DICOM Correction Proposal Form

Transcription

1 DICOM Correction Proposal Form Tracking Information - Administration Use Only Correction Proposal Number STATUS CP-1418 Assigned Date of Last Update Person Assigned Submitter Name Kevin O Donnell Kevin O Donnell Submission date Correction Number CP-1418 Log Summary: Type of Modification Addition Name of Standard PS

2 Rationale for Correction: FDA has released the final rule for the Universal Device Identifier (UDI) for medical devices. Other national regulators (especially those in IMDRF) are also moving towards requiring the use of UDIs. UDI is a unique identifier for a specific device. The scope includes all implantable, life-saving or lifesustaining devices. DICOM should facilitate recording the UDI of relevant devices associated with images, just as we facilitate recording make/model/serial. UDI number is a combination of two numbers (UDI = DI + PI): A device id (DI) which is unique to the manufacturer, make & model A production id (PI) which is the serial #, or lot #, or manufacturing date, or expiration date depending on the type of device Each DI is issued by an FDA accredited Issuing Agency. The issuing Agency may choose a format for their DI s as long as the resulting UDI uses only characters and numbers from the invariant character set of ISO/IEC 646 (ISO 7-bit coded character set aka ISO IR 6) and complies with - ISO/IEC IT Unique identifiers Part 2: Registration procedures; - ISO/IEC :2008 IT Unique identifiers - Part 4: Individual items; - ISO/IEC :2007 IT Unique identifiers - Part 6: Unique identifier for product groupings; GS-1 Formatting for a UDI includes details like preceding the 14 digit DI with (01), and preceding a serial # with (21). FDA guidance about UDIs for medical software are that a different major revision of a software package (e.g. V7.0 vs V6.0) should have a different DI; while a different minor revision (e.g. V7.0.1 vs V7.0.2) can have the same DI but should have a different PI. Software provides a plain-text statement of the UDI displayed whenever the software is started, or through a menu command (e.g., an About... command). The Global Unique Device Identification Database (GUDID) is a publicly searchable database administered by the FDA for cataloging UDIs of any type of device. The GUDID contains the DI (not PI) and the corresponding details like the Manufacturer, Make, Model, Trade Name, 510k Status, etc. The GUDID is not a recall/adverse event database, just an index. Other countries are moving towards similar databases. FDA Final Rule: Questions: <Do we need other places we currently have Manufacturer s Model Name (0008,1090)?> Sections of documents affected PS XXXXX Correction Wording: <include proposed change below, following guidelines for formatting of changes in supplements> Add 10.XX for UDI Macro to PS3.3

3 10.XX UDI Macro Table 10-YY contains IOD Attributes to record details associated with the Universal Device Identifier (UDI). Note: Typically the UDI macro is invoked from inside another sequence. If multiple devices may be described, the invoking sequence will permit multiple items. Table 10-YY UDI MACRO ATTRIBUTES Attribute Name Tag Type Attribute Description Issuing Agency (gggg,xxx1) 1 Organization accredited to operate a system for the issuance of UDIs. Enumerated Value: GS1 HIBCC ICCBBA Details for encoding a valid device identifier are managed by the Issuing Agency. For full documentation, refer to issuer materials: Unique Device Identifier String (gggg,xxx2) 1 The entire Human Readable Form of the UDI string. See 10.XX.1 See The UDI is a combination of the Device Identifier and the Production Identifier. Device Identifier (gggg,xxx3) 3 The Device Identifier (DI) component of the UDI. The DI uniquely identifies the manufacturer and the specific model of the device (or for a software device, the major version). The structure of the DI varies depending on the Issuing Agency. For GS1, the DI is a GTIN (Global Trade Item Number) encoded as a 14-digit numeric value. For HIBCC, the DI is an HIBC-UPN (Health Industry Business Council Universal Product Number) encoded as a 6-23 character alphanumeric value. Note that the leading + character and trailing check character that appear in the HIBC-SLS Primary Identifier are not included in the UPN. For ICCBBA, the DI is an ISBT-PPIC (Processor Product Identification Code) Kevin O'Donnell 10/3/ :56 AM Comment [1]: ces/deviceregulationandguidance/uniquedevi ceidentification/udiissuingagencies/default.htm Kevin O'Donnell 10/3/ :34 PM Comment [2]: After HIBCC assigns your LIC (Labeler Identification Code), you can then begin creating UDIs using the HIBC Supplier Labeling Standard (SLS). See _Errata.pdf Kevin O'Donnell 10/3/ :32 PM Comment [3]: DI = UPN = LIC+Product/Catalog ID+Unit of Measure SLS Primary ID= + +UPN+check character Kevin O'Donnell 10/3/2014 1:09 PM Comment [4]: Currently, ISBT 128 can code the following types of Medical Devices: blood bags and human cells, tissues, and cell/tissue based products.

