The SHIELD Collaborative Community is examining the requirements for support of device identification in lab results. With the expansion in the definition of the Medical Device class in USCDI V6 from implantable to all medical devices, and in light of requirements being written in the European Health Data Space, we are trying to better understand the current capabilities as well as any planned enhancements in your surveillance system.
A visual primer https://www.visiott.com/wp-content/uploads/2021/10/Example-UDI-Image-Mobile.jpgwhere. The device identifier (describes the kind of device) the other 3 are the production identifiers (describing specific instance(s) of the device), not all of them might be present – this is the GS1 format, there are 2 others defined.
A detailed reference for device information in HL7 artifacts is here: HL7 Standards Product Brief - HL7 Cross Paradigm Implementation Guide: UDI Pattern, Release 2 | HL7 International
We are interested in:
#1 is there a specific format you prefer:
- The full UDI as barcode
- The full UDI as human readable string (is minimum required element in HL7)
- The UDI broken out into it’s components
#2 Are there any limitations like field length, format etc that would affect the capture, storage and export?
The working group will be discussing any feedback on our call on Tuesday December 16 9-10 AM EST – here are the call coordinates, in case you can join us:
Join Zoom Meeting
One tap mobile: US: +13462487799,96838399228#,*547139# or +12133388477,96838399228#,*547139#
Meeting URL: https://childrens.zoom.us/j/96838399228?pwd=5floK13Wz61tObNIbdWs3LbaFvFgUr.1&from=addon
Meeting ID: 968 3839 9228
Passcode: 547139
With gratitude for your time to provide input,
Riki
(Chair of the SHIELD Steering Committee)