Proactive Risk Assessment through Failure Mode and Effect Analysis (FMEA) for Perioperative Management Model of Oral Anticoagulant Therapy: A Pilot Project

Abstract

Introduction: Correct perioperative management of anticoagulant therapy is essential to prevent thromboembolic events and reduce the risk of bleeding. The lack of universally accepted guidelines makes perioperative anticoagulant therapy management difficult. The present study aims to identify the perioperative risks of oral anticoagulant therapy and to reduce adverse events through Failure Mode and Effect Analysis (FMEA). Materials and Methods: A multidisciplinary working group was set up, and four main phases of the process were identified. Each of these phases was divided into micro-activities to identify the related possible failure modes and their potential consequences. The Risk Priority Number was calculated for each failure mode. Results and Discussion: Seventeen failure modes were identified in the entire perioperative period; those with a higher priority of intervention concern the incorrect timing between therapy suspension and surgery, and the incorrect assessment of the bleeding risk related to the invasive procedure. Conclusion: The FMEA method can help identify anticoagulant therapy perioperative failures and implement the management and patient safety of surgical procedures.