NordPac 2023 – KEYNOTES

Anne Vanhoestenberghe Professor of Active Implantable Medical Devices (AIMD) Director, MAISI Facility School of Biomedical Engineering & Imaging Sciences King’s College London, UK   Topic: Reliability of Active Implantable Devices: can we predict, and prevent, failure?

Most research on the reliability of AIMD has focused on the prevention of corrosive failure, by limiting the formation of liquid water over the active electronics parts of the implant. Whilst two approaches, conformal coating or rigid hermetic enclosures, are successfully used in CE and FDA approved devices, the hermetic enclosure is by far the most common.

The large titanium cases with only a few metal in glass feedthroughs in use nowadays are well established. For these, there is no attempt at predicting lifetime in use, the accumulated experience of thousands of years in use has demonstrated that they are sufficiently hermetic, provided poorly sealed batches can be identified and excluded before entering service. It has therefore been sufficient to rely on a simple pass/fail test, based on a leak rate calculated on un-aged packages.

However, as we create new treatments and interventions, using innovative technologies, new materials, and much smaller devices, this approach may no longer be satisfactory. In this talk, I will review the basic assumptions and methods to evaluate the reliability of new AIMD, and discuss whether, and how, we can predict, and prevent, failure.