Katrina A. Bramstedt, PhD Associate Professor Bond University School of Medicine

1. Harms and Responsibilities Associated with Battery-Operated Implants (BOI): Who Controls Post-Mortem Explantation? Katrina A. Bramstedt, PhD Associate Professor Bond University School of Medicine

2. Disclosure I have no conflict of interest with any BOI device manufacturers. I thank Medtronic Australia Cardiac Rhythm Disease Management Technical Service for assisting me with geographic regulatory research.

3. What is a BOI? pacemaker defibrillator deep brain stimulator gastric stimulator sacral stimulator intrathecal infusion pump

4. Issues with BOIs • They are battery operated and contain heavy metals; explosive hazards in crematoriums; all are suspected environmental hazards when buried (if titanium case leaks over time). • The devices contain data which is stored inside them electronically. The data is removed by syncing the device with a computer to retrieve the data (interrogation). • The devices themselves hold physical data about the safety and performance of each component – visual analysis and testing of devices can be done post-mortem and yield info re cause of death and silent “problems”.

5. Issues with BOIs • Few devices get explanted and returned to manufacturers for analysis. WHY? • The implant and explant procedures are decoupled rather than coupled during ONE consent process (at the time of implant) • Some morticians are afraid to remove these devices without express consent of pt or NOK (In some jurisdictions it would be illegal; other jurisdictions, no consent reqd for explant prior to cremation.) • Removed devices are often simply thrown away or stored in a lab/office and never returned for analysis despite manufacturers providing packaging and postage for returns.

6. What Data Do We Have? 150 pacemaker & ICD pts surveyed in USA (J CardiovascElectrophysiol 2007;18:478-482) • 82% indicated willingness to have their device interrogated after death • 79% indicated willingness to have their device removed and analysed after death • 5% believed explant was automatically part of the post-mortem procedures

7. No Explant, No Data, So What? Potential harms: • Lack of closure for families and clinicians • Silent clinical and device problems go undetected • Trends in device problems potentially unnoticed • Device failure rates/risk levels are potentially inaccurate • For research devices, an entire data set is lost • Environmental harm if device is buried or cremated

8. Is There a Right to Refuse Explant? (We Allow Autopsy Refusal) • Device explant is NOT the same as an autopsy • Autopsy is the examination of a dead body • Explant, is the reversal of the implant procedure, and simply removes the foreign body from the deceased. • Explant does not cause funeral delays • There is no cost for the explant procedure • Bodies are fully appropriate for open casket viewing

9. Guidance • Device implant and explant should be viewed as conjoined concepts in the consent process. [Patients should consent to both procedures in order to receive the implant, paving the way for legally unobstructed removal, return and analysis]. • Device interrogation should be understood as a longitudinal practice throughout the patient’s life, as well as, after death. • Device use should be considered temporary, removable after death. • Device “ownership” is irrelevant to the concept of explant. Devices can still be returned to NOK after analysis. • Autopsy is not the same as explant. • No role for NOK to veto patients’ consent for explant. • Need to cultivate a culture of stewardship to enhance explant return to manufacturer.