4 encoded as a 10 or 16 character alphanumeric value. Production Identifier (gggg,xxx4) 3 The Production Identifier (PI) component of the UDI. The PI uniquely identifies the serial number or batch number of the device (or for a software device, the minor version). For GS1, the PI is one or more Application Identifiers (AI) encoded as a 2-4 digit numeric value followed by a 1-30 character alphanumeric value. For HIBCC, the PI is an HIBC Secondary Dataset code encoded as a 2-39 character alphanumeric value. Device Description (gggg,xxx5) 3 A description of the device identified in this sequence item. 10.XX.nique Device Identifier String This can be used to distinguish between items when multiple UDIs are recorded in a sequence. The format of the string is defined by a corresponding Issuing Agency. DICOM puts no constraints on the length of the string or the character sets beyond the UT Value Representation. Implementations should be prepared to handle very large strings and unusual characters. Modify the General Equipment Module as shown: Kevin O'Donnell 10/3/ :35 AM Comment [5]: Recording a DI identifies a class /model of device. Recording the PI and/or the composite UDI identifies a specific instance of a device (including also the relevant DI). Are there any specific considerations between those two use cases? Christian Hay 8/27/2015 4:45 PM Comment [6R5]: The PI are attributes to the DI. DI à class of device; DI+PI (as lot/batch) à a smaller class of device; DI+PI (as serial #) à an instance of that device. Christian Hay 8/27/2015 4:46 PM Comment [7]: This is not precise enough. In the GS1 world, PI might include 3 elements, each headed with an AI. The sequence of the PI is left to the labeler. Kevin O'Donnell 6/20/2014 1:00 PM Comment [8]: Consider moving this up to the enclosing module (which may already have taken care of this anyway) Christian Hay 8/27/2015 4:52 PM Comment [9R8]: The Mercy Health pilot in the US shows that providers should take the device description out of the GUDID, respectively their local device masterfiles. C General Equipment Module Table C.7-8 specifies the Attributes that identify and describe the piece of equipment that produced a Series of Composite Instances. Table C.7-8. General Equipment Module Attributes Attribute Name Tag Type Attribute Description Manufacturer (0008,0070) 2 Manufacturer of the equipment that produced the composite instances. Institution Name (0008,0080) 3 Institution where the equipment that produced the composite instances is located. Institution Address (0008,0081) 3 Mailing address of the institution where the equipment that produced the composite instances is located. Station Name (0008,1010) 3 User defined name identifying the machine that produced the composite instances. Institutional Department Name (0008,1040) 3 Department in the institution where the equipment that produced the composite instances is located. Manufacturer's Model Name (0008,1090) 3 Manufacturer's model name of the equipment that produced the composite

5 Attribute Name Tag Type Attribute Description instances. Device Serial Number (0018,1000) 3 Manufacturer's serial number of the equipment that produced the composite instances. Note This identifier corresponds to the device that actually created the images, such as a CR plate reader or a CT console, and may not be sufficient to identify all of the equipment in the imaging chain, such as the generator or gantry or plate. Software Versions (0018,1020) 3 Manufacturer's designation of software version of the equipment that produced the composite instances. See Section C Gantry ID (0018,1008) 3 Identifier of the gantry or positioner. UDI Sequence (gggg,xxxa) 3 Universal Device Identifier (UDI) of the entire equipment. For example, the entire CT Scanner. Include Table 10-YY UDI Macro" Only a single Item is permitted in this Sequence. Component UDI Sequence (gggg,xxxb) 3 Universal Device Identifiers (UDI) of components of the equipment. For example the table, gantry, x-ray tube, detector and console of the CT Scanner. Include Table 10-YY UDI Macro" One or more Items are permitted in this Sequence. Spatial Resolution (0018,1050) 3 The inherent limiting resolution in mm of the acquisition equipment for high contrast objects for the data gathering and reconstruction technique chosen. If variable across the images of the series, the value at the image center. Date of Last Calibration (0018,1200) 3 Date when the image acquisition device calibration was last changed in any way. Multiple entries may be used for additional calibrations at other times. See Section C for further explanation. Time of Last Calibration (0018,1201) 3 Time when the image acquisition device calibration was last changed in any way. Multiple entries may be used. See Section C for further explanation. Pixel Padding Value (0028,0120) 1C Single pixel value or one limit (inclusive) of a range of pixel values used in an image to pad to rectangular format or to signal background that may be suppressed. See Section C for further explanation. Required if Pixel Padding Range Limit (0028,0121) is present and either Pixel Data (7FE0,0010) or Pixel Data Provider URL (0028,7FE0) is present. May be present otherwise only if Pixel Data (7FE0,0010) or Pixel Data Provider URL (0028,7FE0) is present. Note 1. The Value Representation of this Attribute is determined by

