PCD Medical Device IT Management White Paper

Architecture and Use Case Examples

Dan Trainor, John Rhoads, Axel WirthPCD MEM Working Group

Working Copy!

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.

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 11073• MDPnP / ICE• IEC 80001-2-2• (MDISS)• ….

Patient Care Device Domain / Medical Equipment Management

1. Device Architecture(virtual management architecture)

Network I/F

IT Config.

Device Config. and Status

U/I I/O

Monitoring & Logging

Device HW

Device SW

Operating System

VersionWear & Tear PartsPower status

Error & Event logsAccess logMaintenance logs

Version / Patch levelO/S configurationO/S status / messages

PortsConnected devices

UDI, S/NLocationConnection statusPatch / upgrade status

IP AddressCybersecurity Status

AuthenticationSystem Messages

Device Management System (Details TBD)

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.

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.

CMDB CMMS

“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, PC’s, 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.

Patient Care Device Domain / Medical Equipment Management

2. Overall System Architecture(hospital – device ecosystem and types to be considered)

D D

D

D D D D

D/I

L/D

D/TD D/P

PP P

PP

P

Standalone

Connected Wireless Intermittent Legacy Subnet Programmer

Workstation

Device Cloud

(legacy)CMDB

(legacy)CMMS

F FWorkstation

P

Device Management System

PP

PP

Device Cloud

P

CSP

I/F

External

manual (?)

“Filter”

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)

Patient Care Device Domain / Medical Equipment Management

3. CMDB / CMMS(including legacy scenarios)

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

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)

Patient Care Device Domain / Medical Equipment Management

Notes:• TBD

4. Hospital vs. Manufacturer View (peaceful coexistence)

Patient Care Device Domain / Medical Equipment Management

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

Patient Care Device Domain / Medical Equipment Management

Notes:• TBD

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

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

Patient Care Device Domain / Medical Equipment Management

References

Clinical Architecture via MDPnP / ICEhttp://www.mdpnp.org/uploads/F2761_completed_committee_draft.pdf