Impact of cleaning monitoring combined with channel purge storage on elimination of Escherichia coli and environmental bacteria from duodenoscopes.

BACKGROUND AND AIMS: We aimed to determine whether monitoring of duodenoscope cleaning by rapid adenosine triphosphate (ATP) combined with channel-purge storage could eliminate high-concern microorganisms. METHODS: In a simulated-use study, suction channels, as well as lever recesses, from 2 duodenoscopes models and the unsealed elevator guidewire (EGW) channel from 1 of these 2 duodenoscopes (the other model has a sealed EGW) were perfused with ATS2015 containing approximately 8 Log10 colony-forming units (CFU)/mL of both Enterococcus faecalis and Escherichia coli. Pump-assisted cleaning was monitored by rapid ATP testing. Duodenoscopes exceeding 200 relative light units (RLUs) were recleaned. Clean duodenoscopes were processed through an automated endoscope reprocessor and then stored in a channel-purge storage cabinet for 1 to 3 days. Cultures of EGW channel and instrument channel combined with the lever recess (IC-LR) were taken after storage. The impacts of extended cleaning and alcohol flush were evaluated. RESULTS: E coli was reliably eliminated in IC-LR and EGW channels of 119 duodenoscope tests (59 with sealed EGW and 60 with nonsealed EGW). However, actionable levels of E faecalis and environmental bacteria persisted. Neither alcohol flush nor extended cleaning resulted in a reduction of actionable levels for these organisms. Identification of isolates indicated that residual organisms in duodenoscope channels were hardy Gram-positive bacteria (often spore formers) that likely originated from environmental sources. CONCLUSIONS: These data indicate that high-concern Gram-negative bacteria but not E faecalis or environmental bacteria can be reliably eliminated by use of the manufacturer's instructions for reprocessing with ATP monitoring of cleaning and channel-purge storage conditions.

A novel polytetrafluoroethylene-channel model, which simulates low levels of culturable bacteria in buildup biofilm after repeated endoscope reprocessing.

BACKGROUND AND AIMS: Clinical studies have shown variable culture results from flexible endoscope channels possibly because of low levels of bacteria that are difficult to extract. The aim of this study was to develop a simulated-use buildup biofilm (BBF) model that mimics low levels of viable bacteria after repeated rounds of aldehyde fixation and accumulation. METHODS: New endoscope channels were exposed to 8 days of repeated rounds of biofilm formation using ATS2015 containing Enterococcus faecalis and Pseudomonas aeruginosa, rinsing, fixation with glutaraldehyde, and rinsing. Viable count and scanning electron microscopy and borescope examination were used to compare the impact of dry storage over 26 weeks on the level of culturable bacteria and to compare the Centers for Disease Control and Prevention flush method of channel harvesting with a flush-brush-flush method. RESULTS: E faecalis (log10 6.6) and P aeruginosa (log10 8.6) accumulated over 8 days of cyclic biofilm formation and partial glutaraldehyde fixation, but after a final exposure to 2.6% glutaraldehyde the level of culturable bacteria was less than 2 log10. The Centers for Disease Control and Prevention channel harvesting method appeared by borescope to be inferior to a flush-brush-flush sample collection method for detection of viable bacteria. P aeruginosa increased up to 7 log10 after 26 weeks of dry storage, indicating there were viable but nonculturable bacteria present initially that recovered during storage. CONCLUSIONS: Viable but nonculturable P aeruginosa within the BBF model are able to recover, and this phenomenon may explain the variability of culture in patient-used endoscopes. Our data also indicated that friction may be a critical part of sample collection from endoscope channels.

Detection of Clostridium difficile in retail ground meat products in Manitoba.

The aim of the present study was to determine whether Clostridium difficile was present in uncooked retail ground beef and ground pork products sold in Winnipeg, Manitoba. Using an alcohol treatment protocol and inoculation of cultures on C difficile Moxalactam Norfloxacin (CDMN), toxigenic C difficile was found in 6.3% of 48 meat samples. The C difficile isolates belonged to different pulsotypes, all of which had been previously isolated from the stool of Manitoba patients with C difficile disease. Because cooking of meat will not eradicate C difficile spores, this raises a concern regarding potential foodborne transmissibility of this organism.The aim of the present study was to determine whether Clostridium difficile was present in uncooked retail ground beef and ground pork products sold in Winnipeg, Manitoba. Using an alcohol treatment protocol and inoculation of cultures on C difficile Moxalactam Norfloxacin (CDMN), toxigenic C difficile was found in 6.3% of 48 meat samples. The C difficile isolates belonged to different pulsotypes, all of which had been previously isolated from the stool of Manitoba patients with C difficile disease. Because cooking of meat will not eradicate C difficile spores, this raises a concern regarding potential foodborne transmissibility of this organism.

