[Discussion on Technical Evaluation of Tongue Diagnosis Equipment of Traditional Chinese Medicine].

This study briefly introduces the tongue diagnostic equipment of traditional Chinese medicine. It analyzes and discusses the key points of technical evaluation of tongue diagnostic equipment from the aspects of product name, performance parameters, image processing functions, product use methods, clinical evaluation, etc. It analyzes the safety risks and effectiveness indicators of tongue diagnostic equipment, hoping to bring some help to the gradual standardization of tongue diagnostic equipment and the registration of enterprises.

[Analysis of Factors Affecting Effectiveness of Medical Device Registration Self-inspection from Perspective of Technical Evaluation].

Type inspection is a necessary precondition of technical evaluation of medical device. The implementation of The Provisions for Administration of Self-Test for Medical Device Registration facilitates the registration pathway for applicants. How to improve the effectiveness of registration self-test has drawn attention from many stakeholders. In this study, we analyzed and discussed the factors affecting the validity of registration self-test from technical evaluation perspective, and proposed suggestions for improvement accordingly. The aim of this article is to boost the reliability and effectiveness of registration self-test and offer a reference for applicants to carry out registration self-test.

[Analysis of Key Points of Technical Review of Traditional Chinese Medicine Fumigation Treatment Device].

Traditional Chinese medicine fumigation device is the carrier of traditional Chinese medicine fumigation treatment. In recent years, with the rapid development of new technology and new materials, the development of fumigation device changes with each passing day, and a variety of new products continue to emerge. However, at present, the lack of corresponding evaluation norms, resulting in some difficulties in the registration, marketing, quality control, evaluation scale and other aspects of the product. Some products have many disadvantages in clinical use. From the perspective of technical review, this paper elaborates and analyzes the main concerns in technical review, such as product structure, main risks, performance requirements, clinical evaluation, etc., in order to provide a basis for the design, development, production, registration, use and post-marketing supervision of the devices.

[Concerns of Technical Evaluation on Registration of Disposable Endoscopic Injection Needle].

From the point of the technical evaluation of the registration of medical devices, the technical evaluation focus of the disposable endoscopic injection needle registration are briefly described in the chapters of the application overview documents, risk management data, product technical requirements, research data, toxic substance residues, biocompatibility evaluation, clinical evaluation data, et al. The common terms of technical requirements are specified, risk management and research materials list the project requirements for product characteristics. So as to accurately judge the product quality, improve the review efficiency, promote the development of the industry.

[Discussion on Technical Evaluation of Enzyme Electrode Biosensor Blood Glucose Meter].

Enzyme electrode biosensor blood glucose detector is a new rapid blood glucose measurement method. There is no corresponding product standard and industry standard reference at home and abroad, and there is a lack of corresponding reference experience in performance research and clinical evaluation. This study discusses the safety and effectiveness of enzyme electrode biosensor blood glucose detector from the perspective of technical evaluation of medical devices. It is expected to provide some reference for medical device registration technical reviewers and registration application enterprises.

Usefulness of BioFire FilmArray BCID2 for Blood Culture Processing in Clinical Practice.

Rapid pathogen characterization from positive blood cultures (BC) can improve management of patients with bloodstream infections (BSI). The FilmArray blood culture identification (BCID) assay is a molecular test approved for direct identification of BSI causing pathogens from positive BC. A recently updated version of the panel (BCID2) comprises improved species identification characteristics and allows for the detection of one expanded-spectrum ß-lactamase (ESBL)- and several carbapenemase-encoding genes. Here, the clinical performance of the BCID2 assay for species identification in 180 positive BCs was evaluated. BCID2 results were concordant with the standard of care (SOC) in 159/180 (88.3%) BCs; 68/74 (91.9%) and 71/74 (96.0%) of all samples growing monobacterial, Gram-positive or Gram-negative pathogens, respectively, were identified, in agreement with SOC results. Nonconcordance was related to the detection of additional pathogens by the BCID2 assay (n = 4), discrepant species identification (n = 4), or failure of BCID2 to detect on-panel pathogens (n = 1). A number (12/31; 38.7%) of discordant results became evident in polymicrobial BC specimens. BCID2 identified the presence of blaCTX-M-carrying species in 12 BC specimens but failed to predict third-generation cephalosporin resistance in four isolates exhibiting independent cephalosporin resistance mechanisms. Carbapenem resistance related to the presence of blaVIM-2 or blaOxa-48-like was correctly predicted in two isolates. In conclusion, the BCID2 assay is a reliable tool for rapid BC processing and species identification. Despite inclusion of common ESBL- or carbapenemase-encoding markers, the multifactorial nature of ß-lactam resistance in Gram-negative organisms warrants combination of BCID2 with (rapid) phenotypic susceptibility assays.

