First release! The standard of the medical industry is coming.
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Last Update: 2020-07-09
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Source: Internet
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Author: User
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The outbreak has sparked online teaching and accelerated the digitization of medical devicesOn June 12, the official website of the Medical Device Technology Review Center of the State Drug Administration issued: The Basic Principles for the Safety and Performance of Medical Devices, which will guide the post-market supervision of medical devicesaccording to Thesaberg Blue Instrument observation, this principle stresses that medical device manufacturers should be responsible for the safety of equipment, the use of risk synopsis, to ensure that the product has a stable quality management system and risk management system as a support(screenshot source: center for the examination of equipment)can see that in this new crown outbreak, medical equipment at all levels of medical equipment imaging inspection capacity put forward higher requirements;, Seiber Blue Access visited Zheng Jieming, vice president and general manager of customer service business at GE Medical China, Fu Haihong, chairman of the imaging technology branch of the Chinese Medical Association, and the relevant person in charge of medical equipment in three large hospitalsHospital equipment varies in categories and maintenance optionsLu Fajin, head of the Department of Medical Imaging Technology at Chongqing Medical University, told Seiber Blue: Clinically small equipment, each hospital has a corresponding maintenance department, will be regularly tested for the equipment, there are corresponding solutionsHowever, in the case of the Radiology Department of our hospital, the equipment used is relatively large and requires the original servicethe importance of after-sales service is reflected in, not only to ensure quality, but also to ensure safety"The after-sales service departments of many enterprises, sometimes only see the technology itself, and do not extend to the clinical and patient ports, after-sales service system should be defined from maintenance, prevention, quality control and other aspects, and these systems need professionaland and professional tools as a support," Fu Haihong saidOn June 13,, the "GE 1.5T Magnetic Resonance Imaging System Original After Sales Service Expert Consensus" co-prepared by the Imaging Technology Branch of the Chinese Medical Association and clinicians from more than 50 hospitals and GE Medical was officially releasedThe Code is the industry's first aftermarket specification led by end-users of equipmentWhy doesneed to develop a "consensus"? This needs to be traced back to the clinical problems encounteredAccording to Cypress Blue, GE Medical found problems due to improper maintenance during inspections of more than 100 hospitals after the sale of the non-original plant: (survey data provided: GE Medical) and the content of consensus is mainly to introduce a standard system with practical value The parameter criteria for 21 sequences, such as skull, abdomen and knee joint, are defined, the indicators are quantified and standardized, and the tools and response speed used for maintenance are clearly defined "Consensus" need to point out in particular is that it has made a standard for remote digital services, in terms of equipment maintenance, the need for 7 x 24 hours of equipment status operation monitoring, in advance to find customer equipment hidden dangers, active maintenance to reduce the failure rate of equipment Wang Qijun, director of the radiology department of Huangdao People's Hospital in Qingdao, said to Sei-Wan, in practical application, remote monitoring equipment performance and status is a very practical function, in addition to the remote engineer's monitoring, if found to have abnormal equipment, can immediately discharge the fault remote monitoring and maintenance is timely and convenient, but there are also risks to be aware of Lu Fajin pointed out to The Seiber Blue Devices that there are still some problems to be solved in the current implementation process If the hospital connects the internal equipment to the Intel network there will be some security risks, if 24 hours connected, the device will be vulnerable to attack, or even through the port attack to other important departments, so the real implementation is the security of the data, need to solve these problems to promote and implement for the next question, the author interviewed GE Medical China Vice President and General Manager of customer service business Zheng Jieming, he pointed out that: security issues are very important, the state, hospitals, enterprises are very concerned; in an interview, Zhang Guofu, director of the imaging department at Xuchang City Center Hospital, talked about the idea of a remote monitoring of the future Zhang Guofu, , said that considering the different use habits of each hospital, I hope that the platform often out of some operating specifications, but also can increase some APM users between the experience sharing The reason is that most of the communication now is with the original engineers, site engineers or back-office monitoring engineers, we would prefer to communicate between the hospital and the hospital "In the future, to add AI to the remote service system, I believe that more accurate to judge the customer's problems and potential failures, this may be the future direction of development," Zheng Jieming said of the Cypress Blue Equipment.
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