Explanted Device Disposition
The explanted device disposition project aims at developing a consensus statement regarding the disposition of explanted neuromodulation devices. Our goal would be to develop a set of procedures and policies that could be adopted throughout the US by both hospitals and ambulatory surgical centers for the benefit of patients and public health related to explanted neuromodulation devices.
Project Members
- Lawrence Poree, MD, MPH, PhD (chair)
- Joseph J. Fins, MD, MACP, FRCP (ethics)
- Henry T. “Hank” Greely, MD (ethics)
- Penney Cohen (patient advocate)
- Michael Sanchez (patient advocate)
- Danica Marinac-Dabic (legal/liability/regulatory affairs)
- Ellen Doneski (legal/liability/regulatory affairs)
- John Doucet, PhD (legal/liability/regulatory affairs)
- Pierre D’Haese, PhD (data security)
- Ashwini Sharan, MD, FACS
- Robert Foreman, FAHA PhD
- Jaimie Henderson, MD
- Peter Konrad, MD, PhD
- Richard North, MD
- Kiran V. Patel, MD
- David A. Provenzano, MD
- Ali Rezai, MD
- Sarah Staples, MA, ELS
Corporate Partners
- Andrea Morrison (Abbott)
- Rita Bojalian (Boston Scientific)
- Mona Patel (Boston Scientific)
- Sam Tahmasian (Boston Scientific)
- Lauren Ciccarelli, MS (Exponent)
- Autumn Bullard, PhD (Exponent)
- Mariana Garcia, PhD, PMP (Exponent)
- Steven M. Kurtz, PhD (Exponent)
- Nikita Pak, PhD (Exponent)
- Felicia L. Svedlund, PhD (Exponent)
- Robert Gaskill (Medtronic)
- Mark Gryzwa (Medtronic)
- Marshall Stanton, MD (Medtronic)
- Huzefa Mamoola (Nevro)
- Gregory Fiore, MD (Sollis Therapeutics)
Publications
The project members created a device disposition survey, which has been sent out to the NANS membership.
Upcoming Events
Our next meetings will work on further clarification of the types of testing that may be needed and the liability/regulatory consequence of such testing. This committee is dependent on and thankful for the participation of our academic ethicists, patient advocates, industry engineers and legal counsel, as well as our government regulatory consultants.