Reprocessing Effectiveness for Flexible Ureteroscopes: A Critical Look at the Evidence.

Flexible ureteroscopes are essential devices, and reusable models require meticulous cleaning and sterilization between procedures. Reprocessing is complex, time-consuming, and difficult due to the instrument's small size, fragility, and internal channel. The Food and Drug Administration recently raised concerns about the effectiveness of ureteroscope reprocessing. Due to inadequate reprocessing and maintenance, contaminated and damaged ureteroscopes pose risks to patient safety. This review describes ureteroscope reprocessing methods and summarizes evidence on reprocessing effectiveness and documented outcomes associated with the use of damaged or inadequately cleaned and sterilized ureteroscopes.

Duodenoscope-associated infection prevention: A call for evidence-based decision making.

Background Recent outbreaks of duodenoscope-associated multidrug-resistant organisms (MDROs) have brought attention to the infection risk from procedures performed with duodenoscopes. Prior to these MDRO outbreaks, procedures with duodenoscopes were considered safe and low risk for exogenous infection transmission, provided they were performed in strict accordance with manufacturer instructions for use and multisociety reprocessing guidelines. The attention and efforts of the scientific community, regulatory agencies, and the device industry have deepened our understanding of factors responsible for suboptimal outcomes. These include instrument design, reprocessing practices, and surveillance strategies for detecting patient and instrument colonization. Various investigations have made it clear that current reprocessing methods fail to consistently deliver a pathogen-free instrument. The magnitude of infection transmission has been underreported due to several factors. These include the types of organisms responsible for infection, clinical signs presenting in sites distant from ERCP inoculation, and long latency from the time of acquisition to infection. Healthcare providers remain hampered by the ill-defined infectious risk innate to the current instrument design, contradictory information and guidance, and limited evidence-based interventions or reprocessing modifications that reduce risk. Therefore, the objectives of this narrative review included identifying outbreaks described in the peer-reviewed literature and comparing the findings with infections reported elsewhere. Search strategies included accessing peer-reviewed articles, governmental databases, abstracts for scientific conferences, and media reports describing outbreaks. This review summarizes current knowledge, highlights gaps in traditional sources of evidence, and explores opportunities to improve our understanding of actual risk and evidence-based approaches to mitigate risk.

The impact of continuous electrical microcurrent on acute and hard-to-heal wounds: a systematic review.

BACKGROUND: Wound infections result in considerable morbidity, mortality and healthcare costs. Antibiotic resistance has complicated wound healing, and new, non-antibiotic-based treatment methods are being developed. AIMS: To evaluate evidence on the safety, efficacy and real-world effectiveness of electroceutical devices (ECDs) that provide continuous electrical stimulation to wounds. METHOD: A systematic search was conducted to identify primary studies published between 2009 and 2019 that described therapeutic wound treatment using portable ECDs. Studies were included if the ECD delivered continuous electrical current directly to the wound area for the duration of treatment. RESULTS: Of 171 citations identified in the search, 13 articles met the inclusion criteria and were analysed. Nine studies evaluated dressings embedded with zinc and silver particles that generated electricity electrochemically, and four evaluated electrode-based units with external batteries. ECDs were effective in healing complex, hard-to-heal wounds that had not responded to other treatments. Four studies showed that ECDs led to complete closure of wounds without complications, and in some cases healed wounds faster than standard of care (SOC). One study found that ECDs resulted in higher ratings by both patients and surgeons than SOC for the progression of wound healing and scar appearance. Additionally, three studies found ECD treatment was less expensive than SOC, due to patients requiring fewer dressing changes or nurse visits. CONCLUSION: ECDs appeared to be a safe, effective and cost-effective method for treating severe, complex and challenging wounds, including hard-to-heal wounds, surgical incisions and skin graft donor sites.

Challenges in achieving effective high-level disinfection in endoscope reprocessing.

