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1.  Swab culture monitoring of automated endoscope reprocessors after high-level disinfection 
AIM: To conduct a bacterial culture study for monitoring decontamination of automated endoscope reprocessors (AERs) after high-level disinfection (HLD).
METHODS: From February 2006 to January 2011, authors conducted randomized consecutive sampling each month for 7 AERs. Authors collected a total of 420 swab cultures, including 300 cultures from 5 gastroscope AERs, and 120 cultures from 2 colonoscope AERs. Swab cultures were obtained from the residual water from the AERs after a full reprocessing cycle. Samples were cultured to test for aerobic bacteria, anaerobic bacteria, and mycobacterium tuberculosis.
RESULTS: The positive culture rate of the AERs was 2.0% (6/300) for gastroscope AERs and 0.8% (1/120) for colonoscope AERs. All the positive cultures, including 6 from gastroscope and 1 from colonoscope AERs, showed monofloral colonization. Of the gastroscope AER samples, 50% (3/6) were colonized by aerobic bacterial and 50% (3/6) by fungal contaminations.
CONCLUSION: A full reprocessing cycle of an AER with HLD is adequate for disinfection of the machine. Swab culture is a useful method for monitoring AER decontamination after each reprocessing cycle. Fungal contamination of AERs after reprocessing should also be kept in mind.
doi:10.3748/wjg.v18.i14.1660
PMCID: PMC3325533  PMID: 22529696
Automated endoscope reprocessor; Gastrointestinal scope; High-level disinfection; Swab culture; Monitoring; Decontamination
2.  Comparative cost-efficiency of the EVOTECH endoscope cleaner and reprocessor versus manual cleaning plus automated endoscope reprocessing in a real-world Canadian hospital endoscopy setting 
BMC Gastroenterology  2011;11:105.
Background
Reprocessing of endoscopes generally requires labour-intensive manual cleaning followed by high-level disinfection in an automated endoscope reprocessor (AER). EVOTECH Endoscope Cleaner and Reprocessor (ECR) is approved for fully automated cleaning and disinfection whereas AERs require manual cleaning prior to the high-level disinfection procedure. The purpose of this economic evaluation was to determine the cost-efficiency of the ECR versus AER methods of endoscopy reprocessing in an actual practice setting.
Methods
A time and motion study was conducted at a Canadian hospital to collect data on the personnel resources and consumable supplies costs associated with the use of EVOTECH ECR versus manual cleaning followed by AER with Medivators DSD-201. Reprocessing of all endoscopes was observed and timed for both reprocessor types over three days. Laboratory staff members were interviewed regarding the consumption and cost of all disposable supplies and equipment. Exact Wilcoxon rank sum test was used for assessing differences in total cycle reprocessing time.
Results
Endoscope reprocessing was significantly shorter with the ECR than with manual cleaning followed by AER. The differences in median time were 12.46 minutes per colonoscope (p < 0.0001), 6.31 minutes per gastroscope (p < 0.0001), and 5.66 minutes per bronchoscope (p = 0.0040). Almost 2 hours of direct labour time was saved daily with the ECR. The total per cycle cost of consumables and labour for maintenance was slightly higher for EVOTECH ECR versus manual cleaning followed by AER ($8.91 versus $8.31, respectively). Including the cost of direct labour time consumed in reprocessing scopes, the per cycle and annual costs of using the EVOTECH ECR was less than the cost of manual cleaning followed by AER disinfection ($11.50 versus $11.88).
Conclusions
The EVOTECH ECR was more efficient and less costly to use for the reprocessing of endoscopes than manual cleaning followed by AER disinfection. Although the cost of consumable supplies required to reprocess endoscopes with EVOTECH ECR was slightly higher, the value of the labour time saved with EVOTECH ECR more than offset the additional consumables cost. The increased efficiency with EVOTECH ECR could lead to even further cost-savings by shifting endoscopy laboratory personnel responsibilities but further study is required.
doi:10.1186/1471-230X-11-105
PMCID: PMC3198958  PMID: 21967345
3.  EVOTECH® endoscope cleaner and reprocessor (ECR) simulated-use and clinical-use evaluation of cleaning efficacy 
BMC Infectious Diseases  2010;10:200.
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 μg/cm2 of residual protein, < 1.8 μg/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.
doi:10.1186/1471-2334-10-200
PMCID: PMC2914053  PMID: 20618935
4.  Comparison on the Efficacy of Disinfectants Used in Automated Endoscope Reprocessors: PHMB-DBAC versus Orthophthalaldehyde 
Clinical Endoscopy  2011;44(2):109-115.
Background/Aims
Since endoscopes are reusable apparatus classified as semicritical item, thorough reprocessing to achieve high-level disinfection is of utmost importance to prevent spread of infection. To improve disinfection efficacy and safety, disinfectants and endoscope reprocessors are continuously evolving. This study aimed to compare the efficacy of the combination of polyhexamethylenebiguanide hydrochloride-alkyldimethylbenzylammonium chloride (PHMB-DBAC) and orthophthalaldehyde (OPA) used respectively in ultrasonographic cleaning incorporated automated endoscope reprocessors: COOLENDO (APEX Korea) or OER-A (Olympus Optical).
Methods
A total of 86 flexible upper endoscopes were randomly reprocessed with either COOLENDO/PHMB-DBAC or OER-A/OPA. Culture samplings were done at two sites (endoscope tip and working channel) which were later incubated on blood agar plate. Bacterial colonies were counted and identified.
Results
The culture-positive rate at the endoscope tip and working channel was 0% and 2.33% for COOLENDO/PHMB-DBAC and 4.65% and 0% for OER-A/OPA. Staphylococcus hominis was cultured from one endoscope reprocessed with COOLENDO/PHMB-DBAC and Pseudomonas putida was isolated from two endoscopes reprocessed with OER-A/OPA.
