DEV - Device Segment

The Device segment identifies an instance or a type of a manufactured item that is used in the provision of healthcare without being substantially changed through that activity. The device may be a medical or non-medical device. Medical devices include durable (reusable) medical equipment, implantable devices, as well as disposable equipment used for diagnostic, treatment, and research for healthcare and public health. Non-medical devices may include items such as a machine, cellphone, computer, application, etc.

HL7 Attribute Table - DEV - Device Segment

Seq#	Data Element Name	DataType	Usage	Vocabulary	Cardinality	Item #	Length	C.LEN	Flags
DEV
1	Action Code	ID	R	0206(R) Segment Action Code(Required)	[1..1]	00816	[2..2]
2	Unique Device Identifier	EI	C		[0..1]	02457
3	Device Type	CNE	C	0961 Device Type	[0..*]	03483
4	Device Status	CNE	O	0962(S) Device Status(Suggested)	[0..*]	02501
5	Manufacturer/Distributor	XON	O		[0..1]	01247
6	Brand Name	ST	O		[0..1]	01249		60	#
7	Model Identifier	ST	O		[0..1]	01252		60	#
8	Catalogue Identifier	ST	O		[0..1]	01253		60	#
9	UDI Device Identifier	EI	O		[0..1]	03476
10	Device Lot Number	ST	O		[0..1]	03479
11	Device Serial Number	ST	O		[0..1]	03480
12	Device Manufacture Date	DTM	O		[0..1]	03477
13	Device Expiry Date	DTM	O		[0..1]	03478
14	Safety Characteristics	CWE	O	0963 Device Safety	[0..*]	02465
15	Device Donation Identification	EI	O		[0..1]	03481
16	Software Version Number	ST	O		[0..1]	02502
17	Implantation Status	CNE	O	0795	[0..1]	02459

DEV-1: Action Code (ID) 00816

Definition: This field reveals the intent of the message. Refer to HL7 Table 0287 – Problem/goal action code for valid values.

DEV-2: Unique Device Identifier (EI) 02457

Definition: This field contains a unique identifier for the Device represented, either an actual device, or type of device.

When this segment is used as an extension of a PRT segment in the message, e.g., additional device information obtained for an implantable device, DEV-2 must be equal to PRT-10 Participation Device. When PRT-22 Participation Device Type is used, DEV-3 must be equal to PRT-22.

Condition: Either DEV-2 Unique Device Identifier or DEV-3 Device Type must be valued, or both are valued.

DEV-3: Device Type (CNE) 03483

Definition: This field contains the type of device used in the participation.

See Externally HL7 defined 0961 in Chapter 2C for a list of suggested values. This field can repeat.

When intended to have the additional device information for the device referenced in a PRT segment in the message, DEV-2 must be equal to PRT-10 Device. When PRT-22 Device Type is used, DEV-3 must be equal.

When communicating a UDI Carrier, the UDI may either be uniquely identifying an instance of a device, or a type of device. This can be asserted based on the inclusion or absence of a serial number in the Product Identifier section of the UDI. When the serial number is present, PRT-10 must be used, while if it is absent, PRT-22 must be used.

When communicating a UDI Carrier in this field, the coding system used is limited to FDA (FDAUDI), HIBCC (HIBUDI), ICCBBA (ICCUDI), and GS1 (GS1UDI) coding systems defined in HL7 Table 0396.

Condition: Either DEV-2 Unique Device Identifier or DEV-3 Device Type must be valued, or both are valued.

DEV-4: Device Status (CNE) 02501

Definition: The device status indicates the availability of the device, e.g., active, inactive. Refer to Externally HL7 Defined Table 0962 for a list of valid values.

DEV-5: Manufacturer/Distributor (XON) 01247

Definition: This field contains the identity of the manufacturer/distributor.

DEV-6: Brand Name (ST) 01249

Definition: This field contains the name under which the product is marketed by this manufacturer.

DEV-7: Model Identifier (ST) 01252

Definition: This field contains the manufacturer's model identifier for the product.

DEV-8: Catalogue Identifier (ST) 01253

Definition: This field contains the manufacturer's catalogue identifier for the product.

DEV-9: UDI Device Identifier (EI) 03476

Definition: Provides the U.S. FDA UDI device identifier (DI) element. This is not the same as DEV-2, Unique Device Identifier as DEV-2 represents either the full UDI Carrier in the case of an implantable Device,

This is the first component in the UDI and acts as the look up key for the Global Unique Device Identification Database (GUDID²), and may be used for retrieving additional attributes.

When exchanging Device Identifiers (DI) the root shall be the OID, or standards’ appropriate corollary to the OID, assigned to DI and the extension shall be the Human Readable Form of the content. For example, for DIs the root shall be:

    GS1 DIs:     2.51.1.1

    HIBCC DIs:    1.0.15961.10.816

ICCBBA DIs:    2.16.840.1.113883.6.18.1.17 for Blood containers and 2.16.840.1.113883.6.18.1.34 otherwise.

Example:    |00643169001763^^2.51.1.1^ISO|

DEV-10: Device Lot Number (ST) 03479

Definition: Alphanumeric string that identifies the device’s production lot number.

    Example:    |123ABC|

DEV-11: Device Serial Number (ST) 03480

Definition: Manufacturer’s serial number for this device. This field may be the same as DEV-2, Unique Device Identifier when the device does not involve a UDI Carrier for UDI and DEV-2 represents a serial number. The implementation guide would determine whether DEV-11 is then used or not.

DEV-12: Device Manufacture Date (DTM) 03477

Definition: Date and time when the device was manufacturered.

Note: The user system may need to convert the date and optional hour from the UDI Human Readable Form to a timestamp style data type, augmenting the date as required to provide for a complete date and optionally the hour.

Example:    |20140401|

DEV-13: Device Expiry Date (DTM) 03478

Definition: Date and time when the device is no longer approved for use.

Note: The user system may need to convert the date and optional hour from the UDI Human Readable Form to a timestamp style data type, augmenting the date as required to provide for a complete date and optionally the hour.

Example:    |20160712|

CAUTION: See the related privacy considerations discussion in PRT-10.

Example:    |21A11F4855|

DEV-14: Safety Characteristics (CWE) 02465

Definition: This field a safety characteristic of a device, e.g., latex safety, MRI safety.

See Externally HL7 defined 0963 in Chapter 2C for a suggested values.

DEV-15: Device Donation Identification (EI) 03481

Definition: Identifies a device related to a donation.

When exchanging Donation Identification Numbers (DIN) the root shall be the OID assigned to DIN and the extension shall be the Human Readable Form of the content. For example, for DINs the root shall be:

    ICCBBA DINs:    2.16.840.1.113883.6.18.2.1

An ICCBBA DIN OID is available for reference where required, but is not required when the specific data element is scoped to ICCBBA DINs.

Example:    | RA12345678BA123^^2.16.840.1.113883.6.18.1.34^ISO|

DEV-16: Software Version Number (ST) 02502

Definition: The version number of the software that is part of the device.

DEV-17: Implantation Status (CNE) 02459

Definition: This field contains the implantation status of the device, e.g., implanted, explanted. Refer to HL7 Table 0795 – Implanatation Status in Chapter 2C for valid values.