Discussion on Design of Comprehensive Verification and Evaluation Schemes for Electrocardiogram Medical Electronic Instruments / 中国医疗器械杂志

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.

Discussion on Design of Clinical Trial Protocol of Laser Medical Devices / 中国医疗器械杂志

Guidance and reference are provided for protocol designer. The classification of laser medical devices are introduced. The key points such as the selection of control group, evaluation indicators and method, criteria of inclusion and exclusion, and application of blinded, etc. are discussed, and the importance of management of defects in medical device is emphasized.

On Some Issues in Pediatric Clinical Trails / 中国医学伦理学

There are many differences between pediatric clinical trails and general clinical research.This paper discusses specialties and requirements of the pediatric clinical trails,clarifies ethical concerns children deserve in the clinical research,analyses the admission threshold for ethical protection among children subjects,points out that ethics committee should carry out ethical trails and appraisals throughout the research process,identifies some key issues in protocol design,analyses the reasons for dissatisfactory collection and compliance of children subjects,and comes up with concerned countermeasures.