RE: Medical Devices or Equipment Data Class

The following comments are generalizable to all data elements, but examples and specific comments have been made for the device-related data elements.

Level of completeness: _ _It is difficult to understand if the USCDI data elements levels are foundational and there is some level of expansion of use to quality uses.  **

It is assumed that the underlying details that are available for these data elements is derived from comments previously submitted to USCDI.  However, that is difficult to understand without providing the additional quality-specific information.  In some cases the data element may be captured in the healthcare setting and later used as quality measures. 

To maximize the use of real-world data, it would be helpful to have the linkages between USCDI and their "extensions" in USCDI+ clearly articulated.

In addition, should we assume that all USCDI data elements will be available for use in the USCDI+ systems that are implemented?  

For example, the Unique Device Identifier for Implantable devices is in USCDI, but it should also be available for all medical devices subject to UDI as it is the key data element for device identification.  As an example, "Devices Used" is about identifying the devices  that are used in a procedure or for delivery of care.  Therefore, UDI should be expanded beyond implantables, instead of coming up with a new concept to capture the identification of the device.

Level of specificity:  Additional specificity is needed for the data elements listing to include better definitions and/or granularity of the concepts. Medical Devices or Equipment examples include, but are not limited to:

• "Order Time" and "Reason" – What is the importance of the time the device was "ordered/requested" versus the "time/duration" of use by the patient and/or provider?  What is the context of "Reason" here?  Why is the device ordered/requested? or Reason for Use?
• "Device Observations and Measurements" – Depending on the type of device (Point of Care Device - e.g., Vital Signs monitoring, infusion pumps, ventilators) the types of measurements that can be communicated as observations may vary – quantitative, qualitative, etc. and it is difficult to understand the context of what is included for this data element without additional information.
• "Device Settings" - For example,  infusion rates may all require contextual information that may not be included in the existing data elements – e.g., what is being infused - medication, nutrition product, etc.

It would be helpful to provide additional contextual information for all of the data elements - to include their meaning and purpose of use.

Frequency of updates: The frequency of updates initially should follow the USCDI review/update timelines.  It may be difficult to review USCDI+ in isolation of the USCDI updates for some of the reasons stated above.