After countless reports of CRE outbreaks across the Obama administration has made fighting this antibiotic resistant bacteria a national security priority. U.S. Lawmaker Ted Lieu has urged congress to launch an investigation into the action being taken by the U.S. Food and Drug Administration to prevent the superbug from spreading to more and more patients. Lieu has also requested that the House Committee on Oversight and Government Reform hold a hearing on the issue as this committee oversees the activities of the FDA.

The FDA has recently released a notice regarding the infection outbreak, however there are reports that the FDA has been aware of CRE contaminated duodenoscopes and the associated risks for years. Dr. John Allen, President of the American Gastroenterological Association states that the FDA has been aware of the superbug since at least 1987. It's unclear why the FDA didn't take immediate action despite receiving dozens of reports of contaminated duodenoscopes each year. They state that there was no convincing evidence of duodenoscopes being the cause of these infections until 2013 and they wanted to fully understand the issue prior to releasing a statement. 

Both patients and doctors alike are hoping for a solution soon. Dr. Bret Peterson, professor of medicine at the Mayo Clinic and lead author of the 2011 guidelines from the medical societies thinks that it will take a redesign of the scope to solve the problem, or new sterilization technology.

For more information on Lieu's letter to congress click here...
CNN Article - Scope superbug: How long did the FDA Know about problem?

Reports of yet another CRE outbreak have surfaced, this time in North Carolina leaving two patients dead and 16 hospitalized. Once again, these infections can be traced back to contaminated duodenoscopes that were not sufficiently cleaned and disinfected. Because of the complex nature of the elevator mechanism on the tip of the endoscope, it makes it nearly impossible to complete one of the crucial steps in the manual cleaning process; brushing. 

At this time, CRE infections have been reported in almost every American state causing hospitals and clinics to frantically look for ways to prevent the spread of the superbug going forward. The FDA has now released a statement regarding the recent CRE outbreaks which includes recommendations for patients and healthcare providers. Their statement includes steps that can be taken to promote awareness and understanding and provides instructions for reporting incidents, yet does not provide specific methods on how to ensure this bacteria is not transmitted going forward.

As a result, California lawmaker Ted Lieu has requested that congress investigate the issue which he says pose both health and national security risks. Lieu states that if the risk of this superbug is not mitigated, the human and societal costs will continue to rise. Additionally, healthcare facilities could face immense costs resulting from patient lawsuits. In spring 2013, Minnesota based UnitedHealth paid plaintiffs $24 million in compensatory damages and $366 million in punitive damages after referring the centre to patients after it was linked to a hepatitis C outbreak caused by unsafe injection practices. 

This latest outbreak stresses the importance of having the controls in place to ensure that endoscopes are reprocessed in a consistent manner that continually meets and exceeds the regulatory requirements. ARC's products offer results that exceed the current North American requirements and meet the guidelines established in the United Kingdom, which are more detailed and extensive. ARC is currently in the late stages of developing a feature for our ECS1 which supplements the manual cleaning process of duodenoscopes by using a high pressure port to flush the tiny elevator mechanism even if reprocessing staff cannot properly brush it. This high pressure technology is also used in our PT3AER to ensure that all parts of a duodenoscope come into contact with the disinfectant solution for the required length of time to kill remaining bacteria.

It has been confirmed that two patients have died and five more have been infected after undergoing an endoscopic procedure at UCLA's Ronald Reagan Medical Centre in California. 170 other patients may have been exposed as a result of contaminated duodenoscopes used in ERCP procedures from October to January. Although the transmission of CRE bacteria can be deadly, the benefits of the procedures involving duodenoscopes far outweigh the potential hazard to patients. For this reason it is critical that a clear protocol for disinfection is defined to ensure the endoscopes are consistently decontaminated. 

To find out more watch the video below...