Conclusions
The reprocessing efficacy of COOLENDO/PHMB-DBAC was non-inferior to that of OER-A/OPA (p=0.032; confidence interval, -0.042 to 0.042). During the study period, significant side effect of PHMB-DBAC was not observed.
doi:10.5946/ce.2011.44.2.109
PMCID: PMC3363059  PMID: 22741121
Endoscope reprocessing; Disinfectants; High-level disinfection
5.  Transmission of Infection by Flexible Gastrointestinal Endoscopy and Bronchoscopy 
Clinical Microbiology Reviews  2013;26(2):231-254.
SUMMARY
Flexible endoscopy is a widely used diagnostic and therapeutic procedure. Contaminated endoscopes are the medical devices frequently associated with outbreaks of health care-associated infections. Accurate reprocessing of flexible endoscopes involves cleaning and high-level disinfection followed by rinsing and drying before storage. Most contemporary flexible endoscopes cannot be heat sterilized and are designed with multiple channels, which are difficult to clean and disinfect. The ability of bacteria to form biofilms on the inner channel surfaces can contribute to failure of the decontamination process. Implementation of microbiological surveillance of endoscope reprocessing is appropriate to detect early colonization and biofilm formation in the endoscope and to prevent contamination and infection in patients after endoscopic procedures. This review presents an overview of the infections and cross-contaminations related to flexible gastrointestinal endoscopy and bronchoscopy and illustrates the impact of biofilm on endoscope reprocessing and postendoscopic infection.
doi:10.1128/CMR.00085-12
PMCID: PMC3623380  PMID: 23554415
6.  Modeling microbial survival in buildup biofilm for complex medical devices 
Background
Flexible endoscopes undergo repeated rounds of patient-use and reprocessing. Some evidence indicates that there is an accumulation or build-up of organic material that occurs over time in endoscope channels. This "buildup biofilm" (BBF) develops as a result of cyclical exposure to wet and dry phases during usage and reprocessing. This study investigated whether the BBF matrix represents a greater challenge to disinfectant efficacy and microbial eradication than traditional biofilm (TBF), which forms when a surface is constantly bathed in fluid.
Methods
Using the MBEC (Minimum Biofilm Eradication Concentration) system, a unique modelling approach was developed to evaluate microbial survival in BBF formed by repetitive cycles of drying, disinfectant exposure and re-exposure to the test organism. This model mimics the cumulative effect of the reprocessing protocol on flexible endoscopes. Glutaraldehyde (GLUT) and accelerated hydrogen peroxide (AHP) were evaluated to assess the killing of microbes in TBF and BBF.
Results
The data showed that the combination of an organic matrix and aldehyde disinfection quickly produced a protective BBF that facilitated high levels of organism survival. In cross-linked BBF formed under high nutrient conditions the maximum colony forming units (CFU) reached ~6 Log10 CFU/peg. However, if an oxidizing agent was used for disinfection and if organic levels were kept low, organism survival did not occur. A key finding was that once established, the microbial load of BBF formed by GLUT exposure had a faster rate of accumulation than in TBF. The rate of biofilm survival post high-level disinfection (HLD) determined by the maximum Log10CFU/initial Log10CFU for E. faecalis and P. aeruginosa in BBF was 10 and 8.6 respectively; significantly different compared to a survival rate in TBF of ~2 for each organism. Data from indirect outgrowth testing demonstrated for the first time that there is organism survival in the matrix. Both TBF and BBF had surviving organisms when GLUT was used. For AHP survival was seen less frequently in BBF than in TBF.
Conclusion
This BBF model demonstrated for the first time that survival of a wide range of microorganisms does occur in BBF, with significantly more rapid outgrowth compared to TBF. This is most pronounced when GLUT is used compared to AHP. The data supports the need for meticulous cleaning of reprocessed endoscopes since the presence of organic material and microorganisms prevents effective disinfection when GLUT and AHP are used. However, cross-linking agents like GLUT are not as effective when there is BBF. The data from the MBEC model of BBF suggest that for flexible endoscopes that are repeatedly used and reprocessed, the assurance of effective high-level disinfection may decrease if BBF develops within the channels.
doi:10.1186/1471-2334-9-56
PMCID: PMC2689233  PMID: 19426471
7.  A microbiological evaluation of level of disinfection for flexible cystoscopes protected by disposable endosheaths 
BMC Urology  2013;13:46.
Background
Flexible cystoscopy is used in urological outpatient departments for diagnostic cystoscopy of bladder cancer and requires a high-level disinfection between each patient. The purpose of this study was to make a microbiological post disinfection efficacy assessment of flexible cystoscopes (FC) using disposable sterile endosheaths.
Methods
One hundred endosheaths underwent a leak-test for barrier integrity after cystoscopy. Microbiological samples from these cystoscopies were obtained; after removal of the endosheath, and after cleaning the scope with a detergent cloth, rinsing with tap water followed by 70% ethanol disinfection and subsequent drying. The number of colony forming units (cfu) from the samples was counted after 72 hours and then divided in three categories, Clean FC (<5 cfu/sample), Critical FC (5–50 cfu/sample) and High-risk FC (>50 cfu/sample). The result was compared with data of 10 years continuous control sampling recorded in the Copenhagen Clean-Endoscope Quality Control Database (CCQCD) and analyzed with a Chi-square test for homogeneity.
Results
All 100 endosheaths passed the leak-test. All samples showed a Clean FC and low means of cfu. A query to the CCQCD, showed that 99.8% (1264/1267) of all FC with a built-in work-channel reprocessed in a WD were clean before use.
