ECLS Safety Overview: Meeting Regulatory Standards

This session will be on Thusday, June 15 at 1830 central daylight time, USA.  The session will focus on various aspects of safety in CPB and ECMO with the aim of meeting any in-house risk management requirements or outside private or governmental regulatory standards. Failures involving malfunctioning equipment, communication failure, human error and failure to anticipate adverse events will be discussed. These failures and their remedies will be viewed in the context of Failure Modes and Effects Analyses (FMEA).    FMEAs approach potential problems in a design or process by itemizing the conceivable failures, describing the consequences, identifying the causes, listing actions that can prevent or mitigate the failure and ranking each failure as to its possible risk to the patient.