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.