Existing Wording: This profile sets minimum expectations for the Device resource to record, search and fetch UDI information associated with a patient. It identifies which core elements, extensions, vocabularies and value sets SHALL be present in the resource when using this profile.

Proposed Wording: This profile sets minimum expectations for the Device resource to record, search and fetch information associated with a device or tissue product implanted in a patient and subject to UDI regulation. It identifies which core elements, vocabularies and value sets SHALL be present in the resource when using this profile.

Comment:

There is an inconsistency between the mapping the resulting profile. If the "us-core-device" profile is meant to describe an "implanted device" the profile introduction should clarify that purpose and/or the intention to reuse it beyond its intended purpose according to the mapping: http://hl7.org/fhir/us/core/2019Jan/general-guidance.html#the-2015-edition-common-clinical-data-set

Summary:

According to the CCDA mapping, the "us-core-device" is actually "US Core Implanted Device Profile"- the description should describe it accurately.