2006N-0292
  

  
Unique Device Identification
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC13
  



  

  
Submitter : 
  

  
Mr. Jeff fecho
  

  
Date & Time: 
  

  
08/23/2006 12:08:12
  



  

  
Organization : 
  

  
St Jude Medical
  



  

  
Category : 
  

  
Device Industry
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 The design, development, and manufacturing of the equipment necessary to affix the unique identifier (2-d barcode) exists already and cost is in line with other labeling systems.  The technology represents a redundant labeling system however always stays on the device.  Obviously this technology is easier to absorb into high volume or high margin products meaning commodity items or small volume low price items may pose a monetary challenge to some manufacturers.  The key is to place the code on the device as soon as possible in the process, that way the identifier provides traceability info throughout the device build process allowing all process settings, lots, etc to be captured and facilitiates electronic DHR creation and life long maintenance (as field feedback comes back regarding the lot or device).  Device space considerations come into play, however, with the technology today most devices have some available real estate for the marking. 

 A global assignment and maintenance system will be required however can mimick current device ID schemes. 



While it will be a challenge to design and implement for most device manufacturers, it is certainly doable.  A phase in period of at least two-years will be required especially for those firms with a high SKU count.  The placement and delivery of the identifier is not a slam-dunk and will require, at times, specific design features to contain the mark.  Equipment, software, and fixturing will be needed to apply the mark.  Using the mark then in ERP, MES, labeling, complaint, distribution systems willr equire configuration including not only the software piece but definition, implementation, and qualification of the readers necessary to assess and record the identifier as its various points of concern.

From a field feedback perspective there is no better way to tie back into its manufacturing environment down to the second.

Overall, I believe UDIs are needed and beneficial to the patient, the instituitions, manufacturers, suppliers, and especially the UDI application and reader community.



  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  



  

  
 Implementing Unique Device Identifiers

  


  

  


  

  



  

  
How should the UDI and its associated minimum data set be 
  


  

  



  

  
 The UDI system needs a global administrator similar to UDMI.  Public access has to be facilitated through the user (institution) initially and then through the manufacturer.

  


  

  


  

  


  

  
Should a UDI be based on the use of a specific technology 
  


  

  



  

  
 Standard Code only, no alternates.  2-d barcode - a little square with the code imbedded in the dots.  The code should not be compatiable in order to distiguish between drugs and devices.  However, readers should be able to read either code set.

  


  

  


  

  


  

  
Should the UDI be both human readable and encoded in an 
  


  

  








  

  
 Human readable is not a practical solution, there is not enough real estate on most devices to put Human Readable information.  Technology readable is the answer and the UDI should be etched right on the product.

  


  

  


  

  


  

  
What is the minimum data set that should be associated with a 
  


  

  



  

  
Device Reorder or catalog number, lot number, date of manufacture, manufacturing source, company name, company contact number