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 endoscopy, insufficient cleaning, contaminated rinse water, and inadequate drying before storage. Our team suspected that issues with HLD chemistries and monitoring could also contribute to reprocessing failures. We conducted a mixed-methods analysis of published literature, our interviews with frontline personnel, and evidence from our previous studies. 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. HLDs will likely continue to be used for the foreseeable future. More research is needed to assess real-world practice patterns related to the high-level disinfection step and MEC testing and to establish more realistic usage periods for reusable HLD chemistries. Manufacturers and researchers should evaluate the ability of technological solutions and engineered safeguards to overcome human error. Recognition of the need for quality improvement is growing, and infection preventionists should take action to build on this momentum and collaborate with manufacturers, endoscopists, and reprocessing personnel to improve the effectiveness of high-level disinfection.

A Systematic Review of Disposable Sheath Use During Flexible Endoscopy.

Flexible endoscopes are exposed to blood, mucus, and other secretions during procedures. Single-use sheaths are designed to prevent contact between contaminants and reusable endoscope components. This systematic review examined findings from 22 studies that assessed endoscopic sheath use during urologic, gastrointestinal, or respiratory procedures. The evidence showed that sheaths were durable and yielded faster endoscope turnover times because their reusable components did not require high-level disinfection or sterilization. After a brief learning period, health care providers successfully assembled and maneuvered sheathed endoscopes. Patients generally did not experience greater discomfort during procedures in which sheaths were used. Microbial cultures of sheathed endoscopes were negative or similar to unsheathed endoscopes. More research is needed to evaluate the potential effect of disposable sheaths on infection risks. The evidence suggests that sheaths are a viable option for reliably providing a barrier between endoscopes and patients without affecting the quality of endoscopic procedures.

Widespread clinical use of simethicone, insoluble lubricants, and tissue glue during endoscopy: A call to action for infection preventionists.

BACKGROUND: Current methods for reprocessing flexible endoscopes do not consistently eliminate organic soil. The off-label use of simethicone as a defoaming agent may contribute to reprocessing failures, and endoscope manufacturers have cautioned against its use. METHODS: We sought evidence of simethicone use by interviewing hospital personnel, conducting audits, inspecting endoscopes, and conducting tests. RESULTS: Researchers examined 69 fully reprocessed endoscopes in 4 hospitals. Microbial cultures were positive for ≥50% of endoscopes. Researchers observed cloudy, shimmery fluid resembling simethicone inside channels and under a duodenoscope elevator mechanism. Crystallized white fragments were observed protruding from a gastroscope water jet outlet. Oily, sticky residue was found on endoscopes, and a 3-dimensional mass was found inside an endoscopic ultrasound endoscope. Hospital personnel reported the use of simethicone, cooking oil and silicone sprays, and tissue glue during endoscopy. DISCUSSION: The off-label use of defoaming agents, lubricants, and tissue glue is common and many endoscopists consider these products essential. Our findings suggest these substances are not removed during reprocessing and may impact reprocessing effectiveness. CONCLUSIONS: Infection preventionists should determine whether these products are used in their institutions and evaluate methods for removing them. New policies may be needed to support procedural success and effective endoscope reprocessing.

Effectiveness of Reprocessing for Flexible Bronchoscopes and Endobronchial Ultrasound Bronchoscopes.

