institution is the first responsible person of the institution for management of clinical use of medical devices, and require the medical institution to establish and improve the management system of the clinical use of medical devices in the institution, and carry out systematic management for the medical devices.
(II) Organization and Responsibilities. The Measures specify the responsibilities for organizational construction in competent health departments and medical institutions. The Measures clarify the responsibilities of relevant departments, sections and personnel of medical institutions in the management of clinical use of medical devices, and stipulate the qualification conditions of professional personnel and relevant professionals provided by the medical institutions, and the responsibilities of the user sections, etc. The Measures specify the responsibilities of medical institutions in organizing and carrying out the continuing education and training on management of clinical use of medical devices, strengthening information management and self-examination, assessment and evaluation, etc.
(III) Management of Clinical Use. The Measures clarify the responsibilities of medical institutions in the assessment, purchase, installation and acceptance of medical devices, and require medical institutions to establish a medical device acceptance and verification system. The Measures clarify the principles, specifications and precautions of clinical use of medical devices by medical institutions and their medical personnel. The Measures require medical institutions to establish risk management system for clinical use of medical devices, implement safety monitoring and reporting system for key medical devices such as life support, record medical records for large-scale medical devices and implantable and interventional medical devices, carry out evaluation on clinical use of medical devices, and stop using medical devices with potential safety hazards and request maintenance immediately.
(IV) Support Maintenance Management. The Measures clarify that for the support maintenance management of medical devices, attention should be paid to detection and preventive maintenance. The medical institutions should record and analyze the maintenance and repair records, and meanwhile they should have the storage places and conditions adapted to the variety and quantity of medical devices.
(V) Handling of Use Safety Incidents. The Measures clarify the principles on immediate report and timely report of medical device use safety incidents; specify different handling procedures according to the different damage degrees caused by the medical device use safety incidents; and specify that for those with greater impact, local competent health departments at or above the county level can adopt risk prompts and suspend medical institutions within their jurisdiction from using the same batch of medical devices with the same specifications and models, so as to effectively reduce the risk.
(VI) Supervision Management, Legal Responsibilities and Supplementary Provisions. The Measures clarify that the local competent health departments above the county level should strengthen the supervision management of the clinical use of medical devices in medical institutions, and clarify the relevant responsibilities they have the right to exercise; stipulate that the local competent health departments above the county level should organize regular or irregular spot check for management of clinical use of medical devices in medical institutions. The corresponding punishment is provided for the illegal acts in violation of the provisions of the Measures. The concept and adjustment scope of medical device use safety incidents are clarified in the Supplementary Provisions. The concept of medical device use safety incidents is defined in the Supplementary Provisions. The adjustment scope of the Measures is clarified.
The safe and effective use of medical devices is directly related to medical quality and safety and people's health. In accordance with Regulations on the Supervision and Administration of Medical Devices (hereinafter referred to as "Regulations"), the competent health department supervises and administrates the use of medical device according to the responsibilities. In 2010, the original Ministry of Health (now National Health Commission) formulated and issued the Safety Management Standard for Clinical Use of Medical Devices (Trial) (WYGF [2010] No. 4) Since the implementation of the Management Standard, it has played a key role in strengthening the standardized management of clinical use of medical devices, and 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 links of clinical use of medical devices, etc. The Measures are hereby formulated based on the responsibilities of the competent health departments to further implement the relevant provisions of the Regulations, upgrade the effective experience in the management of clinical use of medical devices to departmental rules, strengthen the management of clinical use of medical devices in medical institutions, and ensure the safe and effective clinical use of medical devices.
II. Main Contents
Management Measures for Clinical Use of Medical Devices includes eight chapters: General Provisions, Organizations and Responsibilities, Management of Clinical Use, Support Maintenance Management, Handling of Use Safety Incidents, Supervision Management, Legal Responsibilities and Supplementary Provisions, a total of 51 articles.
(I) General Provisions. The Measures clarify that legislation is to strengthen the management of clinical use of medical devices, ensure the safety and effectiveness of clinical use of medical devices. The Measures define the division of responsibilities of the national competent health departments and local competent health departments for supervision and management of medical devices; clarify that the person chiefly in charge of the medical institution is the first responsible person of the institution for management of clinical use of medical devices, and require the medical institution to establish and improve the management system of the clinical use of medical devices in the institution, and carry out systematic management for the medical devices.
(II) Organization and Responsibilities. The Measures specify the responsibilities for organizational construction in competent health departments and medical institutions. The Measures clarify the responsibilities of relevant departments, sections and personnel of medical institutions in the management of clinical use of medical devices, and stipulate the qualification conditions of professional personnel and relevant professionals provided by the medical institutions, and the responsibilities of the user sections, etc. The Measures specify the responsibilities of medical institutions in organizing and carrying out the continuing education and training on management of clinical use of medical devices, strengthening information management and self-examination, assessment and evaluation, etc.
(III) Management of Clinical Use. The Measures clarify the responsibilities of medical institutions in the assessment, purchase, installation and acceptance of medical devices, and require medical institutions to establish a medical device acceptance and verification system. The Measures clarify the principles, specifications and precautions of clinical use of medical devices by medical institutions and their medical personnel. The Measures require medical institutions to establish risk management system for clinical use of medical devices, implement safety monitoring and reporting system for key medical devices such as life support, record medical records for large-scale medical devices and implantable and interventional medical devices, carry out evaluation on clinical use of medical devices, and stop using medical devices with potential safety hazards and request maintenance immediately.
(IV) Support Maintenance Management. The Measures clarify that for the support maintenance management of medical devices, attention should be paid to detection and preventive maintenance. The medical institutions should record and analyze the maintenance and repair records, and meanwhile they should have the storage places and conditions adapted to the variety and quantity of medical devices.
(V) Handling of Use Safety Incidents. The Measures clarify the principles on immediate report and timely report of medical device use safety incidents; specify different handling procedures according to the different damage degrees caused by the medical device use safety incidents; and specify that for those with greater impact, local competent health departments at or above the county level can adopt risk prompts and suspend medical institutions within their jurisdiction from using the same batch of medical devices with the same specifications and models, so as to effectively reduce the risk.
(VI) Supervision Management, Legal Responsibilities and Supplementary Provisions. The Measures clarify that the local competent health departments above the county level should strengthen the supervision management of the clinical use of medical devices in medical institutions, and clarify the relevant responsibilities they have the right to exercise; stipulate that the local competent health departments above the county level should organize regular or irregular spot check for management of clinical use of medical devices in medical institutions. The corresponding punishment is provided for the illegal acts in violation of the provisions of the Measures. The concept and adjustment scope of medical device use safety incidents are clarified in the Supplementary Provisions. The concept of medical device use safety incidents is defined in the Supplementary Provisions. The adjustment scope of the Measures is clarified.