[Reflections on the Key Points in the Establishment of the Guidelines for Class II Medical Device Technical Review-Example of Intraoral Digital Dental Impression].

Technical Review Guidelines of Medical Devices are standards to standardize and unify registration review of medical devices marketed in China. The writing quality of the guidelines affects not only the time for technical evaluation, but also the safety and effectiveness of approved products. Based on authors' practices of nearly 30 class II medical equipment technical guidelines written and 20-year experience in class II medical device evaluation, this study takes intraoral digital dental impressions as an example to put forward several key points of sections "summary" and "research data" in the guidelines, for researchers on class II medical equipment technical guidelines reference.

[Design Elements of Medical Endoscope and Concerns of Registration Technical Evaluation].

From the point of view of medical device registration technical evaluation, production process of endoscope, three-dimensional imaging(3D), high resolution imaging are discussed. We focus on the process of design and development, especially verification and validation. The general principle is that all risks and unexpected impacts should be minimized and acceptable to ensure that benefits are greater than risks in normal use.

[Discuss about Key Issues of Dual Energy X-ray Absorptiometry Evaluation].

The Dual energy X-ray absorptiometry is the most commonly used for measuring bone mineral density. This method involves core clinical functions, phantom and database. This article discusses the three key issues of dual energy X-ray absorptiometry evaluation, including core clinical functions, phantom and database. This article aims at helping manufacturers to scientifically carry out relevant processes during research and development and also manufacturers may refer to this article when they apply for registration.

[Exploration on Knowledge Management Construction of Medical Device Evaluation].

Knowledge management is an important method for the organization to manage information and knowledge systematically and make knowledge innovate continuously. Knowledge management includes the stages of knowledge acquisition, sharing and use, and finally achieves the goal of taking knowledge as the production factor and improving work efficiency in an organization. The core work of technical evaluation of medical devices is typical knowledge work, and the knowledge management system is of great significance to the review agency in improving work efficiency, promoting talent training, improving management level and service quality. This study briefly introduces the framework of the knowledge management system of medical device technical evaluation in the Center for Certification and Evaluation, SHFDA, and provides reference for relevant organizations to carry out knowledge management of medical device technical evaluation.

[Discussion on the Sterilization Material in the Registration Evaluation of Sterile Medical Device].

This article first introduces the regulation requirements for sterilization material in the registration evaluation of sterile medical devices. Secondly, the article chooses the suture passer set kit with multiple sterilization methods as an example product for technical evaluation. The article hopes to provide a reference for the applicant who prepare the registration material and the technical evaluators how to make the evaluation for the medical device registration.

[Discussion on Technical Evaluation of Magnetocardiography].

There is no corresponding product standard and industry standard for the search and development of magnetocardiograph at home and abroad. In this paper, based on the working principle and clinical application function of magnetocardiograph, and on the basis of relevant regulations and normative documents of medical device registration, some thoughts and concerns about the technical review of this kind of product are put forward.

[Analysis and Improvement Suggestions on Change of Medical Devices Licensing Items].

Based on the statistics of 350 technical evaluations of changes in licensing items of class Ⅱ passive and active medical devices completed in Henan province from July 2017 to November 2018, this paper summarized and analysed the common problems and requirements listed in the correction notifications of the technical evaluation, and put forward relevant countermeasures or suggestions, with a view to further speeding up the evaluation and approval of medical devices.

[Status Analysis and Improvement Suggestions on the Renew Registration of Passive Medical Devices].

The article collected 250 renew registration of domestic Class Ⅱ passive medical devices from Jan. 2016 to Aug. 2017 in Shanghai. It summarized the common problems listed in the correction notifications of the technical evaluation, and then provides some relevant countermeasures or suggestions. So that we can further speed up the evaluation and approval of medical devices.

Feasibility of optimized ultralow-dose pulsed fluoroscopy for upper gastrointestinal tract examinations: a phantom study with clinical correlation.

