[abstract] THE SELECTION OF MEDICAL DEVICES FOR USE IN CLINICAL HYPERBARIC CHAMBERS.

Abstract

The Royal Hospital Haslar Hyperbaric Medicine Unit has been operating for 2 1/2 years. During this time the unit has qualified a number of medical devices as being "fit for purpose" for use in the Clinical Hyperbaric Chamber environment. The presentation gives an overview of the steps taken to introduce these devices into service and the generation of a common procedure for the assessment and authorization of electrical devices and systems for use in hyperbaric chambers. The questions addressed by this process include selection of the device, design of modifications required for hyperbaric use, risk assessment in operating and failure models as well as the affect of the dynamic environment on the instrument itself. These devices were subject to a series of desktop and field studies ofter resulting in some modification before they could be used safely in the chamber. The findings of these assessments are offered for information and debate. This paper will cover the following types of equipment: Patient Monitors, ventilators, blood gas monitors, syringe divers, volumetric pumps.