A VIEW FROM THE FDA GI COUNCIL MEETING – ISSUE NO. 310
May 1, 2015
Last week, I had the opportunity to attend and even participate (in a small way) in the Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting at the FDA Headquarters in Silver Springs, MD. The entire focus of the two days was on the recent CRE outbreaks associated with duodenoscopes, and in a broader way, the challenges related to effective reprocessing of all flexible endoscopes.
This was my first experience at an event like this and it was very impressive. The FDA invited an excellent roster of presenters from industry, government, and healthcare facilities. The panel that heard the presentations was made up of very intelligent, highly educated and trained healthcare industry professionals. The discussions between the panel and FDA staff were very much focused on how to move the industry forward to a place where reprocessing of flexible endoscopes will be much more effective and safer.
The most compelling presentation was from the wife of a patient who succumbed to CRE infection and related health issues, after an ERCP procedure. Her courage and fortitude in presenting was tremendous and you could hear a pin drop in the room as she spoke. Her presentation was a living reminder to all of us that the purpose of reprocessing medical devices is to make ready devices safe for use on the next patient - and when we fail, someone may pay the ultimate price.
I do not know what will be the next steps coming from the FDA as they deliberate and take action based upon those two days (and other activities). But one of the points that was hit home over and over again: making sure that a flexible endoscope is clean, is disinfected/sterilized, is dry and is stored properly is absolutely essential to delivering safe and effective treatment to patients. While we all know this in the abstract, when patients are at risk, when they get sick and even die, the abstract becomes an all too real world reminder.