Manual Reprocessing Research Articles

Automated cleaning significantly better than manual reprocessing

Automated cleaning significantly better than manual reprocessing

Costs of purchase, maintenance, microbiological control, and reprocessing of a reusable duodenoscope.

Background and study aims The costs of reusable endoscope reprocessing have been evaluated, yet external validity of the findings remains challenging. The aim of this study was to assess the costs of purchase, maintenance, microbiological control, and reprocessing of a reusable duodenoscope per endoscopic retrograde cholangiopancreatography (ERCP) in France. Study findings exclude the costs of infection, downtime due to breakdown, reprocessing single-use material disposal, and device disposal, all of which should also be considered. Materials and methods The study encompassed both observational and theoretical approaches. Observational data were collected in four hospitals, from December 2019 to December 2020, with an ad hoc survey, based on 2016 and 2018 national guidelines for duodenoscope reprocessing. Costs were modeled, using the same guidelines, assuming a mean workload of 223 ERCP/duodenoscope/year. Results The mean observed cost of purchase, maintenance, microbiological control, reprocessing (human resources and consumables), and overhead (additional 35%) with a reusable duodenoscope was €80.23 (standard deviation €3.77) per ERCP. The corresponding mean theoretical cost was €182.71 for manual reprocessing without endoscope drying cabinet (EDC), €191.36 for manual reprocessing with EDC, €235.25 for automated endoscope reprocessing (AER) without EDC, and €253.62 for AER with EDC. Conclusions Because procedures, equipment, volume activity, number of duodenoscopes, human resources, and internal work organizations are hospital-dependent, observed costs varied between hospitals. Theoretical costs were higher than observed costs, showing that the theoretical approach is not sufficient. Hypotheses to explain the difference between the two approaches include failing to measure some costs in the survey and challenges in guideline implementation.

Comparison of Targeted and Untargeted Approaches in Breath Analysis for the Discrimination of Lung Cancer from Benign Pulmonary Diseases and Healthy Persons.

The aim of the present study was to compare the efficiency of targeted and untargeted breath analysis in the discrimination of lung cancer (Ca+) patients from healthy people (HC) and patients with benign pulmonary diseases (Ca−). Exhaled breath samples from 49 Ca+ patients, 36 Ca− patients and 52 healthy controls (HC) were analyzed by an SPME–GC–MS method. Untargeted treatment of the acquired data was performed with the use of the web-based platform XCMS Online combined with manual reprocessing of raw chromatographic data. Machine learning methods were applied to estimate the efficiency of breath analysis in the classification of the participants. Results: Untargeted analysis revealed 29 informative VOCs, from which 17 were identified by mass spectra and retention time/retention index evaluation. The untargeted analysis yielded slightly better results in discriminating Ca+ patients from HC (accuracy: 91.0%, AUC: 0.96 and accuracy 89.1%, AUC: 0.97 for untargeted and targeted analysis, respectively) but significantly improved the efficiency of discrimination between Ca+ and Ca− patients, increasing the accuracy of the classification from 52.9 to 75.3% and the AUC from 0.55 to 0.82. Conclusions: The untargeted breath analysis through the inclusion and utilization of newly identified compounds that were not considered in targeted analysis allowed the discrimination of the Ca+ from Ca− patients, which was not achieved by the targeted approach.

Abstract 16688: CZT Equilibrium Radionuclide Angiography (ERNA) Detects Improvements in Right Ventricle Size and Function for Pulmonary Arterial Hypertension Participants Intensifying Therapy

