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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
This is an on-demand recording from the April 2022 event
To ensure the safety of marketed medical devices, manufacturers and regulators typically rely upon surveillance methods through which patients, physicians and others report adverse events through an established system. Such feedback is critical to safety monitoring but is limited in its ability to quickly identify new risks and changes in frequency for known risks.
To address these concerns, an Active Surveillance Task Force was established with the charge of advancing and launching active surveillance projects, and the goal of continuously generating, accessing and evaluating device performance in order to detect emerging safety signals more quickly. Task Force membership includes key stakeholder representation from patients, clinicians, health systems, FDA, payers and the medical device industry.
This active surveillance work builds upon central orchestration strategies for data curation, data quality and data analytics, as well as established surveillance operations with repeatable, scalable digital workflows. The development process addresses six key areas: architecture, interoperability, analytics, data management, compliance and stakeholder collaboration. The Task Force also seeks to extend an established Common Data Model (CDM) for device active surveillance. Finally, an IT Cloud Working Group has been formed and is charged with designing and building the Active Surveillance Cloud Infrastructure platform, which will be used to facilitate the collection and analysis of real-world data (RWD) for medical device safety signal detection and assessment.
The Active Surveillance Cloud Infrastructure approach intends to allow for the continuous monitoring of RWD and provide stakeholders the opportunity to make informed, real-time decisions on behalf of patients.
Omar Badawi, PharmD, MPH, FCCM, is the director of medical device safety at NESTcc, where his primary role is in the development of an active surveillance program for medical device safety. Prior to NESTcc, he led the research for developing product-related predictive algorithms and decision support tools for acute care telehealth systems at Philips Healthcare and was the program manager for the Philips eICU Research Institute which supports collaborative research between industry, academia and clinicians using de-identified clinical data representing over six million ICU patients. He is also an adjunct assistant professor with the University of Maryland School of Pharmacy and a research affiliate at the Massachusetts Institute of Technology.
Omar earned a master’s in public health with a focus in epidemiology and biostatistics from the Johns Hopkins Bloomberg School of Public Health and is also a fellow of the American College of Critical Care Medicine.
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