Active Surveillance Update

From 2019 – 2022, NESTcc and our stakeholders collaborated closely to plan an active surveillance environment for medical device safety. During this period, NESTcc formed the Active Surveillance Task Force; established multiple Working Groups (IT Cloud, Methodology, and Data Curation); completed the setup and testing of a pilot analysis (Phase I) using DELTA within a cloud-based environment followed by the simulation, development, and testing of a pilot federated cloud environment along with the issuance of a draft Active Surveillance Road Map.

In August of 2022 NESTcc provided the FDA with its recommendations for building out an active surveillance system for the medical device ecosystem based on its working groups and pilot testing activities. The NESTcc-led design and development of a medical device active surveillance system was paused effective September 1, 2022, while the FDA assessed the plan to determine the best path forward.

The work completed by NESTcc and its collaborators has informed the FDA’s next phase of work to establish a medical device active surveillance system to provide continued monitoring of electronic health data to quickly identify new potential signals and changes in frequency for known potential signals for marketed medical devices.

As part of its process, the CDRH released a SOURCES SOUGHT NOTICE (Request # FDA-SS 75F40123Q00084) on Wednesday, February 15^th, 2023 in which the FDA seeks to identify businesses with the capabilities to provide the services stated within the notice to inform the next evolution of the medical device active surveillance system.

While establishing a medical device active surveillance system remains a high priority for FDA, we are unsure of the exact nature or timing of any possible future contract(s) by the FDA to advance the development of the medical device active surveillance system. However, we will keep you informed as more information is released.

NESTcc is appreciative for the collaboration with the FDA and the contributions of our stakeholders to advance the development of the active surveillance system. We would like to thank everyone who was involved in the active surveillance project, with a special thank you to those individuals who sat on the Active Surveillance Task Force and Working Groups. For more information on NESTcc’s past activities in active surveillance, please continue to scroll down.

Active Surveillance Past Activities

Active Surveillance Task Force

The NESTcc Governing Committee approved the establishment of a small, multi-stakeholder Active Surveillance Task Force charged with leveraging NESTcc’s work to advance active surveillance and subsequently launched NESTcc’s first active surveillance projects.

Task Force membership included key stakeholder representation from patients, clinicians, health systems, the US Food and Drug Administration (FDA), payers, and the medical device industry. The Task Force also included members with expertise in patient privacy as related to “big data.” This diverse composition provided perspectives essential to building NESTcc’s capacity to support a successful active surveillance program.

Additional information on the background of this Task Force, including the US Food and Drug Administration’s November 2018 update to the Medical Device Safety Action Plan outlining how NESTcc will be leveraged to more quickly detect emerging safety signals through active surveillance, can be found here.

Task Force Membership

Current Members

Daniel Caños, PhD, MPH, U.S. Food and Drug Administration (FDA)/Center for Devices and Radiological Health (CDRH)
Heather Colvin, MPP, Johnson & Johnson
Harlan Krumholz, MD, SM, Yale School of Medicine
Brad Malin, PhD, Vanderbilt University
Bray Patrick-Lake, MFS, Evidation
Frederic Resnic, MD, MSc, Lahey Health
Mary Ritchey, FDA/CDRH

Past Members

Kathleen Blake, MD, MPH, American Medical Association
Kevin Haynes, PharmD, MSCE, Janssen
Jose Pablo Morales, MD, FDA/CDRH
Aron Yustein, MD, FDA/CDRH

Affiliated Members

Felipe Aguel, PhD, FDA/CDRH
Danica Marinac-Dabic, MD, PhD, MMSc, FISPE, FDA/CDRH
Rebecca Torguson, MPH, FDA/CDRH

IT Cloud Working Group

The IT Cloud Working Group was charged with designing and building the Active Surveillance Cloud Infrastructure platform that would be used to facilitate the collection and analysis of real-world data for medical device safety signal detection and assessment.

IT Cloud Working Group Membership

Current Members

Mrinal Bhasker, MBA, Leap Orbit
Daniel Caños, PhD, MPH, FDA/CDRH
Alexandra Cha, PhD, PMP, NESTcc/Booz Allen Hamilton
Matthew Crowson, MD, MPA, MASc, Harvard Medical School, Massachusetts Eye & Ear
Alexander Hanson, NESTcc/Booz Allen Hamilton
Steve Jones, MS, Pandera Systems
Erez Kaminski, MS, MBA, Ketryx Corp.
Michael Matheny, MD, MS, MPH, Vanderbilt University Medical Center
Jacqueline Puigbo, PhD, MS, FDA/CDRH
Frederic Resnic, MD, MSc, Lahey Health
Mary Ritchey, FDA/CDRH
LeRoy Ruggerio, Johnson & Johnson
Henry Ssemaganda, MD, MPH, Lahey Health
Daniel Zagales, Pandera Systems

Past Members

Curtis Dudley, Mercy Health
Joseph Drozda, MD, Mercy Health
T.S. Sundar, MBA, McKesson
Joshua Sutton, MBA, Pandera Systems

Active Surveillance Methodology Working Group

The Active Surveillance Task Force approved the establishment of a small, multi-stakeholder Active Surveillance Methodology Working Group charged with providing oversight and methodologic expertise on NESTcc’s conducted literature review and drafted report determining the strengths and weaknesses of currently used safety signal detection methodology.

Active Surveillance Methodology Working Group Membership

Bill Altonaga, MD, OD, BD
Francis Campion, MD, MITRE Corporation
Paul Coplan, ScD, MBA, MPH, Johnson & Johnson
Heidi Dohse, Tour de Heart
Rachele Hendricks-Sturrup, DHSc, MSc, MA, Duke-Margolis Center
Jacob Hicks, MS, BIOTRONIK, Inc.
April Lavender, RAC, Cook Medical
Theodore Lystig, PhD, Bridgebio
Hilal Maradit Kremers, MD, MSc, Mayo Clinic
Michael Matheny, MD, MS, MPH, Vanderbilt University Medical Center
Stephen Mikita, JD, SMA Foundation
Jacqueline Puigbo, PhD, MS, FDA/CDRH
Mary Ritchey, FDA/CDRH
Nicholas Wold, MS, Boston Scientific

Active Surveillance Data Curation Working Group

The Active Surveillance Task Force approved the establishment of a small, multi-stakeholder Active Surveillance Data Curation Working Group charged with providing expert recommendations on the adoption and extension of a Common Data Model and the creation of a data curation pipeline, on medical devices, for real-world data used in general research and active surveillance.

Active Surveillance Data Curation Working Group Membership

Elodie Baumfeld Andre, PhD, Roche
Kimberly Collison Farr, Mercy Health
Junyong Fang, PhD, FDA
Naeem Hashmi, MS, MSc, Boston Scientific
Rachele Hendricks-Sturrup, DHSc, MSc, MA, Duke-Margolis Center
Andy Iverson, MS, Medtronic
Ashish Khanna, MD, FCCP, FCCM, FASA, Wake Forest School of Medicine
Michelle Leavy, MPH, OM1
Pamela Nesbit, MS, Microsoft
Steven Nichols, GE Healthcare
Mary Ritchey, FDA/CDRH
Emily Rubinstein, MPH, Aetion

Active Surveillance