Introduction: Pulmonary Arterial Hypertension (PAH) is associated with pruning and vasconstriction of the pulmonary arteries, resulting in right ventricular (RV) failure and death. RV size and function are among the most powerful prognostic predictors for disease outcomes and can change in response to therapy. However, obtaining quantitative RV information remains challenging with echocardiography, while cardiac MRI remains expensive, claustrophobic, and relatively less accessible. Hypothesis: CZT ERNA is a simple and readily available cardiac imaging technique that will measure changes in RV size and function for PAH participants intensifying therapy (RVEF, RVEDV, RVESV). Methods: D-SPECT (Spectrum Dynamics) CZT-ERNA was performed on 24 participants using low dose (approximately 10 mCi Tc-99m TCO4 - ; ~2.5 mSv), 10 minute imaging protocol: 12 were imaged just prior to starting or intensifying therapy and again 6 months later (Active), and 12 age- and sex-matched controls on stable therapy were imaged twice within a 3 week period. Additionally, 6 minute walk distance, laboratories (including NTproBNP) and WHO functional class were assessed at the time of each scan. All scans were processed using Cedars Sinai QBS automatic software; we did manual re-processing when chamber separation was poor or extra-cardiac activity was substantial (n=22/40 scans). Results: All 24 participants completed two scans; four (2 Active, 2 control) were excluded from paired analysis due to low intensity images on one scan (of a pair), and one Active participant was excluded due to clinical worsening requiring hospitalization. There were no adverse events related to imaging. RVEF (45% ± 3.5 vs 55% ± 4.2; p=0.008) and RV stroke volume (89mL ± 10.3 vs 108mL ± 12.3; p=0.03) improved in the active group but were stable in the control group (RVEF= 58% ± 3.7 vs 56% ± 5.0; RVSV=108mL ± 12.9 vs 116mL ± 16.6). A participant with particularly striking improvement is illustrated below. Scan times were 10 minutes with total testing time between 60-90 min. Conclusions: CZT-ERNA is quick, easy and seems effective for obtaining quantitative measures of the RV in PAH.

Reprocessing safety issues associated with complex-design orthopaedic loaned surgical instruments and implants

BackgroundThe acquisition of reusable surgical instruments (RSIs) through loaner system is a worldwide phenomenon, particularly in orthopaedic surgeries. Loaner sets contain high-complex design RSIs, which are very difficult to clean, and also include single use implants, such as screws, that remain in the surgical tray and are subjected to multiple reprocessing until they are implanted. Inadequate cleaning of SI and various exposures of single-use implants to physical, chemical and biological agents can compromise their quality/safety and promote biofilm formation. The difficulty in cleaning is compounded in middle and low-income countries where automated cleaning infrastructure at sterilizing service units is often unavailable, and thus manual cleaning only is performed. Thus, we aimed to determine the condition of orthopaedic loaned sets when delivered to the hospital, assess the quality of complex-design RSIs reprocessed by manual cleaning, and evaluate the effect of multiple reprocessing on single-use implant (screw). MethodsFlexible medullary reamers (FMRs), depth gauges and screws used for femur intramedullary nailing, in clinical use for >1 year, were obtained from three Brazilian loaner companies and assessed for residual ATP, protein, bacterial contamination, endotoxin and/or biofilm at delivery at the hospital, following cleaning and steam sterilisation. ResultsBefore cleaning, blood was visible on a RSIs tray, and RSIs/screws were contaminated with high amounts of ATP, protein and bacteria. Visible soil was released during brushing of a FMR lumen and, following cleaning, the inner layer of 34/40 were visible soiled, and over 5/8 were protein test positive. Following sterilisation, biofilm and soil, including fragments appearing to be bone, were detected by scanning electron microscopy on RSIs/screws. A sterilised FMR revealed visible soil on the inner layer. Endotoxin tests were negative. ConclusionThe contaminated condition of loaned-complex-designed RSIs/screws upon arrival at the hospital and after reprocessing points to the insufficiency of manual reprocessing and management practices related to this instruments/implants. A multidisciplinary approach involving expert in design/manufacture, regulating, managing, reprocessing and surgeons is suggested to improve RSIs manufacture that enables complete decontamination and maintain the surgical patient safety.

Standard manual reprocessing of angiographic systems in the hybrid OR

Abstract A current FDA guidance demands the validation of cleaning and disinfecting protocols even for non-sterile medical devices. The aim of this work is to clarify whether this is already possible using the guidance itself as well as the German DIN EN ISO 17664. An angiography system (Artis Zeego / Pheno - Siemens) was selected as a test object for the validation of a cleaning and disinfection protocol for medical devices in a hybrid operating room. In pilot study prior to the trial, critical points of the system were evaluated by means of questionnaires to clinical users (OTA, surgical technicians). An initial assessment of the in-house cleaning protocols used in the hospitals was done by using a fluorescence assay. The microbiological examination took place subsequently by contact plates and swabbing to determine the amount and type of germs on the surfaces of the system. These experiments were done at three different clinical sites. It was found that there was a significant germ count on several surfaces of the product even after in-house cleaning and disinfection (C&D). After application of an enhanced C&D plan, these germs could be greatly reduced at all verified sites. In addition, it could be shown that DIN EN ISO 17664 can in principle be applied to non-sterile medical products.

