Safety and Performance of Suction Apparatus

摘要

This document is a study of the safety and performance of suction apparatus which is used clinically for clearing air passages, removing air and fluid from the pleural space, draining wounds and gastrointestinal contents, and removing fluids, blood, and debris around the operative field during surgery. Risks and hazards associated with these devices were identified through a comprehensive literature review, a survey on currently marketed devices and user interviews. Recommendations and requirements for the safety and performance of suction apparatus are presented as a starting point in the development of a performance standard for these devices.