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

Publication ,  Journal Article
Zeitler, EP; Al-Khatib, SM; Drozda, JP; Kessler, LG; Kirtane, AJ; Kong, DF; Laschinger, J; Marinac-Dabic, D; Morice, M-C; Reed, T; Sedrakyan, A ...
Published in: Am Heart J
January 2016

The MDEpiNet is a public-private partnership between the US Food and Drug Administration's Center for Devices and Radiological Health and participating partners. The PASSION program is an MDEpiNet-sponsored program that aims to demonstrate the goals of MDEpiNet by using cardiovascular medical device registries to bridge evidence gaps across the medical device total product life cycle. To this end, a PASSION Think Tank meeting took place in October 2014 in Silver Spring, MD, to facilitate discussion between stakeholders about the successes, challenges, and future novel applications of medical device registries, with particular emphasis on identifying pilot projects. Participants spanned a broad range of groups including patients, device manufacturers, regulators, physicians/academicians, professional societies, providers, and payers. The meeting focus included 4 areas of cardiovascular medicine intended to cultivate interest in 4 MDEpiNet disease-specific/device-specific working groups: coronary intervention, electrophysiology, valvular disease, and peripheral vascular disease. In addition, more general issues applying to registry-based infrastructure and analytical methodologies for assessing device benefit/risk were considered to provide context for the working groups as PASSION programs going forward. This article summarizes the discussions at the meeting and the future directions of the PASSION program.

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Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

January 2016

Volume

171

Issue

1

Start / End Page

64-72.e1-2

Location

United States

Related Subject Headings

  • United States
  • Safety Management
  • Risk Assessment
  • Registries
  • Interprofessional Relations
  • Humans
  • Congresses as Topic
  • Cardiovascular System & Hematology
  • Cardiovascular Diseases
  • 3201 Cardiovascular medicine and haematology
 

Citation

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Zeitler, E. P., Al-Khatib, S. M., Drozda, J. P., Kessler, L. G., Kirtane, A. J., Kong, D. F., … MDEpiNet, . (2016). Predictable and SuStainable Implementation of National Cardiovascular Registries (PASSION) infrastructure: A think tank report from Medical Device Epidemiological Network Initiative (MDEpiNet). Am Heart J, 171(1), 64-72.e1-2. https://doi.org/10.1016/j.ahj.2015.07.029
Zeitler, Emily P., Sana M. Al-Khatib, Joseph P. Drozda, Larry G. Kessler, Ajay J. Kirtane, David F. Kong, John Laschinger, et al. “Predictable and SuStainable Implementation of National Cardiovascular Registries (PASSION) infrastructure: A think tank report from Medical Device Epidemiological Network Initiative (MDEpiNet).Am Heart J 171, no. 1 (January 2016): 64-72.e1-2. https://doi.org/10.1016/j.ahj.2015.07.029.
Zeitler EP, Al-Khatib SM, Drozda JP, Kessler LG, Kirtane AJ, Kong DF, Laschinger J, Marinac-Dabic D, Morice M-C, Reed T, Sedrakyan A, Stein KM, Tcheng J, Krucoff MW, MDEpiNet. Predictable and SuStainable Implementation of National Cardiovascular Registries (PASSION) infrastructure: A think tank report from Medical Device Epidemiological Network Initiative (MDEpiNet). Am Heart J. 2016 Jan;171(1):64-72.e1–2.
Journal cover image

Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

January 2016

Volume

171

Issue

1

Start / End Page

64-72.e1-2

Location

United States

Related Subject Headings

  • United States
  • Safety Management
  • Risk Assessment
  • Registries
  • Interprofessional Relations
  • Humans
  • Congresses as Topic
  • Cardiovascular System & Hematology
  • Cardiovascular Diseases
  • 3201 Cardiovascular medicine and haematology