2006N-0292
  

  
Unique Device Identification
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC22
  



  

  
Submitter : 
  

  
Ms. susan bushard
  

  
Date & Time: 
  

  
09/26/2006 01:09:56
  



  

  
Organization : 
  

  
River Falls Area Hospital
  



  

  
Category : 
  

  
Health Professional
  



  

  
Issue Areas/Comments 
  


  

  


  

  
 Implementing Unique Device Identifiers

  


  

  


  

  



  

  
How should the UDI and its associated minimum data set be 
  


  

  



  

  
 Question 10

o Manufacturers maintain existing UDI but need to go through the FDA process for new products. Since online and internet is available for most hospitals and clinics this should be the method for finding UDI material. 



  


  

  


  

  


  

  


  

  



  

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


  

  



  

  
 Question 13

o One way the unique device identification would prevent problems is related to disposables used with the wrong item. If an epidural catheter can be attached to an  IV tubing, someone will do this. This has happened somewhere in the nation with obvious negative results to the patient. If someone can attach a  feeding tubing to the balloon outlet of a trach tube balloon it will be done. The nature of this discussion is that (1) devices that are used internally all need to have radio-opaque properties so that they can be seen on x-ray. (2) Physicians and hospital staff have access to device specifics via the internet. (3) Information about products comes from researchers as well as vendors so that one is able to determine the problems associated with products, not just the brief overview a vendor provides. (4) It would be even better if a radio frequency device was attached to all sponges and instruments that are used in surgery so that we dont need to rely on counting the numbers of items to ensure all items are out of the wound after closure. 



  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  



  

  
Should the UDI be both human readable and encoded in an 
  


  

  



  

  
 Question 11

o The UDI should be encoded in most items. It cant be in some items such as suture therefore the UDI is on the box. Small items such as wire tipped cauteries for urethroscopes a UDI can be etched into the item. Instrument manufacturers already etch data on instruments



  


  

  


  

  


  

  


  

  



  

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


  

  



  

  
 Question 9

o The minimum data set varies with the device. If the device has disposable components, the disposables will have more identifiers associated with it. A machine such as a cautery unit may have few data points. The disposables associated with the cautery would indicate the types of machines the device can be used with because there are many manufacturers of disposables, but few manufacturers of cautery machines. Suture boxes would have little in the data set but have references online for users to access. Items such as pacemakers and heart valves would have more data points including a unique identifier for each item rather than a lot number for a large number of devices. Intra ocular lenses would be treated the same way

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  








  

  
 that they are now.