Does the FDA do anything if the users of these FDA approved Class I medical devices do not follow the Operator Manual procedures (see Exhibit D, including sterilization and cleaning off of debris)? 


"Hansatome Microkeratome DRAFT 12-14-2000 Operator's Manual"

Is the new sterilization method is to use EtO which is stringent enough?  Is it followed for all components that come into contact with highly infectious tissue (the cornea and blood) during LASIK?  "he stated that the elimination of EtO sterilization only referred to the components for the tray and that the blades and tubing will continue to be EtO sterilized."



EtO uses low heat instead of autoclaving.


p.17 "26.  Warning  It is important to follow proper surgical procedure and carefully drape the eyelids and lashes.  Failure to do so could result in possible serious permanent patient injury."

"31.... NOTE: Any tissue lodged in the Hansatome microkeratome head should be removed immediately.  This will prevent the tissue from hardening or becoming lodged in the cavity of the Hansatome microkeratome head."

"34. Warning  The Hansatome microkeratome must be cleaned, disinfected and/or sterilized according to the instructions provided in this manual.  Failure to properly clean, disinfect, and sterilize equipment could result in possible serious permanent patient injury."

"36. Warning  Any delay in cleaning can allow residual debris from the procedure to adhere to the Hansatome microkeratome.  Such debris could clog the Hansatome microkeratome and during sterilization, could harden and become permanently lodged.  Debris allowed to build up on the Hansatome microkeratome components could affect the performance of the system resulting in system malfunction and possible permenant patient injury."

"43.  Warning  Do not sterilize the Hansatome microkeratome head with the AccuGlide blade installed.  This could result in the blade becoming wedged in the head or result in damage to the head.  Damage of this nature could result in possible serious permanent patient injury."

p.3-1 indicates using Alcohol for cleaning which apparently changed with the new 510K dated 2001.