Device lag;我が国の現状と課題
Device Lag: The Status Quo and Problems in Japan

Naomi Nakagawa, Masahiro Kamada, Yukiko Ishiguchi, Yuji Moritoh, Seigo Okada, Mayuko Shohi
■ ■ device off-label use 27 JPIC off-label use off-label use ■ Abstract ■ Cardiac catheterization is a ubiquitous treatment of congenital heart diseases. However, issues such as delayed introduction of various devices and the use of these approved devices off-label, in ways unrelated to their intended applications have been seen in Japan. And there is the scarcity of treatment options, and the numerous cases of off-label use are seen in Japan. Although the decisions to select off-label use are
more » ... ased on sufficient comparison studies on alternative therapies of course, adverse events might happen and this is unavoidable problem. The full burden of responsibility would lie on the physician if the off-label use of the devices would inevitably result in adverse events, because off-label use of devices is not officially sanctioned. Thus the expansion of the application of off-label devices would be even more difficult. Breaking the present deadlock requires the sharing of experiences in off-label device use and proactive lobbying of nationally authorized institutions.
doi:10.20599/jjpic.1.2 fatcat:gpjqgpuhdfajvmq5vfexyfizjq