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

Data Element

Device used
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

PACIO Recommends Advancing Device Used to USCDI V6

  • Data Class: Medical Devices
  • Data Element: Device Used (Level 2)
  • Recommendation: Advance Device Used from Level 2 to final USCDI V6.
  • Rationale: The PACIO Project Community* recommends advancing Device Used (Level 2) to USCDI V6. This recommendation aligns with the recommendation provided by (1) CMS-CCSQ, which “advocates for the inclusion of the Device Used data element into the final USCDI v6”, and (2) the Academy of Nutrition and Dietetics that Device Used which states that it represents a critical piece of information that spans every setting of care. Devices used in care can include both implantable or external devices used for a broad range of applications including hearing aids, cochlear implants, augmentative and alternative communication (AAC) devices, glasses, wheelchairs, walkers, canes, oxygen concentrators, adaptive utensils, adaptive drinking vessels, Ventricular Assist Devices (VADs), pacemakers, and many others. Device information is important to document and share across care settings, as many patients use devices to support not only their health but also everyday living, fall prevention, and rehabilitation.
  • Device data is already being captured in various assessments used across care settings, like the FASI, which is used by many Medicaid programs, and the AM-PAC mobility assessment
  • While the Unique Device Identifier is already captured for implantable (but not external) devices, the clinical notion of what that device is, is not captured and it is not inclusive of external devices. Device Used would capture the “what” in a comprehensive and discreet way across all settings and be inclusive of both implantable and external devices. The codeable concepts are well established in both the SNOMED and LOINC ontologies and device used information is essential for supporting patients across care settings, including PAC, through better capture and sharing of this information.
  • These Device Used data are captured in a published FHIR IG titled Personal Functioning and Engagement v 1.0.0, and in another FHIR IG currently in ballot under the same title v 2.0.0, compliant with US Core 6.1.0.
  • * The PACIO (Post-Acute Care Interoperability) Project, established February 2019, is a collaborative effort between industry, government, and other stakeholders, with the goal of establishing a framework for the development of FHIR implementation guides to facilitate health information exchange.

PACIO Recommends Advancing Device Used

  • Data Class: Medical Devices (V5) 
  • Data Element: Device Used (Level 2) 
  • Recommendation: Advance Device Used to the full draft of V6. 
  • Rationale: The PACIO (Post-Acute Care Interoperability) Project, established February 2019, is a collaborative effort between industry, government, and other stakeholders, with the goal of establishing a framework for the development of FHIR implementation guides to facilitate health information exchange.  
  • The PACIO Project agrees with the Academy of Nutrition and Dietetics that Device Used represents a critical piece of information that spans every setting of care. Patients use durable and single-use equipment for a broad range of applications including hearing aids, cochlear implants, augmentative and alternative communication devices, glasses, wheelchairs, walkers, canes, oxygen concentrators, adaptive utensils, adaptive drinking vessels, Ventricular Assist Devices (VADs), pacemakers, and many others. 
  • While the Unique Device Identifier is already captured for implantable devices, the clinical notion of what that device is, is not captured. This data element would capture the “what” in a comprehensive and discreet way across all settings. The codeable concepts are well established in both the SNOMED and LOINC ontologies. 
  • This information is captured in a published FHIR® IG titled Personal Functioning and Engagement. 

CMS-CCSQ Support for Device Used data element for USCDI v6

Data Element: Device Used (Level 2)

  1. Recommendation: Add the Device Used data element to Final USCDI v6.
  2. Rationale: CMS advocates for the inclusion of the Device Used data element into the Final USCDI v6, as it a critical piece of information that is necessary in all care settings and includes devices such as hearing aids, communication devices, glasses, wheelchairs, prosthetics, adaptive utensils, oxygen concentrators, ventricular assistive devices, and many more. It supports completion of required patient assessments at admission and discharge, during long-term care, rehabilitation, and home health care. With established ontologies for medical devices in SNOMED and LOINC, this data element is well-supported and ready for inclusion, ensuring that healthcare providers can effectively track and manage the diverse range of devices used by patients. CMS assessment tools leverage LOINC codes addressing use of devices such as a wheelchair or scooter, including:
  • Does the patient use a wheelchair/scooter during assessment period (95738-1), 
  • Wheel 50 feet with two turns usual functional ability during assessment period (94992-5), 
  • Indicate the type of wheelchair/scooter used during assessment period (95739-9), 
  • Wheel 150 feet – usual functional ability during assessment period (94991-7), 
  • Wheel 150 feet – functional goal (89377-6), Prior devise use (83234-5),
  • Mobility devices normally used during assessment period (86602-0), Stairs (85072-7), 
  • Hearing aid present & used (45499-1, Hearing aid present and not used regularly (45500-6), 
  • Need for and availability of a hearing aid (94900-8), 
  • Need for and availability of a communication device (94901-6) 
  • Number of days of training and skill practice in amputation or prosthesis care (45867-9). 

Including this data element in Final USCDI v6 will facilitate efficient healthcare delivery by assisting providers in identifying critical healthcare interventions.

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.

Log in or register to post comments