The Palm Beach Post: “CRE in medical devices killed 22 in Florida years ago” — click here.
This article discusses two deadly outbreaks of the superbug “CRE” in Florida.
This first outbreak in 2008 and 2009 may be the first instance of a CRE infection recorded in the U.S. that was linked to the contamination of a type of gastrointestinal (GI) endoscope called a side-viewing duodenoscopes, or ERCP endoscope.
According to another news report by BloombergBusiness published last week, Florida health officials revealed only for the first time last week (February, 2015) that this outbreak at two hospitals in Highlands County in central Florida in 2008 and 2009 affected as many as 70 patients, including 15 who died.
A second outbreak 3 years later linked to seven more Floridians deaths was confirmed when 22 people contracted CRE due to contaminated ERCP endoscopes in Charlotte County in 2012.
Quotes
The Florida Health Department (spokesman Steve Huard):
- “There is no Department of Health administrative rule or statute that requires physicians to inform a patient that they have CRE or have been in contact with patients with CRE.”
- Any communication between doctor and patient “would be physician and facility dependent.”
- “On our end, there is always concern with the hospitals, but there is a great concern with the health of the public. The balance is in the middle.”
Lawrence F Muscarella, PhD (President, LFM Heathcare Solutions, LLC):
- “While one death is important as any, 15 patient deaths due to bacterial outbreak not only raise a red flag but seemingly should have caused some type of federal or state action, not the least of which would have been to notify promptly the 70 affected patients that a deadly outbreak was the cause of their infections.”
- “It just strikes me as odd the FDA didn’t follow up on this years ago.”
- “While it might have been inadvertent, their report (Alrabaa et al., 2013) is incomplete and appears to downplay the seriousness of this super bug outbreak in 2008.”
- “Some of these issues (e.g., physicians not informing infected patients of an outbreak) go to the heart of the Hippocratic Oath.”
Dr. John Greene (Moffitt Cancer Center, Tampa, FL):
- “There is a fine line between what you know and what you don’t know and how information gets out. … When we asked the health department to look into it, it turned out there was a facility in Central Florida that was using these endoscopic procedures, and there was this little channel they couldn’t clean properly.”
- “If everyone is following the manufacturer’s recommendation and the outbreaks continue to happen, then obviously there is a design defect.”
FDA:
- “Duodenoscopes may impede effective cleaning.”
U.S. Rep. Ted Lieu, D-Calif.:
- “We can certainly design a device that can be appropriately sterilized without causing people to die,” Lieu told ABC News Radio.
Los Angeles Attorney Pete Kaufman:
- “When you cheat on your taxes, do you blame the IRS? … I think these prior instances will be important because they represent a notice to the industry that it had a problem that needed to be addressed.”
Posted 3/4/2015, Rev A
Doctors bury their mistakes, they do not tell family, victims, administrators, peers or their other patients. They are not required to do so by their oath or laws as far as I can tell. We have deified the healthcare industry too long, to our own detriment. After all, there for the grace of God go I. What are you informed as potential risk when faced with procedures for a loved one or self? You have no idea if you will end up in the collateral column of acceptable statistical probability. When the physician tells you, your wife, mother, or child, is too sick to survive after contracting multiple HAIs of unknown variety. Am I angry and can’t get over the premature death of my husband? YES, but even though I lost my legal battle, it breaks my heart that hundreds or thousands of people are still going through what our family suffered and this manufacturer doesn’t give a damn.