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.”
Submitted By: Joel Andress / Centers for Medicare and Medicaid Services (CMS) Center for Clinical Standards and Quality (CCSQ)
Data Element Information
Rationale for Separate Consideration USCDI v1 includes UDIs for implantable devices. We recommend expanding this to include data exchange for devices used, but external and implantable.
Use Case Description(s)
Use Case Description Device information, including devices applied/used is used extensively by hospitals, clinicians and providers submitting data for quality measurement. Device information is frequently used in quality measurement to identify frailty and advanced illness, but also used to identify health-care interventions for preventing, monitoring, or treating disease (i.e., an intermittent pneumatic compression device [IPC] for VTE prophylaxis or a cardiac pacemaker for heart failure).
The specific devices are currently reported as part of CMS quality measures:
• Frailty device indicators: wheelchair, walker, respiratory devices, continuous oxygen supply, identifier of confined to bed/chair
• Cardiac pacers
• Wearable devices: Graduated Compression socks, Intermittent pneumatic compression, venous foot pump
Estimate the breadth of applicability of the use case(s) for this data element More than 4,000 hospitals and 1 million providers currently capture, access and exchange this device information. This information is currently electronically submitted by providers and hospitals to CMS for quality measurement.
eCQI resource center, includes measure specifications for CMS program eCQMs (i.e. CMS 190, CMS 125): https://ecqi.healthit.gov/ecqms
Link to use case project page https://ecqi.healthit.gov/ecqms
Use Case Description Data exchange of device information is also critical for clinical care. Clinician’s need to be aware of prior and recent healthcare interventions and the presence of implanted devices or use of external or mobility devices for optimal patient health-care provision.
Estimate the breadth of applicability of the use case(s) for this data element Majority of hospitals and clinicians caring for patients should be capturing and exchanging this information.
Healthcare Aims
  • Improving patient experience of care (quality and/or satisfaction)
  • Improving the health of populations
  • Improving provider experience of care
Maturity of Use and Technical Specifications for Data Element
Applicable Standard(s) SNOMED CT (Frailty Device, value set OID: 2.16.840.1.113883.3.464.1003.118.12.1300)
SNOMED CT (Intermittent Pneumatic Compression Devices (IPC), value set OID: 2.16.840.1.113883.3.117.1.7.1.214)
SNOMED CT (Graduated Compression Stockings (GSC), value set OID: 2.16.840.1.113883.3.117.1.7.1.256)
SNOMED CT (Venous Foot Pumps (VFP), value set OID: 2.16.840.1.113883.3.117.1.7.1.230)
SNOMED CT (Cardiac Pacer, value set OID: 2.16.840.1.113883.3.526.3.1193)
ICD-10-CM, SNOMED CT (Cardiac Pacer in Situ, value set OID: 2.16.840.1.113883.3.526.3.368)

https://vsac.nlm.nih.gov/valueset/expansions?pr=ecqm
Additional Specifications HL7 FHIR US Core Implementation Guide STU3 based on FHIR R4, Implantable device profile, already required by USCDI v1 to specify device UUID
(https://www.hl7.org/fhir/us/core/StructureDefinition-us-core-implantable-device.html)
HL7 FHIR QI Core Implementation Guide STU4 based on FHIR R4, Device and DeviceUseStatement profiles.
(http://hl7.org/fhir/us/qicore/StructureDefinition-qicore-device.html , http://hl7.org/fhir/us/qicore/StructureDefinition-qicore-deviceusestatement.html )
CMS Quality Data Model (QDM) version 5.5 Guidance (https://ecqi.healthit.gov/sites/default/files/QDM-v5.5-Guidance-Update-May-2020-508.pdf)
HL7 C-CDA Release 2.0, Unique Device Identifier (UDI) for Implantable Medical Devices (http://www.hl7.org/implement/standards/product_brief.cfm?product_id=486)
Current Use Extensively used in production environments
Supporting Artifacts Device use data is routinely captured in EHR systems used by hospitals and providers, particularly for quality measurement purposes.
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Quality-Programs
https://ecqi.healthit.gov/ecqms

https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Quality-Programs
Extent of exchange 5 or more. This data element has been tested at scale between multiple different production environments to support the majority of anticipated stakeholders.
Supporting Artifacts Device information data for quality measurement is electronically exchanged from an organization’s EHR system to CMS for reporting and payment quality measurement programs, via QRDA files and other architectures. These device data elements have been tested for reliability and validity of capture during the development of CMS eCQMs and can be feasibly captured and exchanged. Ongoing testing for exchanging these data in FHIR standards via HL7 Connectathons.
ONC also requires the availability and exchange of implantable device UIDs, which can be broadened to include the devices used by a patient.
https://ecqi.healthit.gov/qrda
https://www.healthit.gov/test-method/implantable-device-list
https://confluence.hl7.org/display/FHIR/2020-09+Clinical+Reasoning

https://ecqi.healthit.gov/qrda
Potential Challenges
Restrictions on Standardization (e.g. proprietary code) No challenges anticipated. This data is available in standard terminology that can be publicly access via the VSAC and HL7.
Restrictions on Use (e.g. licensing, user fees) We are not aware of any restrictions.
Privacy and Security Concerns This data, like any patient data should be exchanged securely. Current processes exist, governed by CMS and ONC, to securely transfer this data element.
Estimate of Overall Burden Device data is regularly captured by a broad range of healthcare providers, and should not cause excess burden to implement. Some burden may be required to expand the QI Core profiles available for this information to US Core.
Other Implementation Challenges N/A

Comment

Submitted by rdillaire on

CMS-CCSQ Supports Device Used for USCDI v6

Recommendation: CMS CCSQ recommends the Device Used element be added to final USCDI v6.

Rationale: CMS CCSQ advocates for the inclusion of the Device Used data element into the final USCDI v6, as it is 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 Systematized Nomenclature of Medicine (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:
    i. Does the patient use a wheelchair/scooter during assessment period (95738-1), 
    ii. Wheel 50 feet with two turns usual functional ability during assessment period (94992-5), 
    iii. Indicate the type of wheelchair/scooter used during assessment period (95739-9), 
    iv. Wheel 150 feet – usual functional ability during assessment period (94991-7), 
    v. Wheel 150 feet – functional goal (89377-6), Prior device use (83234-5), 
    vi. Mobility devices normally used during assessment period (86602-0), Stairs (85072-7), 
    vii. Hearing aid present & used (45499-1, Hearing aid present and not used regularly (45500-6),
    viii. Need for and availability of a hearing aid (94900-8), 
    ix. Need for and availability of a communication device (94901-6) 
    x. Number of days of training and skill practice in amputation or prosthesis care (45867-9).
    
Additionally, Device Used data are captured in a published FHIR IG titled Personal Functioning and Engagement (PFE) Implementation Guide v 1.0.0, and in another FHIR IG currently in ballot under the same title v 2.0.0, compliant with United States (US) Core 6.1.0.
Including this data element in final USCDI v6 will facilitate efficient healthcare delivery by assisting providers in identifying critical healthcare interventions.

Submitted by jpatterson@mitre.org on

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.

Submitted by HCapon on

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. 

Submitted by rdillaire on

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.

Submitted by sg999 on

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.

Submitted by nedragarrett_CDC on

Unified Comment from CDC

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

Submitted by t.reed.udi on

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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