Abstract:Objective To study the production situation of 13 intermediate frequency electrical stimulators
manufacturers in Beijing in 2014, to analyze the risk and influence factors of links like design, production
and usage for intermediate frequency electrical stimulators and to point out relevant advice on risk
control, so as to improve the safety of listed medical device and ensure safety use of medical device.
Methods The major way of this investigation was instrument detection and questionnaire and onthespot
interview with typical production companies. The questionnaire concerned 6 aspects, including
basic status of companies, products safety testing, retrospective analysis of products design, selfinspection
of quality management system, information collection and analysis of the listed products
(the similar products),as well as collection status of past complaints, feedbacks and adverse events.
Results Altogether 78 questionnaires, 13 initial test reports and 12 retest
reports were collected. Thus
the involved technologies of intermediate frequency electrical stimulators in Beijing were preliminarily
understood, the risk and influence factors for the design, production and usage links were further clarified,
and the relevant risk control suggestions were proposed for these manufacturers. Conclusion After the
companies revamped pertinently in electrical safety and electromagnetic compatibility technology, the
product qualified rate was improved from 7.69% in initial to 80.36% in retest,
which was improved
about 11 times for the overall product security. The suggestions on links of product design, production,
quality testing, sale, aftersale
service, instruction as well as warning information were proposed, which
could greatly improve the security of using intermediate frequency electrical simulators.
杨飞,刘斌,翟伟,钟蕾,焦立公,刘东红. 北京市中频电疗仪生产企业情况调查报告[J]. 中国医疗设备, 2017, 32(3): 130-134.
YANG Fei, LIU Bin, ZHAI Wei,
ZHONG Lei, JIAO Li-gong,
LIU Dong-hong. Situation Survey of Companies Producing Intermediate Frequency Electrical
Stimulators in Beijing. China Medical Devices, 2017, 32(3): 130-134.