20160225 OO FHIR conCall

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HL7 OO on FHIR (for Orders and Observations)

Call in details:
Phone: +1 770-657-9270, Passcode: 398652

Join the meeting at:
https://join.me/vernetzt.us

Date: 2016/02/25
2015 - 02:00 PM (Eastern Time, GMT -04 DST)
Quorum = chair + 4 yes/no


Co chairs Chair Notetaker
Riki Merrick
Rob Hausam
Lorraine Constable
Patrick Lloyd
Ken McKaslin
Hans Buitendijk


Attendees
X Eric Haas
X Riki M
Paul K
X Jose Costa-Teixicara
Dan R
John Moehrke
Kamalini
Mark Jones
X Rob Hausam
Margaret D

  • Roll Call
  • Agenda Check
  • Minutes from
  • Agenda
    • review and propose actual wording for Device elements ( also a Device QA task to review comments and descriptions ) especially in light of the changes from udi to udiCarrier.
*8926 Provide Clearer guidance for UDI components (Eric Haas) Persuasive
  • Intro:

existing:

This resource identifies an instance or a type of a manufactured item that is used in the provision of healthcare without being substantially changed through that activity. The device may be a medical or non-medical device. Medical devices includes durable (reusable) medical equipment, implantable devices, as well as disposable equipment used for diagnostic, treatment, and research for healthcare and public health. Non-medical devices may include items such as a machine, cellphone, computer, application, etc.

determine whether harvested stuff gos here or in new resource

  • Scope

existing:

This resource is primarily used for recording which device performed an action and can also be used to track device location. It is also used for prescribing and dispensing devices for patient use. If the device is implanted in a patient, then the patient element will be present, and there would be no location.

use this instead:

This resource an administrative resource that tracks individual device types or instances of a device and their location. It Is referenced by other resource for recording which device performed an action such as a procedure or an observation. It is also referenced when prescribing and dispensing devices for patient use or for ordering supplies.


  • Boundaries and Relationships

change first part to:

    • Device (this resource)
    • DeviceMetric - Describes a measurement, calculation or setting capability of a medical device.
    • DeviceComponent that the DeviceMetric is part of. This can be a DeviceComponent of any kind like a VirtualMedicalDevice (VMD), a MedicalDeviceSystem (MDS) , or a Channel

(consider adding reference to the IEEE Model)

(rest ok)

NOTE: Determine whether harvested stuff gos here or in new resource and determine boundaries.

  • Device Identifier

Chamge to:

Definitions: Unique instance identifiers assigned to a device by manufacturers other organizations or owners.

Comments: The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used. If the barcode is the 'unique device identifier' (UDI), The FHIR Device.Identifier element corresponds to the variable portion of a UDI that identifies the serial number of a specific device. See <UDI mappings> for a complete mapping of UDI parts to Device.

  • Device.udiCarrier

Change to:

Definition: Unique device identifier (UDI) barcode or rfid string assigned to device label or package. - see http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm.

(note use markup for the reference) ( tracker [#9634] to cover use case if both UDI barcode and rfid)

Comment: The udiCarrier string may identify an unique instance of a device, or it may only identify the type of the device. The Human Readable format (HRF) is required in FHIR. AIDC identifiers cannot be conveyed in FHIR, Because of limitations on character sets in XML and the need to round-trip JSON data through XML. See <UDI mappings> for a complete mapping of UDI parts to Device.


( moves this to devices notes as general discussion or point to a reference.)

A portion of the UDI - the DI part - can be extracted from the UDI when required, and used to look up information about the device through the GUDID ( moves this to devices notes as general discussion or point to a reference.)

  • Device.type

Definition: Code or identifier to identify a kind of device. (no change)

NOTE made tracker[#9635] on GMDN as binding since have to pay for it. switch to 49062001 Device (physical object)Hierarchy

Change to:

Comment: The FHIR Device.tepe element corresponds to the UDI device identifier (DI) part. See <UDI mappings> for a complete mapping of UDI parts to Device. Different code systems with different code value can be represented as translation using <codeableConcept> data type. Different code systems may correspond to different granularity of the same concepts. (add to examples and discuss further in notes)


  • Device.lotNumber

Change to:

Comments: Alphanumeric. The FHIR Device.lotNumber element corresponds to the variable portion of a UDI that identifies the lot or batch number within which a physical instance of a device was manufactured. See <UDI mappings> for a complete mapping of UDI parts to Device.

Alphanumeric Maximum 20. ( tracker why 20?)

  • Device.manufactureDate

Change to:

Comments: The FHIR Device.manufactureDate element corresponds to the variable portion of a UDI that identifies the date a physical instance of a device was manufactured. See <UDI mappings> for a complete mapping of UDI parts to Device.


  • Device.expirationDate

Change to:

Comments: The FHIR Device.expirationDate element corresponds to the variable portion of a UDI that identifies the expiration date of a physical instance of a device. See <UDI mappings> for a complete mapping of UDI parts to Device.

Device.version (tracker comment [#9592] to Devices WG (DeviceComponent Resource) : multiple firmware versions within multiple release of same model.) ? Extensions future use

  • Device.patient

Change to:

Definition: Patient information, if the resource is associated with a person.

Device.location

Change to:

Requirement: Device.location can be used to track device location.

Minutes

Next Steps

Actions (Include Owner, Action Item, and due date)
Next Meeting/Preliminary Agenda Items

2015mmdd_OO_FHIR_concall


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