201801 Medical Device and Implantables Tracking using UDI

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Return to Jan 2018 Proposals

Track Name

Point-of-care Medical Devices and Implantables Tracking

Orientation Slides

Submitting WG/Project/Implementer Group

This track provides a set of simple test cases for Tracking Medical Devices (i.e. diagnostic, therapeutic, monitoring) and Implantables (biologics/tissue/cells and non-biologics/life-supporting/life-sustaining) at point of care addresses current problems relate to information accuracy including procedure-related context. This track specifies test cases related FHIR STU3 Procedure (using three PMDT-specific profiles) and FHIR Device resources (one PMDT profile) used to report information from the point-of-care to enterprise system consistent with the IHE PCC Point-of-care Medical Device Tracking Supplement.

Justification

  • Implantable medical devices are costly and concerns about illegitimate (i.e., counterfeit, stolen) products has become a global issue
  • By 2021 all medical devices that may be used in a point-of-care procedure will be labeled using FDA UDI that will also relate to software/firmware release
  • Post-market surveillance of implantable medical devices can be challenging
  • Implantable medical device adverse events and recalls pose a patient safety issue
  • Acquiring medical device data used at the point-of-care is difficult to retrieve for reuse at a later time
  • A consistent device identification scheme closes the loop on data acquisition at the point-of-care to support reporting of medical device data
  • Medical device data used for:
      • Continuum of care (e.g., Discharge Summary, Referrals)
      • Registries (e.g., Total Joint Registry)
      • Payers (e.g., government provided, private insurance)
    • Can associate a medical device used for monitoring a disease or symptom of a disease (e.g., vital sign monitors, pulse oximeters, blood glucose monitors) to a patient for querying the device or procedure using the UDI
  • Increase patient safety
    • Traceability of medical devices (avoid use of counterfeit or illegitimate products)
    • Quality issues identified (e.g., recalls, adverse events)
  • Increase accurate medical device data capture at the point-of-care
    • Eliminates human error from manual medical device data entry

Implantable workflow.png

Proposed Track Lead

Ioana Singureanu, VA/BZI, Skype: ioanasingureanu

Expected participants

It's basically a HAPI FHIR server using Postgres.

Roles

The test roles for this track are based on the IHE PCC PMDT Actors below:

Actors-pmdt.png

Point-of-Care Medical Device Reporter

  • Point-of-care client; it registers medical device, creates/updates point-of-care procedure information, query patient based on identifier scanned at the point-of-care. This role is played by a system used to track information about medical devices used at the point-of-care. The device and procedure information are populated at the point-of-care using scanned (AIDC) UDI and patient identifier to simplify the accurate tracking of this information.

Medical Device Server

  • FHIR server, exposes Device, Procedure - references Patient. It is used to persist device and procedure information originating at the point of care. This information is made available to other information systems in the enterprise. This role may be played by a Medical Device Registry or an EHR system.

Point-of-Care Medical Device Requester

  • This role is played by any information system that requires to compile an implantable device list for patient, evaluate outcomes based on device type (i.e. DI), respond manufacturers' recalls, and address patient safety events.

Scenarios

The following is a summary test cases proposed for

  1. Register (create) device record using
    1. UDI and DI only
    2. UDI and DI and optional attributes
  2. Start procedure at the point of care. This may an infusion procedure, a diagnostic procedure using a device, a monitoring session, etc. The Procedure resource specifies the status as "in-progress" and the start of the procedure as well as the coded procedure type, patient, practitioner, etc. At the minimum the patient, the device, and the practitioner known at the point-of-care should be specified.
    1. with externally referenced device
  3. Complete procedure; it marks its status to "completed" and specifies the time it was completed.
    1. with externally referenced device
  4. Complete implantable procedure; this a one-time record that a device, tissue, or tissue products was implated.
    1. with externally referenced device; it assumes the device was already registered and its UDI and its other identifiers were captures.
    2. with contained device reference; the device information is included as "contained" resource in the Procedure.
  5. Search procedures; to compute outcomes, compile implantable device lists for transition-of-care, to respond to recall notifications
    1. by patient
    2. by other optional search parameters
  6. Search devices; to track device utilization, for quality control, to compute outcomes, compile implantable device lists for transition-of-care, to respond to recall notifications
    1. by udi-carrier
    2. by patient
    3. by udi-di

Register Medical Device or Implantable from the point-of-care

Action: The 'Tracker' creates a Device resource (using PUT/update), sets Device.id to a 'GUID', Device.udi.carrierAIDC to the base64-encoded, 'scanned UDI', sets Device.status to 'active'. The Device.patient references is set to external reference previously retrieved Patient resource. (see 'Precondition').
Precondition: The 'Tracker' queried the Patient resource using the Patient.identifier scanned at the point-of-care. This external references is used in Device.patient.
Success Criteria: The 'Requester' queries Device by 'udi-carrier' (expression: Device.udi.carrierHRF | Device.udi.carrierAIDC) and retrieves one matching resource containing the correct information. The 'Tracker' can retrieve it by logical id/GUID.
Bonus point: specify optional data elements (S, 0..) of the Device resource.

