Order Catalog Implementation Guide, published by HL7 International - Orders and Observations Work Group. This is not an authorized publication; it is the continuous build for version current). This version is based on the current content of https://github.com/HL7/fhir-order-catalog/ and changes regularly. See the Directory of published versions

Spec - Devices

This page provides the detailed specifications for catalogs of medical devices

Resources and Profiles for catalogs of devices

The figure below shows the resources and profiles used to represent catalogs of medical devices.

Figure 9.1: Artifacts used in catalogs of devices

When method 1 is chosen by the custodian of the catalog of devices, the catalog references its items: the Composition resource constrained by the Catalog profile to represent the whole catalog, references the items of this catalog from its Composition.section.entry elements.

When method 2 is chosen instead, the catalog is referenced by its items: Each DeviceDefinition resource constrained by the DeviceModel profile and representing an item of the catalog, references the Composition resource constrained by the CatalogHeader profile to represent the catalog header, which holds the catalog general properties.

An item of the catalog describes a model or type of device, with its various identifiers, classifications, safety characteristics and properties, instantiated as a DeviceDefinition resource linked to a number of supporting resources providing further details about this item.

Searching and retrieving devices from the catalog

Searching Approaches

The key searcheable assets in a catalog of devices are the model of devices exposed to the consumers as instances of DeviceDefinition.

• Two-step search: A client application browsing the content of the catalog may wish to first get the overview of a collection of devices at first glance, and then retrieve the full details associated with the ones of interest. In this case, the first query will perform a simple search on DeviceDefinition with the desirable criteria listed in the table below ; and then a second narrower search will add the _include:iterate=* parameter, to retrieve the selected DeviceDefinition resource(s) with their supporting resources (ClinicalUseDefinition, ChargeItemDefinition) in the searchset Bundle.
• One-step search: Conversely a client application may wish to retrieve the full details of a device (or a small collection of devices) at first glance. In this case, it uses the appropriate search criteria for DeviceDefinition, in combination with the _include:iterate=* parameter so as to obtain all the supporting resources of each device retrieved, in the searchset Bundle.

Catalog servers may limit the iteration depth to an appropriate level for performance sake.

Search Parameters for models of devices (DeviceDefinition)

Name	Type	Description	Expression	Comment
_lastUpdated	date	Last system point in time of the DeviceDefinition instance		can be used with =gt…
class	token	specific class of models of devices	DeviceDefinition.classification.type	For instance device class in GMDN or EMDN
udi	token	The primary UDI of the device model	DeviceDefinition.udiDeviceIdentifier.deviceIdentifier
packaging-udi	token	The primary UDI of the package containing the device	DeviceDefinition.packaging.udiDeviceIdentifier.deviceIdentifier
identifier	token	A business identifier (other than primary UDI) of the device	DeviceDefinition.identifier
model-number	string	The model number of the device	DeviceDefinition.modelNumber
name	string	a name of the model of device	DeviceDefinition.deviceName.name	A device may have more than one name.
catalog	reference	The reference to a Composition resource (profiled by CatalogHeader) owning this item	DeviceDefinition.extension.where(url=’http://hl7.org/fhir/uv/order-catalog/StructureDefinition/CatalogReference’).valueReference.reference(Composition)	catalog to search from

Examples of searching and retrieving devices from catalogs

In all examples below, base represents the endpoint of the catalog server. The answer of the server comes as a Bundle of type ‘searchset’ encapsulating the resources selected by the search. One particular device catalog is assumed to have Composition.id “a1” on the server.

List all catalogs of the server

GET base/Composition?type:text=Catalog&_summary=true

Obtains the summary of every catalog available on the server. The anwser Bundle contains one entry with a Composition resource for each catalog found.

List all device catalogs

GET base/Composition?type:text=Catalog&category=device&_summary=true

Obtains the summary of each catalog of devices available on the server. The anwser Bundle contains one entry with a Composition resource for each device catalog found.

Retrieve all details for a device model

GET [base]/DeviceDefinition?modelNumber=SCF332&_include:iterate=*

Obtains the full content of instances of DeviceDefinition with modelNumber = “SCF332” accompanied by their supporting resources. The anwser Bundle contains the full details for each: An entry for each matching DeviceDefinition and, below it, as many entries as resources referenced by this one (recursively).