Renal Support for Acute Kidney Injury in the Developing World

There is wide variation in the management of acute kidney injury (AKI) and the practice of renal replacement therapy (RRT) around the world. Clinicians in developing countries face additional challenges due to limited resources, reduced availability of trained staff and equipment, cultural and socioeconomic aspects, and administrative and governmental barriers. In this article, we report the consensus recommendations from the 18th Acute Dialysis Quality Initiative conference in Hyderabad, India. We provide the minimal requirements for provision of acute RRT in developing countries, including patient selection, choice of RRT modality and monitoring, transition, and termination of acute RRT. We also discuss areas of uncertainty and propose themes for future research. These recommendations can serve as a foundation for clinicians to implement renal support for AKI in low resource settings.

Residual bioburden in reprocessed side-view endoscopes used for endoscopic retrograde cholangiopancreatography (ERCP).

Background and study aim: Worldwide some endoscopy units routinely continue to use manual reprocessing techniques for disinfection of side-view endoscopes. The aim of this study was to evaluate the outcome quality of manual reprocessing techniques for removal and inactivation of the bioburden from side-view endoscopes used for endoscopic retrograde cholangiopancreatography (ERCP) in a tertiary referral endotherapy unit in Sri Lanka. Methods: 102 samples obtained from two different flexible side-view endoscopes (Olympus TJF Q 180V and Olympus TJF 160 R) were tested for microbial growth. Three samples were collected each time; one swab from the tip before and another after manual reprocessing. The third sample was collected by flushing the working channel with sterile normal saline after manual reprocessing. Microorganisms were identified by culturing the samples. Result:: After reprocessing, culture-positive rates were 20 % and 9 % for the samples obtained from the tip and the working channel of the side-view endoscopes, respectively. Klebsiella spp. and Candida spp. were found to be the commonest microorganisms in the samples from the tips and from the working channels, respectively, of the reprocessed side-view endoscopes. Conclusion: There is a high culture-positive rate after reprocessing of the side-view endoscopes using the manual reprocessing procedure, despite strict adherence to the protocol for reprocessing.

ESGE–ESGENA guideline: Cleaning and disinfection in gastrointestinal endoscopy

1. Introduction2. Definition of terms3. Endoscopy-related infections4. Principles of infection control5. Chain of infection6. Health and safety of endoscopy personnel7. General requirements7.1. Classification of endoscopic equipment7.2. Aims of the reprocessing procedure7.3. Staff requirements7.4. Reprocessing room7.5. The reprocessing procedure7.6. Manual versus automated reprocessing8. Process chemicals8.1. Detergents8.1.1. Detergents with enzymatic boosters8.1.2. Detergents with alkaline boosters8.1.3. Detergents with enzymatic and alkaline boosters8.1.4. Detergents containing antimicrobial active substances8.2. Disinfectants8.2.1. Glutaraldehyde8.2.2. Orthophthalaldehyde (OPA)8.2.3. Peracetic acid (PAA)8.2.4. Chlorine dioxide8.2.5. Electrolytically generated disinfectants8.3. Rinse aid8.4. Combination of products from different manufacturers8.5. Change of products9. Reprocessing of endoscopes9.1. Manual cleaning9.1.1. Pre-cleaning in the endoscopy room9.1.2. Manual cleaning in the reprocessing room9.2. Reprocessing in washer-disinfectors9.2.1. Definition and process basics for washer-disinfectors9.2.2. Process specifications for washer-disinfectors9.2.3. Specific recommendations for washer-disinfectors9.2.4. Advantages and disadvantages of washer-disinfectors9.3. Reprocessing in automated disinfection devices9.3.1. Definition and process basics for automated disinfection devices9.3.2. Process specifications for automated disinfection devices9.3.3. Specific recommendations for automated disinfection devices9.3.4. Advantages and disadvantages of automated disinfection devices9.4. Manual reprocessing of endoscopes9.4.1. Definition and process basics for manual reprocessing9.4.2. Process specifications for manual reprocessing9.4.3. Advantages and disadvantages of manual reprocessing9.5. Drying, storage and reuse of endoscope10. Quality assurance10.1. Documentation10.2. Maintenance of washer-disinfectors and automated disinfection devices10.3. Process validation and microbiological surveillance10.4. Outbreak management11. Reprocessing of endoscopic accessories11.1. General recommendations11.2. Process specifications11.2.1. Manual cleaning11.2.2. Reprocessing in washer-disinfectors11.2.3. Manual reprocessing11.2.4. Sterilization11.2.5. Storage11.3. Specific recommendations11.3.1. Biliary and pancreatic procedures11.3.2. Injection needles11.3.3. Biopsy forceps11.3.4. Water bottle and its connectors12. AppendicesAppendix 1: Manual cleaning of flexible endoscopesAppendix 2: Reprocessing of flexible endoscopes in washer-disinfectors and automated disinfection devicesAppendix 3: Manual reprocessing of flexible endoscopesAppendix 4: Manual reprocessing of reusable endoscopy accessoriesAppendix 5: Reprocessing of endoscopic accessories in washer-disinfectors and automated disinfection devices13. References