6 Attribute Name Tag Type Attribute Description the value of Pixel Representation (0028,0103). 2. This Attribute is not used in Presentation State Instances; there is no means in a Presentation State to "override" any Pixel Padding Value specified in the referenced images. 3. This Attribute does apply to RT Dose and Segmentation instances, since they include Pixel Data. 4. This Attribute does not apply when Float Pixel Data (7FE0,0008) or Double Float Pixel Data ((7FE0,0009) are used instead of Pixel Data (7FE0,0010); Float Pixel Padding Value (0028,0122) or Double Float Pixel Padding Value (0028,0123), respectively, are used instead, and defined at the Image, not the Equipment, level. C General Equipment Attribute Descriptions Note The attributes Manufacturer (0008,0070), Manufacturer's Model Name (0008,1090) and Device Serial Number (0018,1000) are intended to be a primary identification of the system that produces the data (e.g., modality or workstation application providing the content of the SOP Instance) and not the identification of the component that encodes the SOP Instance (e.g., a commonly used DICOM encoding toolkit). In PS 3.6, Section 6, add the following new attributes: (gggg,xxx1) Issuing Agency IssuingAgency CS 1 (gggg,xxx2) Unique Device Identifier String UniqueDeviceIdentifierString UT 1 (gggg,xxx3) Device Identifier DeviceIdentifier UT 1 (gggg,xxx4) Production Identifier ProductionIdentifier UT 1 (gggg,xxx5) Device Description DeviceDescription UT 1 (gggg,xxxa) UDI Sequence UDISequence SQ 1 (gggg,xxxb) ComponentUDI Sequence ComponentUDISequence SQ 1 PS3.16 Do we want to modify relevant TIDs too? NL Rel with Parent TID 1004 DEVICE OBSERVER IDENTIFYING ATTRIBUTES Type: Extensible Order: Significant VT Concept Name VM Req Type IDREF EV (121012,DCM, Device Observer UID ) Condition Value Set Constraint

7 2 EV (121013,DCM, Device Observer Name ) 3 EV (121014,DCM, Device Observer Manufacturer ) 4 EV (121015,DCM, Device Observer Model Name ) EV (cccccc,dcm, Device Observer Model Name ) 5 EV (121016,DCM, Device Observer Serial Number ) 6 EV (121017,DCM, Device Observer Physical Location during observation ) 7 CODE EV (113876, DCM, Device Role in Procedure ) Defaults to value of Station Name (0008,1010) in General Equipment Module Defaults to value of Manufacturer (0008,0070) in General Equipment Module Defaults to value of Manufacturer s Model Name (0008,1090) in General Equipment Module Defaults to value of Manufacturer s Model Name (gggg,xxxx) in General Equipment Module Defaults to value of Device Serial Number (0018,1000) in General Equipment Module 1-n U BCID (7445) Device Participating Roles Kevin O'Donnell 4/10/2014 8:44 AM Comment [10]: Given that we can add rows to a table for which order is significant, does that still allow us to add in the middle? Content Item Descriptions Row 7 If the device performing the observations has other roles, e.g., as the irradiating device in a dose report, this may be recorded here, if not implicit. TID 1010 Subject Context, Device Identifies (and optionally describes) a device that is the subject of observations. TID 1010 SUBJECT CON, DEVICE Type: Extensible Order: Significant NL Rel with Parent VT 1 EV (121193,DCM, Name ) Concept Name VM Req Type 2 UIDREF EV (121198,DCM, UID ) 3 EV (121194,DCM, Manufacturer ) 4 EV (121195,DCM, Model Name ) 5 EV (121196,DCM, Serial Number ) 6 EV (121197,DCM, Physical Location during observation ) EV (ccccc2,dcm, Model Name ) Condition Value Set Constraint

8 NL Rel with Parent TID 1021 DEVICE PARTICIPANT Type: Extensible Order: Significant VT Concept Name VM Req Type 1 CODE EV (113876, DCM, Device Role in Procedure ) 2 > HAS 3 > HAS 4 > HAS 5 > HAS 6 > HAS UIDREF Content Item Descriptions Row 1 Row 2 EV (113877, DCM, Device Name ) EV (113878, DCM, Device Manufacturer ) EV (113879, DCM, Device Model Name ) EV (113880, DCM, Device Serial Number ) EV (121012,DCM, Device Observer UID ) Condition Value Set Constraint $DeviceProcedureRole If no Device Procedure Role is provided, BCID (7445) Device Participating Roles may be used. This may be used for the name by which the organization manages the device.