An instrument, machine, appliance, implant, software or other article intended to be used for a medical purpose.
Data Element
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Device Settings
Description
Patient-specific settings associated with a device.
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| Submitted By: Sheila Abner
/ CDC/NHSN
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| Data Element Information |
| Use Case Description(s) |
| Use Case Description |
Medical devices are significant risk factors for healthcare-associated infections (HAIs) such as bloodstream infections, urinary tract infections, and ventilator-associated events such as pneumonia. Multiple device-related data elements are needed in EHRs to enable data exchange and automated calculation of measurements needed for HAI surveillance reporting to NHSN to reduce burden on facilities. For COVID reporting of ventilated patients, the following data elements are needed: (1) Device Route: type of airway (nasal cannula, facemask, endotracheal tube, tracheostomy), (2) Device Settings: FiO2, PS, PEEP, Ventilator mode, Tidal Volume delivered, frequency/respiratory rate setting (delivered by the ventilator), (3) Device Observations / Measurements: peak pressure, plateau pressure, spontaneous tidal volume, respiratory rate (spontaneous that the patient breaths).
For central lines, device type/device classification: peripherally inserted central catheter, non-tunneled central venous catheter (including vascath for hemodialysis), tunneled central venous catheters (would classify as implanted) including permcath for dialysis, and Implantable ports. The number of ports would be part of the device type/classification. The unique device identifier should capture this information. Device anatomic location (site): left arm, left internal jugular vein, etc should be in the Procedure. |
| Estimate the breadth of applicability of the use case(s) for this data element
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Beginning 15 years ago with 300 hospitals, NHSN now serves approximately 25,000 medical facilities tracking HAIs. Current participants include acute care hospitals, long-term acute care hospitals, psychiatric hospitals, rehabilitation hospitals, outpatient dialysis centers, ambulatory surgery centers, and nursing homes, with hospitals and dialysis facilities representing the majority of facilities reporting data. Participation among the other facility types is expected to continue to grow in coming years. |
| Link to use case project page |
https://www.cdc.gov/nhsn/index.html |
| Healthcare Aims |
- Improving patient experience of care (quality and/or satisfaction)
- Improving the health of populations
- Reducing the cost of care
- Improving provider experience of care
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| Maturity of Use and Technical Specifications for Data Element |
| Applicable Standard(s) |
Device Type: SNOMED (Implanted port-central lines and tunneled hemodialysis catheters; Non-implantable devices would include ventilators, temporary central lines, urinary catheters)
Location of Device Initiation: HSLOC code system (https://www.cdc.gov/nhsn/cdaportal/terminology/codesystem/hsloc.html)
Device Settings: LOINC (fraction of inspired oxygen, pressure support, positive end-expiratory pressure, ventilator mode, tidal volume delivered, frequency/respiratory rate setting - delivered by the ventilator)
Device Observations / Measurements: LOINC (peak pressure, plateau pressure, spontaneous tidal volume, respiratory rate - spontaneous that the patient breaths)
Device Route: type of airway (nasal cannula, facemask, endotracheal tube, tracheostomy) - delivery, approach - Feedback requested
Device Status: related value sets: http://hl7.org/fhir/R4/valueset-device-status.html (active, inactive) or http://hl7.org/fhir/ValueSet/metric-operational-status (on, off, standby) - weaning trial - may be a property of the Procedure - Feedback requested
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| Additional Specifications |
CDA IG: http://www.hl7.org/implement/standards/product_brief.cfm?product_id=426
FHIR IG: http://hl7.org/fhir/us/hai/
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| Current Use |
Extensively used in production environments |
| Extent of exchange
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5 or more. This data element has been tested at scale between multiple different production environments to support the majority of anticipated stakeholders. |
| Potential Challenges |
| Restrictions on Standardization (e.g. proprietary code) |
none known |
| Restrictions on Use (e.g. licensing, user fees) |
none known |
| Privacy and Security Concerns |
none known |
| Estimate of Overall Burden |
Moderate because device information is available in healthcare facility settings. |
| Other Implementation Challenges |
none known |
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Submitted by minigrrl on
Device Settings - separate out data elements
We strongly recommend splitting out Device Type, Device Status, and Device Route as separate data elements. This will facilitate identification of mechanically ventilated patients, which is essential for informing severity of illness for routine public health surveillance and during pandemic response.
For over a decade, Lantana has supported CDC’s National Healthcare Safety Network (NHSN) in routine public health surveillance for healthcare-associated infections (HAIs) and other healthcare-related harms, and more recently in building surveillance capacity for COVID-19 pandemic response. The COVID-19 pandemic illustrated the importance of knowledge of use of invasive mechanical ventilation in a facility to inform data on the burden of the pandemic on health systems, including the severity of illness of affected patients. Invasive mechanical ventilation is an important clinical intervention for clinicians, clinical researchers and public health entities to track. Invasive mechanical ventilation can signify acute respiratory failure, which is an important clinical outcome associated with several other markers of care, including hospital capacity and resources.
Documentation of an artificial airway and use of a ventilator is part of standard clinical practice. Every patient on a ventilator will have the airway type documented (in addition to ventilator modes) in their clinical record of care. In most cases, patients being invasively ventilated will have an endotracheal tube documented as the route of oxygen delivery (as opposed to a face mask or nasal cannula) and this alone will be sufficient to find the patients who are on a ventilator. In a few scenarios (use of a tracheostomy), additional information will be necessary to find these patients. A new data element to reflect airway device route/oxygen delivery route (“Device route”) would be sufficient for determining which patients are receiving invasive ventilation (vs oxygen alone vs non-invasive ventilation). This is the least burdensome method of identifying patients who are invasively ventilated and does not require details about ventilator modes. This data element is already in extensive use in electronic health record systems and is captured as a regular part of clinical care.