イセキ　ヒロシ   Iseki Hiroshi   伊関　洋    所属   医学研究科 医学研究科 (医学部医学科をご参照ください)    職種   特任顧問
論文種別	その他
言語種別	英語
査読の有無	査読なし
表題	Letter to the Editor. Evaluation of novel neurosurgical devices during clinical testing
掲載誌名	正式名：Journal of neurosurgery 略　 称：J Neurosurg ISSNコード：00223085/19330693
掲載区分	国外
巻・号・頁	131(4),pp.1342-1344
著者・共著者	MURAGAKI Yoshihiro†, MASAMUNE Ken, UEMATSU Miyuki, UMEZU Mitsuo, ISEKI Hiroshi, CHERNOV Mikhail
発行年月	2019/08/09
概要	TO THE EDITOR: With interest we read the article by Vakharia et al.3 reporting on the implementation of cumulative summation (CUSUM) analysis as an early-warning detection and quality assurance method during preclinical testing of robotic stereotactic electrode implantation (Vakharia VN, Rodionov R, McEvoy AW, et al: Improving patient safety during introduction of novel medical devices through cumulative summation analysis. J Neurosurg 130:213–219, January 2019). As noted by the authors, the introduction of novel medical devices, in particular during invasive neurosurgical procedures, is accompanied by potentially increased patient risk. Moreover, the approval of new technology for clinical practice usually requires the demonstration of noninferior effectiveness, whereas safety parameters are given less attention. This issue was previously evaluated by our group through an analysis of the risk-benefit balance in the decision-making of the US Food and Drug Administration (FDA) during premarket approval of 46 high-risk medical devices, which were tested in controlled clinical trials in 2000–2008.1,2 Information on primary and secondary endpoints was extracted from the FDA database available on the web. An original evaluation method was used. An effectiveness score of +1 was assigned if the endpoint of the test arm was significantly better than that of the control arm; a score of 0, if no difference was found; and a score of −1, if the endpoint was worse in the test arm.
DOI	10.3171/2019.3.JNS19677
PMID	31398703