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 Category
Submitted By: Tayler Williams / American Medical Informatics Association (AMIA)
Data Element Information
Data Element 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.
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.
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 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.

Comment

Submitted by Riki Merrick on

SHIELD Community Proposal for Updates in V7

  1. SHIELD requests that ASTP identify / clarify which assigning authorities' format is expected or if any of the FDA approved formats (https://www.fda.gov/media/96648/download?attachment) are allowed; Providing this information will increase clarity and reduce burden on implementers.
  2. For tracking devices in the laboratory domain SHIELD proposes a phased approach: To focus first on capturing and exchanging the device identifier (DI) before incorporating the production identifiers (PI) (which could be lot number (more important for supply elements and reagents and test kits) / expiration date (does not apply to instruments) / serial number (more applicable for instruments)). The reasoning behind this is that capturing the PIs is not currenlty widely implemented and also not easily scalable in the lab domain, while capturing the DI is supported by some of the existing systems already.
  3. SHIELD encourages the implementation of the IHE Laboratory Analytical Workflow (LAW) profile, which supports the exchange of UDI elements like the DI and PI between instruments and the Lab information system, which is at the beginning of the lab data journey.

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