Difference between revisions of "PCD Brief Profile Proposal 2008 MEM WP"

Revision as of 23:20, 11 November 2008

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., Peds ICU 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 (% of full)/Est. operating time left.
Charging / Discharging history
Battery type and installation date
Est. battery life (if manuf. can use charge/discharge data to est. hours or days remaining)

3.4 Operational Status Monitoring

In use? Usage history?
Alarm - which are active, what are trigger levels, if device is active, has the alarm been off for an extended period; active meaning signals are received thus the device is on the patient, etc.
Day/time of last self check and its result, date/time of last error message sent to maintainer.

3.5 Periodic Maintenance

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

3.6 Software Patch Management

Pending software version / "patch"
Patch history w/ version, date, version, company source, etc.

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
Forensic Investigation Support
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?

@@ Line 41: / Line 41: @@
 ===3.3 Battery Management===
 * On A/C or D/C?
-* Charge Level / Estimated battery life
+* Charge level (% of full)/Est. operating time left.
 * Charging / Discharging history
 * Battery type and installation date
+* Est. battery life (if manuf. can use charge/discharge data to est. hours or days remaining)
 ===3.4 Operational Status Monitoring===
 * In use?  Usage history?
-* Alarm - active, history, ...
+* Alarm - which are active, what are trigger levels, if device is active, has the alarm been off for an extended period; active meaning signals are received thus the device is on the patient, etc.
-*
+* Day/time of last self check and its result, date/time of last error message sent to maintainer.
 ===3.5 Periodic Maintenance===
 * Last P/M
 * Next P/M Schedule (predictive ... based on device history / status?)
+* Last repair time/date.
 * Event log review
 * Regulatory status (e.g., eMAR's, recalls, etc.)
@@ Line 62: / Line 63: @@
 ===3.6 Software Patch Management===
 * Pending software version / "patch"
+* Patch history w/ version, date, version, company source, etc.
 ===3.7 Event Log Management===