2015 PCD Domain Update Jeff McGeath Iatric Systems IHE PCD Technical Committee Co-Chair

2015 PCD Domain Update Monroe Pattillo Practical Health Interoperability, LLC IHE PCD Planning Committee Co-Chair

Patient Care Device (PCD) Domain Formed in 2005 to address issues related to integration of Point-of-Care Medical Devices Mission – enable “Out of the Box”, Reliable, “Functionally Interoperable” solutions Using IHE & PCD open Processes and open Standards Technical Underpinnings HL7 version 2.6 baseline, with some profile specific drawing upon 2.7, 2.8, soon IEEE Standards Standardized Nomenclature, – Standardized Information Model Wireless Communication Transfer Protocol (WCTP) version 1.3 IHE ITI domain Consistent Time (CT) profile – Network Time Protocol (NTP) IHE PCD Co-sponsors

Patient Care Device (PCD) Domain Focus is on devices associated with patients, including… Patient monitors, vital signs monitors, pulse oximetry, ventilators, Infusion pumps, syringe pumps, PCA pumps, etc. Collecting and reporting data from devices for immediate access and for retrospective storage and retrieval (EMR) Device to Enterprise Communication (DEC) (leveraged by Continua Alliance for feeding data into health records) Implantable Device - Cardiac Observation (IDCO) Retrospective Data Query (RDQ)

Patient Care Device (PCD) Domain (contd.) Getting alerts (alarms & advisories) to staff (clinicians, clinical engineers, IT, etc.) on mobile & desktop devices Alert Communication Management (ACM) (formerly Alarm Communication Management) Improving infusion order safety (including a 6 th right, right pump) Point of care Infusion Verification (PIV) Infusion Pump Event Communication/Event Communication (IPEC/EC)

Patient Care Device (PCD) Domain (contd.) Harmonizing terminology Rosetta Terminology Mapping (RTM) RTM Management System in conjunction with NIST Waveform support Waveform Content Module (WCM) communicating evidentiary data for storage and alerting Medical Equipment Management Device Management Communication (MEMDMC) Location Services (MEMLS)

Device to Enterprise Communication (DEC)

Alert Communication Management (ACM) HL7 Messages per ACM and WCM profiles HL7 Messages per ACM and WCM profiles Parameters, waveforms, etc. as evidentiary data items Parameters, waveforms, etc. as evidentiary data items DeviceSpecificgraphicsDeviceSpecificgraphics Alert Information Source, Phase, State, Priority PatientLocationInstance Alert text CallbackTimestamp Evidentiary data Dissemination Status Instance Accepted by AC UndeliverableDeliveredReadAcceptedRejectedCancelled Callback start/stop AlertCommunicatorACAlertCommunicatorACAlertManagerAMAlertManagerAMAlertReporterARAlertReporterAR Report Alert PCD-04 → ← PCD-05 Report Alert Status Disseminate Alert PCD-06 → ← PCD-07 Disseminate Alert Status Alert Source

Point of care Infusion Verification (PIV) Medication Physician’s Order Nurse Review Pharmacist Review Nurse confirms 6 Rights: Right Patient Right Medication Right Dose Right Time Right Route Right Device Medication Administered BCMA to Pump (PCD-03) Pump may provide data to EMR (PCD-01)

Infusion Pump Event Communication (IPEC) Pump provides information on infusion-related events to BCMA/EMR (PCD-10) such as: Delivery Start Delivery Stop Delivery Complete Prior to medication administration, nurse confirms the 6 Rights of administration using BCMA/EMR: Right Patient Right Medication Right Dose Right Time Right Route Right Device Infusion-related events are displayed, validated, and/or recorded by the clinician using the BCMA/EMR BCMA/EMR Infusion Pump Event Communication enables reporting of clinical and operational events from an infusion pump to a Bedside Computer-assisted Medication Administration (BCMA) system or EMR. Clinicians can then view and validate this information for infusion documentation. Infusion order sent from BCMA/EMR to Pump (PCD-03)

Implantable Device – Cardiac Observation (IDCO)