PURPOSE: To establish an optimized ultralow-dose digital pulsed fluoroscopy (FP) protocol for upper gastrointestinal tract examinations and to investigate the radiation dose and image quality. MATERIALS AND METHODS: An Alderson-Rando-Phantom with 60 thermoluminescent dosimeters was used for dose measurements to systematically evaluate the dose-area product (DAP) and organ doses of the optimized FP protocol with the following acquisition parameters: 86.7 kV; 77 mA; 0.9 mm3, automatic image noise and contrast adaption. Subjective image quality, depiction of contrast agent and image noise (5-point Likert scale; 5 = excellent) were assessed in 41 patients, who underwent contrast-enhanced FP with the aforementioned optimized protocol by two radiologists in consensus. A conventional digital radiograph (DR) acquisition protocol served as the reference standard for radiation dose and image quality analyses. RESULTS: Phantom measurements revealed a general dose reduction of approximately 96% per image for the FP protocol as compared to the DR standard. DAP could be reduced by 97%. Significant dose reductions were also found for organ doses, both in the direct and scattered radiation beam with negligible orbital (FP 5.6 × 10-3 vs. DR 0.11; p = 0.02) and gonadal dose exposure (female FP 2.4 × 10-3 vs. DR 0.05; male FP 8 × 10-4 vs. DR 0.03; p ≤ 0.0004). FP provided diagnostic image quality in all patients, although reading scores were significantly lower for all evaluated parameters as compared to the DR standard (p < 0.05). CONCLUSION: Ultralow-dose FP is feasible for clinical routine allowing a significant reduction of direct and scattered dose exposure while providing sufficient diagnostic image quality for reliable diagnosis.

[Discussion on Technical Evaluation for Medical Device Registration Material].

This article first introduces the main contents of the requirements for medical device registration. Secondly, this article chooses the vertebral forming surgery system as an example to discuss the technical evaluation for the registration research material. The article hopes to provide a reference for the applicant who prepare the registration material and the technical evaluator who make the evaluation for the medical device registration.

Discussion on Technical Evaluation of Tongue Diagnosis Equipment of Traditional Chinese Medicine / 中国医疗器械杂志

This study briefly introduces the tongue diagnostic equipment of traditional Chinese medicine. It analyzes and discusses the key points of technical evaluation of tongue diagnostic equipment from the aspects of product name, performance parameters, image processing functions, product use methods, clinical evaluation, etc. It analyzes the safety risks and effectiveness indicators of tongue diagnostic equipment, hoping to bring some help to the gradual standardization of tongue diagnostic equipment and the registration of enterprises.

Analysis of Factors Affecting Effectiveness of Medical Device Registration Self-inspection from Perspective of Technical Evaluation / 中国医疗器械杂志

Type inspection is a necessary precondition of technical evaluation of medical device. The implementation of The Provisions for Administration of Self-Test for Medical Device Registration facilitates the registration pathway for applicants. How to improve the effectiveness of registration self-test has drawn attention from many stakeholders. In this study, we analyzed and discussed the factors affecting the validity of registration self-test from technical evaluation perspective, and proposed suggestions for improvement accordingly. The aim of this article is to boost the reliability and effectiveness of registration self-test and offer a reference for applicants to carry out registration self-test.

Technical-financial evaluation of rainwater harvesting systems in commercial buildings-case ase studies from Sonae Sierra in Portugal and Brazil.

Water is an essential and increasingly scarce resource that should be preserved. The evolution of the human population and communities has contributed to the global decrease of potable water availability and the reduction of its consumption is now compulsory. Rainwater harvesting systems (RWHS) are emerging as a viable alternative source for water consumption in non-potable uses. The present study aims to contribute to the promotion of water efficiency, focusing on the application of rainwater harvesting systems in commercial buildings, and comprises four stages: (i) development of a technical evaluation tool to aid the design of RWHS and support their financial evaluation; (ii) validation of the tool using operational data from an existing RWHS installed at Colombo Shopping Center, in Lisbon, Portugal; (iii) assessment of the sensibility of the technical evaluation tool results to the variation of the inputs, namely the precipitation and consumption, through a parametric analysis for the Colombo Shopping Center; and (iv) comparison of the performance and financial feasibility of hypothetical RWHS in two existing commercial buildings. The technical tool was applied to two Sonae Sierra's shopping centers, one in Portugal and one in Brazil. The installation of a 200-m3 tank is advised for the first case study, allowing non-potable water savings of 60% but a payback period of about 19 years. In the Brazilian shopping, the implementation of a tank with a capacity ranging from 100 to 400 m3 leads to non-potable savings between 20 and 50%, but with smaller payback period, under 2 years, due to the relatively lower investment costs and higher water fees.

Suggestions on the evaluation system of science and technology in the field of health policy and management research / 中华医学科研管理杂志

Objective:Health policy and management, and its development as a discipline, play an important role in promoting the development of medicine; however, where is no scientific and reasonable evaluation system of science and technology in practice.Here we will explore and establish a special evaluation system to this research feild.Methods:To analyze the problems, tasks and unique research methods specially solved and used in the field of health management and policy; to discuss the existing problems with theory combined with practice.Results:According to the guidance of national policy, put forward principles and some assessment indicators with their weight grading, index, and examples in detail for the academic evaluation system in the field of this field.Conclusions:Health policy and management is a kind of discipline of the category of social science that possesed the particularity of practice management. Thus, it is important that the academic evaluation should reflect the responsibilities, contributions and characteristics of this subject and the researchers.