Device Exposure

The Device Exposure domain captures information about a Person’s exposure to a foreign physical object or instrument which is used for diagnostic or therapeutic purposes through a mechanism beyond chemical action. Devices include implantable objects (e.g. pacemakers, stents, artificial joints), medical equipment and supplies (e.g. bandages, crutches, syringes), other instruments used in medical procedures (e.g. sutures, defibrillators) and material used in clinical care (e.g. adhesives, body material, dental material, surgical material).

Field	Required	Type	FK Table	Description
device_exposure_id	Yes	bigint		A system-generated unique identifier for each Device Exposure.
person_id	Yes	bigint	PERSON	A foreign key identifier to the Person who is subjected to the Device. The demographic details of that person are stored in the PERSON table.
device_concept_id	Yes	bigint	CONCEPT	A foreign key that refers to a Standard Concept identifier in the Standardized Vocabularies for the Device concept.
device_exposure_start_date	Yes	date		The date the Device or supply was applied or used.
device_exposure_start_datetime	No	datetime		The date and time the Device or supply was applied or used.
device_exposure_end_date	No	date		The date the Device or supply was removed from use.
device_exposure_end_datetime	No	datetime		The date and time the Device or supply was removed from use.
device_type_concept_id	Yes	bigint	CONCEPT	A foreign key to the predefined Concept identifier in the Standardized Vocabularies reflecting the type of Device Exposure recorded. It indicates how the Device Exposure was represented in the source data.
unique_device_id	No	varchar(50)		A UDI or equivalent identifying the instance of the Device used in the Person.
quantity	No	integer		The number of individual Devices used for the exposure.
provider_id	No	bigint	PROVIDER	A foreign key to the Provider who initiated or administered the Device, e.g. the Provider who wrote the prescription or the Provider who implanted the Device.
visit_occurrence_id	No	bigint	VISIT_OCCURRENCE	A foreign key to the Visit Occurrence during which the device was used.
visit_detail_id	No	bigint	VISIT_DETAIL	A foreign key to the Visit Detail during which the Device Exposure was initiated.
device_source_value	No	varchar(100)		The source code for the Device as it appears in the source data. This code is mapped to a standard Device Concept in the Standardized Vocabularies, and the original code is stored here for reference.
device_source_concept_id	No	bigint	CONCEPT	A foreign key to a Device Concept that refers to the code used in the source.

Conventions

• The distinction between Devices or supplies and Procedures are sometimes blurry, but the former are physical objects while the latter are actions, often to apply a Device or supply.
• For medical devices that are regulated by the FDA, a Unique Device Identification (UDI) is provided if available in the data source and is recorded in the unique_device_id field.
• Valid Device Concepts belong to the “Device” domain. The Concepts of this domain are derived from the DI portion of a UDI or based on other source vocabularies, like HCPCS.
• A Device Type is assigned to each Device Exposure to track from what source the information was drawn or inferred. The valid domain_id for these Concepts is “Device Type”.
• The Visit during which the Device was first used is recorded through a reference to the VISIT_OCCURRENCE table. This information is not always available.
• The Visit Detail during which the Device was first used is recorded through a reference to the VISIT_DETAIL table. This information is not always available.
• The Provider exposing the patient to the Device is recorded through a reference to the PROVIDER table. This information is not always available.