Retrospective Data Query (RDQ) Supports retrospective query of PCD data from databases. Supports Use Cases such as Clinical Decision Support, back- filling of EMR databases, etc. EMR, CDSS, CIS, Etc. Data Query PCD-12 Data Response PCD-13 Data Query PCD-12 Data Response PCD-13 Data Requesters Full Disclosure Data Server and/or Data Requester Data Query PCD-12 Data Response PCD-13 Data Servers

Waveform Content Module (WCM)

Device Management (MEMDMC) & Location Services (MEMLS)

Optimized Message Syntax (OMS) Optimized Message Syntax is an effort to adapt IHE PCD profiles for devices that have slow legacy RS-232 serial ports. OMS will optimize the PCD messages to reduce their size but still maintain consistency with mainstream PCD messages. Data Collection System Bedside Computer OMS Messages EMR, CDSS, CIS, Etc.

Device Interoperability CPOE/ Pharmacy System Future PCD Current PCD Infusion Pump Future Non- PCD IDCO Gateway IDCO MEMLS ACM – Alert Communication Management DEC – Device Enterprise Communication EC – Event Communication IPEC – Infusion Pump Event Communication IDCO – Implantable Device Cardiac Observation MEMDMC – Device Management Communication MEMLS – Location Services PIV – Point-of-Care Infusion Verification RDQ – Retrospective Data Query WCM – Waveform Content Module ACM DEC Phones, tablets, and other devices for Clinical and Non-Clinical Staff MEMDMC Alert Communicator Dotted line indicates WAN Connection ACM, WCM DEC, WCM IPEC EMR/EHR CIS Interface Systems LS Systems Alert Manager CMMS Systems Other Medical Devices and Systems Physiologic and Vital Signs Monitoring Home Based Systems Clinical Decision Support System Anesthesia Ventilation Implantable Device PIV Barcode Med Admin System/ Pump Gateway ACM DEC ACM ACM, WCM DEC RDQ ACM Note the high potential for reusability of implementations of common profile actors as reporters, consumers & managers

NIST Testing Tools HL7 Message Definitions IEEE / Rosetta Nomenclature Test Case Specific Assertions Value Set Constraints Etc.

NIST Testing Tools

Current Efforts Alerts (alarms & advisories) & Events Rosetta Terminology Mapping Work with IHE ITI domain on their new mACM profile which uses FHIR Device Specializations – Pulse Oximeter, Infusion Device, Ventilator Medical Device Security Management and Patching whitepapers MEMDMC/MEMLS improve these new profiles through Change Proposals Work with IEEE P1847 Location Services for Healthcare working group Point of Care Identity Management (PCIM) whitepaper – device-pt associations PCD Profile Version Management using MSH-21 and OID mgmt Work with IEEE on integration of new a and starting b FHIR Resources – general FHIR technology review to culminate in a whitepaper describing PCD terminology mapping to FHIR FDA UDI whitepaper – Working with the HL7.org committees to advance UDI support using the HL7 v2.8.2 updates which support UDI Update PCD Technical Framework – volumes 1, 2, & 3 (CPs & housekeeping)

Future Efforts Medical Device Technical Management Error logs, access to device logs Software & Hardware revisions Medical Device Cyber Security Medical Device to Device Communication Medical Device Specializations Improving device management, safety, and availability (DMC, LS) Utilization, Location, Failure alerts, Battery condition, Self Test Improved asset management (qty rented/purchased)

Role of Healthcare Organizations Support the Mission of IHE PCD Participate in IHE PCD The voice of the users of what vendors produce – be heard Plant the Seed Support and Request IHE Interoperability Encourage active IHE participation by vendors Purchase IHE PCD compliant products Request vendors to provide IHE Integration Statements Specify IHE PCD compliant solutions in RFPs by profile/actor

