Submitted by marti.velezis on 2021-09-30
Medical Device Identification and Device-related Information
There are many use cases that would benefit from the inclusion of medical devices or equipment being included in the USCDI. In support of the Devices Used (CMS) and Device Settings (CDC) submissions under the Medical Device or Equipment class -- the data elements included in their submissions would help identify and describe the use of medical devices to include, but not limited to: unique device identifier (UDI), device type, associated device manufacturing information (manufacturer and device name), pertinent device usage information (e.g. location, route, settings, etc.). We would like to see the data elements mentioned in the proposals identified as individual data classes and merged with other device related data classes and elements (e.g., unique device identifier(s) for a patient's implantable device).
Also see our previous comments from FDA/CDRH related to the device-related information.
Submitted by kelly.clarke@j… on 2023-09-20
Comment
Recommend adding the Medical Device Name and Medical Device Use as data elements.
Recommend adding Durable Medical Equipment (DME), Medical Supplies (e.g., Blood Glucose Test Strips, Lancets, Pen Needles), and Medical Devices (e.g., CPAP, Oxygen-air delivery) as part of this data class definition.