Conclusion
The reprocessing of FC using endosheaths, as preformed in this study, provides a patient-ready procedure. The results display a reprocessing procedure with low risk of pathogen transmission, high patient safety and a valid alternative to the recommended high-level disinfection procedure of FC. However, the general impression was that sheaths slightly reduced vision and resulted in some patient discomfort.
doi:10.1186/1471-2490-13-46
PMCID: PMC3852551  PMID: 24099332
Flexible cystoscopy; Endosheaths; Microbiological assessment; Disinfection; Bladder cancer
8.  Elimination of high titre HIV from fibreoptic endoscopes. 
Gut  1990;31(6):657-659.
Concern about contamination of fibreoptic endoscopes with human immunodeficiency virus (HIV) has generated a variety of disruptive and possibly unnecessary infection control practices in endoscopy units. Current recommendations on the cleaning and disinfection of endoscopes have been formulated without applied experimental evidence of the effective removal of HIV from endoscopes. To study the kinetics of elimination of HIV from endoscope surfaces, we artificially contaminated the suction-biopsy channels of five Olympus GIF XQ20 endoscopes with high titre HIV in serum. The air and water channels of two instruments were similarly contaminated. Contamination was measured by irrigating channels with viral culture medium and collecting 3 ml at the distal end for antigen immunoassay. Endoscopes were then cleaned manually in neutral detergent according to the manufacturer's recommendations and disinfected in 2% alkaline glutaraldehyde (Cidex, Surgikos) for two, four, and ten minutes. Contamination with HIV antigens was measured before and after cleaning and after each period of disinfection. Initial contamination comprised 4.8 x 10(4) to 3.5 x 10(6) pg HIV antigen/ml. Cleaning in detergent achieved a reduction to 165 pg/ml (99.93%) on one endoscope and to undetectable levels (100%) on four. After two minutes in alkaline glutaraldehyde all samples were negative and remained negative after the longer disinfection times. Air and water channels, where contaminated, were tested after 10 minutes' disinfection and were negative. These findings underline the importance of cleaning in removing HIV from endoscope and indicate that the use of dedicated equipment and long disinfection times are unnecessary.
PMCID: PMC1378490  PMID: 2379868
9.  Controlled comparison of bioMérieux VITAL and BACTEC NR-660 systems for detection of bacteremia and fungemia in pediatric patients. 
Journal of Clinical Microbiology  1997;35(8):2007-2012.
The bioMérieux VITAL automated blood culture system measures a decrease in fluorescence to detect the presence of microorganisms in blood. To assess the performance of VITAL with AER aerobic medium versus that of the nonradiometric BACTEC NR-660 PEDS PLUS medium for the detection of sepsis in children, a total of 12,146 blood specimens were collected at three university medical centers and inoculated into AER and PEDS PLUS bottles that were weighed before and after filling. The sample volumes were considered adequate in 6,276 bottle pairs. The total yield of isolates was 629, of which 489 (78%) were judged to be the cause of true infections. Staphylococci (P < 0.001) and yeasts (P < 0.05) were detected more often in PEDS PLUS bottles, as were all microorganisms combined (P < 0.001). The improved detection in the PEDS PLUS medium was most marked for patients on antimicrobial therapy (P < 0.001), but remained statistically significant even for patients not on therapy (P < 0.025). There were 431 episodes of sepsis, including 407 considered adequate for analysis. Of the 363 unimicrobial episodes, 278 were detected by both bottles, 64 were detected by PEDS PLUS bottles only, and 21 were detected by AER bottles only (P < 0.01). No false-negative cultures were detected by terminal subculture of the PEDS PLUS bottles when the companion AER bottle was positive. However, there were 14 false-negative cultures (7 yeasts, 5 staphylococci, 1 Enterococcus faecalis, and 1 Enterobacter sp.) on terminal subculture of the AER bottles when the companion PEDS PLUS bottle was positive. When both systems were positive, the VITAL system detected bacteria earlier than did the BACTEC system by a mean of 1.6 h. Also, false-positive signals were less common with the VITAL system. We conclude that the VITAL system with AER medium must be modified to improve the detection of clinically important staphylococci and yeasts if it is to perform comparably to the BACTEC NR-660 nonradiometric system with PEDS PLUS medium for a pediatric population.
PMCID: PMC229892  PMID: 9230371
10.  Discovery of early-stage biomarkers for diabetic kidney disease using ms-based metabolomics (FinnDiane study) 
Metabolomics  2011;8(1):109-119.
Diabetic kidney disease (DKD) is a devastating complication that affects an estimated third of patients with type 1 diabetes mellitus (DM). There is no cure once the disease is diagnosed, but early treatment at a sub-clinical stage can prevent or at least halt the progression. DKD is clinically diagnosed as abnormally high urinary albumin excretion rate (AER). We hypothesize that subtle changes in the urine metabolome precede the clinically significant rise in AER. To test this, 52 type 1 diabetic patients were recruited by the FinnDiane study that had normal AER (normoalbuminuric). After an average of 5.5 years of follow-up half of the subjects (26) progressed from normal AER to microalbuminuria or DKD (macroalbuminuria), the other half remained normoalbuminuric. The objective of this study is to discover urinary biomarkers that differentiate the progressive form of albuminuria from non-progressive form of albuminuria in humans. Metabolite profiles of baseline 24 h urine samples were obtained by gas chromatography–mass spectrometry (GC–MS) and liquid chromatography–mass spectrometry (LC–MS) to detect potential early indicators of pathological changes. Multivariate logistic regression modeling of the metabolomics data resulted in a profile of metabolites that separated those patients that progressed from normoalbuminuric AER to microalbuminuric AER from those patients that maintained normoalbuminuric AER with an accuracy of 75% and a precision of 73%. As this data and samples are from an actual patient population and as such, gathered within a less controlled environment it is striking to see that within this profile a number of metabolites (identified as early indicators) have been associated with DKD already in literature, but also that new candidate biomarkers were found. The discriminating metabolites included acyl-carnitines, acyl-glycines and metabolites related to tryptophan metabolism. We found candidate biomarkers that were univariately significant different. This study demonstrates the potential of multivariate data analysis and metabolomics in the field of diabetic complications, and suggests several metabolic pathways relevant for further biological studies.