La présente étude visait à déterminer si on décelait du Clostridium difficile dans les produits de viande hachée et de porc haché non cuits vendus au détail à Winnipeg, au Manitoba. Au moyen d'un protocole de traitement par l'alcool et d'inoculation de cultures sur la C difficile Moxalactam Norfloxacin (CDMN), les chercheurs ont trouvé du C difficile toxicogénique dans 6,3 % des 48 échantillons de viande. Les isolats de C difficile appartenaient à divers pulsotypes, tous déjà isolés dans les selles de patients manitobains atteints d'une maladie à C difficile. Puisque la cuisson de la viande n'éradique pas les spores C difficile, ce phénomène soulève de l'inquiétude au sujet de la transmissibilité potentielle de cet organisme par voie alimentaire.

Acute Effects of Split Pea-Enriched White Pan Bread on Postprandial Glycemic and Satiety Responses in Healthy Volunteers-A Randomized Crossover Trial.

Pulse consumption has been associated with reduced postprandial glucose response (PPGR) and improved satiety. The objective of this study was (i) to investigate the effects of fortifying white pan bread with split yellow pea (Pisum sativum L.) flour on PPGR and appetite-related sensations, and (ii) to determine whether Revtech heat processing of pea flour alters the postprandial effects. A randomized controlled crossover trial was performed with 24 healthy adults. Participants consumed 50 g available carbohydrate from bread containing 20% pea flour that was untreated (USYP), Revtech processed at 140 °C with no steam (RT0%), Revtech processed at 140 °C with 10% steam (RT10%), or a control bread with 100% white wheat flour (100%W). Blood samples were analyzed for glucose and plasma insulin at 0, 15, 30, 45, 60, 90, and 120 min post-meal. Appetite sensations and product acceptability were measured using visual analogue and 9-point hedonic scales. Results showed no significant difference in the postprandial glucose and insulin responses of different bread treatments. However, pea-containing variants resulted in 18% higher fullness and 16-18% lower hunger, desire to eat, and prospective food consumption ratings compared to 100% W. No differences in the aroma, flavor, color, and overall acceptability of different bread products were observed. This trial supports using pea flour as a value-added ingredient to improve the short-term appetite-related sensations of white pan bread without affecting the overall acceptability.

Adalimumab with or without methotrexate in juvenile rheumatoid arthritis.

BACKGROUND: Tumor necrosis factor (TNF) has a pathogenic role in juvenile rheumatoid arthritis. We evaluated the efficacy and safety of adalimumab, a fully human monoclonal anti-TNF antibody, in children with polyarticular-course juvenile rheumatoid arthritis. METHODS: Patients 4 to 17 years of age with active juvenile rheumatoid arthritis who had previously received treatment with nonsteroidal antiinflammatory drugs underwent stratification according to methotrexate use and received 24 mg of adalimumab per square meter of body-surface area (maximum dose, 40 mg) subcutaneously every other week for 16 weeks. We randomly assigned patients with an American College of Rheumatology Pediatric 30% (ACR Pedi 30) response at week 16 to receive adalimumab or placebo in a double-blind fashion every other week for up to 32 weeks. RESULTS: Seventy-four percent of patients not receiving methotrexate (64 of 86) and 94% of those receiving methotrexate (80 of 85) had an ACR Pedi 30 response at week 16 and were eligible for double-blind treatment. Among patients not receiving methotrexate, disease flares (the primary outcome) occurred in 43% of those receiving adalimumab and 71% of those receiving placebo (P=0.03). Among patients receiving methotrexate, flares occurred in 37% of those receiving adalimumab and 65% of those receiving placebo (P=0.02). At 48 weeks, the percentages of patients treated with methotrexate who had ACR Pedi 30, 50, 70, or 90 responses were significantly greater for those receiving adalimumab than for those receiving placebo; the differences between patients not treated with methotrexate who received adalimumab and those who received placebo were not significant. Response rates were sustained after 104 weeks of treatment. Serious adverse events possibly related to adalimumab occurred in 14 patients. CONCLUSIONS: Adalimumab therapy seems to be an efficacious option for the treatment of children with juvenile rheumatoid arthritis. (ClinicalTrials.gov number, NCT00048542.)

