A Failure Mode Effect Analysis on Extracorporeal Circuits for Cardiopulmonary Bypass

Abstract

Although many refinements in perfusion methodology and devices have been made, extracorporeal circulation remains a contributor to neurological complications, bleeding coagulopathies, use of blood products, as well as systemic inflammatory response. With the exposure of these adverse effects of cardiopulmonary bypass, the necessity to re-examine the safety of extracorporeal circuits is vital. A failure mode effect analysis (FMEA) is a proven proactive technique developed to evaluate system effect or equipment failure. FMEA was used to evaluate the six different types of extracorporeal circuits based on feedback from five clinical experts. Cardiovascular device manufacturers, the Veteran’s Administration National Center for Patient Safety, and the Joint Commission on Accreditation of Healthcare Organizations recommend the use of FMEA to assess and manage risks in current and developing technologies and therapies. This analysis investigates the safety of six types of extracorporeal circuits used in coronary revascularization, including the newer miniaturized extracorporeal circuits. The FMEA lists and ranks the hazards associated with the use of each cardiopulmonary bypass extracorporeal circuit type. To increase the safety of extracorporeal circuits and minimize the effects associated with cardiopulmonary bypass, perfusionists must incorporate FMEA into their clinical practice.