Determining Hospital Procedures for Opened-But-Unused, Single-Use MedicalFrom: Ginsberg, Gregory [gregory.ginsberg@uphs.upenn.edu]
Sent: Thursday, August 29, 2002 9:15 AM
To: 'fdadockets@oc.fda.gov'
Cc: 'P. Joanne Ray' (E-mail); David Carr-locke (E-mail); 'Djensen (E-mail)
Subject: Determining Hospital Procedures for Opened-But-Unused, Single-Use Medical

Dear Drs., Sirs, and Madams, 
In response to the request for comments and information regarding the above, I wish 
to offer my opinion as chairman of the ASGE Technology Committee.  Devices used 
in endoscopy, in that they are passed through the accessory channel of the 
endoscope, become contaminated with oral or colonic flora upon insertion. With this 
in mind, Opened-But-Unused, Single-Use Medical Devices for GI Endoscopy should 
be able to be cleanly re-packaged for use without requiring resterilization. 

Thank you for soliciting comment on this subject. 

Sincerely, 

Gregory G. Ginsberg, M.D. 
Chair, ASGE Technology Committee 
Gastroenterology Division 
Director of Endoscopic Services 
University of Pennsylvania Health Systems 
3 Ravdin 
3400 Spruce St. 
Phila., PA 19104 
P 215-349-8222 
F 215-349-5915