Stream: implementers
Topic: FDA UDI in Connectathon
Todd Cooper (Jun 21 2016 at 20:09):
There are a couple of proposed 201609 connectathon threads that include device-sourced information: Device Integration and Vitals Profile ... and both can include testing of FDA UDI for device identification. Shoiuld these tracks be combined? Should the information set that is included in the device integration track include the set in the VitalsProfile too? NOTE: This is also being discussed in the Argonaut's IG discussion.
Paul Knapp (Jun 22 2016 at 07:15):
If the tracks are fundamentally diffferrent but overlap in that they are both using UDI then I think it is beneficial to keep them as separate tracks as more separate teams testing a think provides better test than fewer larger teams.
Eric Haas (Jun 22 2016 at 20:33):
Vitals Profile is not focused on UDI but rather the collection of data from a device. and UDI is only a small part of Device Integration. So I can see combining them on the basis of using devices and Device and Observation for various use cases but not from the UDI perspective.
Todd Cooper (Jun 23 2016 at 02:15):
That's what I was thinking based on reviewing the Vitals proposal; The more interesting scenario may be reporting (to the FDA) of an ICSR including the UDI.
Eric Haas (Jun 23 2016 at 14:22):
Sorry ICSR?
Todd Cooper (Jun 23 2016 at 16:08):
Individual Case Study Report (ICSR) ... including for FDA reporting: "eMDR uses the Health Level Seven (HL7) Individual Case Safety Report (ICSR) standard to receive medical device adverse events reports (MDRs). Each adverse event report is described by an XML document that follows the ICSR XML schema. Note that eMDR uses the HL7 ICSR Release 1 specification."
Todd Cooper (Jun 23 2016 at 16:30):
Actually ... the FDA site has it wrong (which I thought it was when I first read it). HL7 ICSR is actually an Individual Case Safety Report ... you would think the FDA would get the "safety" part correct ... !
Last updated: Apr 12 2022 at 19:14 UTC