Dementia-Friendly "Design": Impact on COVID-19 Death Rates in Long-Term Care Facilities Around the World.

Persons with dementia (PWD) make up a large portion of the long-term care (LTC) population the world over. Before a global pandemic swept the world, governments and healthcare providers struggled with how to best care for this unique population. One of the greatest challenges is a PWD's tendency to "walk with purpose" and exhibit unsafe wayfinding and elopement, which places them at risk of falls and injury. Past solutions included increased use of restraints and pharmacological interventions, but these have fallen out of favor over the years and are not optimal. These challenges put enormous strain on staff and caregivers, who are often poorly trained in dementia care, underpaid, overworked, and overstressed. PWD are impacted by these stresses, and unmet needs in LTC places an even greater stress on them and increases their risks of morbidity and mortality. The physical design of their environments contributes to the problem. Old, institutionalized buildings have poor lighting, poor ventilation, long dead-end hallways, poor visual cues, lack of home-like décor, shared bedrooms and bathrooms, and are often dense and overcrowded. These design elements contribute to the four 'A's' of dementia: apathy, anxiety, agitation, and aggression, and they also contributed to the rapid spread of COVID-19 in these facilities the world over. In this review, we present current "dementia friendly" design models in the home, community, and LTC, and argue how they could have saved lives during the pandemic and reduced the stresses on both the dementia resident and the caregiver/staff.

Hyper IgG4-Related Disease Presenting with Orbital Tumor and Immune Deficiency.

We report a case of IgG4-RD in a patient with high IgG4 levels, low functional antibodies, and low IgM levels. He presented with bilateral orbital pseudotumors and, after initial improvement on corticosteroids, relapsed with recurrent pleural effusion and pelvic pseudotumor. He had a grossly elevated serum IgG (1905 mg/dl) with elevations in all IgG subclasses but marked elevation in IgG4 (412 mg/dl), low IgM, and low pneumococcal antibodies. Orbital mass biopsy showed polyclonal lymphocytic infiltration and increased IgG4 plasma cells. The patient was started on prednisone and tried several immunosuppressive medications including mycophenolate mofetil, methotrexate, hydroxychloroquine, and azathioprine with decrease in size of the orbital pseudotumor. During a period when the patient stopped his medications, the pseudotumor enlarged with new development of recurrent pleural effusions. He was also found to have a pelvic mass that was biopsy positive for IgG4 proliferation. This case with progression to multiorgan involvement highlights the importance of identifying patients with IgG4-related disease. In contrast to previous cases with normal-to-high IgM, the IgM was low with impaired functional antibodies.

EVOTECH endoscope cleaner and reprocessor (ECR) simulated-use and clinical-use evaluation of cleaning efficacy.

BACKGROUND: The objective of this study was to perform simulated-use testing as well as a clinical study to assess the efficacy of the EVOTECH Endoscope Cleaner and Reprocessor (ECR) cleaning for flexible colonoscopes, duodenoscopes, gastroscopes and bronchoscopes. The main aim was to determine if the cleaning achieved using the ECR was at least equivalent to that achieved using optimal manual cleaning. METHODS: Simulated-use testing consisted of inoculating all scope channels and two surface sites with Artificial Test Soil (ATS) containing 108 cfu/mL of Enterococcus faecalis, Pseudomonas aeruginosa and Candida albicans. Duodenoscopes, colonoscopes, and bronchoscopes (all Olympus endoscopes) were included in the simulated use testing. Each endoscope type was tested in triplicate and all channels and two surface sites were sampled for each scope. The clinical study evaluated patient-used duodenoscopes, bronchoscopes, colonoscopes, and gastroscopes (scopes used for emergency procedures were excluded) that had only a bedside flush prior to being processed in the ECR (i.e. no manual cleaning). There were 10 to 15 endoscopes evaluated post-cleaning and to ensure the entire ECR cycle was effective, 5 endoscopes were evaluated post-cleaning and post-high level disinfection. All channels and two external surface locations were sampled to evaluate the residual organic and microbial load. Effective cleaning of endoscope surfaces and channels was deemed to have been achieved if there was < 6.4 microg/cm2 of residual protein, < 1.8 microg/cm2 of residual hemoglobin and < 4 Log10 viable bacteria/cm2. Published data indicate that routine manual cleaning can achieve these endpoints so the ECR cleaning efficacy must meet or exceed these to establish that the ECR cleaning cycle could replace manual cleaning RESULTS: In the clinical study 75 patient-used scopes were evaluated post cleaning and 98.8% of surfaces and 99.7% of lumens met or surpassed the cleaning endpoints set for protein, hemoglobin and bioburden residuals. In the simulated-use study 100% of the Olympus colonoscopes, duodenoscopes and bronchoscopes evaluated met or surpassed the cleaning endpoints set for protein, and bioburden residuals (hemoglobin was not evaluated). CONCLUSIONS: The ECR cleaning cycle provides an effective automated approach that ensures surfaces and channels of flexible endoscopes are adequately cleaned after having only a bedside flush but no manual cleaning. It is crucial to note that endoscopes used for emergency procedures or where reprocessing is delayed for more than one hour MUST still be manually cleaned prior to placing them in the ECR.