Electronic supplementary material
The online version of this article (doi:10.1007/s11306-011-0291-6) contains supplementary material, which is available to authorized users.
doi:10.1007/s11306-011-0291-6
PMCID: PMC3258399  PMID: 22279428
Diabetic kidney disease; Nephropathy; Metabolite profile; Metabolomics; Urine; GC–MS; LC–MS; Multivariate data analysis
11.  Microalbuminuria among Type 1 and Type 2 diabetic patients of African origin in Dar Es Salaam, Tanzania 
BMC Nephrology  2007;8:2.
Background
The prevalences and risk factors of microalbuminuria are not full described among black African diabetic patients. This study aimed at determining the prevalence of microalbuminuria among African diabetes patients in Dar es Salaam, Tanzania, and relate to socio-demographic features as well as clinical parameters.
Methods
Cross sectional study on 91 Type 1 and 153 Type 2 diabetic patients. Two overnight urine samples per patient were analysed. Albumin concentration was measured by an automated immunoturbidity assay. Average albumin excretion rate (AER) was used and were categorised as normalbuminuria (AER < 20 ug/min), microalbuminuria (AER 20–200 ug/min), and macroalbuminuria (AER > 200 ug/min). Information obtained also included age, diabetes duration, sex, body mass index, blood pressure, serum total cholesterol, high-density and low-density lipoprotein cholesterol, triglycerides, serum creatinine, and glycated hemoglobin A1c.
Results
Overall prevalence of microalbuminuria was 10.7% and macroalbuminuria 4.9%. In Type 1 patients microalbuminuria was 12% and macroalbuminuria 1%. Among Type 2 patients, 9.8% had microalbuminuria, and 7.2% had macroalbuminuria. Type 2 patients with abnormal albumin excretion rate had significantly longer diabetes duration 7.5 (0.2–24 yrs) than those with normal albumin excretion rate 3 (0–25 yrs), p < 0.001. Systolic and diastolic blood pressure among Type 2 patients with abnormal albumin excretion rate were significantly higher than in those with normal albumin excretion rate, (p < 0.001).
No significant differences in body mass index, glycaemic control, and cholesterol levels was found among patients with normal compared with those with elevated albumin excretion rate either in Type 1 or Type 2 patients.
A stepwise multiple linear regression analysis among Type 2 patients, revealed AER (natural log AER) as the dependent variable to be predicted by [odds ratio (95% confidence interval)] diabetes duration 0.090 (0.049, 0.131), p < 0.0001, systolic blood pressure 0.012 (0.003–0.021), p < 0.010 and serum creatinine 0.021 (0.012, 0.030).
Conclusion
The prevalence of micro and macroalbuminuria is higher among African Type 1 patients with relatively short diabetes duration compared with prevalences among Caucasians. In Type 2 patients, the prevalence is in accordance with findings in Caucasians. The present study detects, however, a much lower prevalence than previously demonstrated in studies from sub-Saharan Africa. Abnormal AER was significantly related to diabetes duration and systolic blood pressure.
doi:10.1186/1471-2369-8-2
PMCID: PMC1781433  PMID: 17224056
12.  Bactericidal, virucidal, and mycobactericidal activities of reused alkaline glutaraldehyde in an endoscopy unit. 
Journal of Clinical Microbiology  1993;31(11):2988-2995.
Baths with 2% alkaline glutaraldehyde are often reused for 14 days to decontaminate flexible fiberoptic endoscopes (FFEs) between patients, but the effect of such reuse on the disinfectant's activity has not been known. Many busy endoscopy units also disinfect FFEs with contact times shorter than those recommended by the disinfectant manufacturer. We therefore collected samples of the disinfectant over the 14-day reuse period from two manual and one automatic bath used for bronchoscopes and gastroscopes at a local hospital. Control samples were also collected from a manual bath of 2% alkaline glutaraldehyde which did not receive any endoscopes. The germicidal activities of the samples were assessed in a carrier test against a mixture of hepatitis A virus, poliovirus 1 (Sabin), and Pseudomonas aeruginosa; the mixture also contained either Mycobacterium bovis or Mycobacterium gordonae. Bovine serum (5%) was the organic load. The criterion of efficacy was a minimum of a 3-log10-unit reduction in the infectivity titers of the organisms tested. The initial disinfectant concentration in all the baths was nearly 2.25%; it became about 1.8% in the control bath and fell to approximately 1% in the three test baths after 14 days. No protein was detected in the control bath, while its concentration rose gradually in the test baths to a maximum of 1,267 micrograms/ml after 14 days. With a contact time of 10 min at 20 +/- 2 degrees C, all the samples from the control bath were effective against all the test organisms and all the samples from all the test baths were also effective against P. aeruginosa. With a contact time of 10 or 20 min at 20+/-2 degrees C, the virucidal and mycobactericidal activities of the samples from the test baths showed broad-spectrum germicidal activity when the contact time was increased to 45 min and the temperature was raised to 25 degrees C. These findings emphasize the care needed in the disinfection of FFEs, especially in view of the increasing threat of AIDS and the resurgence of tuberculosis.
PMCID: PMC266182  PMID: 8263184
13.  Early Urinary Markers of Diabetic Kidney Disease: A Nested Case-Control Study From the Diabetes Control and Complications Trial (DCCT) 
Background
Urinary markers were tested as predictors of macroalbuminuria or microalbuminuria in type 1 diabetes.