POC Device.png

Complete an Implantable Procedure

Action: The 'Tracker' creates a Procedure resource (using PUT/update), sets the Procedure.id to a GUID, Procedure.status to 'completed', Procedure.focalDevice.manipulated to reference the device registered above. The 'Tracker' set the Procedure.performedDateTime to the current date/time. The 'Tracker' specifies the Procedure.code corresponding the implant procedure performed.
Precondition: The 'Tracker' queries the Patient resource using the Patient.identifier scanned at the point-of-care. The 'Tracker' registered a medical device or implantable using a pre-defined GUID as its logical identifier.
Success Criteria: The tracker can retrieve the Procedure resource using its _id. The 'Requester' queries Procedure based on the Patient reference.
Bonus point: The 'Requester' searches the Procedure resource based on Procedure.code (expression: code).

POC procedure.png

Start a Point-of-Care Procedure

Action: The 'Tracker' creates a Procedure resource (using PUT/update), sets the Procedure.id to GUID, Procedure.status to 'in-progress', Procedure.focalDevice.manipulated to reference the device registered above. The 'Tracker' set the Procedure.performedPeriod.start to the current date/time.
Precondition: The 'Tracker' queries the Patient resource using the Patient.identifier scanned at the point-of-care. The 'Tracker' registered a medical device or implantable using a pre-defined GUID as its logical identifier.
Success Criteria: The tracker can retrieve the Procedure resource using its _id. The 'Requester' queries Procedure based on the Patient reference.
Bonus point: The 'Requester' searches the Procedure resource based on Procedure.code (expression: code).

Complete a Point-of-Care Procedure

Action: The 'Tracker' updates the Procedure resource (using PUT/update), it sets the Procedure.id to its previously set GUID, Procedure.status to 'completed', Procedure.focalDevice.manipulated to reference the device registered above. The 'Tracker' set the Procedure.performedPeriod.end to the current date/time. The 'Tracker' specifies the Procedure.code corresponding the implant procedure performed.
Precondition: The 'Tracker' queries the Patient resource using the Patient.identifier scanned at the point-of-care. The 'Tracker' registered a medical device or implantable using a pre-defined GUID as its logical identifier. The 'Tracker' created a first version of the Procedure
Success Criteria: The tracker can retrieve the Procedure resource using its _id. The 'Requester' queries Procedure based on the Patient reference.
Bonus point: The 'Tracker' submits the same transaction using a "contained" Device resource.

PMDT start end.png

TestScript(s)

  • TestScript resources will be created/registered for Jan 2018 FHIR Connectathon

January 2018 Connectathon Outcomes

Goal

  • To use FHIR to record information about procedures performed at the point-of-care using medical devices (single-use, implantable, monitoring) and record the procedure (e.g. implant, monitoring), identity of the device(s) (e.g. UDI), references to patient, providers,etc.

This track was intended to validate the FHIR profiles developed to supproto the "Point-of-care Medical Device Tracking" (PMDT) integration profile developed by VA and AORN (Asssociation of PeriOperative Nurses) as an IHE Patient Care Coordination Technical Framework supplement.

Participants

  • Ioana Singureanu, VHA (Track Lead)
  • John Rhodes, Philips Medical Systems
  • Stephen Hollifield, HealthLX
  • Will Tesch, HealthLX
  • Richard Esmond, PenRad
  • Greg Gustafson, PenRad

Notable Achievements

  • In addition to testing out the Device and Procedure resources we also tested Medication, MedicationAdministration, and Location to support the requirements of a new IoT device. The personal injection device is intended to record and transmit the identity of the operator, the geolocation (using Location), the type, route, and medication dose (using Medication and MedicationAdministration).
  • We discovered these resources could be used with RFID tagged devices - using a needle application or could molded into a larger device to provider RFID for the larger implant. The metal alloys used in devices are carefully research to avoid impact on future diagnostic imaging (avoid shadows and echos).The UDI could be used to track devices to the unique id of tumor and share the id of the tumor over time, among various system.

Screenshots

  • Not applicable at this time; this specification is meant to enable automatic data capture of identities, procode time, and location.
  • Some implants can identity location of a lump and provide RFID:
  20180128 142218.jpg

Discovered issues

  • We need to track the a tumor (using a unique id) across systems, over a period of time as treatment are applied to the site. Can we use BodySite to represent a tumor and "treat" the body site?
  • We decided to use "Medication.supportingInformation" to specific a Location reference for the place where the device was used to self-deliver medication (e.g. chemo, insulin).

Next Steps

  • We will add "MedicationAdministration", "Medication", and "Location" to the set resources and profiles we could use to document point-of-care procedures.

September 2017 Connectathon Outcomes

  • Persisted Device resources and procedures performed at the point-of-care for implants (i.e. Complete POC Procedure) in a new FHIR server.
  • We need additional test cases for replacing an implant (i.e. marking the current Device as "inactive") with another implant and documenting the associated new Implant Procedure.
  • Updated several "must support" elements and created the PMDT Device resource. In its next iteration this track will use
    • ImplementationGuide for the overall PMDT integration profile,
    • StuctureDefinition resources for each profiles
      • Point-of-Care Device profile,
      • Point-of-Care Procedure Start,
      • Point-of-Care Procedure Complete,
      • Complete Implant Procedure.
  • The test cases will be further refined for both the FHIR and IHE Connectathon