March 2010                                                                                                                                                                 

  

URGENT

MEDICAL DEVICE USER INFORMATION     

 

What is the issue?

Physio-Control, Inc. a division of Medtronic, Inc. has updated Sterilization Guidelines for internal defibrillation handles and paddles (electrodes) used with the LIFEPAK®9, LIFEPAK 9P, LIFEPAK 12, LIFEPAK 20 or LIFEPAK 20e defibrillator/monitors by removing 100% Ethylene Oxide (EO) from current labeling.   The sterilization methods we recommend are Prevacuum steam or STERRAD® 100S.  

 

Am I affected by this issue?

You are receiving this information because our records show that your facility, in the past, has purchased internal defibrillation handles and paddles (electrodes) used with one of the LIFEPAK defibrillator/monitors indicated above.    If you no longer have these accessory items, you are not affected.

 

What should I do?

If you use the internal defibrillation handles and paddles (electrodes) indicated above, the Sterilization Guidelines enclosed supersede all others for these accessories.  We recommend a copy of this user information is posted in all your sterilization departments.

Copies of the new Sterilization Guidelines are available at www.physio-control-notices.com/guide and can be downloaded from the Resources link.

 

If you have any questions regarding this action, please call our Technical Support Team at 1.800.442.1142 – option 5, 6:00 A.M. to 4:00 P.M. (Pacific), Monday – Friday.   

 

Thank you for your cooperation.

Jonathan Lee

VP Quality Assurance

Physio-Control, Inc. (a division of Medtronic, Inc.)