Study Design
Nested case:control of participants in the Diabetes Control and Complications Trial (DCCT)
Setting & Participants
Eighty-seven cases of microalbuminuria were matched to 174 controls in a 1:2 ratio, while 4 cases were matched to 4 controls in a 1:1 ratio, resulting in 91 cases and 178 controls for microalbuminuria. Fifty-five cases of macroalbuminuria were matched to 110 controls in a 1:2 ratio. Controls were free of micro/macroalbuminuria when their matching case first developed micro/macroalbuminuria.
Predictors
Urinary N-acetyl-β-D-glucosaminidase, pentosidine, AGE fluorescence, albumin excretion rate (AER)
Outcomes
Incident microalbuminuria (two consecutive annual AER > 40 but <= 300 mg/day), or macroalbuminuria (AER > 300 mg/day)
Measurements
Stored urine samples from DCCT entry, and 1–9 years later when macroalbuminuria or microalbuminuria occurred, were measured for the lysosomal enzyme, N-acetyl-β-D-glucosaminidase, and the advanced glycosylation end-products (AGEs) pentosidine and AGE-fluorescence. AER and adjustor variables were obtained from the DCCT.
Results
Sub-microalbuminuric levels of AER at baseline independently predicted microalbuminuria (adjusted OR 1.83; p<.001) and macroalbuminuria (adjusted OR 1.82; p<.001). Baseline N-acetyl-β-D-glucosaminidase independently predicted macroalbuminuria (adjusted OR 2.26; p<.001), and microalbuminuria (adjusted OR 1.86; p<.001).
Baseline pentosidine predicted macroalbuminuria (adjusted OR 6.89; p=.002). Baseline AGE fluorescence predicted microalbuminuria (adjusted OR 1.68; p=.02). However, adjusted for N-acetyl-β-D-glucosaminidase, pentosidine and AGE-fluorescence lost predictive association with macroalbuminuria and microalbuminuria, respectively.
Limitations
Use of angiotensin converting-enzyme inhibitors was not directly ascertained, although their use was proscribed during the DCCT.
Conclusions
Early in type 1 diabetes, repeated measurements of AER and urinary NAG may identify individuals susceptible to future diabetic nephropathy. Combining the two markers may yield a better predictive model than either one alone. Renal tubule stress may be more severe, reflecting abnormal renal tubule processing of AGE-modified proteins, among individuals susceptible to diabetic nephropathy.
doi:10.1053/j.ajkd.2009.11.009
PMCID: PMC2864367  PMID: 20138413
Diabetic nephropathy; Advanced glycosylation end-products; N-acetyl beta glucosaminidase; Albuminuria
14.  Development and Progression of Renal Insufficiency With and Without Albuminuria in Adults With Type 1 Diabetes in the Diabetes Control and Complications Trial and the Epidemiology of Diabetes Interventions and Complications Study 
Diabetes Care  2010;33(7):1536-1543.
OBJECTIVE
This multicenter study examined the impact of albumin excretion rate (AER) on the course of estimated glomerular filtration rate (eGFR) and the incidence of sustained eGFR <60 ml/min/1.73 m2 in type 1 diabetes up to year 14 of the Epidemiology of Diabetes Interventions and Complications (EDIC) study (mean duration of 19 years in the Diabetes Control and Complications Trial [DCCT]/EDIC).
RESEARCH DESIGN AND METHODS
Urinary albumin measurements from 4-h urine collections were obtained from participants annually during the DCCT and every other year during the EDIC study, and serum creatinine was measured annually in both the DCCT and EDIC study. GFR was estimated from serum creatinine using the abbreviated Modification of Diet in Renal Disease equation.
RESULTS
A total of 89 of 1,439 subjects developed an eGFR <60 ml/min/1.73 m2 (stage 3 chronic kidney disease on two or more successive occasions (sustained) during the DCCT/EDIC study (cumulative incidence 11.4%). Of these, 20 (24%) had AER <30 mg/24 h at all prior evaluations, 14 (16%) had developed microalbuminuria (AER 30–300 mg/24 h) before they reached stage 3 chronic kidney disease, and 54 (61%) had macroalbuminuria (AER >300 mg/24 h) before they reached stage 3 chronic kidney disease. Macroalbuminuria is associated with a markedly increased rate of fall in eGFR (5.7%/year vs. 1.2%/year with AER <30 mg/24 h, P < 0.0001) and risk of eGFR <60 ml/min/1.73 m2 (adjusted hazard ratio 15.3, P < 0.0001), whereas microalbuminuria had weaker and less consistent effects on eGFR.
CONCLUSIONS
Macroalbuminuria was a strong predictor of eGFR loss and risk of developing sustained eGFR <60 ml/min/1.73 m2. However, screening with AER alone would have missed 24% of cases of sustained impaired eGFR.
doi:10.2337/dc09-1098
PMCID: PMC2890355  PMID: 20413518
15.  Assessment on Experimental Bacterial Biofilms and in Clinical Practice of the Efficacy of Sampling Solutions for Microbiological Testing of Endoscopes 
Journal of Clinical Microbiology  2012;50(3):938-942.
