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ICE-PAC

ICE-PAC. Todd Cooper President Breakthrough Solutions Foundry. Tracy Rausch, Founder, DocBox Inc tracy@docboxinc.com 617.997.8375. • ICE‐PAC is a joint working group between ASTM: Device in the Integrated the Clinical Environment Standard (ICE) and IHE PCD in order to analyze

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ICE-PAC

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  1. ICE-PAC Todd Cooper President Breakthrough Solutions Foundry Tracy Rausch, Founder, DocBox Inc tracy@docboxinc.com 617.997.8375

  2. • ICE‐PAC is a joint working group between ASTM: Device in the Integrated the Clinical Environment Standard (ICE) and IHE PCD in order to analyze existing standards (IEEE 11073 and ASTM F2761-2009) to explore standards gaps and profile roadmap gaps. • To produce requirements for across the different standards at a systems level • Identify hazards where clinical practice meets engineering systems

  3. Clinical Scenario Clinical Scenario Clinical Workflow Workflow Analysis Risk Analysis State Diagram Technical Solution and Clinical Implementation Requirements • Gathering Requirements from Clinical System • Providing Traceability of System Requirements • Provide Systems Level Risk Analysis • Provides Traceability to Mitigating Risk • Designing for the System, not modifying the system • causing unintended consequences • General Building Blocks and Interactions • between the blocks are key to Safety • If General Building Blocks make up Specific Systems • then Systems are safe Clinicians Clinical Engineers Design Engineers

  4. Work to Date • Began with analysis of 7 scenarios in the ASTM F2961 Standard • Infusion Pump processes, hazards from a systems of systems analysis • Ventilator in process (workflow completed, workflow analysis and hazards in process)

  5. Current Findings • The transfer of just sensor data is not enough • Contextual Data is required for intelligent systems. This includes: • Device characteristics are key for contextual awareness • Device Identification • accuracy, • Precision • Source/source characteristics • Quality of Data is an unsolved problem • communication quality • Data quality • Patient History

  6. Future Work • Complete Ventilator Analysis • Heterogeneous Systems Analysis (monitoring, infusion pumps, ventilators, information systems) • Testing of Analysis with additional clinical scenarios • Demonstration of potential capabilities

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