BACKGROUND: Infections have been linked to inadequately reprocessed flexible bronchoscopes, and recent investigations determined that pathogen transmission occurred even when bronchoscope cleaning and disinfection practices aligned with current guidelines. This multisite, prospective study evaluated the effectiveness of real-world bronchoscope reprocessing methods, using a systematic approach. METHODS: This study involved direct observation of reprocessing methods for flexible bronchoscopes, multifaceted evaluations performed after manual cleaning and after high-level disinfection, and assessments of storage conditions. Visual inspections of ports and channels were performed using lighted magnification and borescopes. Contamination was detected using microbial cultures and tests for protein, hemoglobin, and adenosine triphosphate (ATP). Researchers assessed reprocessing practices, and storage cabinet cleanliness was evaluated by visual inspection and ATP tests. RESULTS: Researchers examined 24 clinically used bronchoscopes. After manual cleaning, 100% of bronchoscopes had residual contamination. Microbial growth was found in 14 fully reprocessed bronchoscopes (58%), including mold, Stenotrophomonas maltophilia, and Escherichia coli/Shigella species. Visible irregularities were observed in 100% of bronchoscopes, including retained fluid; brown, red, or oily residue; scratches; damaged insertion tubes and distal ends; and filamentous debris in channels. Reprocessing practices were substandard at two of three sites. CONCLUSIONS: Damaged and contaminated bronchoscopes were in use at all sites. Inadequate reprocessing practices may have contributed to bioburden found on bronchoscopes. However, even when guidelines were followed, high-level disinfection was not effective. A shift toward the use of sterilized bronchoscopes is recommended. In the meantime, quality management programs and updated reprocessing guidelines are needed.

Residual moisture and waterborne pathogens inside flexible endoscopes: Evidence from a multisite study of endoscope drying effectiveness.

BACKGROUND: Endoscopy-associated infection transmission is frequently linked to inadequate reprocessing. Residual organic material and moisture may foster biofilm development inside endoscopes. This study evaluated the effectiveness of endoscope drying and storage methods and assessed associations between retained moisture and contamination. METHODS: Endoscope reprocessing, drying, and storage practices were assessed at 3 hospitals. Researchers performed visual examinations and tests to detect fluid and contamination on patient-ready endoscopes. RESULTS: Fluid was detected in 22 of 45 (49%) endoscopes. Prevalence of moisture varied significantly by site (5%; 83%; 85%; P < .001). High adenosine triphosphate levels were found in 22% of endoscopes, and microbial growth was detected in 71% of endoscopes. Stenotrophomonas maltophilia, Citrobacter freundii, and Lecanicillium lecanii/Verticillium dahliae were found. Retained fluid was associated with significantly higher adenosine triphosphate levels (P < .01). Reprocessing and drying practices conformed with guidelines at 1 site and were substandard at 2 sites. Damaged endoscopes were in use at all sites. CONCLUSIONS: Inadequate reprocessing and insufficient drying contributed to retained fluid and contamination found during this multisite study. More effective methods of endoscope reprocessing, drying, and maintenance are needed to prevent the retention of fluid, organic material, and bioburden that could cause patient illness or injury.

The effectiveness of sterilization for flexible ureteroscopes: A real-world study.

BACKGROUND: There are no guidelines or quality benchmarks specific to ureteroscope reprocessing, and patient injuries and infections have been linked to ureteroscopes. This prospective study evaluated ureteroscope reprocessing effectiveness. METHODS: Reprocessing practices at 2 institutions were assessed. Microbial cultures, biochemical tests, and visual inspections were conducted on sterilized ureteroscopes. RESULTS: Researchers examined 16 ureteroscopes after manual cleaning and sterilization using hydrogen peroxide gas. Every ureteroscope had visible irregularities, such as discoloration, residual fluid, foamy white residue, scratches, or debris in channels. Tests detected contamination on 100% of ureteroscopes (microbial growth 13%, adenosine triphosphate 44%, hemoglobin 63%, and protein 100%). Contamination levels exceeded benchmarks for clean gastrointestinal endoscopes for hemoglobin (6%), adenosine triphosphate (6%), and protein (100%). A new, unused ureteroscope had hemoglobin and high protein levels after initial reprocessing, although no contamination was found before reprocessing. CONCLUSIONS: Flexible ureteroscope reprocessing methods were insufficient and may have introduced contamination. The clinical implications of residual contamination and viable microbes found on sterilized ureteroscopes are unknown. Additional research is needed to evaluate the prevalence of suboptimal ureteroscope reprocessing, identify sources of contamination, and determine clinical implications of urinary tract exposure to reprocessing chemicals, organic residue, and bioburden. These findings reinforce the need for frequent audits of reprocessing practices and the routine use of cleaning verification tests and visual inspection as recommended in reprocessing guidelines.

