2006N-0292
  

  
Unique Device Identification
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC30
  



  

  
Submitter : 
  

  
Mr. Terry Aasen
  

  
Date & Time: 
  

  
10/31/2006 07:10:49
  



  

  
Organization : 
  

  
Sonitor Technologies, Inc.
  



  

  
Category : 
  

  
International Industry
  



  

  
Issue Areas/Comments 
  


  

  


  

  
UDI Benefits and Costs
  


  

  



  

  
What infrastructure or technological advancements are needed 
  


  

  



  

  
 The hospital should have an Indoor Positioning System (IPS) for automatic and real time information about the current location (and past locations) of an UDI tracked device. This will make it easy and timesaving to quickly locate and retrieve any UDI device or devices which need maintenance or is being recalled. 

When the same IPS also is used for patient location information and tracking, then an automatic audit trail of tracked UDI equipment and patients associated at the same location at the same time can automatically be created. This can be valuable information for patient safety records.

In deploying an IPS for automatick location information and tracking purposes set forth above, it is essentail that the location related information is accurate and relaible to room-level or even bed level.



Several IPS technologies are available, some are based on RFID and WiFi. The most accurate technology for room level or bed/bay level is utilizing airborne ultrasound. The attributes of airborne ultrasound makes room level location accuracy very simple, as the transmitted signals from a Tag attached to a tracked object do not penetrate walls, ceilings or floors, but remain in the room they originate. Any risk of electromagnetic interference with other sensitive medical equipment is eliminated with use of ultrasound IPS instead of radio frequency based IPS. More information is avilable at www.sonitor.com