In order to better understand what tests was being performed (in order to decide, if results are comparable, in order to evaluate test performance, in order to track lab workflow and data quality (within the lab) - OTHER NEEDS - ADD HERE!!!

  • Data elements in question:
    • Test kit (reagent)
    • Test instrument
    • Manual kits (which are basically test kits without instruments)
    • Not yet part of the discussion, but possible: processing steps related devices
  • Level of detail needed:
    • at the model level (covers manufacturer and method)
    • at the instance level
  • Use cases where data needs to be reported
    • from instrument to LIS (or analyzer manager) - internal lab workflow
    • from LIS to EHR-s
    • from LIS to PH / research / regulatory agencies

Available Options in V2 lab messaging:

In the Base standard:

OBX-17 (method)

OBX-18 (equipment instance ID)

PRT segment (after v2.7)

In Implementation guides:

  • For internal lab workflow:
    • IHE LAW = AUTO 16 standard
      • Uses OBX-18: both model level and instance level by using repeats
  • Defined by UDI Cross Paradigm IG
    • Uses PRT
  • Current solution for COVID reporting - from lab to PH:
    • LRI PH_HHS profile:
      • OBX-17
      • Problems with the current solution:
        • these are not really code system, but identifiers that have different levels of specificity - can define make/model or instance, depending on how long they are / which elements are populated.
        • currently defining pseudocodes based on model name of kit and manufacturer name and type of device (EUA, test kit, instrument) - too long for element, no official steward of this data long-term.

Device Identifier (UDI-DI) character ranges based on Issuing Agencies (source: GUDID specs):

  • GS1: Numeric (Num.), DI may be 12, 13 or 14 digit numeric value. GUDID appends zeros to the left or beginning of DI to save a 14 digit value,  include the check digit as part of the DI
  • HIBCC: Alphanumeric (Alphanum.), with 6-23 characters, DO NOT include the check digit as part of the DI
  • ICCBBA: Alphanum., with 10 or 16 characters

The UDI-DI portion of the UDI placed on the lowest package level of a device that is required to meet UDI label requirements.  If the device is not packaged, the UDI may be on the device itself, thereby satisfying both the UDI label and the direct mark (DM) requirement if the UDI is intended to be permanent.   The primary UDI-DI is the main (primary) lookup for a medical device and meets the requirements to uniquely identify a device through its distribution and use.

When the UDI or UDI-DI is not available - we have used Manufacturer, Brand Name, Device Type and Model Number.  Note - some manufacturers will also use Catalog numbers (this is an optional element in accessGUDID).

Manufacturer/Labeler: Company name associated with the model or version of the device

Device/Brand Name: The brand name is a trade/proprietary name assigned by the device labeler, and under which the device is sold, distinguished from other similar devices, and recognized by the user or purchaser. A brand name is often registered and/or protected by a trademark. 

Device Type:  A grouping or categorization assigned to medical devices and related health care products.

Model Number: The version or model identifies all devices that have specifications, performance, size, and composition within limits set by the manufacturer/labeler.  Used to identify a category or design of a device.

Catalog Number: The catalog, reference, reorder or product number used by the labeler for business and clinical transactions to identify a particular product; this number may be found on the device label or labeling (e.g., REF value).