Instrument, apparatus, machine, equipment, implant, software, hardware, or related component or accessory intended to diagnose, treat, cure, mitigate, or prevent disease, or to affect the structure or function of the body.

Data Element
Medical Device Status
Description
Information beyond the UDI is required for patient care and clinical research. If a patient record is transferred to a new provider, the implant date of all active and inactive devices as well as the explant date of previously implantable devices is relevant. To conduct safety and effectiveness research, implant date, explant date and therapy status are relevant. Proposing implanted/inactivated/reactivated/explanted as the status values and that the status history is included as opposed to only current status.
Submitted By: TICIA Louise GERBER / Health Level Seven International
Data Element Information
Data Element Description Information beyond the UDI is required for patient care and clinical research. If a patient record is transferred to a new provider, the implant date of all active and inactive devices as well as the explant date of previously implantable devices is relevant. To conduct safety and effectiveness research, implant date, explant date and therapy status are relevant. Proposing implanted/inactivated/reactivated/explanted as the status values and that the status history is included as opposed to only current status.
Rationale for Separate Consideration Procedure contains dates but is not specific to a patient implantable device. For example, in multi-component systems which contain several UDIs, like a dual chamber pacemaker. A procedure for implant or removal of lead would not specify which lead in the system was implanted or removed in USCDI. Implant, explant, and activation status must be packaged with the patient implantable device information.
Use Case Description(s)
Use Case Description Including information and dates as to when the device was implanted/inactivated/explanted is critical for clinical research including safety surveillance. This information is also relevant for care of the patient related to their implantable device.
Estimate the breadth of applicability of the use case(s) for this data element Every stakeholder that would capture, access, use or exchange the UDI would more appropriately understand device exposure with this information.

It is estimated that approximately 200 million people would use, be exposed to or derive better data to make decisions about implantable devices. This estimates is based upon the following approximations that would also be be more accurate if the implant and explant dates were available in health records:
• Approximately 12 million implant procedures performed in the US per year.
• An average implant life of 10 years
• 100 million people in the US with at least one implant – 20% estimated to have multiple implants – this is equivalent to 1/3 of US population over 50 years old
• Average US household of 2-3 people with estimate that at least one other person besides the person with the implant cares about the implant
• Approximation - 200 million people would benefit from having UDI or know someone they care about with an implanted device and would benefit from the information.
Link to use case project page https://hl7.org/fhir/us/core/StructureDefinition-us-core-implantable-device.html http://hl7.org/fhir/valueset-device-status.html
Healthcare Aims
  • Improving patient experience of care (quality and/or satisfaction)
  • Improving the health of populations
  • Reducing the cost of care
  • Improving provider experience of care
Maturity of Use and Technical Specifications for Data Element
Applicable Standard(s) NCI Thesaurus
Additional Specifications HL7 Cross Paradigm Implementation Guide: UDI Pattern, Release 2 (Normative)
Women's Health Technologies (WHT) Coordinated Registry Network (CRN) FHIR Implementation Guide (STU)
HL7 CDA® R2 IG: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 2 - US Realm (STU)
Current Use In limited use in production environments
Extent of exchange 5 or more. This data element has been tested at scale between multiple different production environments to support the majority of anticipated stakeholders.
Potential Challenges
Restrictions on Standardization (e.g. proprietary code) None
Restrictions on Use (e.g. licensing, user fees) None
Privacy and Security Concerns None
Estimate of Overall Burden Information is already provided as part of device registration to manufacturers and captured discreetly in many certified health IT systems used to document implanting and explanting medical devices.
ASTP Evaluation Details
Each submitted Data Element has been evaluated based on the following criteria. The overall Level classification is a composite of the maturity based on these individual criteria. This information can be used to identify areas that require additional work to raise the overall classification level and consideration for inclusion in future versions of USCDI
Criterion #1
Maturity - Current Standards		 Level 2 - Data element is represented by a terminology standard or SDO-balloted technical specification or implementation guide.
Criterion #2
Maturity - Current Use 		Level 2 - Data element is captured, stored, or accessed in multiple production EHRs or other HIT modules from more than one developer.
Criterion #3
Maturity - Current Exchange		 Level 2 - Data element is electronically exchanged between more than two production EHRs or other HIT modules of different developers using available interoperability standards.
Criterion #4
Use Case(s) - Breadth of Applicability		 Level 2 - Use cases apply to most care settings or specialties.

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