Device regulation and surveillance in vascular care: Challenges and opportunities-Reference-Cited by-同舟云学术

Device regulation and surveillance in vascular care: Challenges and opportunities

Published:2024-04-19 Issue:1 Volume:104 Page:84-91
ISSN:1522-1946
Container-title:Catheterization and Cardiovascular Interventions
language:en
Short-container-title:Cathet Cardio Intervent

Author:

Pyun Alyssa J.¹,Goodney Philip P.²³^ORCID,Eldrup‐Jorgensen Jens³,Wadzinski James³,Secemsky Eric A.⁴,Cigarroa Joaquin E.⁵^ORCID

Affiliation:

1. Division of Vascular Surgery and Endovascular Therapy Keck Medical Center of University of Southern California Los Angeles California USA

2. Heart and Vascular Center, Dartmouth Health Lebanon New Hampshire USA

3. The Society for Vascular Surgery's Patient Safety Organization (SVS‐PSO) and Vascular Quality Initiative (VQI) Chicago Illinois USA

4. Division of Vascular Interventions Beth Israel Deaconess Medical Center Boston Massachusetts USA

5. Division of Cardiovascular Medicine, Department of Medicine Oregon Health Sciences University (OHSU) Portland Oregon USA

Abstract

AbstractCardiovascular devices are essential for the treatment of cardiovascular diseases including cerebrovascular, coronary, valvular, congenital, peripheral vascular and arrhythmic diseases. The regulation and surveillance of vascular devices in real‐world practice, however, presents challenges during each individual product's life cycle. Four examples illustrate recent challenges and questions regarding safety, appropriate use and efficacy arising from FDA approved devices used in real‐world practice. We outline potential pathways wherein providers, regulators and payors could potentially provide high‐quality cardiovascular care, identify safety signals, ensure equitable device access, and study potential issues with devices in real‐world practice.

Publisher

Wiley

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/ccd.31053

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