Opinions differ on the value of microbiological testing of endoscopes, which varies according to the technique used. We compared the efficacy on bacterial biofilms of sampling solutions used for the surveillance of the contamination of endoscope channels. To compare efficacy, we used an experimental model of a 48-h Pseudomonas biofilm grown on endoscope internal tubing. Sampling of this experimental biofilm was performed with a Tween 80-lecithin-based solution, saline, and sterile water. We also performed a randomized prospective study during routine clinical practice in our hospital sampling randomly with two different solutions the endoscopes after reprocessing. Biofilm recovery expressed as a logarithmic ratio of bacteria recovered on bacteria initially present in biofilm was significantly more effective with the Tween 80-lecithin-based solution than with saline solution (P = 0.002) and sterile water (P = 0.002). There was no significant difference between saline and sterile water. In the randomized clinical study, the rates of endoscopes that were contaminated with the Tween 80-lecithin-based sampling solution and the saline were 8/25 and 1/25, respectively (P = 0.02), and the mean numbers of bacteria recovered were 281 and 19 CFU/100 ml (P = 0.001), respectively. In conclusion, the efficiency and therefore the value of the monitoring of endoscope reprocessing by microbiological cultures is dependent on the sampling solutions used. A sampling solution with a tensioactive action is more efficient than saline in detecting biofilm contamination of endoscopes.
doi:10.1128/JCM.06221-11
PMCID: PMC3295158  PMID: 22170930
16.  Hygienic safety of reusable tap water filters (Germlyser®) with an operating time of 4 or 8 weeks in a haematological oncology transplantation unit 
Background
Microbial safe tap water is crucial for the safety of immunosuppressed patients.
Methods
To evaluate the suitability of new, reusable point-of-use filters (Germlyser®, Aquafree GmbH, Hamburg, Germany), three variations of a reusable filter with the same filter principle but with different outlets (with and without silver) and inner surface coating of the filter encasements (with and without nano-crystalline silver) were tested. The filter efficacy was monitored over 1, 4 and 8 weeks operating time in a haematological oncology transplantation unit equipped with 18 water outlets (12 taps, 6 showers).
Results
The filtered water fulfilled the requirements of absence of pathogens over time. From 348 samples, 8 samples (2.3%) exceeded 100 cfu/ml (no sample ≥ 500 cfu/ml). As no reprocessed filter exhibited 100% filter efficacy in the final quality control after each reprocessing, these contaminations could be explained by retrograde contamination during use.
Conclusion
As a consequence of the study, the manufacturer recommends changing filters after 4 weeks in high risk areas and after 8 weeks in moderate infectious risk areas, together with routine weekly alcohol-based surface disinfection and additionally in case of visible contamination. The filter efficacy of the 3 filters types did not differ significantly regarding total bacterial counts. Manual reprocessing proved to be insufficient. Using a validated reprocessing in a washer/disinfector with alkaline, acid treatment and thermic disinfection, the filters were effectively reprocessable and now provide tap water meeting the German drinking water regulations as well as the WHO guidelines, including absence of pathogens.
doi:10.1186/1471-2334-7-45
PMCID: PMC1892024  PMID: 17521416
17.  Aldehyde-Resistant Mycobacteria Associated with the Use of Endoscope Reprocessing Systems 
Bacteria can develop resistance to antibiotics, but less is known about their ability to increase resistance to chemical disinfectants. This study randomly sampled three AERs in the USA using aldehydes for endoscope disinfection. Bacterial contamination was found post-disinfection in all AERs and some mycobacteria isolated demonstrated significant resistance to glutaraldehyde and OPA disinfectants. Bacteria can survive aldehyde-based disinfection and may pose a cross-contamination risk to patients.
doi:10.1016/j.ajic.2011.11.004
PMCID: PMC3523318  PMID: 22325730
18.  Disinfection for infection prevention over the course of time 
In recent years and decades increasingly more emphasis has been placed on alcohol-based solutions for hygienic and surgical hand disinfection. Traditional handwashing with soap and water has been largely replaced in the everyday clinical setting, as has the use of disinfectant soap-based solutions for surgical hand disinfection. It has been possible in recent years to reduce the exposure time for alcohol-based hand disinfection in surgery from 5 to 3 minutes, and there are plans to reduce this even further. The growing awareness of the tolerability issues has also given rise to favorable developments here. There have also been dramatic changes in preoperative skin disinfection. The non-alcoholic solutions with a slow onset of action (e.g. iodophors) have been virtually replaced by alcohol-based solutions of demonstrated efficacy. Non-alcoholic solutions continue to be used for disinfection of mucous membranes, but iodine-based products are being phased out here.
The term “instrument disinfection” has been largely supplanted now by the expression “instrument reprocessing or medical device decontamination” (which is also underpinned by legislation) and it takes account of the trend towards thermal disinfection. Meticulous cleaning is thus an indispensable precondition for sterilization, which normally follows disinfection.
The greatest lack of consensus at European level relates to surface disinfection. Routine, parallel cleaning and disinfection of all surfaces close to and remote from the patient is being increasingly replaced by selective disinfection, whenever warranted, of surfaces close to the patient. The problem here is that medical personnel continue to view cleaning and disinfection as interchangeable tasks. This situation is further compounded by the fact that hospitals are finding it increasingly more difficult to assure adequately successful cleaning and disinfection outcomes. To ensure effective infection control, cleaning and disinfection of surfaces in special situations must also be assured whenever warranted outside the regular working hours.
Disinfection and decontamination of highly complex medical devices that pose special challenges (heat-sensitive devices with an intricate design and, correspondingly, with surfaces that are difficult to access, e.g. flexible endoscopes) will present the main challenge in the future. There is still much to be accomplished here to assure the hygienic safety of the patient.
PMCID: PMC2831498  PMID: 20200677
19.  The antimicrobial effect of Octenidine-dihydrochloride coated polymer tracheotomy tubes on Staphylococcus aureus and Pseudomonas aeruginosa colonisation 
BMC Microbiology  2009;9:150.
Background
The surface of polymeric tracheotomy tubes is a favourable environment for biofilm formation and therefore represents a potential risk factor for the development of pneumonia after tracheotomy. The aim of this in-vitro study was to develop octenidine-dihydrochloride (OCT) coated polymer tracheotomy tubes and investigate any effects on Staphylococcus (S.) aureus and Pseudomonas (P.) aeruginosa colonization. Additionally the resistance of the OCT coating was tested using reprocessing procedures like brushing, rinsing and disinfection with glutaraldehyde
Results
Contamination with S. aureus: Before any reprocessing, OCT coated tracheotomy tubes were colonized with 103 cfu/ml and uncoated tracheotomy tubes with 105 cfu/ml (P = 0.045). After reprocessing, no differences in bacterial concentration between modified and conventional tubes were observed.
