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 15th, 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
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