Capacity assessment for EHR-based medical device post-market surveillance for synthetic mid-urethral slings among women with stress urinary incontinence: a NEST consortium study
Using EHR data alone, identification of medical devices and surgical approaches was feasible among women with MUS surgery for SUI, but long-term follow-up ascertainment rates were low. Medical device surveillance using EHR data should be evaluated in the context of the clinical use case, as applicability may vary.
Authors
- Jialin Mao (ORCID: https://orcid.org/0000-0001-6671-3474)
- Michael E. Matheny (ORCID: https://orcid.org/0000-0003-3217-4147)
- Bilal Chughtai (ORCID: https://orcid.org/0000-0002-0515-2578)
- Wade L. Schulz (ORCID: https://orcid.org/0000-0002-2048-4028)
- Art Sedrakyan (ORCID: https://orcid.org/0000-0003-3882-9765)
- Robert Winter (ORCID: https://orcid.org/0000-0002-5013-503X)
- Suvekshya Aryal (ORCID: https://orcid.org/0000-0002-6077-4919)
- Joseph S. Ross (ORCID: https://orcid.org/0000-0002-9218-3320)
- Emanuel C. Trabuco (ORCID: https://orcid.org/0000-0001-7425-022X)
- William M. Reynolds (ORCID: https://orcid.org/0000-0003-3444-1421)
- Sameer Pandya
- Nilay D. Shah (ORCID: https://orcid.org/0000-0002-8597-3447)
- Amy M. Perkins (ORCID: https://orcid.org/0000-0001-9052-3558)
- Victoria Bartlett
- Arthur Mourtzinos
- Kimberly Rieger‐Christ (ORCID: https://orcid.org/0000-0002-8425-132X)
- Edward Frankenberger (ORCID: https://orcid.org/0000-0003-4951-4312)
- Susan P. Robbins (ORCID: https://orcid.org/0000-0002-0677-204X)
- Daniel Park (ORCID: https://orcid.org/0000-0002-1919-0460)
- Ahra Cho
- Michael Solotke
- Danielle Bostrom
- Aron Yustein
Institutions
- Northwestern University (US)
- Brigham and Women's Hospital (US)
- United States Food and Drug Administration (US)
- Delta Air Lines (United States) (US)
- Yale New Haven Hospital (US)
- Mayo Clinic (US)
- Cornell University (US)
- WinnMed (US)
- Yale University (US)
- VA Tennessee Valley Healthcare System (US)
- Lahey Medical Center (US)
- Geriatric Research Education and Clinical Center (US)
- Mayo Clinic in Florida (US)
- Weill Cornell Medicine (US)
- Vanderbilt University Medical Center (US)
Publication Details
- Journal
- BMJ Surgery Interventions & Health Technologies
- Published
- 2025-02-01
- DOI
- https://doi.org/10.1136/bmjsit-2023-000193
- Primary Topic
- Pelvic floor disorders treatments
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- U.S. Department of Health and Human Services
- U.S. Department of Veterans Affairs
- Yale University
- Vanderbilt University
- Vanderbilt University Medical Center
- Medical Device Innovation Center
- U.S. Food and Drug Administration