Recently there have been countless stories in the news centered around the deadly Superbug that is believed to be transmitted via contaminated endoscopes. Due to the complex nature of duodenoscopes/ERCP endoscopes, it can be extremely difficult to adequately disinfect an endoscope following the existing reprocessing guidelines and standards. As a response to this issue, industry experts have provided recommendations for preventing the spread of this deadly bacteria, many of which focus on the importance of the cleaning that occurs prior to reprocessing. Endoscope reprocessing expert Lawrence F Muscarella (PhD) states that the difficulty with reprocessing endoscopes can be traced back to shortcuts and skipped steps in the tedious reprocessing procedure.  

Dr. Muscarella points out that this extremely scrupulous task is often performed by workers making as little as $13 an hour. It has been recommended that these technicians be certified to ensure that everyone undergoes the training required to properly perform the steps. However, at this time, certification of reprocessing technicians is only required in New Jersey & New York in the United States. On top of the laborious job and often modest salaries, technicians are faced with enormous pressure to reprocess endoscopes quickly and work towards increasing scope throughput in their facility. 

Often because of the countless factors working against technicians, steps in the critical cleaning process are not performed as thoroughly as required, or steps can be missed altogether. Without effective cleaning to remove organic material from the endoscope, the disinfection process will not be as effective in high-level disinfecting the endoscope. 

Each year, the ECRI institute releases a list of the top patient safety hazards as a reference for Healthcare Organizations. Inadequate reprocessing was included on last year's list in the #10 spot, and has moved up to #8 on this year's list. This issue has also been included for 6 years in a row on ECRI's top 10 list of Health Technology Hazards. The issue of inadequate reprocessing continues to be a critical health issue due to the continued occurrence of infection outbreaks resulting from infectious agents remaining on medical devices such as endoscopes. Because there are multiple steps involved in the process, there is a lot of room for error when it comes to reprocessing an endoscope. ECRI states that if organisms are not removed from an endoscope during the cleaning process, the disinfection process may not affect the organisms adequately. Additionally, endoscopes that are not thoroughly dried create an environment that allows organisms to grow even after reprocessing. ECRI notes that because there are so many variables that are critical to the process, even one small change to the process can impact the quality of disinfection. Because of the highly manual process and detailed steps involved, there is a lot of potential for scopes to go through the process without being adequately disinfection which can result in patient harm, or in serious cases, death.

Last week the Food and Drug Administration (FDA) released a final guidance document aimed at helping manufacturers improve the safety of reusable medical devices. Following the recent news coverage of the Superbug Outbreaks in the U.S. we are all aware of how complex device designs can inhibit effective reprocessing of endoscopes; the same is true for other reusable medical devices. 

The FDA's guidance document, titled "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labelling" includes six criteria that medical device manufacturers should take into consideration when designing a reusable medical device and when creating the instructions for use. Essentially, these criteria recommend that manufacturers validate the reprocessing methods for their devices to ensure that a technician can effectively disinfect or sterilize the devices by following the manufacturer's instructions for use. The FDA believes that when manufacturers adhere to this guidance document, the risk of device contamination and infection transmission will be significantly reduced. 

This guidance document also provides more detailed information on when issues must be reported to the FDA. After the superbug outbreak, numerous cases of unreported infections came to the surface; it was found that many were not reported due to unclear reporting guidelines. 

For more information, you can download a copy of the guidance document here...

Patients all over the United States are being infected with deadly bacteria after undergoing procedures involving duodenoscopes. Most recently, an outbreak has been reported in Wisconsin where 5 people were infected with the 'Superbug'. The infected patients contracted NDM1, a subgroup of CRE bacteria, after undergoing the relatively common ERCP procedure at the Wisconsin facility. After examination by a third party infection prevention expert, the facility has been processing endoscopes according to the current reprocessing guidelines. 

Similarly, 281 patients from Hartford Hospital in Connecticut have been contacted after the hospital determined that they may have been exposed to a strain of E. coli which, like the CRE bacteria is resistant to some drugs. The hospital has since taken 2 endoscopes out of service as they believe they are to blame for the transmission of the bacteria. The hospital believes that the duodenoscope model they were using for endoscopy procedures are to blame because of how difficult they are to clean. 

To read more about these two recently reported outbreaks click here, or here.

With the recent CRE outbreaks occurring in countless American Hospitals due to the design of specialized duodenoscopes, you can't help but wonder how infection control practices for reprocessing endoscopes can be improved to further prevent the spread of harmful infections. Separation of clean and dirty areas of a reprocessing space is critical to ensure that endoscopes are not recontaminated after reprocessing. This requirement is outlined in CSA's Standard for the decontamination of reusable medical devices (Z314.8-14). It specifies that the areas where clean and contaminated items reside should be separated by walls or partitions to control traffic flow and contain contaminants. 

The easiest way to meet this requirement is by using a pass through AER which is built into the wall separating the clean and dirty areas of the MDRD. A pass through AER ensures that only clean endoscopes make their way over to the clean side for drying and storage. This approach is recommended in the ISO Requirements and tests for washer disinfectors
employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008), which is the recognized standard in Europe. 

Using a pass through AER like ARC's PT3AER can ensure a one-way workflow and limits the room for error in your MDRD, significantly reducing the chances of recontaminating an endoscope after completing the disinfection process.

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...