[abstract] APPROVAL PROCESS FOR MEDICAL DEVICES USED IN A MULTIPLACE CHAMBER.

Abstract

INTRODUCTION: Most medical device manufacturers do not warranty their devices for use inside a Class A chamber. Consequently many facility operators feel that the topic of medical device selection and use should be limited to "off the record" discussions. The objective of this presentation is to discuss and put to paper an acceptable method for the development, implementation and maintenance of a facility based approval process for medical devices that meet regulatory agency recommendations. It falls on each facility to have in place a policy for the use of medical devices in their chamber.METHODS: Through lecture and slides present the following: 1) The need for facility based medical device approval; 2) What the regulatory requirements are; 3) Dispel myths and rumors; 4) Provide a program template. CONCLUSIONS: It is hoped that these recommendations can serve as a model for operating facilities to allow them to meet and/or exceed compliance and regulatory agency recommendations for the use of medical devices in Class A hyperbaric chambers. The liability rests with each institution, so they need to be comfortable with the final product. approval process, hyperbaric chamber, medical devices