Quality Improvement Program to Minimize Complications from Retained Blood in Heart Surgery Patients
Anaheim, CA — (May 10, 2016) — ClearFlow, Inc., a California-based company that develops technology to maximize post-operative blood evacuation after cardiac surgery, has signed an agreement with Mayo Clinic in Rochester, MN for research on a Continuous Quality Improvement (CQI) program for patients recovering from heart surgery. Simon Maltais, M.D., Mayo Clinic Associate Professor, Division of Cardiovascular Surgery, is the Principal Investigator. Originally implemented in Japanese manufacturing companies in the 1950’s, CQI programs have been adopted by many industries and are an important tool now being used in leading hospitals to improve the quality and safety of patient care in the healthcare setting.
“Recent studies have demonstrated that up to 20% of patients recovering from heart surgery have some form of intervention due to retained blood that can slow recovery and increase the costs of care,” said Edward Boyle, MD, co-founder and Chairman of ClearFlow. “The goal of this study is to implement structured protocols in the ICU that can facilitate improved recovery for patients after heart surgery. These protocols will include use of PleuraFlow® Active Clearance Technology® (ACT®) System, a simple bedside device used to keep chest tubes free from clogging during the first 24–48 hours of recovery after heart surgery.”
An award-winning innovation developed by cardiothoracic surgeons, PleuraFlow ACT has been shown to reduce both Retained Blood Syndrome (RBS) and post-operative atrial fibrillation in published studies. A key aim of this study is to develop structured ICU protocols to minimize the potential for retained blood within the framework of a continuous quality improvement program and measure patient outcomes improvement.
A recent study by independent investigators in Germany, published in the Journal of Thoracic and Cardiovascular Surgery, affirmed a reduction in retained blood interventions required after surgery from 20% to 11% (43% reduction) in all cardiac surgery patients when the PleuraFlow System was used, as well as a reduction in Postoperative Atrial Fibrillation (POAF) from 30% to 20% (a 33% reduction) in propensity matched patients. The study results demonstrate that by implementing a quality improvement protocol to reduce chest tube clogging, complications can be reduced and patient outcomes can be improved. The cost to treat these complications add an enormous burden to the healthcare system.
“It’s an honor to work with Mayo Clinic on this research – an organization known world-wide for its commitment to continuous quality improvement to optimize patient care,” said Paul Molloy, CEO of ClearFlow, Inc. “In light of mounting data from multiple sources clearly demonstrating that there is an unmet need for reduction of retained blood resulting from clogged chest tubes among patients recovering from cardiac surgery, Mayo Clinic’s proactive move to explore protocol enhancements in this area is sure to resonate with the medical community at large.”
The PleuraFlow Active Clearance Technology System is approved for use in the U.S., Europe, Australia, Brazil, and Canada, and has either cleared or is pending clearance in nine additional countries. The PleuraFlow System is exclusively distributed in the US by Maquet Medical Systems/Getinge Group.
About ClearFlow, Inc.
ClearFlow, Inc. is an Anaheim, CA based medical device company that has developed a patented active blood and fluid evacuation system to speed recovery, reduce complications and lower healthcare costs related to medical tube obstruction. The company has been awarded several prestigious awards, including the European Association of Cardiothoracic Surgeons Techno-College Innovation Award for worldwide innovation that has the potential to change the standard of care in heart and lung surgery, and the Innovations in Cardiovascular Interventions Award, among others.
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