ADE is an adverse event reporting system for medical devices, which refers to events such as adverse reactions, accidents, or failures of medical devices in the process of using them, and involves a variety of types of equipment, consumables, and diagnostic reagents, etc. The ADE system is a standardized specification that guides hospitals, doctors, and patients in the safe use of medical devices, and an important means of overseeing the direction of the medical device market. The State Drug Administration (SDA) and provincial and municipal drug administration bureaus have set up ADE platforms where medical institutions and individuals can report adverse events of medical devices through the ADE website.
The ADE system improves the efficacy of medical device supervision, thus safeguarding the safety of patients' medication. The use of medical devices carries certain risks, and may cause harm to the human body if there are problems in the process of use.ADE system can not only record adverse events in a timely manner and analyze the occurrence of the events, but also take timely measures to improve the safety and efficacy of medical devices, and to prevent and control the occurrence of adverse events from the root.
The establishment of ADE system for medical devices heralds a new stage in the supervision of medical devices in China. Driven by national policies such as centralized purchasing of major equipment, various types of medical devices have shown rapid growth and brought more risks and challenges.The implementation of the ADE system will strengthen the enforcement power of the regulatory authorities and strictly control the occurrence of adverse events, thus promoting the safe use of medical devices and improving public satisfaction and trust.