Immediately after the 2020 NANS Annual Meeting, the explanted device disposition project completed a second meeting aimed at developing a consensus statement regarding the disposition of explanted neuromodulation devices. At our first meeting we focused on the ethics and patient rights related to explanted devices. The consensus from our first meeting in December of 2019 was that policies related to explanted devices should prioritize public health first and foremost. Our second meeting focused on and prioritized the disposition of explanted device based on clinical circumstances. Devices explanted for routine expected end of service life would be processed according to the Federal, State, and hospital policies. In many instances these devices are delivered to pathology departments. For devices explanted earlier than expected due to under performance, failure, or patient injury should be processed according to hospital protocol and then transferred to an appropriate agency for in-depth analysis and electronic testing.
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. 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.
The project members have also created a device disposition survey, which will be sent out to the NANS membership soon.
2021 NANS Annual Meeting
Harnessing the Force of Neuromodulation
NANS 24th Annual Meeting