Stream: inferno
Topic: UDI for Implantable Devices
Lakshmi Bhamidipati (Feb 24 2021 at 03:35):
Hello,
Is UDI (Unique Device Identifier) required when adding implantable device to a patient's chart? Our EHR allows an implantable device to be added with/without UDI. When a device is added without UDI, the inferno test cases fail. Is that expected? The specification states - "Implantable medical devices that have UDI information SHALL represent this information in either carrierAIDC or carrierHRF. (Note that the UDI may not be present in all scenarios such as historical implantable devices, patient reported implant information, payer reported devices, or improperly documented implants.)".
Thank you!
Yunwei Wang (Feb 24 2021 at 13:52):
UDI is a Must Support element which means the sever must demonstrate that it supports the element when the data exist. In order to test that, Inferno asks the server to provide at least one Device instance with UID element.
Lakshmi Bhamidipati (Feb 24 2021 at 14:27):
Thank you @Yunwei Wang . So it is not required that all devices in a patient's chart have a UID element. As long as one device has it and all the "must support" members are populated in the FHIR response, we are should be good?
Yunwei Wang (Feb 24 2021 at 15:18):
The simple answer is yes.
Inferno uses all returned Device instances as a collection when testing Must Support. Inferno test if the collection of Device instances have all MS populated.
Cooper Thompson (Feb 24 2021 at 16:00):
Note that the FDA is really tying to get everyone to document UDI for implants. Having discrete UDIs is a huge benefit for things like recalls. Because of historical data that may not have a UDI, as well as some challenges with supply management systems, they are not strictly required, and getting operational buy-in to document them regularly is hard, but in general we do want to encourage documenting them as much as possible.
Lakshmi Bhamidipati (Feb 25 2021 at 22:45):
@Yunwei Wang @Cooper Thompson
In my system, a patient has 2 devices - one is recorded with UDI and the other is recorded with just the DI. The Inferno tool is giving an error on the instance with just the DI, even though the bundle satisfies the MS requirement because 1 of the records has all the UDI information.
What I mean is this -
One of the resources is this
"resource": {
"resourceType": "Device",
"id": "1",
"udiCarrier": [
{
"deviceIdentifier": "08717648200274",
"carrierHRF": "=/08717648200274=,000025=A99971312345600=>014032=}013032&,1000000000000XYZ123"
}
],
"status": "active",
"manufactureDate": "2013-02-01T00:00:00+00:00",
"expirationDate": "2014-02-01T00:00:00+00:00",
"lotNumber": "000000000000XYZ123",
"serialNumber": "000025",
"type": {
"coding": [
{
"display": "Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated"
}
],
"text": "Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated"
},
"patient": {
"reference": "Patient/xxxx"
}
}
and the other is this
"resource": {
"resourceType": "Device",
"id": "2",
"udiCarrier": [
{
"deviceIdentifier": "M996SH75Y0"
}
],
"status": "entered-in-error",
"type": {
"coding": [
{
"display": "Oxygen administration kit, non-sterile"
}
],
"text": "Oxygen administration kit, non-sterile"
},
"patient": {
"reference": "Patient/xxxx"
}
}
}
For the 2nd one, id = 2, I am getting this error in Inferno -
USCID-07: Device resources returned from previous search conform to the US Core Implantable Device Profile. results...
Device/2: Device: us-core-12: Implantable medical devices that have UDI information SHALL represent this information in either carrierAIDC or carrierHRF. [udiCarrier.empty() or (udiCarrier.carrierAIDC.exists() or udiCarrier.carrierHRF.exists())]
Device/2: Device: us-core-9: For implantable medical devices that have UDI information, at least one of the Production Identifiers (UDI-PI) SHALL be present. [udiCarrier.empty() or (manufactureDate.exists() or expirationDate.exists() or lotNumber.exists() or serialNumber.exists() or distinctIdentifier.exists())]
Should I resolve this or ignore because 1 of the devices is not returning an error?
Thank you.
Yunwei Wang (Feb 26 2021 at 15:01):
Some US Core profiles have additional invariant rules. ImplantableDevice indicates that "Implantable medical devices that have UDI information SHALL represent this information in either carrierAIDC or carrierHRF." (invariant: us-core-12: udiCarrier.empty() or (udiCarrier.carrierAIDC.exists() or udiCarrier.carrierHRF.exists()))
This means that for an ImplantableDevice resource, if it has udiCarrier, then it must populate at least one of udiCarrier.carriderAIDC and udiCarrier.carriderHDF
The 2nd error was caused by this invariant: "For Implantable medical devices that have UDI information, at least one of the Production Identifiers (UDI-PI) SHALL be present." (invariant us-core-9: udiCarrier.empty() or (manufactureDate.exists() or expirationDate.exists() or lotNumber.exists() or serialNumber.exists() or distinctIdentifier.exists()))
Lakshmi Bhamidipati (Feb 26 2021 at 22:05):
@Yunwei Wang - Thank you!
Last updated: Apr 12 2022 at 19:14 UTC
