About This Session
This MPSC 2026 Minogue Award-winning session outlines a practical, systemwide model for hardwiring safety practices for medical device and recall management through multidisciplinary collaboration, standardized processes, and an equity-driven focus. Participants will learn who the essential champions and stakeholders are for an effective Medical Device Safety Committee (MDSC) and how to engage them across frontline clinical practice, biomedical engineering, supply chain, quality, risk, and patient advocacy departments. In addition, the presenters will review a reproducible, system-level workflow for identifying, triaging, and remediating device-related operational issues and patient safety events; and examine the key elements of policies and SOPs for device management, product surveillance, and recall alert communication. The session also uses case studies to surface common system vulnerabilities, illustrate successful interventions, and prompt actionable opportunities to strengthen governance, communication, documentation, and equity considerations in device safety and product recall programs.
Learning Objectives
By the end of this session, participants will be able to:
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Identify health system leadership champions and stakeholders required to support an effective Medical Device Safety Committee (MDSC).
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Describe a standardized, system-wide process for reviewing medical device–related operational issues, patient safety events, and risk mitigation.
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Describe key components of policies and standard operating procedures (SOPs) related to medical device management, products, and recall management.
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Analyze de-identified case examples to recognize system vulnerabilities and opportunities for improvement.
Speakers
Stacy Shilling, MS, RN
Portfolio Manager, Johns Hopkins Health System Patient Safety
Stacy Shilling, MS, RN, brings more than 27 years of distinguished clinical and leadership experience as a critical care nurse, grounded in deep expertise across complex, high-acuity patient populations. She earned her Bachelor of Science in Nursing (BSN) from West Virginia Wesleyan College and later completed a Master of Science in Population-Based Care Coordination at Stevenson University in Maryland, advancing her ability to lead system-level improvements in care delivery.
Throughout her career, Stacy’s clinical focus was extensively on neuroscience, critical care, and medical oncology, developing a comprehensive understanding of the clinical, operational, and safety needs of these intricate environments.
In 2022, Stacy transitioned to the Armstrong Institute for Patient Safety and Quality, where she serves as the Portfolio Manager for Patient Safety. Cochair of the Medical Device Safety Committee. In the role of Cochair of the Medical Device Safety Committee, she has strengthened and expanded a multidisciplinary team—bringing together Human Factors engineers, Supply Chain partners, Value Analysis specialists, and Clinical Engineering—to systematically review safety events, identify trends, and drive organization-wide learning. Her leadership has advanced the health system’s ability to implement medical devices and products, with a focus on proactive risk mitigation and shared accountability.
Nicole Fitzpatrick MPH, RN
Clinical Program Director, Recall Management
Nicole Fitzpatrick, MPH, RN, has worked in acute healthcare for over 12 years, having transitioned into nursing after a decade working in public health, honing her diplomacy and dancing skills through many years in the Peace Corps and non-profit/research work in Latin America. Her acute healthcare career has targeted improving patient safety through leading infection prevention programs focused on reducing healthcare-acquired infections and ensuring safe care environments.
She joined the Johns Hopkins Health System team in 2021 as a consultant overseeing COVID testing operations and transitioned into her current role as the Clinical Program Director of Recall Management in 2024. She has discovered this fascinating area of healthcare that is often overlooked and under-appreciated. She is passionate about working to increase awareness, improve response rates, and enhance vendor relations/communications surrounding recalled products. She envisions a future of automated processes to match purchases to recalls and seamless communication to end users impacted by recalls.