Example PCD Compliant Systems COMPANYSYSTEMSYSTEM TYPEPROFILES ALERT Life Sciences ComputingALERT® EHREHRDEC, IPEC AmcomMessengerAlarm ManagerACM BIOTRONIK SE & Co. KGHome Monitoring Service CenterImplantable Cardiac Device Observer SystemIDCO B BraunINTEGRA™Infusion Pump GatewayACM, DEC, IPEC, PIV BaxterSigma Spectrum GatewayInfusion Pump GatewayDEC, IPEC BIT Computer Co., Ltd.Dreamcare Medical Gateway (DMG)GatewayDEC CapsuleTechSmartLinx™Medical Device Information SystemACM, DEC CarefusionCCEGatewayDEC, IPEC, PIV CernerCareAware iBusEnterprise Device Connectivity PlatformACM, DEC, PIV CovidienVital Sync – Integrated Patient IntelligenceRemote MonitoringACM, DEC EpicEpicCare Inpatient and associated modulesEMR/EHRDEC, IDCO, IPEC, PIV Fresenius kabiLink + AgiliaInfusion Pump GatewayACM, DEC Fukuda DenshiDynabase CVW-6000Gateway and Full Disclosure Reviewing SystemDEC GE HealthCareCARESCAPE GatewayGatewayDEC HospiraHospira MedNetInfusion pump gatewayDEC, IPEC, PIV Iatric SystemsAccelero Connect®Medical Device IntegrationDEC, IPEC, PIV iMDsoftMetaVision SuiteCIS, AIMSDEC MasimoPatient SafetyNetRemote Monitoring & Clinician Notification SystemACM, DEC Mindray DS USA, Inc. eGatewayHL7 GatewayACM, DEC A5Anesthesia machineDEC NantHealth DeviceConXMedical Device IntegrationDEC MagellanAlert ManagerDEC COSClinical Operating SystemPDQ Nihon Kohden AmericaPlatinum HL7 GatewayPhysiologic MonitorDEC NuvonVEGA™Interface Overlay Architecture & AppliancesACM, DEC OZ SystemseSP™InterfaceDEC Philips Healthcare IntelliSpace Event ManagementAlarm ManagerACM Philips IntelliVue and Philips IntelliBridgeMonitoring central station and gatewayDEC IntelliBridge EnterprisePhilips Expression IP5 Information Portal (MRI Patient Monitoring)DEC IntelliBridge Enterprise Philips IntelliVue Guardian System (SpotCheck, central station and gateway) DEC IntelliBridge EnterprisePhilips SureSigns VS Monitor with GatewayDEC ScottCareScottCare OneView SysrtemImplantable Cardiac Device Observer SystemIDCO St. Jude Medical, Inc.Merlin.net MN5000Implantable Cardiac Device Observer SystemIDCO SunTech Medical, Inc.VitalShareVital Signs Device InterfaceDEC Surgical Information SystemsSIS PeriopCIS, EHR, AIMSACM, DEC True ProcessVeriScan RxBPOCDEC Vocera CommunicationsVocera Voice and Vocera Messaging ACM Welch Allyn Connex CSCentral StationDEC Connex CSKConnectivity Solutions KitDEC From IHE PCD 2014 Commercially Available Devices and Systems

Additional Resources IHE PCD Getting Started – Tiny.cc/PCDStart IHE PCD User Guide – Tiny.cc/PCDHandbook IHE web site – PCD web site – IHE ftp site – ftp://ftp.ihe.net PCD ftp site – ftp://ftp.ihe.net/Patient_Care_Devices/ PCD wiki – wiki.ihe.net/index.php?title=Patient_Care_Devices Test Tool web sites PCD Pre-Connectathon – tinyurl.com/NIST-PCDtt PCD Connectathon – tinyurl.com/NIST-PCDctt Rosetta Terminology – tinyurl.com/NIST-RTMMS

Contacts IHE PCD Planning Committee Co-Chairs Monroe Pattillo, PHI, LLC Kurt, Elliason, Smiths Medical IHE PCD Technical Committee Co-Chairs Jeff McGeath, Iatric Systems, Inc. Tom Kowalczyk, BBraun IHE PCD Technical Project Manager Paul Sherman IHE – IHE PCD – Connectathon Results – Folder containing PCD list of Commercially Available solutions ftp://ftp.ihe.net/Patient_Care_Devices/Deployment/Comm ercially_Available_PCD_Systems/