The eRPS system for medical device registration of National Medical Products Administration was officially launched on June 24, 2019. This paper focused on the following two aspects of the electronic declaration process of medical device regulatory agencies in the whole world:one is whether the electronic submission format is consistent, the other is whether the electronic submission path is convenient. Suggestions are put forward for the next nationwide implementation of the electronic submission so as to speed up the process of the electronization of medical device evaluation in China.
China ; Electronics, Medical

Around the features of low power and high integration of portable electronic medical equipment design, the primary low power MCU series from the current semiconductor manufacturers were compared. The analysis results showed that the 32-bit MCUs based on the low cost and high energy efficient ARM Cortex-M architectures, have comprehensive advantages on power level, operational performance and integrated peripherals obviously.
Electronics, Medical ; instrumentation ; Equipment Design

This study introduced the current testing content and standards of ECG medical electronic instruments, combined with actual clinical needs, and discussed the comprehensive verification and evaluation protocol for ECG medical electronic instruments. The protocol mainly includes hardware performance testing, automatic diagnostic function testing and clinical application evaluation. The protocol emphasizes the clinical practicality and importance of the comprehensive verification and evaluation program, and provides a reference for the institutions involved in the program.
Electrocardiography ; Electronics, Medical ; Reference Standards

Medical electronic endoscope is one of the indispensable tools in medical diagnosis and treatment. With the development of science and technology, electronic endoscope has higher safety and accuracy than traditional optical endoscope. Due to the sophisticated construction and high price, hospitals spend a lot of money on maintenance every year. In order to prolong the working life of electronic endoscope, reduce the incidence of artificial failure and save hospital costs, this study made a retrospective analysis on the common faults of electronic endoscope, and summarized the maintenance strategies for reference.
Electronics, Medical ; Endoscopes ; Retrospective Studies

OBJECTIVES: Clinical documents (CDs) have evolved from traditional paper documents containing narrative text information into the electronic record sheets composed of itemized records, where each record is expressed as an item with a specific value. We defined medical record (MR) items to be information entities with a specific value. These entities were then used to compile form-based clinical documents as part of an electronic health record system (EHR-s). METHODS: We took a reusable bottom-up developmental approach for the MR items, which provided three things: efficient incorporation of the local needs and requirements of the medical professionals from various departments in the hospital, comprehensive inclusion of the essential concepts of the basic elements required in clinical documents, and the provision of a structured means for meaningful data entry and retrieval. This paper delineates our experiences in developing and managing medical records at a large tertiary university hospital in Korea. RESULTS: We collected 63,232 MR items from paper records scanned into 962 CDs. The MR item database was constructed using 13,287 MR items after removing redundant items. During the first year of service users requested changes to be made to 235 (1.8%) attributes of the MR items and also requested the additional 9,572 new MR items. In the second year, the attributes of 70 (0.5%) of the existing MR items were changed and 3,704 new items were added. The number of registered MR items increased by 72.0% in the first year and 27.9% in the second year. CONCLUSIONS: The MR item concept provides an easier and more structured means of data entry within an EHR-s. By using these MR items, various kinds of clinical documents can be easily constructed and allows for medical information to be reused and retrieved as data. The success of the use of MR items in a large tertiary university hospital system provides evidence that verifies our approach as being an efficient means of user-oriented and structured data entry, enabling the easy reuse of medical records.
Electronic Health Records ; Electronics ; Electrons ; Medical Records

Implementing the instruction N10 of the MOH concerning the renovation of medical library and information in some libraries, the look was getting new changes. Computer and LAN were preliminarily used for services, sharing resources, standardizing the technique improving traditional services and promoting moderm forms of services, concentrating the fund for acquisition of material and qualifying the staff
Electronics ; Libraries, Medical ; Community Health Services

The article introduces the EMC tests involved in YY0505-2005 (standard of Medical electrical equipment about EMC), and the requirements of test equipment meet the standard and practical tests. I hope it can be useful for select the EMC test system of Medical electrical equipment.
Electromagnetic Fields ; Electronics, Medical ; instrumentation ; Equipment Design

The article introduces the requirements of accompanying documents on the new EMC standard of medical electrical equipment (YY 0505-2012), hope it can be useful for the manufacturers of medical electrical equipment.
Electronics, Medical ; instrumentation ; Equipment and Supplies ; standards

OBJECTIVETo discuss the methods of implantable medical device supervision reform.

METHODSMethods of literature review, comparative study, the research of situation, developmental study and case study were adopted.

RESULTSIt is the untrue and asymmetric information of implantable medical device that results in improper behavior in the implantable medical device industry.

CONCLUSIONSA implantable medical device electronic monitoring system, namely establishing the independent but interrelated real-time dynamic updating of the databases, which would guarantee the information of implantable medical device is open and transparent, eliminate false food information transmission, vindicate the good order of domestic implantable medical device industry and protect the vital interests of the public.

This paper presents a three-dimensional electronic laparoscopy system, including three-dimensional laparoscope pipe and medical video system. The three-dimensional laparoscope pipe adopts a dual-optical structure, which can collect three-dimensional information of the surgical region. By selecting a reasonable initial structure, the MTF curve of the objective lens is close to the diffraction limit, and the distortion is less than 25%. The medical video system also achieved high-definition image with 1 080 P, 30 Hz by GPU. At the mean time, the three-dimensional electronic laparoscope has achieved quantitative production and has been tested in a number of animals, which has broad application prospects and significant clinical application value.
Electronics, Medical ; Imaging, Three-Dimensional ; Laparoscopes ; Laparoscopy