






  
  2006N-0292
  
  Unique Device Identification
  

  
  
  

  
  FDA Comment Number : 
  
  EC26
  


  
  Submitter : 
  
  Mr. Heinrich Oehlmann
  
  Date & Time: 
  
  10/12/2006 12:10:58
  


  
  Organization : 
  
  European HIBCC (EHIBCC)
  


  
  Category : 
  
  Health Care Association
  


  
  Issue Areas/Comments 
  

  
  

  
   Developing a System of Unique Device Identifiers (UDI)

  

  
  

  
  


  
  At what level of packaging (that is, unit of use) should UDIs be 
  

  
  


  
  Yes, for products being subject to traceability to the lowest packaging or item level possible.
  

  
  


  
  Have you implemented some form of UDI in your product line? 
  

  
  


  
   UDI is implemented by help of:

a) by HIBC Code 39, Code 128, CODABLOCK F, Datamatrix and QR Code

b) by HIBC UIM 2002-12-20 - The World Wide Unique Identification Mark (UIM) for Medical Devices, 

c) by DIN V66401 - Unique Identification Mark (UIM) 

d) by ISO 22742 Packaging - linear and two-dimensional symbols for product packaging

e) by ISO/IEC 15459 Unique Identifiers (originally Unique Identification of Transport Units) 

Note: HIBC UIM and DIN V66401 are based on ISO/IEC specifications ISO/IEC 15418, 15459, 16022 and 18004

  

  
  

  
  

  
  

  
  

  
  

  
  

  
  

  
  


  
  How should a unique device identification system be developed?
  

  
  


  
   The attributes of an UDI are ideally those from existing national and international standards, accepted world wide already. 

1)The key standard for "Unique Identifiers" ISO/IEC 15459 is being under maintenance for extension global uniqueness for ITEMS, PRODUCTS, TRANSPORT UNITS, RETURNABLE UNITS and GROUPS of ENTITIES. Issuing Agencies as HIBCC/EHIBCC, GS1, Dun & Bradstreet and about 20 others supply unique Company and Labeler Identifications Codes for acheaving unique UDI's.

This UDI specification ISO/IEC 15459 ise useful for 

a) Barcode

b) 2-dimensional symbols

c) RFID (ISO/IEC 18000 series)

2) In addition to it ISO/IEC 15418 GS1 Application Identifiers and ASC MH 10 Data Identifiers is the relevant attribut for identifying the data elements and its content. 

3) DOD "UID strategy" includes same attributes (Department of Defense Guide to Uniquely Identifying Items, version 1.5, June 7, 2005.)

  

  
  

  
  

  
  

  
  

  
  

  
  

  
  

  
  

  
  

  
  

  
  

  
  

  
  

  
  


  
  Should unique device identifiers be considered for all devices? 
  

  
  


  
  UID's should be considered for all devices which are subject of traceability.
  

  
  

  
  What are the barriers for establishing unique device 
  

  
  







  
   Barriers are the lack on know how about the harmonisation and standardisation on ISO level and misinterpretaions. Barriers are also developments of new access key's for information such as EPC, causing delay in implementation of given solutions which are backward interoperabel. 

  

  
  

  
  

  
  What are the incentives for establishing a uniform, standardized 
  

  
  


  
   A UID system based on ISO/IEC 15459 enables world wide uniqueness regardless of the numbering system itself. The incentive is that it does not require any modification or changes of existing numbering schemes but supplies rules how to identify it uniquely in an interoperable way.

Another incentiv is, that it gets the support from any national standards body and its member organisations.

  

  
  

  
  

  
  


  
  What should be the role, if any, of FDA in the development and 
  

  
  


  
   FDA should refer to the ISO and ISO/IEC standards covering UID because ANSI and the other national bodies achieved world wide operability for it. FDA should take a voluntary role supplying guidance how to use the full scope of the ISO standards where GS1, HIBC and ASC structures are included, relevant for Health Care.

  

  
  

  
  

  
  


  
  What solutions have you developed or could be developed for 
  

  
  


  
   a)HIBC UIM 2002-12-20 - The World Wide Unique Identification Mark (UIM) for Medical Devices (serialized) 

b) HIBC Guide_Spectaris-VDDI rev2004-05-19

c) eHIBC-ISOpoweredRFID_2004-02-28f 

d) UniqueHIBC+WristBand-ID-ISOIEC-2006-03



Sources: Heinrich.Oehlmann@HIBC.de, www.HIBC.de



	Barriers are the lack on know how about the harmonisation and standardisation on ISO level and misinterpretaions. Barriers are also developments of new access key's for information such as EPC, causing delay in implementation of given solutions which are backward interoperabel.


	What are the incentives for establishing a uniform, standardized


	A UID system based on ISO/IEC 15459 enables world wide uniqueness regardless of the numbering system itself. The incentive is that it does not require any modification or changes of existing numbering schemes but supplies rules how to identify it uniquely in an interoperable way. Another incentiv is, that it gets the support from any national standards body and its member organisations.




	What should be the role, if any, of FDA in the development and


	FDA should refer to the ISO and ISO/IEC standards covering UID because ANSI and the other national bodies achieved world wide operability for it. FDA should take a voluntary role supplying guidance how to use the full scope of the ISO standards where GS1, HIBC and ASC structures are included, relevant for Health Care.




	What solutions have you developed or could be developed for
	What solutions have you developed or could be developed for

	a)HIBC UIM 2002-12-20 - The World Wide Unique Identification Mark (UIM) for Medical Devices (serialized) b) HIBC Guide_Spectaris-VDDI rev2004-05-19 c) eHIBC-ISOpoweredRFID_2004-02-28f d) UniqueHIBC+WristBand-ID-ISOIEC-2006-03 Sources: Heinrich.Oehlmann@HIBC.de, www.HIBC.de