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8.18 Resource DeviceDefinition - Content

Orders and Observations icon Work GroupMaturity Level: 1 Trial UseSecurity Category: Anonymous Compartments: No defined compartments

The definition of a kind of device or device component. Typically, this definition corresponds to a device model although it may be a broader category of device.

8.18.1 Scope and Usage

Devices include durable (reusable) medical equipment, implantable devices, as well as disposable equipment used for diagnostic, treatment, and research for healthcare and public health, as well as devices such as a machine, cellphone, computer, software, application, etc. The DeviceDefinition resource is used to describe the common characteristics and capabilities of a device of a certain type or kind, e.g., a certain model or class of a device such as a x-ray model or personal wearable device model, whereas a Device resource documents an actual instance of a device such as the actual x-ray machine that is installed or the personal wearable device being worn.

Devices can also be subdivided into the following categories:

'Active device' means any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy. Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be deemed to be active devices. Software shall also be deemed to be an active device. MDR (EU) 2017/745 icon

Active Implantable Medical Devices include the definition for both active devices and implantable devices (see below). Examples include: Implantable cardiac pacemakers; Implantable defibrillator; Implantable neurostimulator systems; Leads, electrodes, adaptors for implantable pulse generators; Brachytherapy systems; Ventricular Assist Devices (VADs); Cochlear implants; Implantable infusion pumps; Implantable glucose monitors; Micro Electro-Mechanical Systems (MEMS); and their accessories where applicable.

This category of devices communicates electronically to peer information systems or possibly another device. In addition to patient observations for use by clinicians in providing care and for building a health record, the device communicates metadata about its own state and the protocol used to transfer that information.

To support the use and evaluate the reliability of the patient data, it is important to collect and record data about the identity and operational status of the device that generated the observations. The Device resource is an important locus for such information. The information it generates for clinical and other purposes goes into other resources such as the Observation or Medication resource depending upon what the device does. To support device-related information about Communicating Medical Devices the Device resource needs to have elements that describe not only the basic information like the serial number, manufacturer name and model number, but information about the protocol, its version, its certification, the properties it has to perform its purposed tasks such as internal clocks, synchronization state, resolution, etc.

Equipment and supplies that provide therapeutic benefits to a patient in need because of certain medical conditions and/or illnesses, and which are ordered by a health care provider for everyday or extended use.

Examples include: oxygen equipment, suction pumps, traction equipment, home infusion services, continuous positive airway pressure (CPAP) devices, hospital beds, wheelchairs, crutches walkers, canes, or blood testing strips and meters for diabetics.

A home use medical device is a medical device intended for users in any environment outside of a professional healthcare facility (although that does not preclude such devices being used in a professional healthcare facility).

  • A user is a patient (care recipient), caregiver, or family member that directly uses the device or provides assistance in using the device.
  • A qualified healthcare professional is a licensed or non-licensed healthcare professional with proficient skill and experience with the use of the device so that they can aid or train care recipients and caregivers to use and maintain the device.

Implant means a device that is placed into a surgically or naturally formed cavity of the human body. A device is regarded as an implant for the purpose of this part only if it is intended to remain implanted continuously for a period of 30 days or more, unless the Commissioner determines otherwise to protect human health. 21CFR Part 860.3 icon Accessed 12 May 2022

'Implantable device' means any device, including those that are partially or wholly absorbed by the body, which is intended:

  • to be totally introduced into the human body, or
  • to replace an epithelial surface or the surface of the eye,

by clinical intervention and which is intended to remain in place after the procedure.

Any device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days shall also be deemed to be an implantable device; MDR (EU) 2017/745 icon Accessed 12 May 2022

In vitro diagnostics (IVD) are tests done on samples such as blood or tissue that have been taken from the human body. In vitro diagnostics can detect diseases or other conditions, and can be used to monitor a person 's overall health to help cure, treat, or prevent diseases.

In vitro diagnostics may also be used in precision medicine to identify patients who are likely to benefit from specific treatments or therapies. These in vitro diagnostics can include next generation sequencing tests, which scan a person 's DNA to detect genomic variations.