Hygienic safety of reusable tap water filters (Germlyser®) with an operating time of 4 or 8 weeks in a haematological oncology transplantation unit

BackgroundMicrobial safe tap water is crucial for the safety of immunosuppressed patients.MethodsTo 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).ResultsThe 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.ConclusionAs 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.

Dialyzer Reuse—Part I: Historical Perspective

The first apparatus for hemodialysis in animals, made painstakingly by Abel et al. in their laboratory at the beginning of 20th century, was cleaned with acid-pepsin to digest blood, disinfected with thymol, and reused for up to 30 experiments for as long as 8 months. The obvious incentive was saving time. In the early years of hemodialysis in patients, dialyzers and lines were assembled and sterilized immediately before dialysis. Various methods of dry and moist heat sterilization and miscellaneous chemical agents were employed for disinfection. Significant time was required to assemble the dialyzers, so there was an incentive to reuse previously assembled dialyzers to save time, especially for home hemodialysis. Bleach to clean and formaldehyde to disinfect the membranes and lines was used for this purpose. Preassembled dialyzers, commercially introduced in the 1950s, were the most expensive components of hemodialysis systems, therefore reprocessing of these dialyzers was the most effective way to save money. Refrigeration of coil dialyzers with blood, introduced in the mid-1960s, was associated with frequent febrile reactions and was soon abandoned. Preassembled coil and plate dialyzers permitted almost complete return of blood after dialysis and led to the introduction of chemical disinfection for dialyzer reprocessing. A variety of disinfectants have been used. Formaldehyde was the most common disinfectant until the end of the 1970s. Sodium hypochlorite was used to clean the majority of dialyzers and to sterilize dialyzers with polyacrylonitrile membranes. In the early 1980s, peracetic acid and glutaraldehyde started to compete with formaldehyde. By the 1990s, formaldehyde had become less popular than peracetic acid. In the mid-1990s, disinfection and membrane cleaning with acetic acid and heat was introduced. Manual reprocessing was replaced by early reuse machines in the mid-1970s and a more sophisticated second generation of automated hemodialyzer reprocessing machines followed in the late 1970s. Recently disinfection of dialyzers with moist heat has resumed. Saving both time for the patient and money for the provider were the main motivations for designing a new machine for daily home hemodialysis. The machine, developed in the 1990s, cleans and moist-heat disinfects the dialyzer and lines in situ so they do not need to be changed for a month. In contrast, the reuse of dialyzers in home hemodialysis patients treated with other hemodialysis machines has become less popular and is almost extinct.

Resolving ASCUS without recourse to HPV testing: Manual reprocessing of residual automated liquid-based cytology (ALBC) material using manual liquid-based cytology (MLBC)

We show that residual cell material from ThinPrep PapTest (Cytyc Corporation, Boxborough, MA) atypical squamous-cells of undetermined significance (ASCUS) cases may be manually reprocessed to triage women into actionable diagnostic categories (HSIL, LSIL, and Negative). Material remaining from each of 358 ThinPrep ASCUS cases was manually reprocessed as two slides, labeled "A" and "B." Interobserver agreement between case contributors (CCs) and three sequential reviewers (SRs) was analyzed with 186 cases (Study 1), and diagnostic reproducibility between SRs was examined with an additional 172 cases (Study 2). In Study 1, CCs classified 33% of cases as LSIL or greater, SRs classified 60% as LSIL or greater, and there was 58% diagnostic agreement between CCs and SRs. No "Negative" case assignment by one group afforded an "HSIL" assignment by the complementary group. In Study 2, there was 95% agreement between SRs A slide and B slide diagnoses with 54% of A slides and 55% of B slides classified as LISL or greater. Again, no "Negative" case assignment to one slide afforded an "HSIL" assignment to the complementary slide. Overall, 12.6% of the 358 cases showed HSIL, and all HSILs by one observer group were ASCUS or greater by the complementary observer group. Using manual reprocessing beyond the 21-day specimen outdate for HPV testing by the Hybrid Capture II High Risk HPV test (HR-HCII; Digene Corporation, Beltsville, MD), many ThinPrep ASCUS cases were reclassified as LSIL or HSIL. The 12.6% HSIL proportion of this study approximated the 11.5% CIN 2 or greater proportion of the ALTS ASCUS arm. Similar to ALTS, manual liquid-based cytology (MLBC) would have referred nearly 60% of women to colposcopy for a definitive diagnosis of HSIL or LSIL without resorting to HPV testing. These data demonstrate that many cases of automated liquid-based cytology (ALBC)-diagnosed ASCUS represent unrecognized SIL, which is present in the ALBC specimen vial at the time the ASCUS diagnosis is rendered.

