2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
FDA Comment Number : EC179
Submitter : Dr. Kenneth Stone Date & Time: 12/07/2005 01:12:51
Organization : Dr. Kenneth Stone
Category : Health Professional
Issue Areas/Comments
I am an anesthesiologist at Bridgeport Hospital in Bridgeport, CT. Long before anesthesiologists became involved in sedation for GI endoscopy, our hospital identified this area as a high risk for adverse patient outcomes. We instituted various measures to improve sedation techniques by gastroenterologists but 'near misses' continued to occur.

Eventually, the anesthesiologists were asked to provide sedation for GI endoscopy and propofol is now used on all cases. With the risk of apnea and need for airway support and rescucitation, only anesthesia trained personnel should be allowed to administer propofol.

I believe that the use of anesthesia personnel is in the spirit of the recent report by the Institute of Medicine in which patient deaths due to medical errors was estimated at 100,000 per year. The same report identified the field of anesthesiology as an example of how to provide safe patient care.