1. 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

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
(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
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 
Stand alone
Connected
External
Wireless
Intermittent
Legacy
Subnet
Programmer
manual (?)
(legacy) CMDB
(legacy) CMMS
Workstation
Device Management System F
“Filter” F

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
CMDB = Configuration Management Data Base
CMMS = Computerized Maintenance Management System
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. Clinical Architecture via MDPnP / ICE
References
Clinical Architecture via MDPnP / ICE