Some tests are used in laboratory or other health professional settings and other tests are for consumers to use at home. iconUS Food and Drug Administration Center for Devices and Radiological Health In Vitro Diagnostics icon and Drug Administration Center for Devices and Radiological Health In Vitro Diagnostics icon Accessed 12 May 2022

Patient-use (also known as personal health device), or home use devices, intended for users in any environment outside of a professional healthcare facility. This includes devices intended for use in both professional healthcare facilities and homes US Food and Drug Administration Center for Devices and Radiological Health. Home Use Devices. icon Accessed 13 March 2020. PHDs are the subset of patient-use devices that report their information to a peer via a protocol.

One class of communicating devices is the Personal Health Device or PHD. PHDs are medical devices that can be used by patients or others who are typically not medical professions, to gather patient observations and information. These devices can often be purchased in department stores or online by anyone. They may be regulated as medical devices, or not.

PHDs include the popular fitness trackers often combined with heart rate monitors, but also blood pressure monitors, weight scales, pulse oximeters, thermometers, and, for those that require them, glucose meters. Over time more sophisticated devices such as continuous glucose monitors, insulin pumps, vital signs monitors including ECGs, and even spirometers are entering the PHD consumer market. These devices communicate measurement data and data about themselves via a digital transport protocol to some peer entity, often a mobile phone or tablet. The protocol may follow a standard but most protocols are proprietary. In either case, it is common practice for manufacturers to provide free applications that run on these mobile platforms for the purpose of communicating with their devices.

The fields populated in the Device resource by PHDs, typically via a gateway, is the information a PHD reports about itself electronically. There is no input by the patient except for information the patient may enter on the device through some UI. This device reporting capability distinguishes communicating PHDs from the general set of patient-use devices.

Point-of-care medical devices (PoCD) are intended for use by qualified professionals. PoCDs are typically found at the patient's bedside and convey measurements and supporting data to receiving systems for use in electronic medical records, clinical decision support, and medical data archiving for aggregate quality measurement and research purposes.

PoCDs are of another level of complexity compared to PHDs: they include devices like multi-parameter physiological patient monitors, anesthesia workstations, infusion pumps and numerous other kinds of devices that provide near-real-time information about patient condition or therapy, potentially including dozens or hundreds of variables coming from a single device system. They may be structurally complex, involving multiple subsystems that are themselves complex, such as a ventilator or gas analyzer functioning within an anesthesia workstation, or pluggable modules in a patient monitor controlling invasive blood pressure or gathering EEG data.

Information systems using such data need to be able to understand the structure and dynamic state of the devices originating them. This requires more than a single Device resource - a hierarchy of Device resources is constructed carrying data about the top-level containing device (for example a monitor), and a hierarchy of contained Device resources representing subsystems (in the monitor, builtin and attached modular measurement capabilities), channels, and DeviceMetric resources representing individual measurements or computations.

A device that is intended to be used on one individual during a single procedure; MDR (EU) 2017/745 icon Accessed 12 May 2022

Reusable medical devices are devices that health care providers can reuse to diagnose and treat one or multiple patients. Examples of reusable medical devices include surgical forceps, endoscopes and laryngoscopes. US Food and Drug Administration Center for Devices and Radiological Health Reusable Medical Devices icon

The Device resource can represent an instance of a software component or application. A software item like a data transformer or converter, or a clinical support algorithm, may be an independently deployed, managed and configured entity that contributes to patient care and needs to be documented just a surely as, say, a physical cardiac monitor. The FHIR Device resource can contain instance data such as version information and operational attributes. It can also represent the relationship of the software item to other device and information system components through reference linkages. This category includes software regardless of whether or not is regulated. Device resource instances documenting software items are important to traceability of data and analyzing adverse events, and so have important patient safety roles.

8.18.2 Boundaries and Relationships

The DeviceDefinition resource contains the "catalog" definition of a device - whether that definition is authored by the manufacturer or a regulatory entity and allows defining valid hierarchical device configurations (devices as part of other devices).

The DeviceDefinition may vary by jurisdiction and the product may be considered a medication or biologically derived product.

Device vs deviceDefinition: The Device resource is meant to refer to a physical instance of a device - hence having attributes like lot number, patient, location, operational status which the DeviceDefinition resource does not have.