Race- and Sex-Based Disparities in Alzheimer's Disease Clinical Trial Enrollment in the United States and Canada: An Indigenous Perspective.

Randomized clinical trials (RCT) involve labor-intensive, highly regulated, and controlled processes intended to transform scientific concepts into clinical outcomes. To be effective and targeted, it is imperative they include those populations who would most benefit from those outcomes. Alzheimer's disease (AD) is most detrimental to the aging population, and its clinical manifestation is influenced by socio-economic factors such as poverty, poor education, stress, and chronic co-morbidities. Indigenous populations in the United States and Canada are among the minority populations most influenced by poor socio-economic conditions and are prone to the ravages of AD, with Indigenous women carrying the added burden of exposure to violence, caregiving stresses, and increased risk by virtue of their sex. Race- and sex-based disparities in RCT enrollment has occurred for decades, with Indigenous men and women very poorly represented. In this review, we examined literature from the last twenty years that reinforce these disparities and provide some concrete suggestions and guidelines to increase the enrollment numbers in AD RCT among this vulnerable and poorly represented population.

The polytetrafluoroethylene (PTFE) channel model of cyclic-buildup biofilm and traditional biofilm: The impact of friction, and detergent on cleaning and subsequent high-level disinfection.

OBJECTIVE: To evaluate the efficacy of detergent and friction on removal of traditional biofilm and cyclic-buildup biofilm (CBB) from polytetrafluoroethylene (PTFE) channels and to evaluate the efficacy of glutaraldehyde to kill residual bacteria after cleaning. METHODS: PTFE channels were exposed to artificial test soil containing 108 CFU/mL of Pseudomonas aeruginosa and Enterococcus faecalis, followed by full cleaning and high-level disinfection (HLD) for five repeated rounds to establish CBB. For traditional biofilm, the HLD step was omitted. Cleaning with enzymatic and alkaline detergents, bristle brush, and Pull Thru channel cleaner were compared to a water flush only. Carbohydrate, protein, viable count, adenosine triphosphate (ATP) levels were analyzed and atomic force microscopy (AFM) was performed. RESULTS: In the absence of friction, cleaning of traditional biofilm and CBB was not effective compared to the positive control (Dunn-Bonferroni tests; P > .05) regardless of the detergent used. ATP, protein, and carbohydrate analyses were unable to detect traditional biofilm or CBB. The AFM analysis showed that fixation resulted in CBB being smoother and more compact than traditional biofilm. CONCLUSION: Friction during the cleaning process was a critical parameter regardless of the detergent used for removal of either traditional biofilm or CBB. Glutaraldehyde effectively killed the remaining microorganisms regardless of the cleaning method used.

Evaluation of an overnight non-culture test for detection of viable Gram-negative bacteria in endoscope channels.

