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Digital QR/Barcode Questions/Integration Issues

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Digital Symbology Background/Standards

Background:

    • Digital symbologies for devices can be used for many use cases especially in infusion pumps:
      • Auto-Programming Requests (APRs)
      • Alarms Manager Association
      • Asset Tracking

Standards:

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    • Digital symbology standards for medical devices are limited to broad standards that are independent of medical deivces:
      • For 1D barcodes – ISO 15416
      • For 2D symblogies such as QR codes- ISO 18004
        • Pixels- at least 1 pixel per module or 78 pixels by 78 pixels, whichever is greater
        • At least 4 boxes/modules

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Problems with Integration

Barcode Components

Cerner

Epic

Prefix

KH

HH

1D or 2D

2D

Receives only text (1D or 2D is dependent on the barcode scanner)

ID

Pump ID Prefix (LVP)

Pump ID Prefix (Syringe)

Pump Serial Number

Pump Channel

Serial Number

Symbology

Aztec and QR

Symbology supported depends on the barcode scanner, which could be from any of a large number of third-party vendors

Example

KHM8100S13992251/A

HH14657044; ID in Epic does not have to be the same as the serial number; as Epic can map the number if needed

Example of Vendor Differences

- With Digital symbologies, Device Manufacturers have the responsibility both for the string/data encoded and the symbology type for vendors

-Potential Problems:

-Using a vendor specific encoding

strategy may not be unique

-Hospital with multiple vendors: have to support multiple symbologies due to different formats/data needs for integration

- Do not have a use case agnostic

symbology method

-Therefore Standardization is needed

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A Possible Solution: GS1

  • FDA requires using the GS1 standard for Unique Device Identification
  • This standard gives stringent guidelines for both the data needed, how strings are encoded, and the format of the symbology
  • Proposed Solution:
    • Use the GS1 standard to standardize digital symbologies for multiple vendors and use cases
    • By using the identifiers in the standard (e.g. (21) for serial numbers, vendors can parse the information that is needed for a particular use case (e.g. serial number for APRs)

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