Section 2: Clinical and Administrative Domains
HL7 Domain Analysis Model: Unique Device Identification (UDI), Release 1
DESCRIPTION
The DAM contains the requirements for reporting and utilizing Unique Device Identifiers (UDIs) for the identification of implantable medical devices. Implantable devices are subject to UDI labeling regulations, and because implantables pose heightened safety risk, reporting of the UDI information for implantable devices is a priority. Although the scope of this document is initially focused on implantable medical devices. Similar requirements apply to all medical devices and adoption of UDI.
ALTERNATIVE NAMES
HL7 Domain Analysis Model: Unique Device Identification (UDI), Release 1 may also go by the following names or acronyms:
"HL7 DAM: UDI IG Requirements, R1", UDI, Unique Device Identification, UDI DAM
BENEFITS
- Supports the adoption of UDI in healthcare
RELATED DOCUMENTS
 |
HL7 Domain Analysis Model: Unique Device Identification (UDI), Release 1 |
(Download) (1.94 MB) |
TOPIC
- Healthcare Devices
BALLOT TYPE
- Informative
STATUS DATE
2021-10-06RESPONSIBLE WORK GROUP
PRODUCT TYPE
- Domain Analysis Model
STAKEHOLDERS
- Clinical and Public Health Laboratories
- EHR, PHR Vendors
- Emergency Services Providers
- Equipment Vendors
- Health Care IT Vendors
- Healthcare Institutions
- HIS Vendors
- Lab Vendors
- Local and State Departments of Health
- Medical Imaging Service Providers
- Payors
- Regulatory Agency
FAMILY
- Cross-paradigm
CURRENT STATE
- Active
REALM
- Universal