According to the American Society for Gastrointestinal Endoscopy (ASGE, 2008), the proper reprocessing of endoscopes and accompanied accessories is vital to the patient’s safety and health in treatment. The Society for Gastroenterology Nurses and Associates Inc. (SNGA) and the ASGE have supported research that improves the design, reprocessing, and verification for cleaning endoscopes to a high level of disinfection. When endoscopes are reprocessed in accordance to reprocessing guidelines, it is determined that patients have little to no risk of transmission of microorganisms. According to Nelson and Muscarella (2006), all cases of infection are associated with infection control guidelines that have been violated or breached at one or multiple points of the procedure. However, some research may suggest some problems with this claim. Thus, the purpose of this article is to bring awareness to the significant difficulties of reprocessing endoscopes.
The United States Food and Drug Administration allows automated endoscope reprocessors to be cleaned without using manual brushes and water. However, according to the American Society for Gastrointestinal Endoscopy Quality Assurance in Endoscopy Committee, manual cleaning and brushing should be used for high-level disinfection. Thus, redundancy of using two methods, manual and automatic, provides additional safety (ASGE, 2008).
The challenges with reprocessing endoscopes begin with the fact that methods used to reprocess them are very different among medical institutions. There are several individual pieces of equipment, chemical substances, protocols and materials that vary significantly. This variance is important to note because some automated endoscope reprocessors perform more robustly with an additional cleaning cycle, while others only perform standard high-level disinfection. Also, the overall cost of reprocessing one endoscope was found to range from $114 to $280, not including the significant cost of waste disposal (Ofstead et al., 2017).
Another difficulty is that personnel must be vigilant about personal protective equipment such as hair covers, eye protection, gloves, impermeable gowns and shoe covers, as endoscopes are highly contaminated after use. In fact, bacteria can double every 20 minutes on the instrument after each use. Endoscopes that are not properly tested for damage can transmit microorganisms via tiny, invisible holes that allow fecal matter, blood, and reprocessing chemicals to cross into the endoscope lining. However, investigators have discovered failed leak tests during outbreaks (Ofstead et al., 2017).
The manual cleaning process is the most important reprocessing step, as disinfection is not possible if the endoscopes are still dirty. Many outbreaks of infection have been associated with inadequate manual cleaning. During the manual cleaning process, the environment in which the cleaning occurs is also at risk for exposure to fecal matter, body secretions, and tissue remaining inside the endoscopes. Therefore, it is important that surfaces like counters and sinks be manually cleaned to prevent contamination. Endoscope reprocessing personnel must also take additional measures to visually inspect the endoscope after the manual cleaning process, and before high-level disinfection is attempted. Thus, it is critical that the reprocessing is done in an environment with sufficient lighting and magnification. Investigators have found that endoscopes involved with outbreaks had debris that was not identified under typical room lighting (Ofstead et al., 2017).
Research has also revealed that cleaning is often not effective after the first round, so cleaning verification tests should be implemented. A large problem that researchers uncovered is that 10% to 92% of endoscopes are not clean after the first round even when personnel followed all the standards (Ofstead et al., 2017). This is concerning because, even under the appearance of following the standards, proteins are very difficult to remove. One company’s endoscopes had contamination and visual defects after multiple rounds of cleaning, and the manufacturer discovered that every endoscope needed to be repaired.
While most institutions only send out endoscopes for repair after they have failed leak tests or exhibit functional problems, scientific studies have suggested that this is may not be sufficient. Outbreak investigators found that endoscopes may need maintenance more frequently to ensure safety. Specifically, even after multiple cycles of reprocessing, researchers found that visible damage and contamination cannot be removed. In one case, a manufacturer found that every endoscope sent out for repair in one study had defects that required them to be refurbished or repaired. This is troubling because almost all outbreaks are associated with visible damage and debris inside the endoscopes. Researchers have concluded that a high proportion of endoscopes require repair when visual inspections and contamination tests are conducted. The total cost to repair one endoscope is high; the average cost to repair is $5833, and associated administrative costs are $64 to $128 (Ofstead et al., 2017). Finally, personnel have noted that endoscope reprocessing produces an immense amount of waste. The trash generated from reprocessing one endoscope can fill multiple large trash bags.
Taken as a whole, the difficulties in reprocessing endoscopes can be characterized by a lack of standardized materials and procedures, which creates vast processing differences between institutions. Personnel who reprocess endoscopes often have varying degrees of experience, responsibilities and workloads at the institution. Additionally, there may be a high proportion of damaged endoscopes in use; therefore, instruments should be maintained and repaired more frequently.
More research is needed on the additional support, time, and resources endoscope reprocessing personnel require to ensure the safety of patients and personnel.
American Society for Gastrointestinal Endoscopy. (2008). Infection control during GI endoscopy. Gastrointestinal Endoscopy, 67, 781-790.
Nelson, D.B., & Muscarella, L.F. (2006). Current issues in endoscope reprocessing and infection-control during gastrointestinal endoscopy. World Journal Gastroenterology, 12, 3953-3964
Ofstead, C.L., Quick, M.R., Eiland, J.E., & Adams, S.J. (2017). A glimpse at the true cost of reprocessing endoscopes: Results of a pilot project. The International Association of Healthcare Central Service Materiel Management. Chicago, IL: Author.
Society of Gastroenterology Nurses and Associates, Inc. (2012). Standards of infection control in reprocessing of flexible gastrointestinal endoscopes. Chicago, IL: Author.
By William DeLuca,
CRCST, CIS, CHL
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