1www.HL7.org

HL7 Working Group SessionMay 3-7, 2004

San Antonio, TX

Standards for Implantable Devices - Cardiac

2

Overview

• Project Progress• Next Steps• Artifact Review• Appendix:

– Implantable Cardiac Device Overview– Current Clinician Environment– Implantable Device – Cardiac (IDC) Project

Overview– Participants

3

Project Progress

• Validated requirements through interviews and site visits• Compiled HL7 v3.0 artifacts for Device Summary

message– Storyboard– Application Roles– Trigger Event– Message Type– Interaction Diagram– Refined Message Information Model (R-MIM)– Hierarchical Message Definition (HMD)

• Identified nomenclature terms to be balloted via IEEE Vital Signs Nomenclature

4

Next Steps

• Obtain feedback from participants and enhance current artifacts

• Prepare Device Summary artifacts for ballot • Participate in enhancements to IEEE Vital

Signs Nomenclature• Gather additional requirements through

interviews and site visits• Create new HL7 v3.0 artifacts to support

additional messages in this area

5

Scenario Overview: Office Follow-Up

Place wandInterrogate

Device

Device Data SentTo EHR Using

HL7 ObservationMessage

Clinician ReviewsSettings / Events /

Patient Status

Change DeviceSettings?

Print Final Report

Program DeviceWith New Settings

Physician's EHRSends Follow-upLetters to PCP,

EP, Internist, etc.

No

Yes

Device SettingsAuto populate

Form(Printed for Patient

Record)

Discharge Patient

Patient InOffice forFollow-upHL7 Follow-Up

Order MessageSent to EP

EHR

In OfficeFollow-Up

Requested &Confirmed via

HL7 Messaging

Print Settings/Report

Device Data Inproprietary formatconverted to HL7Standard format

Post-implantDischargeProcessing

* Gray process flow boxesindicate HL7 messaging

6

Device Summary Data

•Aggregated set of data that is typically filed in the patient’s chart at follow-up

• Implanted Device Data Types:– Device Therapy Settings

• Pacing settings• Defibrillation settings

– Arrhythmia Logging Data • Event Counters

– Diagnostic Data • Diagnostics on device functionality (e.g., lead impedance,

sensing thresholds, pacing thresholds)

7

Office Follow-Up: Interaction Diagram

Implantable DeviceInterrogation System

Electrophysiologyor CardiologyOrder Fulfiller

ObservationOrder Placer

Observation Order ActivateFulfillment Request

Observation Order ActivateConfirmation

Interrogation ObservationEvent Complete Notification

Observation Event CompleteNotification

Medical RecordsSystem

Original Document with Content (RCMR_IN000002)

8

Office Follow-Up: Interactions, Roles & Trigger Events

Interaction Sending App Role Recv. App Role Trigger Event Message Type Observation Order Activate Fulfillment Request

Observation Order Global Placer

Observation Order Global Fulfiller (EP/Cardiology Dept System)

Observation Order Activate Fulfillment Request (Scheduled follow-up – post-implant)

General Observation Order

Observation Order Activate Confirmation

Observation Order Global Confirmer (EP/Cardiology Dept System)

Observation Order Global Confirmation Receiver

Observation Order Activate Confirmation (EP/Cardiology Dept System accepts ordered follow-up)

General Observation Order

Interrogation Observation Event Complete Notification

Interrogation Observation Event Informer (Implantable device interrogator, plus data conversion app)

Interrogation Observation Event Tracker (EP/Cardiology Dept System)

Interrogation Observation Event Complete Notification (Data retrieved from device and converted to standard format)

Implanted Cardiac Device Summary

Observation Event Complete Notification

Observation Event Informer (EP/Cardiology Dept System)

Observation Event Tracker

Observation Event Complete Notification (Exam completion)

General Observation Event

Original Document with Content (RCMR_IN000002)

Document Originator (RCMR_AR000001) (EP/Cardiology Dept System)

Document Management System Content Required (RCMR_AR000003)

Original Document Notification (RCMR_TE000102)

Document Event, with Content (RCMR_MT000002)

9

R-MIM

10

Appendix

– Implantable Cardiac Device Overview– Current Clinician Environment– Implantable Device – Cardiac (IDC) Project

Overview

11

Implantable Cardiac Device Overview

• Pacemakers• Implantable Cardioverter Defibrillators• Heart Failure devices• Sensors

• Programmer

• Implantable cardiac devices exist as siloed subsystems

12

Current Clinician Environment

Implantable Cardiac Device

Data

Referring, Implanting &Following Physicians

Integrated EHR/HIS/CIS

Clinicians will prefer systems that integrate with their CIS

Data IntegrationOpportunity

13

IDC Project Overview

Current Working Relationships• Project under the sponsorship of the O&O Tech. Cmte.• Participate in LAPOCT SIG and IEEE Joint Working Group• Work with IEEE on extending Nomenclature

Intended Working Relationships• Monitor the work of the Vocabulary Tech. Cmte.• This group will stay alert to and be prepared to work with any outside

organization with similar or related goals, including:– DICOM WG1– IEC (International Electrotechnical Commission) SC62D– IHE (Integrating the Healthcare Enterprise) Cardiology– NASPE (North American Society of Pacing and Electrophysiology) – Heart

Rhythm Society– SNOMED

14

Participants

• Implantable Device Companies & Medical Instrument Companies

• Interested Clinicians• EHR Vendors• Providers• Payors• Remote Monitoring Companies• Electrophysiology (EP) Lab Diagnostic Vendors• Healthcare Consulting Companies

15

Implantable Cardiac Device Process FlowImplantable Device Process Flow

Oth

er H

CP

rofe

ssio

nal

Pat

ient

Fo

llow

ing

Phy

sici

anIm

plan

ting

Phy

sici

anP

hysi

cian

Sta

ffR

efer

ring

Phy

sici

an Indication forPacemaker, ICD,

or HF DeviceTherapy

Implantation ofDevice

Post OperativeMonitoring in

HospitalDischarge

Post OperativeDevice

Management

Device Follow-up

History

- Placement of leads- Placement of device- Device testing andprogramming- Registration, that triggers: - Billing - Technical support - Device tracking

- 24-72 hrs- Wound care- Pain mgmt- Arrhythmia mgmt.- Fluid mgmt.

- Pre-discharge device &lead test- Pre-discharge chest x-ray- Post operative careinstructions

- Infection risks- Driving- Identification card- Restriction of Arm/Shoulder motion- Follow-up visit schedule- Emergency procedure- Other precautions

Follow-up Schedule- Initial: 7-10 days post-implant- Pacemaker: 6 mo. intervals- Defibrillator: 6 mo. intervals- HF Device: 3-6 mo intervals

DeviceInterrogation and/or Manipulation

- Surgical procedures - Inpatient - Outpatient- Diagnostic procedures(e.g., MRI)

Explant- Battery expiration- Qualified for new therapy protocol

16

Device Data Overview

• Implanted Device Data Types:– Device Therapy Settings

• Pacing settings• Defibrillation settings • Therapy tuning features

– Arrhythmia Logging Data • Stored details on each episode• Electrograms and event markers before, during, and after an event

– Diagnostic Data • Trended diagnostics on device functionality (e.g., lead impedance, sensing

thresholds, pacing thresholds)• Diagnostic data for titration of patient therapy

– Data from in-clinic testing• Inductions• Various device status tests