Mapping of jurisdictional device databases to FHIR Resources

GUDID	EUDAMED	DeviceDefinition	Device
Brand Name	FLD-UDID-22: Device Name (under Basic UDI)	deviceName (type = registered-name)	deviceName (type = registered-name)
n.a.	FLD-UDID-176: Name/Trade name(s)	deviceName (type = user-friendly-name)	deviceName (type = user-friendly-name)
Version or Model	FLD-UDID-20: Device model (under Basic UDI)	modelNumber	modelNumber
Catalog Number	FLD-UDID-163: Reference-catalogue number	partNumber	partNumber
Primary DI Number	FLD-UDID-178: UDI-DI code	udiDeviceIdentifier.deviceIdentifier	udiCarrier.deviceIdentifier
Issuing Agency (for Primary DI Number)	FLD-UDID-291: Issuing Entity UDI-DI	udiDeviceIdentifier.issuer	udiCarrier.issuer
Device description	FLD-UDID-175: Additional Product description	description	n.a.
Company Name	FLD-UDID-353: Actor/Organisation name	manufacturer.display or manufacturer.reference->Organization.name	manufacturer
Secondary DI Number	FLD-UDID-136: Secondary UDI-DI code	identifier.value (use = secondary, type = UDI)	identifier.value (use = secondary, type = UDI)
Issuing Agency (for Secondary DI Number)	FLD-UDID-293: Issuing Entity Secondary DI	identifier.assigner (use = secondary, type = UDI)	identifier.assigner (use = secondary, type = UDI)
DM DI Number	FLD-UDID-138: Direct Marking UDI-DI code	identifier.value (use = official, type = DIRECT-MARKING)	identifier.value (use = official, type = DIRECT-MARKING)
n.a.	FLD-UDID-294: Issuing Entity Direct marking DI	identifier.assigner (use = official, type = DIRECT-MARKING)	identifier.assigner (use = official, type = DIRECT-MARKING)
Unit of Use DI Number	FLD-UDID-135: Unit of Use DI code	identifier (use = official, type = SINGLE-ITEM)	identifier (use = official, type = SINGLE-ITEM)
n.a.	FLD-UDID-14: Basic UDI-DI	regulatoryIdentifier (type = basic)	n.a.
PACKAGE DI Number	FLD-UDID-120: Package UDI-DI	packaging[.packaging]*.udiDeviceIdentifier.deviceIdentifier	n.a.
Commercial Distribution Status	FLD-UDID-130: Device status (on EU market, no longer on EU market, not intended for EU market)	inferred from marketDistribution.marketPeriod	n.a.
n.a.	FLD-UDID-250: Start date (per EU member country where device is commercialized)	marketDistribution.marketPeriod.start	n.a.
Commercial Distribution End Date	FLD-UDID-251: End date (per EU member country where device is commercialized)	marketDistribution.marketPeriod.end	n.a.
n.a.	FLD-UDID-252: Member State were the device is or is to be made available	marketDistribution.subJurisdiction	n.a.
Device Count (Number of MDs contained in the base package)	FLD-UDID-121: Quantity of item(s)(for any package level, including the base package)	packaging.count	n.a.
Labeler D-U-N-S Number	FLD-UDID-10: Legal manufacturer SRN	manufacturerReference->Organization.identifier (type = PRN, system = appropriate namespace for D-U-N-S in the US or SRN in EU)	n.a.
n.a.	FLD-UDID-16: Risk Class	classification.type (system representing Risk Class code system)	n.a.
Device GMDN classification	n.a.	classification.type (system = http://terminology.hl7.org/CodeSystem/GMDN)	n.a.
n.a.	Device EMDN classification	classification.type (system = urn:oid:1.2.250.1.213.2.68)	n.a.
Previous DI (same version or model of device)	?	?	n.a.
MRI safety information: safe, unsafe, conditional, not stated (ASTM F2503)	FLD-UDID-144: List of critical warnings (FLD-UDID-212: Critical warnings type) : safe, unsafe, conditional, consider hazards for magnetic fields, do not store near magnets or magnetic devices	safety: ValueSet device-safety (ASTM F2503 with C-codes from NCIthesaurus)	safety: ValueSet device-safety (ASTM F2503 with C-codes from NCIthesaurus)
Device required to be labeled as containing latex (Y/N)	?	?	n.a.
Device labeled as containing latex	FLD-UDID-156: Containing latex (Boolean)	safety: ValueSet device-safety (ASTM F2503 with C-codes from NCIthesaurus)	safety: ValueSet device-safety (ASTM F2503 with C-codes from NCIthesaurus)
For Single Use	?	property	n.a.
Prescription Use	?	property	n.a.
Over the Counter	?	property	n.a.
Human Cell, Tissue or Cellular or Tissue-Based Product	?	property	n.a.
n.a.	FLD-UDID-28: Active Device	property	n.a.
n.a.	FLD-UDID-30: Implantable	property	n.a.

Resources and Profiles for catalogs of IVD testing devices

See the LIVD Implementation Guide.