2006N-0292
  

  
Unique Device Identification
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC4
  



  

  
Submitter : 
  

  
Mr. Chester Arnold
  

  
Date & Time: 
  

  
08/16/2006 04:08:54
  



  

  
Organization : 
  

  
Mr. Chester Arnold
  



  

  
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 
  


  

  



  

  
 AT each level; the End Item, the sub-assembly, the sub-sub-assembly. The Aviation industry (initiated by the military) has this in a logical progression, and it would work appriciably well for the medical industry as well.

  


  

  


  

  



  

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


  

  



  

  
We utilize the ECRI developed UMDNS. this has worked flawlessly for us.
  


  

  


  

  
How should a unique device identification system be developed?
  


  

  



  

  
 Since there is already a system inplace developed by the ECRI, that is in use by the World Health Organization. it is my opinion that this system be adopted by the FDA.

  


  

  


  

  


  

  
Should unique device identifiers be considered for all devices? 
  


  

  



  

  
 YES! Every device should have a UDI assigned to it for uniform identification and tracking purposes. This would possibly help to decrease the number incidents and would provide imeasurable assistance in the identification of recall devices. 

  


  

  


  

  


  

  
What are the barriers for establishing unique device 
  


  

  



  

  
 Barriers are the mfg's not wanting to ascribe to the rules and laws. By making this a part of the CFR this barrier would be removed. New technology could present a minor delay of one to two days for an identifier to be developed. This delay is nothing is the overall scope of the approval process, and could be overcome by providing for a timeline of identification development and implimentation. 

  


  

  


  

  


  

  



  

  
What are the incentives for establishing a uniform, standardized 
  


  

  



  

  
 Standardization of a common nomenclature where a trade name does not influence and or confuse the practitioner, that regularly ends up costing the healthcare industry thousands of unnecessary dollars due to a 'Trade Name' issue. 



Those in the enforcement end would spend much less time looking for and trying to identify the devices due to trade name confusion. 

  


  

  


  

  


  

  


  

  



  

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


  

  



  

  
 The system should be mandatory and inforced through a 21 CFR. The FDA should review and but not restrict the development of this system. No product should be allowed to enter the market until it has had a unique idetifier assigned to it.



  


  

  


  

  








  

  
What solutions have you developed or could be developed for 
  


  

  



  

  
Those already in use by the ECRI are more than adequate for this operation. Why re-invent the wheel when it has been provided for us already.