RESUMO
Active medical device is a kind of medical device which is widely used. In order to realize the goal of high-quality development, product with high reliability is a necessary requirement for the domestic active medical device industry. By means of literature research, data collection, field research, materials comprehensive combing and analysis, this paper systematically analyzes and studies the current situations and the existing problems of reliability and evaluation from the dimensions of Chinese active medical device industry policy, enterprise situation and evaluation method. In addition, by considering the technical characteristics of reliability work, concrete suggestions for solving the problems are given from the directions of standard and guiding principle, so as to provide reference for active medical device industry to develop scientific and objective reliability technical standard system and guiding principle, which are in accord with the current characteristics of Chinese active medical device industry and supervision.
Assuntos
Indústrias , Reprodutibilidade dos Testes , ChinaRESUMO
Immunity reaction has been regarded as a key step for clinical acupuncture and moxibustion treatment. In the present paper, we review current situations about studies on acupuncture-moxibustion induced immunoregulation from 1) related project fundings of National Natural Science Foundation (NCFS) of China from 1989-2017; 2) papers published in SCI and Chinese medical journals from 2010-2018; 3) clinical conditions or disorders treated by acupuncture and moxibustion and their clinical therapeutic effects; 4) the commonly used acupoints for studying immune regulation functions; 5) some mechanisms of innate immunity and adaptive immunity involved; and 6) immune adjustment pathways involved. Moreover, in our future studies, we suggest to pay more attention to 1) the detailed cellular molecular mechanisms; 2) interactions among the immune cells, the immune cells and non-immune cells and cytokines responsible for regulation effects of acupuncture-moxibustion; 3) interrelationship of different systems as skin-brain axis, brain-intestinal axis, nerve-blood vessel unit of brain tissues, etc. involving acupuncture-moxibustion induced immunoregulation by using new techniques as proteomics, genomics, two-photon imaging technology, tracer technique, cryo-electronic microscope technology, etc.