Capillary preconditioning for analysis of anions using indirect UV detection in capillary zone electrophoresis: Systematic investigation of alkaline and acid prerinsing techniques by designed experiments

It is widely accepted in capillary zone electrophoresis, that the use of alkaline prerinse procedures can improve the reproducibility of migration times and of corrected peak areas. In this study we present a systematic investigation of alkaline and acid preconditioning procedures for anion analysis using indirect UV detection by designed experiments according to the methodology of Taguchi. Four frequently used electroosmotic flow modifiers (diethylenetriamine, hexamethonium hydroxide, tetradecyltrimethylammonium hydroxide, and hexadimethrine hydroxide) were examined. The optimized procedures were evaluated with regard to the necessary preconditioning time compared to the analysis time. Furthermore, it was demonstrated that the optimized preconditioning technique could be applied to other indirect detection based CE systems. For all examined electrolyte systems, relative standard deviations below 0.5% for migration times and below 5% for corrected peak areas ( n=20) were achieved using automated peak integration without further manual reprocessing.

Advantages and limitations of automatic flexible endoscope reprocessors

The advantages and limitations of automatic flexible endoscope reprocessors (AFERs) are presented. These medical devices can increase patient safety and minimize personnel exposure to the liquid chemical germicide and its vapors. Some models feature a printer to document important reprocessing parameters, an in-line tap water filtration system to reduce the likelihood of endoscope (and patient) contamination, and a heater to satisfy the elevated temperature requirements of some liquid chemical germicide labels. Although they offer significant advantages compared with manual reprocessing, AFERs have their limitations. Current models do not automate every endoscope reprocessing step and are not typically designed to reprocess every endoscope channel. Some AFER models may have to be periodically decontaminated to ensure that their internal components do not support microbial colonization. Moreover, their cost per cycle can be considerably more than manual reprocessing without necessarily reducing overall reprocessing time. Its limitations notwithstanding, an AFER is likely to be an asset in a busy endoscopy center. In addition to comparing automated and manual reprocessing, this article addresses important reprocessing issues and purchasing concerns.

National Surveillance of Dialysis-Associated Diseases in the United States, 1988

To determine trends in a variety of dialysis-associated diseases and practices, the Centers for Disease Control surveyed 1,734 chronic hemodialysis centers in the United States in 1988 in conjunction with the annual facility survey performed by the Health Care Financing Administration. The response rate to a mailed questionnaire was 91%. These 1,586 centers represented 107,804 patients and 28,501 staff members. Over the last 13 years, the incidence of hepatitis B virus (HBV) infection decreased from 3.0 to 0.2% among patients and from 2.6 to 0.1% among staff members. Over the same time, the prevalence of HBsAg-positivity declined from 7.8 to 1.5% among patients and from 0.9 to 0.3% among staff members. Hepatitis B vaccine was given by 90% of the centers. By the end of 1988, 17% of susceptible patients and 53% of susceptible staff members had received all three doses of hepatitis B vaccine. From 1982 to 1988, as a result of receiving vaccine, the prevalence of antibody to HBsAg increased from 12 to 20% among patients and from 18 to 54% among staff. The incidence of non-A, non-B hepatitis in 1988 was reported to be 1.0% among patients and 0.1% among staff members. Fifteen percent of the centers reported pyrogenic reactions in the absence of septicemia among their patients and 45% reported septicemia. The reported incidence of dialysis dementia among hemodialysis patients was 0.2%, with a case fatality rate of 25%. In 1988, 67% of centers reported that they reused disposable dialyzers; these centers treated 72% of the dialysis patient population. Among centers that reused disposable dialyzers, the average number of reuses ranged from 2 to 50 (mean, 11) and the maximum number of times a disposable dialyzer was reused ranged from 3 to 131 (mean, 28). Chemical germicides used for reprocessing dialyzers included formaldehyde; Renalin, a peracetic acid-hydrogen peroxide-based germicide; and glutaraldehyde-based germicides. Reuse of disposable dialyzers was not associated with any increased risk of acquiring HBV infection among either patients or staff. However, pyrogenic reactions occurring in clusters were more frequently reported in centers that reused conventional dialyzer membranes compared with centers that did not. This increased risk was only associated with centers that reused these dialyzers in a manual reprocessing system, a result consistent with those obtained in 1986 and 1987. Eighteen percent of centers reported treating at least some of their patients by high flux dialysis.(ABSTRACT TRUNCATED AT 400 WORDS)

