Quantifying the utilization of medical devices necessary to detect postmarket safety differences: A case study of implantable cardioverter defibrillators-Reference-Cited by-同舟云学术

Quantifying the utilization of medical devices necessary to detect postmarket safety differences: A case study of implantable cardioverter defibrillators

Published:2018-06-12 Issue:8 Volume:27 Page:848-856
ISSN:1053-8569
Container-title:Pharmacoepidemiology and Drug Safety
language:en
Short-container-title:Pharmacoepidemiol Drug Saf

Author:

Bates Jonathan¹,Parzynski Craig S.¹,Dhruva Sanket S.¹²³,Coppi Andreas¹,Kuntz Richard⁴,Li Shu-Xia¹,Marinac-Dabic Danica⁵,Masoudi Frederick A.⁶,Shaw Richard E.⁷,Warner Frederick¹,Krumholz Harlan M.¹²⁸⁹,Ross Joseph S.¹²⁸¹⁰^ORCID

Affiliation:

1. Center for Outcomes Research and Evaluation; Yale-New Haven Health System; New Haven CT USA

2. National Clinician Scholars Program; Yale School of Medicine; New Haven CT USA

3. Veterans Affairs Connecticut Healthcare System; West Haven CT USA

4. Medtronic, Inc.; Minneapolis MN USA

5. Division of Epidemiology; Center for Devices and Radiological Health, U.S. Food and Drug Administration; Silver Spring MD USA

6. Division of Cardiology, Department of Medicine; University of Colorado Anschutz Medical Campus; Aurora CO USA

7. Department of Clinical Informatics; California Pacific Medical Center; San Francisco CA USA

8. Department of Health Policy and Management; Yale School of Public Health; New Haven CT USA

9. Section of Cardiovascular Medicine, Department of Medicine; Yale School of Medicine; New Haven CT USA

10. Section of General Internal Medicine, Department of Medicine; Yale School of Medicine; New Haven CT USA

Funder

Medtronic

U.S. Food and Drug Administration

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/pds.4565/fullpdf

Reference27 articles.

1. U.S. Food and Drug Administration FDA's Sentinel Initiative 2016 https://www.fda.gov/Safety/FDAsSentinelInitiative/ucm2007250.htm

2. Big data and adverse drug reaction detection;Harpaz;Clin Pharmacol Ther,2016

3. Sentinel Coordinating Center Sentinel 2017 https://www.sentinelinitiative.org/

4. Automated surveillance to detect postprocedure safety signals of approved cardiovascular devices;Resnic;JAMA,2010

5. Registry-based prospective, active surveillance of medical-device safety;Resnic;N Engl J Med,2017

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