2006N-0292
  

  
Unique Device Identification
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC3
  



  

  
Submitter : 
  

  
Dr. Steven Morefield
  

  
Date & Time: 
  

  
08/16/2006 04:08:43
  



  

  
Organization : 
  

  
Personal Comment
  



  

  
Category : 
  

  
Health Professional
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 I am concerned that RFID are being considered for inplantable medical devises (e.g. pacemakers). RFIDs have the advantage of being "readable" without direct visualization of the device. It is this same ease that creates certain privacy problems. Encoding inplantable devices with RFIDs would mandate that consumer "broadcast" signifiant medical information to anyone in proximity with an RFID reader. It would not be acceptable to publish a database of device recipients. Neither do I think it is acceptable to force inplantable medical device recipients to broadcast the presence of their device to others.



Also, since many of these implanted devices are likely to broadcast serial numbers, the RFID chip in effect becomes a personal identifier. The potential for abuse of RFIDs in implanted devices in the identification and tracking of individuals without their consent is of grave concern. Once the potential for this abuse is known I fear it may affect decisions by patients who are in medical need of these devices.