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

Data Element

Information from the submission form

Devices used (applied)
Devices are an identifiable grouping of mobility devices (i.e., wheelchairs), implantable devices (i.e., pace makers), or other wearable devices (i.e. compression socks or venous foot pump) with significant impact on patient functionality and health. The QDM v5.5 notes that “Device represents an instrument, apparatus, implement, machine, contrivance, implant, in-vitro reagent, or other similar or related article, including a component part or accessory, intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and not dependent on being metabolized to achieve any of its primary intended purposes.”


CMS-CCSQ Continued Support for Devices Used: USCDI v3

Discrete codes related to types of devices used by patients – specifically mobility (i.e., wheelchair), wearable (i.e., venous foot pump), and implantable devices (i.e., pacemaker)– are critical information that must travel with a patient to ensure safe, effective care, as these devices can have significant impact on a patient’s functionality and health. This data element can complement Disability Status data element (added to Draft v3), by providing additional information about devices used/needed by the patient to support participation in their care. Maturity:
  • Current standards:
    • Extensive guidance exists in FHIR US Core and QI Core IGs for how to exchange device information (as observations, procedures)
    • Devices used concepts are captured in mature terminology: SNOMED, LOINC, HCPCS
  • Current uses, exchange, and use cases: This information continues to be widely captured and exchanged for nationwide CMS quality measurement. For example, it supports identification of disability (i.e., walking or hearing assistive devices) and/or frailty. Device use information is also critical information for prior authorization activities, as many DMEPOS require prior authorization.

Unified Comment from CDC

CDC considers this element to be high priority and strongly recommends its inclusion in the USCDI V3

Support for using UDI as part of CMS Quality Measures

Symmetric Health Solutions response to Level 2 comment:  We support CMS comments calling for UDI-DI to be used to identify these devices for CMS quality reporting purposes and agree that most of these products include a UDI on the device label and have associated data in AccessGUDID.  Some frailty devices fall under the FDA classification Class I.  Currently, FDA has postponed the enforcement of the UDI regulatory requirements for Class I products until September 2022.  We believe that this postponement should be reconsidered allow for quality reporting of these devices and to address concerns with supply chain transparency outlined in President Biden’s Executive Order calling for a Sustainable Public Health Supply Chain.

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