Adverse events of medical devices refers to the approved marketing of qualified medical devices in the normal use of the situation occurs, resulting in or may lead to human injury of all kinds of harmful events.
Medical device manufacturers, operators and users should establish a medical device adverse event monitoring and management system, designated institutions and specialized (part-time) staff to undertake the monitoring and reporting of adverse events of medical devices. The report involves its production, operation and use of products occurring in the cause or may lead to serious injury or death of the adverse events of medical devices.
The reasons for the occurrence of adverse events of medical devices:
1, design factors, by the present scientific and technological conditions, cognitive level, process and other factors, medical devices in the research and development process, to varying degrees, there is a simple purpose, a single consideration, the design of the actual mismatch with the clinic, the application of the positioning of the fuzzy and other issues, resulting in difficult to avoid the design defects.
2, the material factor, medical devices, many materials from the industry, often inevitably have to face the biocompatibility, radioactivity, microbial contamination, chemical residues, degradation and other practical problems.
3, medical devices, whether it is the choice of materials, or clinical applications, the span is very large; and the human body is also subjected to the complexity of the internal and external environmental factors, so a very good material for the medical device itself, not necessarily can be fully used in clinical.
The above references? Baidu Encyclopedia-Medical Device Adverse Events