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

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Presentation on theme: "PCD Medical Device IT Management White Paper Architecture and Use Case Examples Dan Trainor, John Rhoads, Axel Wirth PCD MEM Working Group Working Copy!"— Presentation transcript:

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

2 Patient Care Device Domain / Medical Equipment Management Objective - Architecture 1.Device Architecture 2.Overall System Architecture 3.CMDB/CMMS, including legacy 4.Hospital vs. Manufacturer View (peaceful coexistence) 5.Legacy devices (does not comply to guidelines). 6.Considerations implied in above: a)Looking at existing systems (CMDB/CMMS) to see what their architectural decisions were. b)Connected vs. Standalone Devices. Intermittent. c)Use mode of device (e.g. - Fixed hospital, traveling, mobile, home based, etc.

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

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

5 Patient Care Device Domain / Medical Equipment Management 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 Patient Care Device Domain / Medical Equipment Management 2. Overall System Architecture (CMMS/CMDB legacy vs. future device management system) IT Centric -OS Ver. -IP Address -etc. Device Centric -Asset ID / UDI -Descriptor -Maint. Schedule -etc. CMDBCMMS The New Thing Traditional CMMS (Computerized Maintenance Management System), typically manual device management database Traditional CMDB (Configuration Management DataBase), IT centric for management of IT assets (servers, PCs, etc.) 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 Patient Care Device Domain / Medical Equipment Management 2. Overall System Architecture (hospital – device ecosystem and types to be considered) DD D DDDD D/I L/D D/TDD/P P P P P P P Stand alone ConnectedWirelessIntermittentLegacySubnetProgrammer Workstation Device Cloud (legacy) CMDB (legacy) CMMS FF Workstation P Device Management System P P P P Device Cloud P CSP I/F External manual (?) Filter

8 Patient Care Device Domain / Medical Equipment Management 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 Patient Care Device Domain / Medical Equipment Management 3. CMDB / CMMS (including legacy scenarios)

10 Patient Care Device Domain / Medical Equipment Management Notes: TBD 3. CMDB / CMMS (including legacy scenarios) Working – need to speak with Steve Grimes or Steve Merritt

11 Patient Care Device Domain / Medical Equipment Management 11 CMDB/ CMMS Manufacturer Support: -Monitoring -Maintenance -Patching -Troubleshooting -Authentication Example: Home Care Example: Hospital CMDB (IT) Examples: Mobile Monitoring, Personal Fitness M2M Device Cloud CMMS (CE) 4. Hospital vs. Manufacturer View (peaceful coexistence)

12 Patient Care Device Domain / Medical Equipment Management Notes: TBD 4. Hospital vs. Manufacturer View (peaceful coexistence)

13 Patient Care Device Domain / Medical Equipment Management 5. Legacy devices (does not comply to guidelines).

14 Patient Care Device Domain / Medical Equipment Management Notes: TBD 5. Legacy devices (does not comply to guidelines).

15 Patient Care Device Domain / Medical Equipment Management Objective – Use Cases 1.Architecture 2.Risk Management 3.Regulatory Compliance 4.Functional Categories: a)Discovery b)Lifecycle Management c)Asset Management and Tracking d)Configuration Management e)Patch Management f)Event Communication g)Monitoring and Logging h)Security i)Privacy

16 Patient Care Device Domain / Medical Equipment Management References Clinical Architecture via MDPnP / ICE


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