2006D-0504
  

  
 Guidance for Industry and Food and Drug Administration Staff; Radio-Frequency Wireless Technology in Medical Devices

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC13
  



  

  
Submitter : 
  

  
Mr. Anthony Barrueta
  

  
Date & Time: 
  

  
04/03/2007 07:04:04
  



  

  
Organization : 
  

  
Kaiser Permanente
  



  

  
Category : 
  

  
Other Organization
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Thank for you for the opportunity to comment on the above reference draft guidance relating to radio-frequency wireless technologies in the health care settings.  As wireless consumer products (used by patients and their families and caregivers) and other medical devices are filling the airways in our medical centers, the risk of interference that may affect other medical devices that are important to patient care has the potential to grow substantially.  We are pleased that FDA is taking this problem seriously, and we support FDAs development of this guidance.



We believe that FDA has done a very credible job in outlining to medical device manufacturers guidance pertinent to safe and effective use of radio frequency (RF) wireless technology in medical devices (e.g., limiting device RF output to the lowest power necessary to reliably accomplish their intended functions, and addressing issues of the electromagnetic environment in which these devices will be used, including wireless coexistence, performance, data integrity, security, and EMC). 



We further believe that the wireless device manufacturers responsibility should be explicit.  Implementing initial and ongoing robust testing and controls -- through methodologies noted by the FDA -- to limit the impact of interfering products/devices should be the responsibility of medical device manufacturers utilizing wireless technology.  Kaiser Permanente, and other operators of health care facilities, will have only a very limited ability to control the wireless environments in which RF devices will be operating.  



Thanks again for the opportunity to comment on this important guidance.  Please contact me with any questions you may have.



Anthony Barrueta

Vice President, Government Relations

Kaiser Foundation Health Plan, Inc.

One Kaiser Plaza

Oakland CA 94612

510-271-6835

anthony.barrueta@kp.org