Special Edition on Sterile Processing Imperatives Special Edition- Sterile Processing Imperatives | Page 10

shortening or disabling AER cleaning and rinsing cycles in order to save time and improved turnaround. During previous studies, we discovered that AER manufacturers’ representatives had disabled AER cleaning cycles in two other hospitals. Incidents where AERs were disabled or cycles were improperly programmed have also been reported to the FDA. Ofstead, Hopkins and Buro, et al. (2020) observe, “We are troubled by mounting evidence demonstrating that HLD effectiveness is suboptimal in real-world settings. Previous research has established that multiple factors contribute reprocessing failures … Clearly, these long-standing barriers to adherence and overall reprocessing effectiveness must be addressed however the groundbreaking research described in this manuscript identified additional problems specific to the high-level disinfection step and MEC testing that ensures the chemistries are strong enough to reliably eliminate microbes. As Rutala and Weber stated, the margin for error with high-level disinfection is simply not large enough to tolerate any deviations from optimal practices. They have recommended a shift towards sterilization, and we agree that sterilization may be necessary for improving patient safety. In the meantime, high-level disinfection will continue to be used by many institutions and it is essential to address the quality issues described in this paper.” The researchers recommend that researchers undertake the following endeavors: ● Conduct multi-site studies and ongoing surveillance to assess real-world practice patterns and determine the nature and prevalence of breaches related to the high-level disinfection step and MEC testing. ● Conduct research to establish realistic usage periods for reusable HLD chemistries in real-world settings. ● Assess the ability of technological solutions such as automation and engineered safeguards such as an AER that shuts down when anything does not need manufacturer criteria, to overcome shortcomings that have been attributed to human error. As the researchers emphasize, “For these technological innovations to be successful it is essential that manufacturers and their representatives be partners in striving for excellence in the field. Neither company representatives nor customer should seek to deviate from if you or to shorten automated Cycles to save time. Before implementing time-saving or cost-cutting measures, infection prevention and reprocessing managers should review evidence provided by the manufac- turer that reprocessing is still effective when these steps are skipped or processes are truncated. Ideally, manufacturers and facility personnel will provide mutual support and account- ability for ensuring that practices align with guidelines and IFUs.” They add, “Given the current situation, it is essential for infection preventionists to leverage this momentum and take the lead in coordinating efforts of endoscopists, reprocessing personnel, and others to implement robust quality management programs that address all of the factors that impact HLD effectiveness.” As we have seen, a recent survey of sterile processing technicians confirmed ongoing challenges to performance, with IFU adherence at the top of the list of concerns. Damien Berg, BS, BA, CRCST, regional manager of sterile 10 processing for UC Health in Aurora, Colo. and immediate past-president (2019-2020) of IAHCSMM, reminds us All these that issues of concern “vary from facility errors can to facility and the size of the department lead to (as well as number of items processed) and, of course, what is reported by the surgeon and OR staff customer about mistakes (errors can be frustration, but more very subjective and under reported),” importantly, they can Berg says. “I have the unique viewpoint of being an active manager in two jeopardize patient safety, large hospitals and one surgery center. cause case delays, or I not only deal with the real day-to-day infections.” operations, but I also travel the world — — Damien Berg, BS, BA, visiting many departments and talking to sterile processing professionals who CRCST share these and other issues that impact the everyday SPD. I see some of the top errors ranging from missing integrators, holes in wrap and missing instruments to some type of foreign debris remaining in the tray or on the instruments. All these errors can lead to surgeon and OR staff frustration, but more importantly, they can jeopardize patient safety, cause case delays, or infections).” “The top mistakes that I see in sterile processing are related to the inability to, or decision not to, follow the manufacturer’s instructions for use,” says Bob Marrs, CRCST, CIS, CHL, vice president of organizational development for Beyond Because Clean. “Because sterile processing staff sterile typically are concerned with keeping pace with the OR schedule, steps processing often get circumvented. On a perfect staff typically are day, following the manufacturer’s IFU concerned with keeping is challenging. Trying to do it for every instrument, every time, is pretty much pace with the OR impossible. These short cuts can be schedule, steps often get related to improper cleaning and dis- circumvented.” infection. Sometimes staff will choose — Bob Marrs, CRCST, manual cleaning over the validated CIS, CHL process of thermal disinfection. With thermal disinfection the patient receives the same level of cleaning with each cycle. Manual cleaning is different, much like washing your dishes at home. Everyone has their own idea about how to clean their dishes. The typical sterile processing staff member is no different. What is clean to one person may not be considered clean to another.” Marrs continues, “At times, sterile processing staff will completely bypass the inspection of the instruments prior to assembly. This allows bioburden, foreign material, broken and non-functioning instruments to make their way into the operating room. When this happens, the surgeon becomes the quality manager often discovering the error while operating on their patient. This takes the focus away from the patient and places it on the instrument. This is never a good position for the surgeon. I’ve also seen staff shorten the sterilization cycle and not follow the prescribed instructions. The manufacturer’s instructions for use were developed and designed to ensure that proper procedures are followed. When these procedures are not followed, the patient will ultimately pay the price.” Sterile Processing Imperatives 2020 • www.healthcarehygienemagazine.com