Longitudinal assessment of reprocessing effectiveness for colonoscopes and gastroscopes: Results of visual inspections, biochemical markers, and microbial cultures.

BACKGROUND: Flexible endoscopes are currently reused following cleaning and high-level disinfection. Contamination has been found on endoscopes, and infections have been linked to gastrointestinal, respiratory, and urologic endoscopes. METHODS: This longitudinal study involved visual inspections with a borescope, microbial cultures, and biochemical tests for protein and adenosine triphosphate to identify endoscopes in need of further cleaning or maintenance. Three assessments were conducted over a 7-month period. Control group endoscopes reprocessed using customary practices were compared with intervention group endoscopes subjected to more rigorous reprocessing. RESULTS: At final assessment, all endoscopes (N = 20) had visible irregularities. Researchers observed fluid (95%), discoloration, and debris in channels. Of 12 (60%) endoscopes with microbial growth, 4 had no growth until after 48 hours. There were no significant differences in culture results by study group, assessment period, or endoscope type. Similar proportions of control and intervention endoscopes (~20%) exceeded postcleaning biochemical test benchmarks. Adenosine triphosphate levels were higher for gastroscopes than colonoscopes (P = .014). Eighty-five percent of endoscopes required repair due to findings. CONCLUSIONS: More rigorous reprocessing was not consistently effective. Seven-day incubation allowed identification of slow-growing microbes. These findings bolster the need for routine visual inspection and cleaning verification tests recommended in new reprocessing guidelines.

Assessing residual contamination and damage inside flexible endoscopes over time.

Researchers evaluated flexible endoscope damage and contamination levels at baseline and 2 months later. Postcleaning test results exceeded benchmarks for all gastroscopes and no colonoscopes. Microbial growth was found in samples from 47% of fully reprocessed endoscopes at baseline and 60% at follow-up. Borescope examinations identified scratches, discoloration, debris, and fluid inside endoscopes. Irregularities changed over time. Study evaluations allowed damaged and contaminated endoscopes to be identified and re-reprocessed or sent for repairs.

Practical toolkit for monitoring endoscope reprocessing effectiveness: Identification of viable bacteria on gastroscopes, colonoscopes, and bronchoscopes.

BACKGROUND: Experts have recommended microbiologic surveillance by external reference laboratories for certain flexible endoscopes. There is currently insufficient evidence on the feasibility and utility of cultures. Researchers evaluated a preassembled toolkit for collecting and processing samples from endoscopes. METHODS: A pilot study was performed in a large academic medical center. A toolkit was used to aseptically sample biopsy ports and suction/biopsy channels of 5 gastroscopes, 5 colonoscopes, and 5 bronchoscopes after full reprocessing. Blinded specimens were packaged and transported on icepacks to a reference laboratory that used standard methodologies for microbial cultures. RESULTS: The laboratory detected bacteria in samples from 60% of patient-ready endoscopes, including gram-positive and gram-negative species. Viable microbes (<10 CFU) were recovered from 2 gastroscopes, 3 colonoscopes, and 4 bronchoscopes. Stenotrophomonas maltophilia and Delftia acidovorans were recovered from all 3 endoscope types. Subsequent environmental testing detected S maltophilia in the reprocessing rinse water. CONCLUSIONS: A preassembled toolkit facilitated the aseptic collection of samples for culturing by a reference laboratory that detected viable microbes on fully reprocessed endoscopes. Speciation allowed identification of potential pathogens and a possible common contamination source, demonstrating that microbial cultures may have value even when colony counts are low.

Emergency preparedness--is your OR ready?

Emergency situations only recently have come to include terrorist threats, such as radiation, biological and chemical attacks, and bombings. The importance of emergency preparedness in health care facilities has increased as a result of recent terrorist threats. Perioperative leaders must meet the challenge of preparing their departments for a wide range of potential disasters. This article describes how a facility can prepare for both natural and man-made disasters and reviews modifications to the Joint Commission on Accreditation of Healthcare Organizations' disaster preparedness standards.