FDA officer advises on live case demonstrations of devices
Published date : 24 February 2012
Article date : 24 February 2012
Dr Andrew Farb, a medical officer at the U.S. Food and Drug Administration (FDA) has advised clinicians on live case demonstrations of devices.
A study in the Journal of the American College of Cardiology: Cardiovascular Interventions suggests that broadcasting heart procedures live to doctors at medical meetings may not present a risk to the patient on the table. Doctors at Rambam Medical Center in Haifa, Israel reviewed 101 patients treated during live transmissions from a single center in 15 invasive-cardiology conferences between 1998 and 2010. The study found that procedural and 30-day clinical outcomes were similar to those found in daily practice and to those that have been reported in the contemporary published data, and concludes that these results suggest that broadcasting live case demonstrations in selected patients from selected centers may be safe.
Such demonstrations must first be approved by the FDA. In an interview with Reuters Health, Dr Andrew Farb, who co-wrote an editorial published with the findings said the main goal of these demonstrations is to increase awareness of a clinical trial, and possibly get more doctors to enroll patients in it. This, he stated, is part of the FDA's "mission" to help get clinical trials done in a timely manner and get effective treatments into practice.
Dr Farb also noted that the demonstrations must clearly state that the procedure involves an "investigational device," and the operators cannot try to commercially promote the device.
The full article from the Journal of the American College of Cardiology can be found here.
Read the Reuters Health interview with Dr Andrew Farb here.
