**2. Risk management process**

In Europe, as well as in the rest of the world, the general risk management process applicable for all medical devices is described in the ISO EN 14971 [2]. This concerns also ICDs and PMs. Detailed recommendations for medical devices used specifically in hyperbaric chamber systems are presented in the Annex B of the European Norm CEN EN14931 [3]. This Annex includes a description of all potential hazards that can be created by the use of specific medical devices, as well as the risks induced by them inside medical hyperbaric chambers. Moreover, in order to ensure the highest possible level of safety of the patient treated with the Hyperbaric Oxygen Therapy (HBOT) and the attendants, recommendations are given to both manufacturers of such devices and medical users of hyperbaric installations [3].

Generally speaking, there are three hazards related to the use of medical devices in the hyperbaric chamber:


The preferred method of using medical devices inside hyperbaric chambers is having manufacturer's clearance for specific ambient conditions, confirmed by the appropriate certificated, e.g., "CE certificate" in European Union. However, there are some cases when the medical devices need to be introduced into the hyperbaric environment, but the manufacturer does not certify them for use in such conditions. In those cases, the user of the device (staff of hyperbaric centers) must conduct the safety evaluation before introducing it to the hyperbaric environment. This process includes at least checking the structure of the device, taking into account:


In case of any doubt, the use of this medical device in hyperbaric chamber should be abandoned.