Contamination with P. aeruginosa: Before reprocessing, OCT coated tubes were colonized with 106 cfu/ml and uncoated tubes with 107 cfu/ml (P = 0.006). After reprocessing, no significant differences were observed.
Conclusion
OCT coating initially inhibits S. aureus and P. aeruginosa colonisation on tracheotomy tubes. This effect, however, vanishes quickly after reprocessing of the tubes due to poor adhesive properties of the antimicrobial compound. Despite the known antimicrobial effect of OCT, its use for antimicrobial coating of tracheotomy tubes is limited unless methods are developed to allow sustained attachment to the tube.
doi:10.1186/1471-2180-9-150
PMCID: PMC2726150  PMID: 19630994
20.  Quantitative analysis of residual protein contamination of podiatry instruments reprocessed through local and central decontamination units 
Background
The cleaning stage of the instrument decontamination process has come under increased scrutiny due to the increasing complexity of surgical instruments and the adverse affects of residual protein contamination on surgical instruments. Instruments used in the podiatry field have a complex surface topography and are exposed to a wide range of biological contamination. Currently, podiatry instruments are reprocessed locally within surgeries while national strategies are favouring a move toward reprocessing in central facilities. The aim of this study was to determine the efficacy of local and central reprocessing on podiatry instruments by measuring residual protein contamination of instruments reprocessed by both methods.
Methods
The residual protein of 189 instruments reprocessed centrally and 189 instruments reprocessed locally was determined using a fluorescent assay based on the reaction of proteins with o-phthaldialdehyde/sodium 2-mercaptoethanesulfonate.
Results
Residual protein was detected on 72% (n = 136) of instruments reprocessed centrally and 90% (n = 170) of instruments reprocessed locally. Significantly less protein (p < 0.001) was recovered from instruments reprocessed centrally (median 20.62 μg, range 0 - 5705 μg) than local reprocessing (median 111.9 μg, range 0 - 6344 μg).
Conclusions
Overall, the results show the superiority of central reprocessing for complex podiatry instruments when protein contamination is considered, though no significant difference was found in residual protein between local decontamination unit and central decontamination unit processes for Blacks files. Further research is needed to undertake qualitative identification of protein contamination to identify any cross contamination risks and a standard for acceptable residual protein contamination applicable to different instruments and specialities should be considered as a matter of urgency.
doi:10.1186/1757-1146-4-2
PMCID: PMC3023740  PMID: 21219613
21.  The Effects of Dietary Patterns on Urinary Albumin Excretion: Results of the Dietary Approaches to Stop Hypertension (DASH) Trial 
Background
Dietary studies designed to lower urinary albumin excretion rate (AER) typically reduce protein by increasing lower protein plant foods and reducing higher protein animal products.
Study Design
We evaluated AER while increasing protein intake in the Dietary Approaches to Stop Hypertension (DASH) Trial (randomized, parallel group, 8 week controlled feeding).
Setting & Participants
378 individuals without diabetes with prehypertension or stage I hypertension.
Intervention
The DASH diet, 18% energy from protein, emphasizes, among other features, lowfat dairy products; and the fruit/vegetable (FV) and Control diets, each with 15% energy from protein.
Outcome
AER
Measurements
We measured AER by immunoassay and covariates at baseline and after 8 weeks.
Results
Baseline AER had geometric mean ± standard error 4.0 ± 0.2 mg/24hr. Among 285 participants with baseline AER<7 mg/24hr, AER was unchanged by diet treatment (geometric mean 2.5 ± 0.2 mg/24hr in Control, 3.0 ± 0.2 mg/24hr in FV, 2.8 ± 0.2 mg/24hr in DASH). In contrast, among 93 participants with baseline AER ≥7 mg/24hr, end of feeding AER was lower in FV (6.6 ± 1.0 mg/24hr) than in Control (11.4 ± 1.8 mg/24hr (p=0.01) or DASH (11.7 ± 1.6 mg/24hr p = 0.005). The DASH and control diets were not different (p=0.9).
Limitations
Long term AER change not studied.
Conclusions
Reduction in AER after 8 weeks occurred only in those with high normal baseline AER in FV, in a pattern distinct from blood pressure reduction. The DASH diet did not increase AER despite 3% increase in energy from protein.
doi:10.1053/j.ajkd.2008.10.048
PMCID: PMC2676223  PMID: 19167797
22.  The Plant Pathogen Ralstonia solanacearum Needs Aerotaxis for Normal Biofilm Formation and Interactions with Its Tomato Host▿  
Journal of Bacteriology  2007;189(17):6415-6424.
Ralstonia solanacearum is a soilborne pathogen that causes bacterial wilt of diverse plant species. To locate and infect host plant roots R. solanacearum needs taxis, the ability to move toward more favorable conditions. However, the specific signals that attract this pathogen were unknown. One candidate is aerotaxis, or energy taxis, which guides bacteria toward optimal intracellular energy levels. The R. solanacearum genome encodes two putative aerotaxis transducers. Cloned R. solanacearum aer1 and aer2 genes restored aerotaxis to an Escherichia coli aer mutant, demonstrating that both genes encode heterologously functional aerotaxis transducers. Site-directed mutants lacking aer1, aer2, or both aer1 and aer2 were significantly less able to move up an oxygen gradient than the wild-type parent strain; in fact, the aerotaxis of the aer mutants was indistinguishable from that of a completely nonmotile strain. Tomato plants inoculated with either the aer2 or the aer1/aer2 mutant had slightly delayed wilt disease development. Furthermore, the aer1/aer2 double mutant was significantly impaired in the ability to rapidly localize on tomato roots compared to its wild-type parent. Unexpectedly, all nonaerotactic mutants formed thicker biofilms on abiotic surfaces than the wild type. These results indicate that energy taxis contributes significantly to the ability of R. solanacearum to locate and effectively interact with its host plants.
doi:10.1128/JB.00398-07
PMCID: PMC1951909  PMID: 17601784
23.  Computer-aided recording of automatic endoscope washing and disinfection processes as an integral part of medical documentation for quality assurance purposes 
BMC Gastroenterology  2010;10:76.