Background and study aims Prevention of infection transmission from contaminated endoscopes would benefit from a rapid test that could detect low levels of viable bacteria after high level disinfection. The aim of this study was to evaluate the rapid NOW! (RN) test's ability to detect endoscope contamination. Materials and methods The RN test kit and the accompanying fluorometer were evaluated. The manufacturer states that a fluorometer signal > 300 units is indicative of viable Gram-negative bacteria. Suspension testing of varying concentrations of Escherichia coli, Pseudomonas aeruginosa and Enterococcus faecalis were used to determine the RN test limit of detection. Simulated-use testing was done using a duodenoscope inoculated with 10 % blood containing approximately 35 CFU E. coli per channel. Samples were extracted from the duodenoscope instrument channel and tested using the manufacturer's instructions. Results The RN test could consistently detect 10 CFU of E. coli and P. aeruginosa (fluorescent signal of 9,000 to 11,000 units) but not E. faecalis. Sensitivity and specificity for Gram-negative bacteria were 93 % and 90 %, respectively, using all of the suspensions in the study. Extraction of E. coli from an inoculated duodenoscope instrument channel repeatedly provided a positive signal (i. e. > 2,000 units). Conclusions The RN test can reliably detect low levels of Gram-negative bacteria in suspension as well as from samples extracted from endoscope channels. These preliminary findings are encouraging but further assessment of extraction efficacy, impact of organic residuals and clinical workflow are still needed.

UV-visible marker confirms that environmental persistence of Clostridium difficile spores in toilets of patients with C. difficile-associated diarrhea is associated with lack of compliance with cleaning protocol.e.

BACKGROUND: An ultraviolet visible marker (UVM) was used to assess the cleaning compliance of housekeeping staff for toilets in a tertiary healthcare setting. METHODS: The UVM was applied to the toilets of patients who were on isolation precautions due to Clostridium difficile-associated diarrhea (CDAD) as well as for patients who were not on isolation precautions. Cleaning was visually scored using a numeric system where 0, 1, 2, and 3 represented; no, light, moderate or heavy residual UVM. Rodac plates containing CDMN selective agar were used to test for the presence of C. difficile on the surfaces of patient's toilets. RESULTS: Despite twice daily cleaning for the toilets of patients who were on CDAD isolation precautions, the average cleaning score was 1.23 whereas the average cleaning score for toilets of patients not on isolation precautions was 0.9. Even with optimal cleaning (UVM score of 0) C. difficile was detected from 33% of the samples taken from toilets of patients with CDAD (4% detection in toilet samples from patients who had diarrhea not due to CDAD). CONCLUSION: Our data demonstrated the value of UVM for monitoring the compliance of housekeeping staff with the facility's toilet cleaning protocol. In addition to providing good physical cleaning action, agents with some sporicidal activity against C. difficile may be needed to effectively reduce the environmental reservoir.

Improper positioning of the elevator lever of duodenoscopes may lead to sequestered bacteria that survive disinfection by automated endoscope reprocessors.

BACKGROUND: Some outbreaks associated with contaminated duodenoscopes have been attributed to biofilm formation. The objective of this study was to determine whether bacteria within an organic matrix could survive if the elevator lever was improperly positioned in the automated endoscope reprocessor (AER) after 1 round of reprocessing. METHODS: Duodenoscope lever cavities with an open or sealed elevator wire channel were inoculated with 6-7 Log10 of both Escherichia coli and Enterococcus faecalis in ATS2015 (Healthmark Industries, Fraser, MI) and dried for 2 hours. The duodenoscopes with the lever in the horizontal position were processed through 2 makes of AERs. The cavity was sampled using a flush-brush-flush method to determine the quantity of surviving bacteria. RESULTS: E faecalis (range, 21-6 Log10 CFU) and E coli (range, 0-3 Log10 CFU) survived disinfection of sealed or unsealed elevator wire channel duodenoscopes in 2 different AERs with and without cleaning cycles. CONCLUSION: If bacteria in organic residue are under the improperly positioned lever, then just 1 round of use is sufficient for bacteria to survive both liquid chemical sterilization and liquid chemical HLD regardless of whether or not the AER had a cleaning cycle.

A randomized trial to determine the impact of a digestion resistant starch composition on the gut microbiome in older and mid-age adults.

