Current Status And Supervision Countermeasures Of Implantable Medical Devices

Implantable medical devices are more and more widely used in clinic, which plays an important role in the treatment of many diseases and maintaining the healthy life of patients. In this paper, the current situation and the existing problems of implantable medical device industry are deeply studied, including that products are not standardized, procurement channels are disordered, quality is not guaranteed, records is not complete to be traced back, which is prone to result in adverse event. We have collected and compared the data of the medical device adverse event information, medical device adverse events, the report of the passive medical devices, and the actual occurrence of the medical devices. At the same time, the paper discusses the supervision mode of American implantable medical devices, and the inspiration to improve the supervision system and mode of medical devices in China. In order to establish and optimize scientific, efficient government supervision of implantable medical devices, several actions must be scheduled and implemented: firstly, raise awareness and pay more attention to the particularity of implantable medical devices; secondly, make related laws to support implantable medical device event; thirdly, electronic supervision is recommended to trace the whole chain of implantable medical device; fourth, arrange professional supervisor with high quality to improve the regulatory capacity; fifth, strengthen the publicity and training; sixth, strengthen the management of medical institutions; seventh, establish the credit system to urge participants to act in accordance with the law; eighth, improve technical support. It is hoped that through the actions, an efficiency administrative supervision of implantable medical devices will be built to protect the safety and development of implantable medical devices, to form a fully active participation involving implantable medical device manufacturers, sailing companies, hospital and patients, so as to improve the overall health level and protect the safe use of the masses of implantable medical device.