Ensuring the sterility of critical medical instruments is a topic near and dear to anyone responsible for patient safety. To help increase awareness of important information, Cogentix Medical is sponsoring a webinar series called the Path to Sterile Endoscopy. The webinar series is presented by Judy Bringhurst, infection preventionist and safety officer for the University of North Carolina Hospitals in Chapel Hill.
The fourth session in this series was “Differentiating Sheathing Technologies.” The talk built upon topics that were covered in previous sessions, namely the shortcomings involved with high-level disinfections, challenges of adequate endoscope reprocessing and the shift toward using single-use microbial barriers in endoscopy. The highlights from this webinar involve important differences between available sheaths.
Sheathing: a Solution or a Problem?
As discussed in a previous webinar, there are a number of safety hazards inherent to endoscopic reprocessing. Due to a lack of standardization, the stress on resources and human factors involved with high-level disinfection (HLD), endoscopes are often not properly reprocessed.
One of the ways hospitals and others in the medical profession have tried to streamline and increase the effectiveness of the HLD process is to cover semi-critical devices, such as endocavity probes, with a covering such as a probe cover or a condom. Even with this extra layer of protection, the instruments still need to be properly reprocessed, so ultimately, using a sheath does not save any time or resources. In fact, rather than reduce instances of contamination, using a sheath can provide a false sense of security, leading staff to think they can skip a step or cut corners.
In some cases, organizations mistakenly think that using one of these sheaths allows them to skip the HLD process altogether. This is a dangerous misconception. Many peer-reviewed papers have concluded that sheaths and covers are not suitable substitutes for HLD on semi-critical devices. What’s more, as Bringhurst emphasized, “The guidelines from the CDC, The Society of Gastroenterology Nurses and Associates, The Multi-Society Guidelines for Reprocessing Flexible GI Endoscopes, and others also, of course, have indicated that sheaths are simply not an indication to avoid high-level disinfection.”
One of the big reasons for this is that unless specified, sheaths, probe covers and condoms have not been cleared by the FDA and are not validated for use on reusable probes. These types of sheaths also have a high rate of perforation, which should be an automatic red flag. A 2011 study showed that of the three brands of sterile transvaginal probe covers tested, all had a wide range of perforation rates: 0, 25 and 65 percent perforations. Condoms perform better, but have perforations of 0.9 percent and 2 percent.
The alarming part of these findings is that any rate of perforation exposes the patient to cross-contamination and infection. These are just some of the reasons behind the directive to not rely on these types of sheaths.
Not all Sheaths Are Created Equal
However, there are “sheaths” that can provide a safer, more efficient alternative to HLD. The EndoSheath barrier is a sterile microbial barrier that is a lot different than conventional sheaths.
First, in order to be called a microbial barrier, it must be cleared by the FDA. For this to happen, the FDA requires that it is tested to protect against a test virus that should be as small as a hepatitis A virus, which is 30 nanometers in diameter, one of the smallest human pathogenic viruses. EndoSheath was tested and found to be impermeable to organisms as small as 27 nanometers, the size of the Polio virus.
Second, the EndoSheath includes the channels, ports and seals to specially fit it to a PrimeSight endoscope. These are the locations where bioburden most often collects in standard endoscopes; and the inclusion of these elements in the EndoSheath means that they are discarded after each procedure, removing the need to soak, brush, and flush and ensuring a sterile working channel for every patient. The EndoSheath is validated for (that is, engineered to fit) the device it goes with.
Third, every EndoSheath leak tested during the manufacturing process with a 0% acceptable failure rate. This is something that needs to be emphasized. It means the EndoSheath barrier you use has been individually tested and does not have a leak. “Cogentix Medical has deployed a five-step checkpoint towards a goal of zero defects,” Bringhurst points out. “Equipment and environment monitoring occurs, random post sterility inspections, random daily quality assurance and manufacturing inspections, 100 percent visual inspection of every sheath, 100 percent EndoSheath barrier leak testing.”
Sterile Endoscopy With EndoSheath
There is an enormous difference among sheaths for medical devices. The EndoSheath microbial barrier provides protection from pathogens as small as 27 nanometers, exceeding the standards the FDA has put forward for something to be called a microbial barrier.
“There's multiple peer-reviewed studies on the EndoSheath. The infection prevention community supports the move from high-level disinfection to sterile endoscopy,” Bringhurst concluded near the end of her talk. “The EndoSheath barrier is different from high-level disinfection, since every patient every time receives a sterile device.”
In short, the EndoSheath barrier can help healthcare facilities achieve their goal of sterile endoscopy.
Learn More: Webinar on Demand
To learn more about sterilization in endoscopy, watch the webinar on Differentiating Sheathing Technologies.