2006N-0292
  

  
Unique Device Identification
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC23
  



  

  
Submitter : 
  

  
Ms. susan bushard
  

  
Date & Time: 
  

  
09/26/2006 01:09:05
  



  

  
Organization : 
  

  
River Falls Area Hospital
  



  

  
Category : 
  

  
Health Professional
  



  

  
Issue Areas/Comments 
  


  

  


  

  
UDI Benefits and Costs
  


  

  



  

  
 For hospitals and other device user facilities considering 
  


  

  



  

  
 Question 18

o We are in process of implementing the electronic medical record. We are part of a consortium of hospitals. A UDI system would be implemented incrementally in this system in the same manner the EMR was. We wont be the first. The large downtown hospital will work out the bugs first.



  


  

  


  

  


  

  


  

  



  

  
From your perspective, what is the expected rate of technology 
  


  

  



  

  
 Question 16

o Rate of acceptance: the larger companies should be able to move on this quickly. The standard is going to be harder to determine. The VHS and 8 track systems were a similar problem. We need one of the big guys to move quickly so that the lesser companies comply.



  


  

  


  

  


  

  


  

  



  

  
From your perspective, what public health and patient safety 
  


  

  



  

  
 Question 14. 

o The costs will be substantial but less than the costs of patient injury and death



  


  

  


  

  


  

  


  

  
Referring specifically to completing medical device recalls in 
  


  

  



  

  
 Question 20

o Since I have to deal with the recalls, I would be thrilled to death to have a mechanism that is much easier than what I have now which is thoroughly manual. I have to search the shelves for items. I depend on the person in the store room to find items that havent gotten to the OR yet. I have to look at each box for the lot number or serial number since we dont have an online system that identifies what we have received.