8.18.3 References to this Resource

8.18.4 Resource Content

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. DeviceDefinition TU DomainResource The definition of a kind of device or device component

Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
Interfaces Implemented: CanonicalResource
... url ΣC 0..1 uri Canonical identifier for this DeviceDefinition, represented as an absolute URI (globally unique)
+ Warning: URL should not contain | or # - these characters make processing canonical references problematic
... identifier Σ 0..* Identifier Additional identifier for the DeviceDefinition

... version Σ 0..1 string Business version of the DeviceDefinition
... versionAlgorithm[x] Σ 0..1 How to compare versions
Binding: Version Algorithm (Extensible)
.... versionAlgorithmString string
.... versionAlgorithmCoding Coding
... name Σ 0..1 string Name for this DeviceDefinition (computer friendly)
... title Σ 0..1 string Name for this DeviceDefinition (human friendly)
... status ?!Σ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (Required)
... experimental Σ 0..1 boolean For testing only - never for real usage
... partNumber 0..1 string The part number or catalog number of the device
... manufacturer Σ 0..1 Reference(Organization) Name of device manufacturer
... modelNumber Σ 0..1 string The catalog or model number for the device for example as defined by the manufacturer
... date Σ 0..1 dateTime Date last changed
... contact Σ 0..* ContactDetail Contact details for the publisher

... publisher Σ 0..1 string The name of the organization responsible for publishing the definition
... useContext Σ 0..* UsageContext The context that the content is intended to support

... jurisdiction ΣXD 0..* CodeableConcept Intended jurisdiction for DeviceDefinition (if applicable)
Binding: Jurisdiction ValueSet (Extensible)

... purpose 0..1 markdown Why this DeviceDefinition is defined
... copyright 0..1 markdown Use and/or publishing restrictions
... copyrightLabel T 0..1 string Copyright holder and year(s)
... udiDeviceIdentifier 0..* BackboneElement Unique Device Identifier (UDI) Barcode string

.... deviceIdentifier 1..1 string The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier
.... issuer 1..1 uri The organization that assigns the identifier algorithm
.... jurisdiction 1..1 uri The jurisdiction to which the deviceIdentifier applies
.... marketDistribution 0..* BackboneElement Indicates whether and when the device is available on the market

..... marketPeriod 1..1 Period Begin and end dates for the commercial distribution of the device
..... subJurisdiction 1..1 uri National state or territory where the device is commercialized
... regulatoryIdentifier 0..* BackboneElement Regulatory identifier(s) associated with this device

.... type 1..1 code basic | master | license
Binding: Device Definition Regulatory Identifier Type (Required)
.... deviceIdentifier 1..1 string The identifier itself
.... issuer 1..1 uri The organization that issued this identifier
.... jurisdiction 1..1 uri The jurisdiction to which the deviceIdentifier applies
... deviceName Σ 0..* BackboneElement The name or names of the device as given by the manufacturer

.... name Σ 1..1 string A name that is used to refer to the device
.... type Σ 1..1 CodeableConcept registered-name | user-friendly-name | patient-reported-name
Binding: Device Name Type (Extensible)
... classification Σ 0..* BackboneElement What kind of device or device system this is

.... type Σ 1..1 CodeableConcept A classification or risk class of the device model
Binding: Device Type (Example)
.... justification 0..* RelatedArtifact Further information qualifying this classification of the device model

... conformsTo Σ 0..* BackboneElement Identifies the standards, specifications, or formal guidances for the capabilities supported by the device

.... category Σ 0..1 CodeableConcept Describes the common type of the standard, specification, or formal guidance
Binding: Device Specification Category (Example)
.... specification Σ 1..1 CodeableConcept Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type
Binding: Device Specification Type (Example)
.... version Σ 0..* string The specific form or variant of the standard, specification or formal guidance

.... source 0..* RelatedArtifact Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance

... hasPart Σ 0..* BackboneElement A device, part of the current one

.... reference Σ 1..1 Reference(DeviceDefinition) Reference to the part
.... count 0..1 integer Number of occurrences of the part
... packaging 0..* BackboneElement Information about the packaging of the device, i.e. how the device is packaged

