Cedars-Sinai Medical Center reported today that four patients receiving treatment at the hospital have been infected with the same super virus that killed two patients last month at UCLA Ronald Reagan Medical Center and now the FDA is reporting to CNN that the manufacturer never received clearance to sell the device.
All of the patients infected at both UCLA and Cedars-Sinai were exposed to the bacteria during endoscopic procedures using the same model of scope. With the spread of the virus to another hospital, the number of patients at risk for infection has now increased to 246.
In a statement, the scopes’ manufacturer, Olympus said that the company didn’t think that they needed to apply for approval before making the scope available for use in hospitals, but has now done so at the request of the FDA.
The FDA continues to investigate the scope and cleaning procedures in an effort to find the source of the infections and reduce patient risk.
Olympus spokesman Mark Miller told the Los Angeles Times, “while any complication affecting a patient’s health is a serious matter, the reported incidence of infections is extremely low” when compared to the 500,000 procedures performed annually using the scope.
Officially known as CRE (carbapenem-resistant Enterobacteriaceae.), this supergerm has become immune to even the most aggressive antibiotic treatments. Center for Disease Control Director Tom Frieden, M.D., M.P.H. calls CRE a “nightmare bacteria” due to the fact that “CRE bacteria can transfer their resistance to other bacteria in the same bacterial family, leaving otherwise healthy people with life-threatening infections.” The CDC website also notes that up to 50 percent of people infected with CRE will die.
In their official statement, Cedars-Sinai says that they have “removed the particular duodenoscope from use and continues to use enhanced disinfection procedures – above and beyond manufactures recommendations – as it has since first hearing reports about other hospitals on February 19 that the manufacturer’s disinfection recommendations may not be sufficient to protect patients.
Cedars-Sinai has also sent letters and home testing kits to all 71 patients that had a duodenoscope procedure with the scope in question between August 2014 and February 2015. The hospital claims that they sent the tests to these patients “out of abundance of caution” and that “there is no evidence at this point that anyone other than the four patients acquired CRE from a duodenoscope.”
In the case of the CRE outbreak at UCLA, the contamination was linked to two out of the seven scopes that are routinely used for medical procedures involving the digestive tract.
In an official statement, UCLA stated that the medical center “followed both the national guidelines and the sterilization standards stipulated by the instrument’s manufacturer.” However, new decontamination procedures put in place by the university exceed those standards. After the current cleaning process is complete, the scopes will now undergo a secondary sterilization process conducted off-site.
The CRE outbreak has not been isolated these incidents in California. The FDA reports that there have been 135 possible patient infections in procedures using the scope from January 2013 to December 2014.
With the increased awareness of CRE and other drug-resistant infections in the medical community, our own Klotz Student Health Center is staying vigilant in keeping the CSUN community infection free.
A source at the health center, who wished to remain anonymous, noted that the CRE outbreak is mainly an infectious disease found in hospitals and in conjunction with instruments that are not currently in use at Klotz.
“We are primarily an ambulatory medical facility,” she said. “Students should feel confident that there is no concern in connection with UCLA’s CRE outbreak spreading to this campus.”
Symptoms of CRE include fever, chills and severe sepsis. If you should experience any of these symptoms, or if you visited the Cedars-Sinai Medical Center between August 2014-February 2015, you can contact the hospital at 1-800-CEDARS-1.
For patients concerned with their risk from procedures at the UCLA Medical Center, the medical center website suggests that you should contact your doctor or call UCLA Clinical Epidemiology and Infection Prevention at 310-794-0189.