BACKGROUND: The elderly often have a diet lacking resistant starch (RS) which is thought to lead to gut microbiome dysbiosis that may result in deterioration of gut colonocytes. OBJECTIVE: The primary objective was to assess if elderly (ELD; ≥ 70 years age) had microbiome dysbiosis compared to mid-age (MID; 30-50 years age) adults and then determine the impact of daily consumption of MSPrebiotic® (a RS) or placebo over 3 months on gut microbiome composition. Secondary objectives included assessment of stool short-chain fatty acids (SCFA) and inflammatory markers in ELD and MID Canadian adults. DESIGN: This was a prospective, placebo controlled, randomized, double-blinded study. Stool was collected at enrollment and 6, 10 and 14 weeks after randomization to placebo or MSPrebiotic®. Microbiome analysis was done using 16S rRNA sequencing of DNA extracted from stool. SCFA analysis of stool was performed using gas chromatography. RESULTS: There were 42 ELD and 42 MID participants randomized to either placebo or MSPrebiotic® who completed the study. There was significantly higher abundance of Proteobacteria (Escherichia coli/Shigella) in ELD compared to MID at enrollment (p < 0.001) that was not observed after 12 weeks of MSPrebiotic® consumption. There was a significant increase in Bifidobacterium in both ELD and MID compared to placebo (p = 0.047 and 0.006, respectively). There was a small but significant increase in the stool SCFA butyrate levels in the ELD on MSPrebiotic® versus placebo. CONCLUSIONS: The study data demonstrated that MSPrebiotic® meets the criteria of a prebiotic and can stimulate an increased abundance of endogenous Bifidobacteria in both ELD and MID without additional probiotic supplementation. MSPrebiotic® consumption also eliminated the dysbiosis of gut Proteobacteria observed in ELD at baseline. CLINICAL TRIAL REGISTRY NUMBER: NCT01977183 listed on NIH website: ClinicalTrials.gov. The full trial protocol is available on request from the corresponding author. NUCLEOTIDE SEQUENCE ACCESSION NUMBERS: The 16S rRNA sequencing data and metadata generated in this study have been submitted to the NCBI Sequence Read Archive (SRA: http://www.ncbi.nlm.nih.gov/bioproject/381931).

Characterization of endotoxins on orthopaedic fixation screws, using physicochemical surface analyses.

The objective of this study was to determine if surface analysis techniques could be used to detect endotoxin on stainless steel malleolus screws. New malleolus screws were compared to ones that had been coated in purified lipopolysaccharide (LPS) or Artificial Test Soil (ATS) containing lipopolysaccharide. X-ray photoelectron spectroscopy (XPS), scanning electron microscopy (SEM), and time-of flight secondary ion mass spectrometry (TOF-SIMS) were used to assess the fixation screws surface. Organic material was visualized on the LPS and ATS-LPS inoculated screws but not on the new unsoiled screws. This was further supported by the peaks observed at masses between 40 and 100 D in TOF-SIMS spectra of the LPS and ATS-LPS inoculated screws. After deconvolution of N1s high resolution XPS spectra, the LPS inoculated screws showed amide groups whereas the ATS-LPS inoculated screws showed predominantly nitroso groups (C-NO). Our data demonstrate that surface analysis can be used to detect organic residuals present on fixation screws. The XPS data confirmed that LPS reacted predominantly with positively charged surface metallic ions (Fe and Cr), whereas proteins reacted with the surface oxide layer of fixation screws, forming C-NO groups. The application of these surface analysis techniques will be helpful in determining if the reprocessing of such items results in an accumulation of organic material that might lead to aseptic loosening, when implanted. © 2016 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 35:240-247, 2017.

Simulated-Use Polytetrafluorethylene Biofilm Model: Repeated Rounds of Complete Reprocessing Lead to Accumulation of Organic Debris and Viable Bacteria.

OBJECTIVE Biofilm has been implicated in bacterial persistence and survival after endoscope reprocessing. In this study, we assessed the impact of different methods of reprocessing on organic residues and viable bacteria after repeated rounds of biofilm formation when each was followed by full reprocessing. METHODS ATS-2015, an artificial test soil containing 5-8 Log10 colony-forming units (CFU) of Enterococcus faecalis and Pseudomonas aeruginosa, was used to form biofilm in polytetrafluroethylene channels overnight on 5 successive days. Each successive day, full pump-assisted cleaning using bristle brushes or pull-through devices in combination with enzymatic or nonenzymatic detergents followed by fully automated endoscope reprocessor disinfection using peracetic acid was performed. Residuals were visualized by scanning electron microscopy (SEM). Destructive testing was used to assess expected cutoffs for adenosine triphosphate (ATP; <200 relative light units), protein (<2 µg/cm2), and viable bacteria count (0 CFU). RESULTS Protein residuals were above 2 µg/cm2, but ATP residuals were <200 relative light units for all methods tested. Only when enzymatic cleaner was used for cleaning were there no viable bacteria detected after disinfection irrespective of whether bristle brushes or pull-through devices were used. SEM revealed that some residual debris remained after all reprocessing methods, but more residuals were detected when a nonenzymatic detergent was used. CONCLUSIONS Surviving E. faecalis and P. aeruginosa were only detected when the non-enzymatic detergent was used, emphasizing the importance of the detergent used for endoscope channel reprocessing. Preventing biofilm formation is critical because not all current reprocessing methods can reliably eliminate viable bacteria within the biofilm matrix. Infect Control Hosp Epidemiol 2017;38:1284-1290.

Sterile Reverse Osmosis Water Combined with Friction Are Optimal for Channel and Lever Cavity Sample Collection of Flexible Duodenoscopes.

INTRODUCTION: Simulated-use buildup biofilm (BBF) model was used to assess various extraction fluids and friction methods to determine the optimal sample collection method for polytetrafluorethylene channels. In addition, simulated-use testing was performed for the channel and lever cavity of duodenoscopes. MATERIALS AND METHODS: BBF was formed in polytetrafluorethylene channels using Enterococcus faecalis, Escherichia coli, and Pseudomonas aeruginosa. Sterile reverse osmosis (RO) water, and phosphate-buffered saline with and without Tween80 as well as two neutralizing broths (Letheen and Dey-Engley) were each assessed with and without friction. Neutralizer was added immediately after sample collection and samples concentrated using centrifugation. Simulated-use testing was done using TJF-Q180V and JF-140F Olympus duodenoscopes. RESULTS: Despite variability in the bacterial CFU in the BBF model, none of the extraction fluids tested were significantly better than RO. Borescope examination showed far less residual material when friction was part of the extraction protocol. The RO for flush-brush-flush (FBF) extraction provided significantly better recovery of E. coli (p = 0.02) from duodenoscope lever cavities compared to the CDC flush method. DISCUSSION AND CONCLUSION: We recommend RO with friction for FBF extraction of the channel and lever cavity of duodenoscopes. Neutralizer and sample concentration optimize recovery of viable bacteria on culture.

A Randomized Placebo Controlled Clinical Trial to Determine the Impact of Digestion Resistant Starch MSPrebiotic® on Glucose, Insulin, and Insulin Resistance in Elderly and Mid-Age Adults.

INTRODUCTION: Type 2 diabetes (T2D) has reached epidemic proportions in North America. Recent evidence suggests that prebiotics can modulate the gut microbiome, which then plays an important role in regulating lipid metabolism, blood glucose, and insulin sensitivity. As such, prebiotics are appealing potential therapeutic strategies for prediabetes and T2D. The key objectives of this study were to determine the tolerability as well as the glucose and insulin modulating ability of MSPrebiotic® digestion resistant starch (DRS) in healthy mid-age (MID) and elderly (ELD) adults. MATERIALS AND METHODS: This was a prospective, blinded, placebo-controlled study. Prediabetes and diabetes were among the exclusion factors. ELD (>70 years) and MID (30-50 years) Canadian adults were recruited and, after 2 weeks of consuming placebo, they were randomized to consume 30 g of either MSPrebiotic® or placebo per day for 12 weeks. In total, 42 ELD and 42 MID participants completed the study. Blood samples were collected over the 14-week study and analyzed for glucose, lipid profile, and CRP, lipid particles, TNF-α, IL-10, insulin, and insulin resistance (IR). RESULTS: At baseline, the ELD population had a significantly higher percentage (p < 0.01) with elevated glucose and significantly higher TNF-α (p < 0.01) compared to MID adults. MSPrebiotic® DRS was well tolerated in both MID and ELD adults. There was a significant difference over time in blood glucose (p = 0.0301) and insulin levels (p = 0.009), as well as IR (HOMA-IR; p = 0.009) in ELD adults who consumed MSPrebiotic® compared to placebo. No significant changes were found in MID adults. CONCLUSION: Our results suggest that dietary supplementation with prebiotics such as MSPrebiotic® may be part of an effective strategy to reduce IR, a major risk factor for developing T2D, in the ELD. CLINICAL TRIAL REGISTRATION: NCT01977183 listed on NIH website: ClinicalTrials.gov, The metadata generated in this study have been submitted to the NCBI Sequence Read Archive (http://www.ncbi.nlm.nih.gov/bioproject/381931).

Automated washing with the Reliance Endoscope Processing System and its equivalence to optimal manual cleaning.

BACKGROUND: Manual cleaning of flexible endoscopes is prone to error. To date, attempts to automate this process have been unsuccessful. The aim of this project was to compare the efficacy of the washing phase in the new Reliance EPS (STERIS Corp, Mentor, OH) with that of optimal manual cleaning. METHODS: Using simulated-use testing, all channels in 3 different flexible endoscopes, including a bronchoscope (Pentax, Pentax Medical Company, Miami, FL), a side-viewing duodenoscope (Olympus, Olympus Corporation), and a colonoscope (Fujinon, Fujinon Corporation, Wayne, NJ) were evaluated. All of the channels in the flexible endoscope were soiled with artificial test soil (ATS) (test soil that mimics the worst case levels of hemoglobin, protein, carbohydrate, and endotoxin from patient-used flexible endoscopes) containing 10(8) cfu/mL of Enterococcus faecalis and Pseudomonas aeruginosa The soiled scopes were allowed to dry for 1 hour prior to processing. Hemoglobin, protein, and viable organism counts for the flexible endoscopes were determined before and after cleaning. RESULTS: Both the Reliance EPS washing phase and optimal manual cleaning achieved >90% reduction of hemoglobin and protein, resulting in <6.4 microg/cm2 after the cleaning cycle. The reduction factor for viable organisms was not significantly different between the 2 methods, which ranged from 2.06 to 6.21 for manual cleaning and from 2.1 to 5.93 for the Reliance EPS washing phase. The mean reduction factor (all tests) was 4.32 +/- 1.03 for manual cleaning compared with 4.24 +/- 1.11 for Reliance EPS washing phase. CONCLUSION: The efficacy of the Reliance EPS washing phase for flexible endoscopes was equivalent to optimal manual cleaning for all the makes and models of flexible endoscopes tested.

Comparative sensitivity of stopwatch methodology and conventional pain assessment measures for detecting early response to triptans in migraine: results of a randomized, open-label pilot study.

BACKGROUND: The standard measure of efficacy used in migraine trials is a 4-point patient-rated headache pain intensity (HPI) scale. However, it has been suggested that using a stopwatch to measure the time to meaningful pain relief can provide a more precise measurement of treatment response. OBJECTIVE: This study evaluated the sensitivity of a stopwatch method for detecting meaningful relief of headache pain and the correlation of this method with the HPI scale and a 5-point pain relief scale. METHODS: In this open-label, parallel-group pilot study, patients were randomized to receive oral eletriptan 40 mg, eletriptan 80 mg, or rizatriptan 10 mg for the treatment of a single acute migraine attack. The effect of study treatment on migraine pain was assessed immediately before dosing and at 0.5, 1, 1.5, 2, 3, and 4 hours after dosing. At each time point, patients recorded the 3 types of pain assessment in a patient diary. HPI was rated using the standard 4-point International Headache Society pain intensity scale (from 0 = no pain to 3 = severe pain). Pain relief was rated on a 5-point pain relief scale (from 4 = no relief to 0 = complete relief). The time to the onset of meaningful pain relief was measured using a stopwatch. At 4 hours after dosing, patients provided a global rating of the overall efficacy of study medication on a 5-point scale (from 0 = poor to 4 = excellent). RESULTS: Seventy-nine patients participated in the trial (78.5% female; mean [SD] age, 37.7 [9.8] years; 58.2% white). The median times to meaningful pain relief measured by stopwatch were 84, 72, and 93 minutes for eletriptan 40 mg, eletriptan 80 mg, and rizatriptan 10 mg, respectively (log-rank P = 0.029, eletriptan 80 mg vs rizatriptan 10 mg). At 90 minutes (approximating the median time to meaningful pain relief on the stopwatch), headache response rates using HPI scoring (mild to no pain) were 65%, 68%, and 52% in the respective treatment groups, with no significant difference between groups. On the pain relief scale, the corresponding mean (SD) scores at 90 minutes were 1.6 (1.2), 1.4 (1.3), and 2.0 (1.4) (P = NS). The pain relief-defined response (> or = 75% pain relief) at 90 minutes did not differ significantly between the 3 treatment groups (62%, 56%, and 48%). Detection of early improvement (0.5 and 1 hour) was similar with the HPI and pain relief scales. CONCLUSION: The results of this open-label pilot study suggest the convergent validity of 3 pain-assessment methods in migraine, but indicate that the use of a stopwatch may be a more sensitive method for detecting between-group differences.