PCD Brief Profile Proposal 2008 MEM WP

1. Proposed Workitem: White Paper - Medical Equipment Management (MEM)

• Proposal Editor: Todd Cooper, Manny Furst
• Editor: Steve Merritt
• Date: N/A (Wiki keeps history)
• Version: N/A (Wiki keeps history)
• Domain: PCD

NOTE: This white paper proposal is based on the previous profile proposal: PCD_Profile_MEM_Proposal_Brief

2. The Problem

Most healthcare delivery organizations (HDO) must manage 10,000's of medical devices representing 1,000's of make/model combinations. Managing these devices runs from simply having a consistent unique identification method, to determination of the device's location, operational status, battery level and charging profile, software / hardware configuration (incl. serial numbers), pending upgrades or software updates, etc.

The problem is that there are no common standards-based technologies for supporting these device management & maintenance activies. These technology profiles should address both the actors and transactions that are required to perform management activites, as well as the basic content that is needed to perform specific tasks (e.g., device identification, or representation of battery charge status).

This white paper discusses the general topic of MEM, focusing in on key activity areas and problems, identifying the use cases and requirements that should be addressed in future PCD profile development.

3. Key Use Case

3.1 Device Configuration Management

• Unique Device Identification (EUI-64, GS1, GMDN, GHTF/FDA UDI, etc.)
• Hardware Configuration (serial numbers, etc.)
• Software Configuration
• Sub-component Configuration
• Discovery - What devices exist?
• User Configuration Profiles (e.g., PICU vs. ... Role Based configurations)

3.2 Location Tracking Services

• Where is the device
• Where has it been (location tracking / trending)
• Notification when it crosses a boundary or is out of defined areas

3.3 Battery Management

• On A/C or D/C?
• Charge Level / Estimated battery life
• Charging / Discharging history
• Battery type and installation date

3.4 Operational Status Monitoring

• In use? Usage history?
• Alarm - active, history, ...

3.5 Periodic Maintenance

• Last P/M
• Next P/M Schedule (predictive ... based on device history / status?)
• Event log review
• Regulatory status (e.g., eMAR's, recalls, etc.)
• Warranty periods / licensing / ...

3.6 Software Patch Management

• Pending software version / "patch"

3.7 Event Log Management

• Processing of event logs, which could include key strokes, alarm events, power on/off cycles, etc.
• Archiving event logs

3.8 Remote-Maintenance Service Profile

• Would be pretty broad in its focus, include security - might become a separate profile

3.9 Risk Management Support

IEC 80001 requires a life cycle risk management process for networked medical devices that includes not only pre-deployment risk analysis (incl. network configuration documentation) but also dynamic / periodic assessment of network performance and functioning of risk controls. Any set of MEM profiles should provide the information and services needed to support all 80001 activities and documentation artifacts (e.g., that would become part of the HDO's risk management file).

4. Proposed Topics / Outline

Note: This is highly subject to change!

Introduction

• Overview (problem statement)
• Scope (incl. WP objectives)
• Use Case Organization
• Document Organization

Coordination with Other IHE Profiles

• PCD Profiles: DEC & DPI & TFv3
• ITI Profiles
• Other Domains

Device Configuration Management

• Software and hardware configuration information
• Software upgrade management

Device Location & Status Tracking

• Location tracking services
• Battery Management
• Usage / Activity Tracking

Remote Device Maintenance

• Event Log Retrieval
• Remote Service Support

Risk Management

• Support for IEC 80001 Risk Management File components

MEM Profile Roadmap

• Proposed profiles to be developed
• Phasing of profile development
• Coordination with other IHE profile development activities

5. Discussion

• RTLS - is this a profile that should be addressed within PCD or should this be joint with other IHE working groups?