The Device 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).
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.
Source codes and source text fields mapped to Standard Concepts of the
Device Domain have to be recorded here.
CDM Field
|
User Guide
|
ETL Conventions
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Datatype
|
Required
|
Primary Key
|
Foreign Key
|
FK Table
|
FK Domain
|
device_exposure_id
|
The unique key given to records a person’s exposure to a foreign
physical object or instrument.
|
Each instance of an exposure to a foreign object or device present
in the source data should be assigned this unique key.
|
integer
|
Yes
|
Yes
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No
|
|
|
person_id
|
|
|
integer
|
Yes
|
No
|
Yes
|
PERSON
|
|
device_concept_id
|
The DEVICE_CONCEPT_ID field is recommended for primary use in
analyses, and must be used for network studies. This is the
standard concept mapped from the source concept id which
represents a foreign object or instrument the person was exposed
to.
|
The CONCEPT_ID that the DEVICE_SOURCE_VALUE maps to.
|
integer
|
Yes
|
No
|
Yes
|
CONCEPT
|
Device
|
device_exposure_start_date
|
Use this date to determine the start date of the device record.
|
Valid entries include a start date of a procedure to implant a
device, the date of a prescription for a device, or the date of
device administration.
|
date
|
Yes
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No
|
No
|
|
|
device_exposure_start_datetime
|
|
This is not required, though it is in v6. If a source does not
specify datetime the convention is to set the time to midnight
(00:00:0000)
|
datetime
|
No
|
No
|
No
|
|
|
device_exposure_end_date
|
The DEVICE_EXPOSURE_END_DATE denotes the day the device exposure
ended for the patient, if given.
|
Put the end date or discontinuation date as it appears from the
source data or leave blank if unavailable.
|
date
|
No
|
No
|
No
|
|
|
device_exposure_end_datetime
|
|
If a source does not specify datetime the convention is to set the
time to midnight (00:00:0000)
|
datetime
|
No
|
No
|
No
|
|
|
device_type_concept_id
|
You can use the TYPE_CONCEPT_ID to denote the provenance of the
record, as in whether the record is from administrative claims or
EHR.
|
Choose the drug_type_concept_id that best represents the
provenance of the record, for example whether it came from a
record of a prescription written or physician administered drug. Accepted
Concepts. A more detailed explanation of each Type
Concept can be found on the vocabulary
wiki.
|
integer
|
Yes
|
No
|
Yes
|
CONCEPT
|
Type Concept
|
unique_device_id
|
This is the Unique Device Identification (UDI-DI) number for
devices regulated by the FDA, if given.
|
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.
|
varchar(255)
|
No
|
No
|
No
|
|
|
production_id
|
This is the Production Identifier (UDI-PI) portion of the Unique
Device Identification.
|
|
varchar(255)
|
No
|
No
|
No
|
|
|
quantity
|
|
|
integer
|
No
|
No
|
No
|
|
|
provider_id
|
The Provider associated with device record, e.g. the provider who
wrote the prescription or the provider who implanted the device.
|
The ETL may need to make a choice as to which PROVIDER_ID to put
here. Based on what is available this may or may not be different
than the provider associated with the overall VISIT_OCCURRENCE
record.
|
integer
|
No
|
No
|
Yes
|
PROVIDER
|
|
visit_occurrence_id
|
The Visit during which the device was prescribed or given.
|
To populate this field device exposures must be explicitly
initiated in the visit.
|
integer
|
No
|
No
|
Yes
|
VISIT_OCCURRENCE
|
|
visit_detail_id
|
The Visit Detail during which the device was prescribed or given.
|
To populate this field device exposures must be explicitly
initiated in the visit detail record.
|
integer
|
No
|
No
|
Yes
|
VISIT_DETAIL
|
|
device_source_value
|
This field houses the verbatim value from the source data
representing the device exposure that occurred. For example, this
could be an NDC or Gemscript code.
|
This code is mapped to a Standard Device Concept in the
Standardized Vocabularies and the original code is stored here for
reference.
|
varchar(50)
|
No
|
No
|
No
|
|
|
device_source_concept_id
|
This is the concept representing the device source value and may
not necessarily be standard. This field is discouraged from use in
analysis because it is not required to contain Standard Concepts
that are used across the OHDSI community, and should only be used
when Standard Concepts do not adequately represent the source
detail for the Device necessary for a given analytic use case.
Consider using DEVICE_CONCEPT_ID instead to enable standardized
analytics that can be consistent across the network.
|
If the DEVICE_SOURCE_VALUE is coded in the source data using an
OMOP supported vocabulary put the concept id representing the
source value here.
|
integer
|
No
|
No
|
Yes
|
CONCEPT
|
|
unit_concept_id
|
UNIT_SOURCE_VALUES should be mapped to a Standard Concept in the
Unit domain that best represents the unit as given in the source
data.
|
There is no standardization requirement for units associated with
DEVICE_CONCEPT_IDs, however, it is the responsibility of the ETL
to choose the most plausible unit. If there is no unit associated
with a Device record, set to NULL.
|
integer
|
No
|
No
|
Yes
|
CONCEPT
|
Unit
|
unit_source_value
|
This field houses the verbatim value from the source data
representing the unit of the Device. For example, blood
transfusions are considered devices and can be given in mL
quantities.
|
This code is mapped to a Standard Condition Concept in the
Standardized Vocabularies and the original code is stored here for
reference. Using the blood transfusion example, blood transfusion
is represented by the DEVICE_CONCEPT_ID and the unit (mL) would be
housed in the UNIT_SOURCE_VALUE and mapped to a standard concept
in the unit domain.
|
varchar(50)
|
No
|
No
|
No
|
|
|
unit_source_concept_id
|
This is the concept representing the UNIT_SOURCE_VALUE and may not
necessarily be standard. This field is discouraged from use in
analysis because it is not required to contain Standard Concepts
that are used across the OHDSI community, and should only be used
when Standard Concepts do not adequately represent the source
detail for the Unit necessary for a given analytic use case.
Consider using UNIT_CONCEPT_ID instead to enable standardized
analytics that can be consistent across the network.
|
If the UNIT_SOURCE_VALUE is coded in the source data using an OMOP
supported vocabulary put the concept id representing the source
value here.
|
integer
|
No
|
No
|
Yes
|
CONCEPT
|
|