NDLI: Safety and performance evaluation methods for implantable cardioverter defibrillator

Content Provider	IEEE Xplore Digital Library
Author	San Kim Yoonsu Hwang Tae-Hee Kwon Jaewon Lee Il-kwon Lim Su-Kang Park Yong-Kyun Kim Hyeogju Kim Shin-Jung Kang
Copyright Year	2013
Description	Author affiliation: Ministry of Food and Drug Safety, Laboratory Aduit and Policy Division, MFDS, Osong-eup, Korea (Tae-Hee Kwon) \|\| Korea Testing Certification, Medical Device Center, KTC, Gunpo-si, Korea (Il-kwon Lim; Su-Kang Park; Yong-Kyun Kim) \|\| Ministry of Food and Drug Safety, Medical Device Research Division, MFDS, Osong-eup, Korea (San Kim; Yoonsu Hwang; Jaewon Lee; Hyeogju Kim) \|\| Ministry of Food and Drug Safety, Pharmaceutical and Medical Device Research Department, MFDS, Osong-eup, Korea (Shin-Jung Kang)
Abstract	An implantable cardioverter defibrillator (ICD) is an active implantable medical device that is utilized in correcting atrial or ventricular fibrillation through the delivery of an electrical shock to the heart via an implanted electrode in the human body. Since an ICD is remains in the body of a patient for a long period of time and since adverse reactions to the device or defects in the device can cause critical injury to the human body, more sophisticated evaluation methods should be employed similar to the procedures used in evaluating ordinary electronic medical devices. Ensuring safety and high performance of an ICD is essential. However, much needed reference standards for the assessment of safety and efficacy of ICDs have not been defined in Korea. In this study, ICD issues were investigated, including product characteristics and permission status, to provide grounds for test items, establish methods and standards in testing and assessing the safety and performance of ICDs, which conform to international standards. Relevant documents such as those pertaining to domestic standards and FDA guidance were analyzed. Moreover, safety and performance assessment items, test standards, and test methods were successfully formulated in conformity with international standards by test validation of the proposed test methods. The output of this study is expected to contribute to the competitiveness of Korean electronic medical device industry by promoting quality and safety of ICDs.
Starting Page	377
Ending Page	382
File Size	1116232
Page Count	6
File Format	PDF
ISBN	9781479906987
DOI	10.1109/ICTC.2013.6675376
Language	English
Publisher	Institute of Electrical and Electronics Engineers, Inc. (IEEE)
Publisher Date	2013-10-14
Publisher Place	Korea (South)
Access Restriction	Subscribed
Rights Holder	Institute of Electrical and Electronics Engineers, Inc. (IEEE)
Subject Keyword	Implantable cardioverter defibrillator(ICD) Active implantable medical device Standard Safety and performance evaluation
Content Type	Text
Resource Type	Article

Sl.	Authority	Responsibilities	Communication Details
1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
5	Website/Portal (Helpdesk)	Queries regarding NDLI and its services	support@ndl.gov.in
6	Contents and Copyright Issues	Queries related to content curation and copyright issues	content@ndl.gov.in
7	National Digital Library of India Club (NDLI Club)	Queries related to NDLI Club formation, support, user awareness program, seminar/symposium, collaboration, social media, promotion, and outreach	clubsupport@ndl.gov.in
8	Digital Preservation Centre (DPC)	Assistance with digitizing and archiving copyright-free printed books	dpc@ndl.gov.in
9	IDR Setup or Support	Queries related to establishment and support of Institutional Digital Repository (IDR) and IDR workshops	idr@ndl.gov.in

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