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Optimizing Medical Device Safety: A Closed Loop Process

February 22, 2017 — 08:30AM - 09:30AM EST
Orange County Convention Center
Session ID: 


Biomedical Engineers in the Veterans Healthcare Administration (VHA) have led the charge to standardize and optimize the process for safety alerts, recalls and incidents involving medical devices through the lean process re-design. This work has reduced redundancies and duplicative steps and improved the understanding of roles and responsibilities of all stakeholders. The re-designed process is now a closed loop utilizing multiple internal software applications and databases as well as standardized nomenclature and SQL reporting tools. The re-designed process ensures that facilities comply with and complete assigned actions and allows for oversight review by local, regional and national levels of the VHA organization. Deliverables of this presentation will benefit any healthcare organization by providing an example of assessing and improving a large, complex process, providing checklists for responding to incidents and recalls, valuable reports and developing a comprehensive patient safety training plan.

Learning Objectives: 

  • Define and analyze the complexities of medical device safety issues inclusive of recalls and incident response
  • Apply lean principles for process re-design
  • Develop tools for a closed loop process for addressing medical device safety issues at healthcare organizations that mitigate patient safety risks
  • Describe a case study of an incident which resulted in a recall of medical devices across 150+ hospitals and the mitigation of vulnerabilities


Clinical Engineering Professional
Management Engineer and Process Improvement Prof.




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