MASAMUNE Ken
   Department   Research Institutes and Facilities, Research Institutes and Facilities
   Position   Professor
Article types Other
Language English
Peer review Non peer reviewed
Title Letter to the Editor. Evaluation of novel neurosurgical devices during clinical testing
Journal Formal name：Journal of neurosurgery
Abbreviation：J Neurosurg
ISSN code：00223085/19330693
Domestic / ForeginForegin
Volume, Issue, Page 131(4),pp.1342-1344
Author and coauthor MURAGAKI Yoshihiro†, MASAMUNE Ken, UEMATSU Miyuki, UMEZU Mitsuo, ISEKI Hiroshi, CHERNOV Mikhail
Authorship 2nd author
Publication date 2019/08/09
Summary 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