2006N-0292
  

  
Unique Device Identification
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC9
  



  

  
Submitter : 
  

  
Mr. David Stiles, CBET
  

  
Date & Time: 
  

  
08/22/2006 09:08:36
  



  

  
Organization : 
  

  
Long Beach Memorial Medical Center
  



  

  
Category : 
  

  
Health Professional
  



  

  
Issue Areas/Comments 
  


  

  


  

  
 Developing a System of Unique Device Identifiers (UDI)

  


  

  


  

  



  

  
How should a unique device identification system be developed?
  


  

  



  

  
 May I suggust that you use a system in place, or develop the same identification system based on selected system. I would consider using the "Universal Medical Device Code" developed by ECRI. ECRI should also give the system to the FDA at no charge or allow you to use you groups (eg MedSun folks) to design your ID system. I would prefer to use an established standard blessed and approved by the FDA.

  


  

  


  

  


  

  



  

  
What are the incentives for establishing a uniform, standardized 
  


  

  



  

  
 Consistant reporting and identification based on excepted benchmarks and guidelines.

Standardized Computerized maintenancemanagement systems (CMMS).







  


  

  


  

  


  

  


  

  


  

  


  

  



  

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


  

  



  

  
 Because of the potencial of errors associated with misidentification, or HIPPA issues the FDA should have a major role in medical device RFID systems. There is no current standard on this system and we need FDA guidence on this issue. Perhaps look to AAMI. or IEEE for help. I really don't need the additional frequency and bandwidth issue to contend with on the various hybrid systems these manufacturers of RF devices are placing on medical centers.