201709 Implantables Tracking

Track Name

Point-of-care Medical Device and Implantable Tracking

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 and it provides procedure contextual information. This track specifies test cases related FHIR STU3 Procedure and Device resources 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
• 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
• 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

Proposed Track Lead

Ioana Singureanu, VA/BZI, Skype: ioanasingureanu See Connectathon_Track_Lead_Responsibilities

Expected participants

• Department of Veterans Affairs
• Magpie360
• Eversolve, LLC

Roles

Please include information here regarding how much advance preparation will be required if creating a client and/or server.

Point-of-Care Medical Device Tracker

• 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

Point-of-Care Implantable Registry

• FHIR server, exposes Device, Procedure - references Patient

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...
   1. with externally referenced device
3. Complete procedure
   1. with externally referenced device
4. Complete implantable procedure
   1. with externally referenced device
   2. with contained device reference
5. Search procedures
   1. by patient
   2. by optional search parameter
6. search devices
   1. by patient
   2. by DI

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

Action: Create a Device resource (using POST/update), set Device.id to 'GUID', Device.udi.carrierAIDC to the base64-encoded, 'scanned UDI', set Device.status to 'active'. Set the Device.patient references the previously retrieved Patient (see 'Precondition').

Precondition: Query Patient service using thePatient.identifier scanned at the point-of-care

Success Criteria:Search Device by 'udi-carrier' (expression: Device.udi.carrierHRF | Device.udi.carrierAIDC).

Bonus point: specify optional data elements (S, 0..) of the Device resource.

Complete an Implantable Procedure

Action:

Precondition:

Success Criteria:

Bonus point: