Director of the food and drug administration research high value consumables, release important information!

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On September 12, jiao hong, director of the food and drug administration, led a team to the general hospital of the people's liberation army of China to conduct field research on the status quo of the management of high-value medical consumables in medical institutions using the labels of medical devices.

In July this year, the general office of the state council issued the notice on the reform plan for the management of high-value medical consumables (guo ban fa [2019] no.37).In order to actively implement the relevant work plans of the CPC central committee and the state council, the food and drug administration and the health and fitness commission jointly launched the pilot work of the identification system for medical devices in July, and issued the rules for the identification system for medical devices in August.

Research group listened to the hospital medical equipment identification based on the performance of the networking construction of the development of medical supplies, anesthesia surgery center, field visit to the hospital to understand the medical consumables from purchasing, using, and settlement and report adverse events such as whole process management of medical equipment, the application of the logo, also drugs on the management and hospital medical equipment of hospital leaders and relevant departments heads in the discussion.

Learned through the research, research group of the hospital medical equipment identification based medical equipment to carry out the whole subject, total factor, the whole life cycle of information management, greatly improve the modernization level of the medical behavior and logistics, at the same time profound experience in extended to speed up the implementation of medical equipment identification policy around the necessity and urgency.

In the investigation, jiao hong pointed out that the implementation of medical device identification is an innovation of medical device management means, which is conducive to the realization of standardized, refined and intelligent management of the entire life cycle of medical devices, and is of great significance in the promotion and application.

Big data of medical device supervision based on medical device identification can provide strong data support and decision support for medical device quality and safety supervision, clinical rational application, health economic evaluation, and scientific and technological innovation development.

In accordance with the deployment requirements of the reform and management plan for high-value medical consumables, we should explore the establishment of a linkage mechanism for medicine, medical treatment and medical insurance, so as to form a governance pattern with controllable quality and standardized use, so as to ensure the safety of people's use of equipment.

In the next step, the fda should continue to strengthen research on the demonstration application, standard construction and clinical use evaluation of medical device identification, and further promote the effective implementation of the medical device identification policy.