PCD Brief Profile Proposal MEM

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 work item proposal is based on the MEM whitepaper released in Sept. 2009: PCD_MEM_WP_Discussion

2. The Problem

Medical equipment is quickly becoming less manageable by traditional methods. Most healthcare delivery organizations (HDO) must manage tens of thousands of medical devices representing numerous makes and models. The management of these devices involves a wide array of activities including planning, procurement, inspection, inventory, testing, monitoring, maintanence, and de-commissioning. Common activities include unique device identification, ongoing or periodic determination of the device's location, operational status, battery level and charging profile, software / hardware configuration including serial numbers, pending upgrades or software updates, remote maintanence, and risk management. Traditionally medical devices have functioned as stand alone, or perhaps locally networked without the capability to transmit information outside of their own realm. As more equipment becomes connected to the enterprise network, it would be beneficial to equipment management activities to also be able to use these networking capabilities. Currently there are no common standards-based technologies for supporting these device management and maintenance activies. There are several vendor dependant methods in use across the industry showing that this is possible. This profile will provide data to those responsible for managing the devices and systems, primarily the clinical engineering (CE) professional. Devices/systems will send operational data to Computerized Maintenance Management Systems (CMMS) for data logging, event notification and other applications.

There are several potential benefits of this electronic approach to medical equipment management.

• Increases in patient safety by having safer, more reliable equipment available to clinicians when and where they need it
• Reducing equipment failures through proactive maintanence
• Managing the risk associated with networking medical devices
• Making sure devices are configured correctly
• Evidence based maintanence planning could be fully realized with the automated, electronic reporting of maintanence information, this could allowdevices to be scheduled for maintence when they actually need it
• Devices could also be more effectively used requiring less inventory.

Key Use Case

Device Configuration Management

Use Case 1

Increasing numbers of medical devices and complexity, along with perhaps increased attention to field problems has led to an increasing number of recalls. The absence of Unique Device Identification (UDI) means hospitals often must use manual and imprecise systems to find and properly identify recalled devices. Implementing UDI in combination with device tracking would potentially increase patient safety and decrease the work load and cost to address recalls.

Use Case 2

Medical devices often require reconfiguration when used in different clinical contexts. For example, when an IV pump is used in the NICU it may require different libraries, alarm settings, and control parameters than the same IV pump used in the OR. Such devices should have pre-programmed or user-configurable profiles based on use-contex

Battery Management

Use Case 4

Mobile patient care devices are often submitted for service due to battery problems, are put on regular maintenance schedules for periodic battery replacement, or batteries may fail prematurely interrupting patient care. Patient care devices using batteries should send periodic power status messages to a management system containing information such as current battery charge level, battery type and installation date, estimated battery life remaining, and current power source status (i.e. currently running on A/C or D/C).

Operational Status Monitoring and Predictive Maintenance

Use Case 5

Today ventilators typically have preventative maintanence (PM) performed every 6 months and as needed because its not necessarily known when a PM is actually required. Awareness of the need for maintenance sometimes comes too late after a problem occurs or too soon when maintenance is not needed, resulting in extra cost to the organization and/or unplanned loss of availability of the device. Therefore is beneficial going forward for the ventilator to send periodic data back to a computerized medical maintanence system (CMMS) reporting device usage parameters, event logs, and other information required to predict necessary preventative maintenance. The system should have the ability to analyze the data streams to predict calibration problems. The CMMS could automatically generate work orders based on a defined algorithm of the actual use and event logs. The ventilator would also send aperiodic data as it occurs of equipment technical alarm conditions such as loss of A/C power loss, low battery, loss of gas, etc

Use Case 7

Self test and other data provide timely information about the condition of medical devices. Transmission of this information to CMMS systems has the potential of improving the accuracy and uninterrupted availability of patient data, reducing downtime, increasing clinical engineering efficiency, documenting device condition more frequently and improving the management of these assets.

5. Discussion

• The existing PCD-01 transaction and actors could be leverage to send this information. The specific content of those PCD-01 transactions should be detailed out and the specific nomenclature added to the RTM and harmonized with existing IEEE nomeclature standards.

• To use the PCD-01 transaction CMMS vendors would need to act as the DOC and receive the HL7 v2.6 messages and parse the content appropriately