Outbreak of Gram-Negative Bacteremia and Pyrogenic Reactions in a Hemodialysis Center

During the period from April 4, 1988, to April 20, 1988, nine pyrogenic reactions and five gram-negative bacteremias occurred in 11 patients undergoing dialysis. All pyrogenic reactions and gram-negative bacteremias occurred among patients in whom a reprocessed dialyzer was used. The rate of pyrogenic reactions or bacteremias per 100 sessions using a reprocessed dialyzer was higher than in sessions during which a new dialyzer was used (4.5 vs. 0; p = 0.03). Dialyzers were manually reprocessed with 2.5% Renalin germicide. The Renalin concentrations varied widely in 12 dialyzers stored after manual reprocessing during the epidemic period (0.9-4.2%); the median endotoxin concentrations varied from 0 to 246 ng/ml and were higher in dialyzers with Renalin concentrations less than or equal to 1.0% than in dialyzers with higher concentrations (p = 0.01). Experiments using a dilution technique described by a technician resulted in Renalin concentrations ranging from 1.4% at the surface to 3.5% at the bottom of the preparation container. These findings suggest that failure to adequately admix Renalin during dilution may be associated with low levels of disinfectant, high levels of bacteria and endotoxins in dialyzers, and outbreaks of pyrogenic reactions and gram-negative bacteremias in dialysis patients.

Mycobacterium chelonae Infection among Patients Receiving High-Flux Dialysis in a Hemodialysis Clinic in California

Between July 1987 and January 1988, five patients dialyzed at a hemodialysis outpatient clinic developed systemic Mycobacterium chelonae abscessus (MCA) infections. Four of the five patients had arteriovenous graft infections, and two died during antimicrobial therapy. Case-patients were more likely than control-patients to have received high-flux dialysis during the 6 mo before their infection (100% vs. 30%, P = .009). MCA was cultured from the hose connected to a water spray device used for manual reprocessing of high-flux but not regular dialyzers. Renalin was the germicide used to manually disinfect dialyzers for reuse and was prepared at a concentration of 2.5%. Laboratory studies documented survival of MCA from two high-flux dialyzers that were reprocessed in a manner similar to that used in the clinic. Early diagnosis with complete rather than partial graft removal in combination with antimicrobial therapy is recommended for MCA graft infections. In addition, 2.5% Renalin did not appear to ensure complete killing of MCA in high-flux dialyzers that were manually reprocessed at this hemodialysis clinic.

Reuse of hemodialyzers. Results of nationwide surveillance for adverse effects.

In 1986, the Centers for Disease Control, in collaboration with the Health Care Financing Administration, surveyed 1350 chronic hemodialysis centers in the United States to ascertain practices associated with the reuse of disposable hemodialyzers and the frequency of pyrogenic reactions and septicemia among patients. Reuse of hemodialyzers was reported by 63% of the centers. Centers that used RenNew-D (n = 5) for reprocessing hemodialyzers, compared with centers that did not reuse (n = 495), were more likely to report pyrogenic reactions (60% vs 13%) and episodes of septicemia (100% vs 55%) among their patients. Reusing hemodialyzers more than 20 times and, in some instances, also using manual reprocessing systems was significantly associated with clustering of pyrogenic reactions regardless of the type of germicide used. To detect membrane leaks developing after multiple reuses, air-pressure-leak tests should be performed on all reprocessed hemodialyzers.