Special Edition on Sterile Processing Imperatives Special Edition- Sterile Processing Imperatives

cover story endoscopy, insufficient cleaning, contaminated rinse water, and inadequate drying before storage.” As they explain, human factors contributing to non-ad- herence with guidelines, standards, and manufacturer instructions for use include: Human Factors, Under-Resourcing Contribute to Sterile Processing Challenges By Kelly M. Pyrek I nfection risks from sterile processing errors has once more made the list in ECRI Institute’s 2020 list of Top 10 Health Technology Hazards. As the report explains, “Insufficient attention to sterilization processes in medical offices, dental offices, and some other ambulatory-care settings can expose patients to contaminated instruments, implants, or other critical items.” Coming in at No. 3 on the hazards list, the report adds, “…failure to consistently and effectively clean and disinfect or sterilize contaminated items before use can expose patients to virulent pathogens. This concern exists in all healthcare settings where patients may come in contact with contaminated items, particularly those intended to enter sterile tissue or the vascular system. However, not all healthcare settings have similar resources for core infection prevention and control (IPC) practices. Settings that may lack the sterilization program resources commonly found in acute-care facilities, for example, include medical offices (e.g., OB/GYN, dermatology), dental offices, and similar locations that are not serviced by a central sterile processing department. During IPC consultations in these settings, ECRI has observed numerous oversights and improper actions associated with sterilization processes. While the prevalence of such failures is unknown, the potential exists for this to be an insidious, widespread patient safety risk.” ECRI Institute emphasizes that key safety measures include “designating a qualified staff member or contractor to support office IPC practices and providing appropriate training for, and conducting periodic competency testing of, benchtop sterilizer operators.” A 2018 survey of the IAHCSMM membership by epi- demiologist Cori Ofstead, MSPH and her team, found that many sterile processing technicians continued to struggle with adherence to guidelines and recommended practices. And as Ofstead, Hopkins and Buro, et al. (2020) note, “Endoscope reprocessing is often ineffective, and microbes frequently remain on endoscopes after the use of high-level disinfectants (HLDs). Several factors impact reprocessing effectiveness, including non-adherence to guidelines, use of damaged endoscopes, use of insoluble products during 8 • Clinical use of endoscopes with visible damage • Use of products that may interfere with reprocessing such as simethicone lubricants and tissue glue • Presence of residual soil after manual cleaning • Rinse-water quality issues • Retained moisture in fully reprocessed endoscopes “In this context, reprocessing failures would not be unexpected,” the researchers say. “However, reprocessing failures have also been documented when no breaches were apparent.” Ofstead and her team suspected that issues with HLD chemistries and monitoring could also contribute to repro- cessing failures. Ofstead, Hopkins and Buro, et al. (2020) conducted a mixed-methods analysis of published literature, their interviews with frontline personnel, and evidence from their previous studies. They report, “The evidence showed that reusable HLDs commonly failed tests for minimum effective concentration (MEC) before their maximum usage periods. MEC tests also detected failures associated with single-use HLDs that did not fully deploy. These failures were due to product issues, process complexities, and personnel non-adherence with guidelines and manufacturer instructions.” Ofstead, Hopkins and Buro, et al. (2020) say they have observed widespread non-adherence to minimum standards for high-level disinfection use and MEC testing at many sites and note, “One common barrier described by Frontline staff was reprocessing instruction for use complexity. Most IAHCSMM survey respondents had read IFUs for flexible endoscopes, but one-third of them reported that the IFUs were not understandable or feasible.” They add, “Concerns about IFU complexity are amplified by in insufficient training. Most survey respondents received a week or less of training before beginning to reprocess endoscopes independently. Only 46 percent received model specific training that covered unique steps required for reprocessing each type of endoscope used in their facilities. Multiple types of AERs were in use at 17 percent of facilities, and the use of multiple systems increase the number of IFUs that technicians must understand and remember. This also raises the possibility of using the wrong combination of HLD chemistries and MEC testing materials.” The researchers continue, “Most survey respondents (70 percent) reported feeling pressure to reprocess endoscopes more quickly, and 26 percent reported one of their biggest challenges was not having enough time for reprocessing. Our studies have found a proper endoscope reprocessing requires well over one hour per endoscope yet frontline staff reported being expected to turn endoscopes around much more rapidly. In addition, 17 percent of survey respondents reported skipping steps or doing them were quickly then they should do to time pressure. Two interviewees reported that manufacturer sales representatives had recommended Sterile Processing Imperatives 2020 • www.healthcarehygienemagazine.com

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