Reporting of adverse events of medical devices should follow the principle of suspicious that report.
The principle of reporting on suspicion means that when it is not clear whether a medical device is an adverse event, it should be reported as a suspected medical device adverse event. For a part of the medical device does not achieve the desired effect of the use of safety issues, these events can be related to the use of medical devices, but also can not be excluded from the events related to medical devices. The report should be true, complete and accurate.
Suspected adverse events of medical devices that cause or may cause serious injury or death should be reported, and innovative medical devices should be reported in the first registration cycle of all medical device adverse events of the product. Common medical device adverse events include injury events and malfunction events.
Medical poly device adverse event reporting, analysis, evaluation are completed through the network platform (the new system), the use of units, holders, operating companies are required to register in the new system account, maintain information and in the new system to carry out the work related to adverse event monitoring. Medical devices include medical equipment and medical supplies.
Medical devices are instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials and other similar or related items used directly or indirectly in the human body, including the required computer software. Effectiveness is obtained primarily by physical means, not by pharmacological, immunological or metabolic means, or only in an ancillary manner despite the involvement of such means.
Common Types of Medical Devices:
The first type is a medical device that has a low level of risk and whose safety and effectiveness can be assured by routine management.
The second category is a moderate risk, need to strictly control the management to ensure its safety and effectiveness of medical devices.
The third category is a high risk, need to take special measures to strictly control the management to ensure its safety and effectiveness of medical devices.