Active Surveillance Update – December 5th, 2024
Below is a brief update on the Active Surveillance program since last year’s update.
May 2023 – NESTcc issued a request for proposals soliciting the interest of organizations to partner in generating high-quality solutions and expertise with real-world data (RWD) to support improved evidence for medical devices.
November 2023 – NESTcc selected Booz Allen Hamilton to partner on the design and implementation of an active surveillance system using electronic health data to better understand the safety of medical devices used in clinical practice.
January 2024 – NESTcc appointed Lisa Weiss to lead Active Surveillance work.
August 2024 – Government Accountability Office (GAO) issued a Report to Congressional Requestors- “MEDICAL DEVICES: FDA Has Begun Building an Active Postmarket Surveillance System”, which outlines the status of the system and includes NESTcc’s work on the program.
Expanding on our previous work, NESTcc has been actively identifying partners that have capacity to collaborate in using electronic health data for active surveillance and is establishing the Central Data Operations Hub for the active surveillance system. The system is being designed using privacy-preserving and federated learning techniques in a cloud-based environment to monitor for signals. In addition to facilitating governance and day-to-day operation for standardized data curation and analytics, the Central Data Operations Hub is also establishing best practices and prioritizing enhancements for data architecture, IT systems and infrastructure, patient privacy and ethics, and active surveillance methodologies. NESTcc plans to begin active postmarket surveillance of two medical devices are underway.
Active Surveillance Update – July 11th, 2023
NESTcc is pleased to inform our stakeholders that the United States Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) is continuing investment in the national medical device active surveillance system with NESTcc. Based on research conducted by FDA, there is not an existing distributed data network already conducting the types of analyses that satisfy CDRH’s requirements for signal detection. With the new leadership of NESTcc and MDIC, CDRH has determined that there are many potential benefits of including the AS system within the NEST Marketplace which provide synergism and will not impede NESTcc’s ongoing work to enable premarket uses of Real-World Evidence.
Establishing a medical device active surveillance system is a high priority for FDA and NESTcc is honored to continue our collaboration with CDRH under our existing cooperative agreement (U01FD006292), which includes a goal of developing new systems of data collection and/or analysis to permit prospective active medical device post-market risk identification.
NESTcc appreciates the collaboration with the FDA and the contributions of our stakeholders to advance the development of the active surveillance system to this point. This past work funded by CDRH has prepared both CDRH and NESTcc for the continued work under the current award.
NESTcc will provide additional information as it becomes available. Our first action will be to issue a Request for Proposal (RFP) for the Central Data Operations Hub for NESTcc’s Active Surveillance program for Medical Devices on July 17th. We will send notices to stakeholders who have requested to receive NESTcc updates once the RFP is open.
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
Previous 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, FDA/CDRH
- Frederic Resnic, MD, MSc, Lahey Health
- Mary Beth 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
Previous Members
- Mrinal Bhasker, MBA, Leap Orbit
- Daniel Caños, PhD, MPH, FDA/CDRH
- Alexandra Cha, PhD, PMP, Booz Allen Hamilton
- Matthew Crowson, MD, MPA, MASc, Harvard Medical School, Massachusetts Eye & Ear
- Alexander Hanson, 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, Previously FDA/CDRH
- Frederic Resnic, MD, MSc, Lahey Health
- Mary Beth Ritchey, Previously 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 Previous 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, Previously FDA/CDRH
- Mary Beth Ritchey, Previously 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 Previous 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 Beth Ritchey, Previously FDA/CDRH
- Emily Rubinstein, MPH, Aetion