An instrument, machine, appliance, implant, software or other article intended to be used for a medical purpose.

Data Element
Medical Device Category
Description

AMIA recommends a more thorough breakdown of the Medical Devices Data Class. For medical devices, there should be a distinguishment between permanent versus temporary data classes. Temporary devices for example PICC line, indwelling foley and suprapubic catheters, and wound vacs. Medical applications should also be included as they are considered medical digital devices, such as digital therapeutics, standard languages, payor exchanges, what is included and excluded in this category.
Submitted By: Tayler Williams / American Medical Informatics Association (AMIA)
Data Element Information
Use Case Description(s)
Use Case Description For medical devices, there should be a distinguishment between permanent versus temporary data classes Temporary devices for example PICC line, indwelling foley and suprapubic catheters, and wound vacs. Medical applications should also be included as they are considered medical digital devices, such as digital therapeutics, standard languages, payor exchanges, what is included and excluded in this category. There are many examples of permanent and temporary medical devices and would allow for a more comprehensive Data Class and standard to promote interoperability.
Estimate the breadth of applicability of the use case(s) for this data element All health systems use medical devices and by adding permanent and temporary data classes would assist the Data Class in understanding the evolution of the industry.
ONC Priority
  • Address public health interoperability needs of reporting, investigation, and emergency response
Maturity of Use and Technical Specifications for Data Element
Applicable Standard(s) FDA Unique Device Identification (UDI) System
Additional Specifications N/A
Current Use Not currently captured, stored, or accessed
Extent of exchange N/A
Potential Challenges
Restrictions on Standardization (e.g. proprietary code) There could be restrictions on the standardization of this data element and class with potential use of proprietary code used by an EHR.
Restrictions on Use (e.g. licensing, user fees) There could be restrictions on the use of this data element and class with potential user fees and associated costs for reporting the use of certain medical devices.
Privacy and Security Concerns Medical devices used by an individual and health care organization contains sensitive information and should be held to a standard of privacy for health care and only securely transferred.
Estimate of Overall Burden There could be a burden of time for health systems that do not currently capture the medical devices used and which are permanent and temporary. The EHR systems could be burdened in developing software to allow the ability to capture this information.
ONC 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 0 - Data element is not represented by a terminology standard or SDO-balloted technical specification or implementation guide.
Criterion #2
Maturity - Current Use 		Level 0 - Data element is captured, stored, or accessed in limited settings such as a pilot or proof of concept demonstration.
Criterion #3
Maturity - Current Exchange		 Level 0 - Data element is electronically exchanged in limited environments, such as connectathons or pilots.
Criterion #4
Use Case(s) - Breadth of Applicability		 Level 0 - Use cases apply to a limited number of care settings or specialties, or data element represents a specialization of other, more general data elements.
Evaluation Comment This data element is a component of a more general data element concept of Device Used.

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