.... identifier 0..1 Identifier Business identifier of the packaged medication
.... type 0..1 CodeableConcept A code that defines the specific type of packaging
.... count 0..1 integer The number of items contained in the package (devices or sub-packages)
.... distributor 0..* BackboneElement An organization that distributes the packaged device

..... name 0..1 string Distributor's human-readable name
..... organizationReference 0..* Reference(Organization) Distributor as an Organization resource

.... udiDeviceIdentifier 0..* see udiDeviceIdentifier Unique Device Identifier (UDI) Barcode string on the packaging

.... packaging 0..* see packaging Allows packages within packages

... deviceVersion 0..* BackboneElement The version of the device or software

.... type 0..1 CodeableConcept The type of the device version, e.g. manufacturer, approved, internal
.... component 0..1 Identifier The hardware or software module of the device to which the version applies
.... value 1..1 string The version text
... safety Σ 0..* CodeableConcept Safety characteristics of the device
Binding: Device Safety (Example)

... shelfLifeStorage 0..* ProductShelfLife Shelf Life and storage information

... outputLanguage 0..* code Language code for the human-readable text strings produced by the device (all supported)
Binding: All Languages (Required)
Additional BindingsPurpose
Common Languages Starter


... property 0..* BackboneElement Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc

.... type 1..1 CodeableConcept Code that specifies the property being represented
Binding: Device Property Type (Example)
.... value[x] 1..1 Value of the property
..... valueQuantity Quantity
..... valueCodeableConcept CodeableConcept
..... valueString string
..... valueBoolean boolean
..... valueInteger integer
..... valueRange Range
..... valueAttachment Attachment
... link 0..* BackboneElement An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device

.... relation 1..1 Coding The type indicates the relationship of the related device to the device instance
Binding: Device Definition Relation Type (Extensible)
.... relatedDevice 1..1 CodeableReference(DeviceDefinition) A reference to the linked device
... note 0..* Annotation Device notes and comments

... material 0..* BackboneElement A substance used to create the material(s) of which the device is made

.... substance 1..1 CodeableConcept A relevant substance that the device contains, may contain, or is made of
Binding: Substance Code (Example)
.... alternate 0..1 boolean Indicates an alternative material of the device
.... allergenicIndicator 0..1 boolean Whether the substance is a known or suspected allergen
... productionIdentifierInUDI 0..* CodeableConcept lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version
Binding: Device Production Identifier In UDI (Extensible)

... guideline 0..1 BackboneElement Information aimed at providing directions for the usage of this model of device
.... useContext 0..* UsageContext The circumstances that form the setting for using the device

.... usageInstruction 0..1 markdown Detailed written and visual directions for the user on how to use the device
.... relatedArtifact 0..* RelatedArtifact A source of information or reference for this guideline

.... indication 0..* CodeableConcept A clinical condition for which the device was designed to be used

.... contraindication 0..* CodeableConcept A specific situation when a device should not be used because it may cause harm

.... warning 0..* CodeableConcept Specific hazard alert information that a user needs to know before using the device

.... intendedUse 0..1 string A description of the general purpose or medical use of the device or its function
... correctiveAction 0..1 BackboneElement Tracking of latest field safety corrective action
.... recall 1..1 boolean Whether the corrective action was a recall
.... scope 0..1 code model | lot-numbers | serial-numbers
Binding: Device Corrective Action Scope (Required)
.... period 1..1 Period Start and end dates of the corrective action
... chargeItem 0..* BackboneElement Billing code or reference associated with the device

.... chargeItemCode 1..1 CodeableReference(ChargeItemDefinition) The code or reference for the charge item
.... count 1..1 Quantity Coefficient applicable to the billing code
.... effectivePeriod 0..1 Period A specific time period in which this charge item applies
.... useContext 0..* UsageContext The context to which this charge item applies


doco Documentation for this format icon

See the Extensions for this resource

 

Additional definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) , the spreadsheet version & the dependency analysis

8.18.4.1 Terminology Bindings

Path ValueSet Type Documentation
DeviceDefinition.versionAlgorithm[x] VersionAlgorithm Extensible

Indicates the mechanism used to compare versions to determine which is more current.
DeviceDefinition.status PublicationStatus Required

The lifecycle status of an artifact.
DeviceDefinition.jurisdiction JurisdictionValueSet Extensible

This value set defines a base set of codes for country, country subdivision and region for indicating where a resource is intended to be used.