Background
The reprocessing of medical endoscopes is carried out using automatic cleaning and disinfection machines. The documentation and archiving of records of properly conducted reprocessing procedures is the last and increasingly important part of the reprocessing cycle for flexible endoscopes.
Methods
This report describes a new computer program designed to monitor and document the automatic reprocessing of flexible endoscopes and accessories in fully automatic washer-disinfectors; it does not contain nor compensate the manual cleaning step. The program implements national standards for the monitoring of hygiene in flexible endoscopes and the guidelines for the reprocessing of medical products. No FDA approval has been obtained up to now. The advantages of this newly developed computer program are firstly that it simplifies the documentation procedures of medical endoscopes and that it could be used universally with any washer-disinfector and that it is independent of the various interfaces and software products provided by the individual suppliers of washer-disinfectors.
Results
The computer program presented here has been tested on a total of four washer-disinfectors in more than 6000 medical examinations within 9 months.
Conclusions
We present for the first time an electronic documentation system for automated washer-disinfectors for medical devices e.g. flexible endoscopes which can be used on any washer-disinfectors that documents the procedures involved in the automatic cleaning process and can be easily connected to most hospital documentation systems.
doi:10.1186/1471-230X-10-76
PMCID: PMC2912802  PMID: 20615248
24.  Sphingomyelin is associated with kidney disease in type 1 diabetes (The FinnDiane Study) 
Metabolomics  2011;8(3):369-375.
Diabetic kidney disease, diagnosed by urinary albumin excretion rate (AER), is a critical symptom of chronic vascular injury in diabetes, and is associated with dyslipidemia and increased mortality. We investigated serum lipids in 326 subjects with type 1 diabetes: 56% of patients had normal AER, 17% had microalbuminuria (20 ≤ AER < 200 μg/min or 30 ≤ AER < 300 mg/24 h) and 26% had overt kidney disease (macroalbuminuria AER ≥ 200 μg/min or AER ≥ 300 mg/24 h). Lipoprotein subclass lipids and low-molecular-weight metabolites were quantified from native serum, and individual lipid species from the lipid extract of the native sample, using a proton NMR metabonomics platform. Sphingomyelin (odds ratio 2.53, P < 10−7), large VLDL cholesterol (odds ratio 2.36, P < 10−10), total triglycerides (odds ratio 1.88, P < 10−6), omega-9 and saturated fatty acids (odds ratio 1.82, P < 10−5), glucose disposal rate (odds ratio 0.44, P < 10−9), large HDL cholesterol (odds ratio 0.39, P < 10−9) and glomerular filtration rate (odds ratio 0.19, P < 10−10) were associated with kidney disease. No associations were found for polyunsaturated fatty acids or phospholipids. Sphingomyelin was a significant regressor of urinary albumin (P < 0.0001) in multivariate analysis with kidney function, glycemic control, body mass, blood pressure, triglycerides and HDL cholesterol. Kidney injury, sphingolipids and excess fatty acids have been linked in animal models—our exploratory approach provides independent support for this relationship in human patients with diabetes.
Electronic supplementary material
The online version of this article (doi:10.1007/s11306-011-0343-y) contains supplementary material, which is available to authorized users.
doi:10.1007/s11306-011-0343-y
PMCID: PMC3351624  PMID: 22661917
Diabetic nephropathy; NMR metabonomics; Fatty acids; Sphingolipids; Phospholipids; Lipoprotein subclasses
25.  Rinsability of Orthophthalaldehyde from Endoscopes 
Orthophthalaldehyde high level disinfectants are contraindicated for use with urological instruments such as cystoscopes due to anaphylaxis-like allergic reactions during surveillance of bladder cancer patients. Allergic reactions and mucosal injuries have also been reported following colonoscopy, laryngoscopy, and transesophageal echocardiography with devices disinfected using orthophthalaldehyde. Possibly these endoscopes were not adequately rinsed after disinfection by orthophthalaldehyde. We examined this possibility by means of a zone-of-inhibition test, and also a test to extract residues of orthophthalaldehyde with acetonitrile, from sections of endoscope insertion tube materials, to measure the presence of alkaline glutaraldehyde, or glutaraldehyde plus 20% w/w isopropanol, or ortho-phthalaldehyde that remained on the endoscope materials after exposure to these disinfectants followed by a series of rinses in water, or by aeration overnight. Zones of any size indicated the disinfectant had not been rinsed away from the endoscope material. There were no zones of inhibition surrounding endoscope materials soaked in glutaraldehyde or glutaraldehyde plus isopropanol after three serial water rinses according to manufacturers' rinsing directions. The endoscope material soaked in orthophthalaldehyde produced zones of inhibition even after fifteen serial rinses with water. Orthophthalaldehyde was extracted from the rinsed endoscope material by acetonitrile. These data, and other information, indicate that the high level disinfectant orthophthalaldehyde, also known as 1,2-benzene dialdehyde, cannot be rinsed away from flexible endoscope material with any practical number of rinses with water, or by drying overnight.
doi:10.1155/2012/853781
PMCID: PMC3361992  PMID: 22665966

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