Business club on July 17, reporter learnt from the state health and family planning commission, 16, to strengthen the management of medical planted instruments, medical security, national health and family planning commission recently issued "about strengthening clinical medical planted instruments use supervision notice, further strengthen the supervision of the clinical use of medical planted instruments.
"Notice" pointed out that medical planted instruments belong to high-risk medical devices. Local health (family planning) health administrative departments at all levels should further standardize medical planted instruments, centralized purchasing work earnestly the high value medical consumables centralized purchasing job specification (try out) "the implementation of, should be included in the scope of centralized purchasing of medical planted instruments to firmly into, and explore continuously expand the scope of centralized purchasing varieties.
"Notice" regulation, work centralized procurement institutions and medical institutions to establish implantable medical device production enterprise qualification system, the implantable medical device manufacturing enterprise to submit the medical device manufacturing enterprise license "medical device registration certificate shall be the medical equipment business license and the product quality certificates such as qualification, audit inspection in accordance with the provisions of relevant laws and regulations, and in conjunction with relevant departments to crack down on all kinds of illegal behavior.
"Notice" pointed out that the medical institutions should strengthen the information management of medical planted instruments, and establish and improve the medical planted instruments procurement, inbound and outbound inspection system, detailed record product category, name and other relevant information, realize the source traceability, to can query, responsibility can be investigated. Medical staff before using implantable medical devices, to check the related information, in strict accordance with the relevant diagnostic standard is used, and to fulfill its obligation to inform the patients or their family members, signed informed consent, recorded in the medical record information related to medical planted instruments.
"Notice" requirements, the medical institutions to strictly implement the medical device adverse event reporting system. Found in the use of adverse events, according to the process of medical device adverse event reports in a timely manner, report to the administrative department for health (health family planning) at the corresponding level, and shall, in accordance with the relevant regulations of medical devices shall be sealed. If discover fake medical apparatus and instruments, to timely report to the public security organ, and report to the administrative department for health (health family planning) at the corresponding level.