Literature DB >> 25563662

Medical device postapproval safety monitoring: where does the United States stand?

Prashant V Rajan1, Daniel B Kramer1, Aaron S Kesselheim2.   

Abstract

Entities:  

Keywords:  United States Food and Drug Administration; equipment and supplies; product surveillance, postmarketing; registries

Mesh：

Year:  2015        PMID： 25563662      PMCID： PMC4385582          DOI： 10.1161/CIRCOUTCOMES.114.001460

Source DB:  PubMed          Journal:  Circ Cardiovasc Qual Outcomes        ISSN： 1941-7713


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  36 in total

Review 1.  Quality assessment of spontaneous triggered adverse event reports received by the Food and Drug Administration.

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2.  Europeans are left to their own devices.

Authors:  Deborah Cohen; Matthew Billingsley
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3.  Use of national clinical databases for informing and for evaluating health care policies.

Authors:  Nick Black; Stefanie Tan
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4.  Inclusion of comparative effectiveness data in high-risk cardiovascular device studies at the time of premarket approval.

Authors:  Connie E Chen; Sanket S Dhruva; Rita F Redberg
Journal:  JAMA       Date:  2012-11-07       Impact factor: 56.272

5.  The 510(k) ancestry of a metal-on-metal hip implant.

Authors:  Brent M Ardaugh; Stephen E Graves; Rita F Redberg
Journal:  N Engl J Med       Date:  2013-01-10       Impact factor: 91.245

6.  Postmarket surveillance for medical devices: America's new strategy.

Authors:  Sharon-Lise T Normand; Laura Hatfield; Joseph Drozda; Frederic S Resnic
Journal:  BMJ       Date:  2012-10-11

7.  Safety of the open-irrigated ablation catheter for radiofrequency ablation: safety analysis from six clinical studies.

Authors:  Albert L Waldo; David J Wilber; Francis E Marchlinski; William G Stevenson; Brenda Aker; Lee Ming Boo; Warren M Jackman
Journal:  Pacing Clin Electrophysiol       Date:  2012-07-22       Impact factor: 1.976

8.  An evaluation of a distributed medical device safety surveillance system: the DELTA network study.

Authors:  Venkatesan D Vidi; Michael E Matheny; Sharon Donnelly; Frederic S Resnic
Journal:  Contemp Clin Trials       Date:  2011-02-26       Impact factor: 2.226

9.  Postmarket surveillance of medical devices: current capabilities and future opportunities.

Authors:  Kathleen Blake
Journal:  J Interv Card Electrophysiol       Date:  2013-03-12       Impact factor: 1.900

10.  Deaths caused by the failure of Riata and Riata ST implantable cardioverter-defibrillator leads.

Authors:  Robert G Hauser; Raed Abdelhadi; Deepa McGriff; Linda Kallinen Retel
Journal:  Heart Rhythm       Date:  2012-03-23       Impact factor: 6.343
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  8 in total

Review 1.  Predictable and SuStainable Implementation of National Cardiovascular Registries (PASSION) infrastructure: A think tank report from Medical Device Epidemiological Network Initiative (MDEpiNet).

Authors:  Emily P Zeitler; Sana M Al-Khatib; Joseph P Drozda; Larry G Kessler; Ajay J Kirtane; David F Kong; John Laschinger; Danica Marinac-Dabic; Marie-Claude Morice; Terrie Reed; Art Sedrakyan; Kenneth M Stein; James Tcheng; Mitchell W Krucoff
Journal:  Am Heart J       Date:  2015-07-30       Impact factor: 4.749

2.  Association of Type and Frequency of Postsurgery Care with Revision Surgery after Total Joint Replacement.

Authors:  Heather A Prentice; Priscilla H Chan; Robert S Namba; Maria Cs Inacio; Art Sedrakyan; Elizabeth W Paxton
Journal:  Perm J       Date:  2019-10-11

Review 3.  Impact of Health Care Reform on Technology and Innovation.

Authors:  Preethi Kesavan; Christopher J Dy
Journal:  Hand Clin       Date:  2020-05       Impact factor: 1.907

4.  Nonadjunctive Use of Continuous Glucose Monitors for Insulin Dosing: Is It Safe?

Authors:  Alan R Shapiro
Journal:  J Diabetes Sci Technol       Date:  2017-03-01

5.  Efficacy and Safety of Combined Ultrasonic and Bipolar Energy Source in Laparoscopic Surgery.

Authors:  Daniel C Steinemann; Sebastian H Lamm; Andreas Zerz
Journal:  J Gastrointest Surg       Date:  2016-07-25       Impact factor: 3.452

6.  Landscape of Cardiovascular Device Registries in the United States.

Authors:  Prashant V Rajan; Jessica N Holtzman; Aaron S Kesselheim; Robert W Yeh; Daniel B Kramer
Journal:  J Am Heart Assoc       Date:  2019-06-01       Impact factor: 5.501

7.  Navigating Medical Device Certification: A Qualitative Exploration of Barriers and Enablers Amongst Innovators, Notified Bodies and Other Stakeholders.

Authors:  Rebecca Baines; Petra Hoogendoorn; Sebastian Stevens; Arunangsu Chatterjee; Liz Ashall-Payne; Tim Andrews; Simon Leigh
Journal:  Ther Innov Regul Sci       Date:  2022-10-04       Impact factor: 1.337

8.  Characterizing Complications of Deep Brain Stimulation Devices for the Treatment of Parkinsonian Symptoms Without Tremor: A Federal MAUDE Database Analysis.

Authors:  Josiah Bennett; Jack MacGuire; Ena Novakovic; Huey Huynh; Keri Jones; Julian L Gendreau; Antonios Mammis; Mickey E Abraham
Journal:  Cureus       Date:  2021-06-09
  8 in total

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