Bioburden (bio dirt) is bacteria that live on the surface that haven’t been sterilized.
Researchers presented the findings at the 40th Annual Conference of the Association for Professionals in Infection Control and Epidemiology (APIC). An analysis conducted by the 3M Infection Prevention Division included a total of 275 flexible duodenoscopes, gastroscopes, and colonoscopes. The investigators found that 30 percent, 24 percent, and 3 percent of the scopes (respectively) failed to pass the cleanliness rating.
Marco Bommarito, PhD, lead investigator and lead research specialist of the 3M Infection Prevention Division, said: “Three out of 20 is an unexpectedly high number of endoscopes failing a cleanliness criterion. Clearly, we’d like no endoscopes to fail a cleanliness rating.”
Over the past few years there have been several reports of health facilities across the country improperly cleansing their endoscopes. The majority of healthcare-associated outbreaks have been caused by contaminated medical devices, such as endoscopes, according to the U.S. Centers for Disease Control and Prevention.
Findings from a Patient’s Association Survey in the U.K, raised grave concerns about the quality of medical instrument decontamination, stating that it could put patients at severe health risk.
The ECRI Institute, which is an independent organization that analyzes patient safety and quality, identified cross-contamination from flexible endoscopes.
Every year, around 20 million endoscopy procedures are conducted using reusable endoscope devices to screen a patient’s GI tract and identify polyps or colon cancer on the surface of the organ.
The scopes examine the first section of the small intestine, called the duodenum, the stomach, and the colon.
Dr. Bommarito, said:
“The cleaning protocols for flexible endoscopes need improvement, such as guidelines tailored to the type of scope or identifying if there is a critical step missing in the manual cleaning process, and documented quality control measures. These types of improvements could have a positive impact on patient safety.”
Before an endoscope is reused on another patient, it has to be sent for cleaning. This generally involves two steps:
- Using an enzymatic cleaning device.
- Soaking the endoscope in disinfectant.
However, the study highlights how in some cases the devices can remain contaminated even after visual inspection.
In this latest study, the researchers assessed the cleanliness of the devices by asking technicians to flush the scopes with water and analyze them for any adenosine triphosphate (ATP) – a marker of bio contamination.
Using a hand-held luminometer they were able to calculate the amount of ATP – in relative light units (RLUs).
The “pass/fail” was set at 200 RLUs, anything above 200 was considered to be a cleaning failure.
Dr. Bommarito, said:
“The cleaning protocols for flexible endoscopes need improvement, such as guidelines tailored to the type of scope or identifying if there is a critical step missing in the manual cleaning process, and documented quality control measures. These types of improvements could have a positive impact on patient safety.”
The FDA along with the CDC and the Department of Veterans Affairs issued a joint safety communication in 2008 warning healthcare facilities about the risks to patients if endoscopes aren’t properly cleaned.
Preventing Cross Contamination in Endoscope Processing (February 2010)
In the future, there could be cheap disposable endoscopes for minimally invasive operations on the human body. These devices, which are being developed by the Fraunhofer Institute for Reliability and Microintegration (IZM) in Berlin, Germany, could eliminate the need for exhaustive cleaning procedures every time normal endoscopes are used.
Written by Joseph Nordqvist