Méthodologie d'intégration de dispositifs médicaux en milieu hyperbare

Abstract: The use of medical devices within hyperbaric chambers has always been slowed down by the specific difficulties of this environment. Indeed, installing a medical device within a pressure level much higher than atmospheric pressure and in an oxygen enriched atmosphere is an interesting challenge. In fact, few manufacturers dare engage in this way. Besides, for many years numerous working groups have emerged in hyperbaric medecine. Currently a european standard is being finalized and based on a risk analysis identifying, among other things, a certain number of potential hazards. They can potentially generate dangers during the use of a hyperbaric chamber. Installing a medical device in a hyperbaric chamber is not an easy thing to do. Indeed, the risks induced by a use in a hyperbaric chamber cannot be minimized. Furthermore the medical device must not cause additional risks within the chamber or, anyway, the risks must be evaluated, reduced and accepted. Consequently, prior to installing a medical device, this study proposes a methodology which enables to evaluate the risk management concerning the use of a medical device. Once the methodology completed, the manager of hyperbaric oxygen therapy unit is able to decide whether to install the device or not. [Copyright &y& Elsevier]