Introduction: During a hyperbaric oxygen therapy (HBOT) session, every medical device that is used within the hyperbaric chamber is exposed to several hazards, including an increased ambient pressure and partial pressure of oxygen. In Europe, all medical devices marketed and/or sold for use in hyperbaric conditions must be tested by the manufacturer and marked 'CE' if approved. At the moment, no left ventricular assist device (LVAD) has been formally approved and CE-marked for HBOT.
Case: A 65-year-old male was referred to our Hyperbaric Centre for HBOT due to a persistent life-threating soft tissue infection of the non-removable wire connecting the external controller with the pump implanted into the left ventricle of the heart (Heartware LVAD). The aim of the intervention reported here was to safely conduct HBOT sessions with this non-CE marked medical device. After risk analysis, the decision was made to isolate the external part of the LVAD (controller and batteries) from the ambient conditions in the hyperbaric chamber by placing it in a pressure-resistant housing that was vented to the external atmosphere. The housing, a 'Hyperbaric Protective Tube' was built and tested, and the resulting operating procedures were practiced by personnel involved in the patient's care. Thirty uneventful HBOT standard sessions were conducted with subsequent clinical improvement of the soft tissue infection, resulting in an extended timeframe for awaiting heart transplantation.
Conclusion: An isolation housing that vents into the dumping system of the hyperbaric chamber allows for the safe use of critical medical devices without prior testing for their compatibility with the hyperbaric environment.
Keywords: Case reports; Hyperbaric oxygen therapy (HBOT); Medical devices; Risk factors; Safety.
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