Note: The codes for countries and country subdivisions are taken from ISO 3166 icon while the codes for "supra-national" regions are from UN Standard country or area codes for statistical use (M49) icon.
DeviceDefinition.regulatoryIdentifier.type DeviceDefinitionRegulatoryIdentifierType (a valid code from Device Regulatory Identifier Type) Required

Regulatory Identifier type
DeviceDefinition.deviceName.type DeviceNameType Extensible

The type of name the device is referred by.
DeviceDefinition.classification.type DeviceType Example

Codes used to identify medical devices. Includes concepts from SNOMED CT (http://www.snomed.org/) where concept is-a 49062001 (Device) and is provided as a suggestive example.
DeviceDefinition.conformsTo.category DeviceSpecificationCategory (a valid code from FHIR Device Specialization Category) Example

The kind of standards used by the device.
DeviceDefinition.conformsTo.specification DeviceSpecificationType Example

The type or specification of a standard that devices can adhere to
DeviceDefinition.safety DeviceSafety Example

Codes used to identify medical devices safety characteristics. These codes are taken from the NCI Thesaurus icon and are provided here as a suggestive example.
DeviceDefinition.outputLanguage AllLanguages (a valid code from Tags for the Identification of Languages icon) Required

This value set includes all possible codes from BCP-47 (see http://tools.ietf.org/html/bcp47)
  Common Languages starter
DeviceDefinition.property.type DeviceType Example

Codes used to identify medical devices. Includes concepts from SNOMED CT (http://www.snomed.org/) where concept is-a 49062001 (Device) and is provided as a suggestive example.
DeviceDefinition.link.relation DeviceDefinitionRelationType Extensible

Description Needed Here
DeviceDefinition.material.substance SubstanceCode Example

This value set contains concept codes for specific substances. It includes codes from SNOMED icon where concept is-a 105590001 (Substance (substance))
DeviceDefinition.productionIdentifierInUDI DeviceProductionIdentifierInUDI Extensible

Device Production Identifier in UDI
DeviceDefinition.correctiveAction.scope DeviceCorrectiveActionScope Required

Device - Corrective action scope

8.18.4.2 Constraints

UniqueKeyLevelLocationDescriptionExpression
img cnl-1Warning DeviceDefinition.urlURL should not contain | or # - these characters make processing canonical references problematicexists() implies matches('^[^|# ]+$')

8.18.5 Notes:

8.18.6 Search Parameters

Search parameters for this resource. See also the full list of search parameters for this resource, and check the Extensions registry for search parameters on extensions related to this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.

Name Type Description Expression In Common
device-name string A server defined search that may match any of the string fields in DeviceDefinition.name or DeviceDefinition.classification.type - the latter to search for 'generic' devices. DeviceDefinition.deviceName.name | DeviceDefinition.classification.type.coding.display | DeviceDefinition.classification.type.text
has-part reference The manufacturer of the device DeviceDefinition.hasPart.reference
(DeviceDefinition)
identifier token The identifier of the component DeviceDefinition.identifier | DeviceDefinition.udiDeviceIdentifier 35 Resources
manufacturer reference The manufacturer of the device DeviceDefinition.manufacturer
(Organization)
model-number token The model of the device DeviceDefinition.modelNumber
part-number string The part number or catalog number of the device. DeviceDefinition.partNumber
publisher string The contact for the publisher of the device definition DeviceDefinition.contact.name | DeviceDefinition.publisher 31 Resources
specification token The specification that the device conforms to DeviceDefinition.conformsTo.specification
specification-version composite A composite of both specification and version On DeviceDefinition.conformsTo:
  specification: specification
  version: version
type token The device type DeviceDefinition.conformsTo.category
url N uri The uri that identifies the code system DeviceDefinition.url 35 Resources
version token The specific version of the device DeviceDefinition.deviceVersion.value 32 Resources
version-type composite Value and type of version On DeviceDefinition.deviceVersion:
  type: type
  value: value