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Medical Device or Equipment

Data Element

Information from the submission form

Devices used (applied)
Description
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.”

Comment

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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