2006N-0292
  

  
Unique Device Identification
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC12
  



  

  
Submitter : 
  

  
Mr. James Howard
  

  
Date & Time: 
  

  
08/23/2006 12:08:53
  



  

  
Organization : 
  

  
Kaweah Delta Health Care District
  



  

  
Category : 
  

  
Health Professional
  



  

  
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.  As stated previously in the report, identifying and eliminating device compatability issues would aid in the reduction of medical device errors.

  


  

  


  

  



  

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


  

  



  

  
 Our facility utilizes a Bar-Code process of identification for the majority of our Electrical, Electronic, and Electro-Mechanical Health Care devices, which provides for inventory control tracking of our Medical Equipment Database.  This is a Non-RF based system which is linked to our database for all device histories.  This system does not provide for instantaneous tracking of equipment or utilization reviews however.





  


  

  


  

  


  

  


  

  


  

  


  

  


  

  
How should a unique device identification system be developed?
  


  

  



  

  
 At the manufacturing level, a system for implementing a unique tracking system could be an integral part of the device, either RFID, or Non- RFID, that could provide instantaneous tracking and identification capability, much the same way product companies track inventory through unique labeling devices.



As most RFID devices on the market today are somewhat large in relation to the device being applied to, a smaller, passive device could be manufactured into the housing, giving the device a "built-in" advantage.  This could also be made to be immediately compatabile with existing infrastructures, saving many thousands of dollars.

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  



  

  
Should unique device identifiers be considered for all devices? 
  


  

  



  

  
"Considered" for all devices yes.  However, practicality may prohibit the application of this capability to ALL devices.  
  


  

  


  

  
What are the barriers for establishing unique device 
  


  

  



  

  
 The most visible barrier would be costs involved.  Dependent upon the type or method of tracking or identification employed, present technology suggests a "Passive" method of identification would be the most cost effective, be it "Bar-Code" or Non-RF Transmitting label technology.

  


  

  


  

  



  

  
What are the incentives for establishing a uniform, standardized 
  


  

  



  

  
Taking into account the already numerous advantages listed in the initial report, one could also add the amount of time that could be saved in
  


  

  








  

  
locating medical devices so equipped, for Recall Notice Tracking, Repair or PM inspections, as well as tracking device utilization.
  


  

  



  

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


  

  



  

  
 The FDA should mandate this as part of the initial acceptance and approval process of any new medical technology.  The trend towards unique identification and tracking of medical devices must make allowances for the latest developments in technology, and adjust its processes accordingly.

  


  

  


  

  


  

  


  

  
What solutions have you developed or could be developed for 
  


  

  



  

  
 Suggest the implementation process be at the basic level of manufacturing.  Have any such capability be a "built-in" feature for the majority of devices.