It’s pretty amazing to think that 150 years ago, people didn’t know about germs or about bacteria. Doctors and surgeons went from patient to patient without washing hands and without realizing that they were largely responsible for spreading life-threatening bacteria and infections.
Washing hands dramatically reduced this, preventing millions of needless deaths. Indeed, it has been said that the simple act of washing hands has probably saved more lives than any vaccine, antibiotic or miracle drug.
Today, hospitals are still looking for ways to thoroughly disinfect and sterilize instruments, rooms and hands to prevent the spread of bacteria and diseases. Despite remarkable efforts and advances, the problem of cross contamination persists, endangering patients and caregivers alike.
Ensuring product sterility is a particularly important issue for reusable medical devices such as endoscopes. This subject was the topic as part of the Path to Sterile Endoscopy webinar series presented by Judy Bringhurst. During a session titled, “The Complexities of High-level Disinfection: Can We Shift to a Simpler and Safer Technology?” Bringhurst covered the following points.
Criteria for Cleanliness
When it comes to procedures for disinfection, almost all major societies and healthcare advisory institutions subscribe to the Spaulding Classification, which gives a clear approach on how to disinfect an object based on its intended use. The three categories are:
- Critical: The device will enter normally sterile tissue or the vascular system or an area through which blood flows. It should be sterilized between each use.
- Semi-critical: The medical device requires a high-level disinfection (HLD) process that kills all microorganisms and a high number of bacterial spores.
- Noncritical: Because the device only touches intact skin (it does not penetrate), the device requires low-level disinfection.
Though Spaulding Classification offers a logical, straightforward guide, there is a gray area with instruments that fall under the semi-critical category. At a minimum, these require a high-level disinfection, though if feasible, it would be better if they were fully sterilized. While endoscopes, laryngoscope blades, ultrasound probes and other devices that contact mucous membranes all fall in the semi-critical category, some of these instruments, particularly endoscopes, are more prone to cross contamination.
For endoscopes, there is a real concern over whether the high-level disinfection process is sufficient. Unfortunately, the evidence shows that it is not.
An Unseen Danger
In 2017, the ECRI ranked "inadequate cleaning of complex reusable instruments" as No. 2 on its list of Top Health Technology Hazards. Reusable endoscopes are a prime example of a complex instrument that is hard to fully disinfect and clean. You can’t disinfect 99 percent or 99.8 percent; the disinfection process must be done perfectly or you run the risk of infecting patients. This danger is evident by the more than 100 infectious outbreaks from GI colonoscopes and bronchoscopes documented in the literature. Some of the main issues with high-level disinfection process are:
Lack of standardization
- While there are manufacturer guidelines for high-level disinfection reprocessing, there is no industry standard when it comes to high-level disinfection.
- This lack of standardization leads to processes breaking down and results in many devices being inadequately reprocessed.
- Healthcare workers often neglect to follow reprocessing guidelines, which is the main cause of endoscopy-associated infections.
- When observed, only 1.4 percent of endoscopes were properly reprocessed using manual cleaning methods with automated high-level disinfection.
Intrinsic features of the device
- Even in institutions with well-documented adherence to reprocessing guidelines, organic residue often remains after manual cleaning.
- Microscopy studies have found residual protein and biofilm are not completely removed from the channels, even after multiple rounds of reprocessing and cleaning.
A Sterile, Single Use Endoscopy Option
Though everyone knows how important it is to properly disinfect and reprocess medical devices, the lack of standardization, human error and the intrinsic complexities of devices such as an endoscope put patients at risk. Even when reprocessing guidelines have been followed, infections have been traced to endoscopes.
Because of this, many have expressed concern with the current practice of reprocessing endoscopes through high-level disinfection. The complexities and risk involved are highly worrisome, leading many to change over to single-use EndoSheath protective barriers an easy to provide patients a sterile barrier in each case.
Learn More: Webinar On Demand
To learn more about the complexities of high level disinfectant and what we can do about the issue, view the Sterile Endoscopy Webinar which is currently on demand.