Miyoshi Takekazu, Kato Atsuko, Yasukochi Satoshi, Takahashi Sara, Ho Mami, Yamamoto Haruko, Inuzuka Ryo, Kim Sung-Hae, Sakamoto Kisaburo, Kobayashi Tohru
Division of Project Management, Department of Clinical Research Promotion, Clinical Research Center, National Center for Child Health and Development Tokyo Japan.
Department of Pediatric Cardiology, National Cerebral and Cardiovascular Center Suita Japan.
Circ Rep. 2021 Jan 26;3(3):153-160. doi: 10.1253/circrep.CR-20-0136.
In Japan, the choice of pediatric medical devices is limited because of 2 "device lag" problems: Japan lags behind the USA and Europe in device development, and development of pediatric devices lags behind that of adult devices. We aimed to identify the problems with and impediments to pediatric medical device development as recognized by pediatric physicians in Japan. A voluntary survey of pediatric medical devices for all council members of the Japanese Society of Pediatric Cardiology and Cardiac Surgery was conducted in 2019. The response rate was 47.1% (154/327). The respondents were 115 pediatric cardiologists (74.7%) and 39 cardiovascular surgeons (25.3%). Approximately 90% believed that difficulties in development existed. Approximately 70% were dissatisfied with the pediatric medical devices currently available in Japan, which was a result of the unavailability of medical devices approved overseas, few types and sizes, and off-label use. Factors that hindered the development of pediatric medical devices included anatomical issues specific to children with congenital heart disease, as well as system issues such as lack of corporate profitability, development cost, and amount of time for development. Pediatric cardiologists and cardiovascular surgeons regard "device lag" and "off-label use" in Japan as important hindrances to the delivery of better medical care for pediatric patients with congenital heart disease.
在日本，儿科医疗设备的选择有限，这是由于两个“设备滞后”问题导致的：日本在设备研发方面落后于美国和欧洲，并且儿科设备的研发落后于成人设备。我们旨在确定日本儿科医生所认识到的儿科医疗设备开发中的问题和障碍。2019年，对日本小儿心脏病学会和心脏外科学会的所有理事会成员进行了一项关于儿科医疗设备的自愿调查。回复率为47.1%（154/327）。受访者包括115名儿科心脏病专家（74.7%）和39名心血管外科医生（25.3%）。约90%的人认为存在开发困难。约70%的人对日本目前可用的儿科医疗设备不满意，这是由于海外批准的医疗设备无法获得、类型和尺寸较少以及标签外使用等原因造成的。阻碍儿科医疗设备开发的因素包括先天性心脏病患儿特有的解剖学问题，以及缺乏企业盈利能力、开发成本和开发时间等系统问题。儿科心脏病专家和心血管外科医生认为，日本的“设备滞后”和“标签外使用”是为先天性心脏病儿科患者提供更好医疗服务的重要障碍。
