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PCD Medical Device IT Management White Paper

Working Copy!. PCD Medical Device IT Management White Paper. Architecture and Use Case Examples Dan Trainor , John Rhoads, Axel Wirth PCD MEM Working Group. Objective - Architecture. Device Architecture Overall System Architecture CMDB/CMMS, including legacy

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PCD Medical Device IT Management White Paper

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  1. Working Copy! PCD Medical Device IT Management White Paper Architecture and Use Case Examples Dan Trainor, John Rhoads, Axel Wirth PCD MEM Working Group

  2. Objective - Architecture • Device Architecture • Overall System Architecture • CMDB/CMMS, including legacy • Hospital vs. Manufacturer View (peaceful coexistence) • Legacy devices (does not comply to guidelines). • Considerations implied in above: • Looking at existing systems (CMDB/CMMS) to see what their architectural decisions were. • Connected vs. Standalone Devices. Intermittent. • Use mode of device (e.g. - Fixed hospital, traveling, mobile, home based, etc.

  3. 1. Device Architecture(scope definition) • Clinical Parameters: • Functional Settings • Demographics • Clinical alarms • Diagnostic Data • Etc. Out of Scope • Reference: • IEC 11073 • MDPnP / ICE • IEC 80001-2-2 • (MDISS) • …. • Device Parameters: • System Status • Maintenance • Techn. Alarms • Version / SW Config. • Device ID • Etc. In Scope • Network Basics: • IP Address • MAC Address • Wireless settings (if applicable) • Etc. • Subnet settings

  4. 1. Device Architecture(virtual management architecture) U/I I/O Authentication System Messages Ports Connected devices Operating System Version / Patch level O/S configuration O/S status / messages Device SW Device HW Version Wear & Tear Parts Power status Monitoring & Logging Error & Event logs Access log Maintenance logs Device Config. and Status UDI, S/N Location Connection status Patch / upgrade status IT Config. Network I/F IP Address Cybersecurity Status Device Management System (Details TBD)

  5. 1. Device Architecture • Notes: • Technical information flow, not clinical / functional view • Callouts are examples only, not a complete list • Currently shows device metadata from device to Management System – how about the other way around? • Not every device will contain all components.

  6. 2. Overall System Architecture(CMMS/CMDB legacy vs. future device management system) “The New Thing” • IT Centric • OS Ver. • IP Address • etc. • Device Centric • Asset ID / UDI • Descriptor • Maint. Schedule • etc. CMDB CMMS Traditional CMDB (Configuration Management DataBase), IT centric for management of IT assets (servers, PC’s, etc.) Traditional CMMS (Computerized Maintenance Management System), typically manual device management database Note that at this point the CMDB/CMMS topic needs to be further researched (architecture, typical functionality, standards used, market adoption) to make more educated decisions on how to move forward.

  7. 2. Overall System Architecture(hospital – device ecosystem and types to be considered) Device Cloud Device Cloud P P P P P P P P P P P P  CSP L/D D D D D  D D I/F D D D/T D/I D/P Workstation  Standalone Connected External Wireless Intermittent Legacy Subnet Programmer manual (?) (legacy)CMDB (legacy)CMMS Workstation F “Filter” F Device Management System

  8. 2. Overall System Architecture(in hospital • Notes: • Align terminology with existing standards, e.g. MDPnP • CMDB and CMMS may be existing legacy systems (optional) • Device Database – to be named • Abbreviations: • D = Device • I/F = general interface (device manager, router, firewall, gateway, etc.) • CSP = Communications Service Provider (i.e. public network) • L/D = Legacy Device • D/T = Device Translator • D/I = Device Intermediary • P = Patient-worn or managed device (e.g. implant or holter) • D/P = Device Programmer • CMDB = Configuration Management Database (traditional IT function) • CMMS = Computerized Maintenance Management System (traditional CE function) • F = Filter (conceptual, e.g. to separate general IT devices from medical devices)

  9. 3. CMDB / CMMS(including legacy scenarios)

  10. 3. CMDB / CMMS(including legacy scenarios) • Notes: • TBD Working – need to speak with Steve Grimes or Steve Merritt

  11. 4. Hospital vs. Manufacturer View (peaceful coexistence) CMMS (CE) CMDB (IT) Example: Hospital Example: Home Care “M2M Device Cloud” CMDB/CMMS • Manufacturer Support: • Monitoring • Maintenance • Patching • Troubleshooting • Authentication Examples: Mobile Monitoring, Personal Fitness

  12. 4. Hospital vs. Manufacturer View (peaceful coexistence) • Notes: • TBD

  13. 5. Legacy devices(does not comply to guidelines).

  14. 5. Legacy devices(does not comply to guidelines). • Notes: • TBD

  15. Objective – Use Cases • Architecture • Risk Management • Regulatory Compliance • Functional Categories: • Discovery • Lifecycle Management • Asset Management and Tracking • Configuration Management • Patch Management • Event Communication • Monitoring and Logging • Security • Privacy

  16. References Clinical Architecture via MDPnP / ICE http://www.mdpnp.org/uploads/F2761_completed_committee_draft.pdf

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