Sterile disposable elevator cap in the reduction of cross-contamination.
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ABSTRACT:
SUBMITTER: Robles-Medranda C
PROVIDER: S-EPMC7483758 | biostudies-literature | 2020 Sep
REPOSITORIES: biostudies-literature
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Sterile disposable elevator cap in the reduction of cross-contamination.
Robles-Medranda Carlos C Oleas Roberto R Alcívar-Vásquez Juan J Pitanga-Lukashok Hannah H
VideoGIE : an official video journal of the American Society for Gastrointestinal Endoscopy 20200609 9
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Project description:ImportanceInfection transmission following endoscopic retrograde cholangiopancreatography (ERCP) can occur due to persistent contamination of duodenoscopes despite high-level disinfection to completely eliminate microorganisms on the instrument.ObjectiveTo determine (1) contamination rates after high-level disinfection and (2) technical performance of duodenoscopes with disposable elevator caps compared with those with standard designs.Design, setting, and participantsIn this parallel-arm multicenter randomized clinical trial at 2 tertiary ERCP centers in Canada, all patients 18 years and older and undergoing ERCP for any indication were eligible.InterventionThe intervention was use of duodenoscopes with disposable elevator caps compared with duodenoscopes with a standard design.Main outcomes and measuresCoprimary outcomes were persistent microbial contamination of the duodenoscope elevator or channel, defined as growth of at least 10 colony-forming units of any organism or any growth of gram-negative bacteria following high-level disinfection (superiority outcome), and technical success of ERCP according to a priori criteria (noninferiority outcome with an a priori noninferiority margin of 7%), assessed by blinded reviewers.ResultsFrom December 2019 to February 2022, 518 patients were enrolled (259 disposable elevator cap duodenoscopes, 259 standard duodenoscopes). Patients had a mean (SD) age of 60.7 (17.0) years and 258 (49.8%) were female. No significant differences were observed between study groups, including in ERCP difficulty. Persistent microbial contamination was detected in 11.2% (24 of 214) of standard duodenoscopes and 3.8% (8 of 208) of disposable elevator cap duodenoscopes (P = .004), corresponding to a relative risk of 0.34 (95% CI, 0.16-0.75) and number needed to treat of 13.6 (95% CI, 8.1-42.7) to avoid persistent contamination. Technical success using the disposable cap scope was noninferior to that of the standard scope (94.6% vs 90.7%, P = .13). There were no differences between study groups in adverse events and other secondary outcomes.Conclusions and relevanceIn this randomized clinical trial, disposable elevator cap duodenoscopes exhibited reduced contamination following high-level disinfection compared with standard scope designs, without affecting the technical performance and safety of ERCP.Trial registrationClinicalTrials.gov Identifier: NCT04040504.
| S-EPMC9871945 | biostudies-literature
Project description: Not available
| S-EPMC11489489 | biostudies-literature
Project description:Bacterial contamination of angiographic materials and fluids has been shown to occur during human angiographic procedures. Angiographic examinations and experiments must be performed under sterile conditions to avoid complications due to contamination and possible subsequent infections. However, data regarding the frequency and the clinical consequences are limited. Our aim was to investigate the incidence of bacterial contamination during experimental angiographies. We tested angiographic fluids, syringes and endovascular materials from the angiographic supply tables for bacterial contamination, collecting 252 samples during 18 experimental angiographies in pigs. After sterile filtration, samples were cultured on media, and individual colony-forming units were identified by matrix-assisted laser desorption ionization-time of flight mass spectrometry. Contamination was detected in the majority of samples (60%). There was no angiography in which all samples remained sterile. The highest contamination rates (94%) were found in fluids from the working bowls and on the outer surface of syringes (85%) at the end of angiography. At this time, working bowls were significantly more frequently and extensively contaminated than the control bowls. Among the samples, the frequency and extent of contamination increased with the duration of the experimental angiographic procedures. Our findings show that bacterial contamination during angiography is common and the manipulation of endovascular working materials as well as the duration of angiographic procedures both increase bacterial contamination. While the clinical impact on the laboratory animal remains unclear, the quality of biomedical research mandates that efforts to minimize bacterial contamination should be taken as far as possible.
| S-EPMC11581324 | biostudies-literature
Project description:BackgroundFew studies have investigated the difference in bacterial contamination between conventional reused ventilator systems and disposable closed ventilator-suction systems. The aim of this study was to investigate the bacterial contamination rates of the reused and disposable ventilator systems, and the association between system disconnection and bacterial contamination of ventilator systems.MethodsThe enrolled intubated and mechanically ventilated patients used a conventional reused ventilator system and a disposable closed ventilator-suction system, respectively, for a week; specimens were then collected from the ventilator circuit systems to evaluate human and environmental bacterial contamination. The sputum specimens from patients were also analyzed in this study.ResultsThe detection rate of bacteria in the conventional reused ventilator system was substantially higher than that in the disposable ventilator system. The inspiratory and expiratory limbs of the disposable closed ventilator-suction system had higher bacterial concentrations than the conventional reused ventilator system. The bacterial concentration in the heated humidifier of the reused ventilator system was significantly higher than that in the disposable ventilator system. Positive associations existed among the bacterial concentrations at different locations in the reused and disposable ventilator systems, respectively. The predominant bacteria identified in the reused and disposable ventilator systems included Acinetobacter spp., Bacillus cereus, Elizabethkingia spp., Pseudomonas spp., and Stenotrophomonas (Xan) maltophilia.ConclusionsBoth the reused and disposable ventilator systems had high bacterial contamination rates after one week of use. Disconnection of the ventilator systems should be avoided during system operation to decrease the risks of environmental pollution and human exposure, especially for the disposable ventilator system.Trial registrationClinicalTrials.gov PRS / NCT03359148.
| S-EPMC5856346 | biostudies-literature
Project description:The purpose of the study is to compare the efficacy of device assisted colonoscopy (DAC) with standard colonoscopy (SC) in detecting adenomas in a randomized fashion.
| 2194636 | ecrin-mdr-crc
Project description:IntroductionPhysicians frequently use point-of-care ultrasound for intravenous access and bloodwork in the ED. Recently, AIUM and ACEP released recommendations on ultrasound-guided peripheral intravenous lines (USPIVs), but there are no agreed upon standardized policies. We sought to determine whether the use of sterile-covered transducers (SCT) decreases the rate of contamination when compared to uncovered transducers (UCT) after standard low-level disinfection (LLD).MethodsThis is a randomized control trial comparing contamination rates of US transducers between SCT and UCT after their use for USPIV by the vascular access team, also known as the "PICC" team, over a 3-month period. A sample of admitted patient with an USPIV order were included and randomized to SCT (experimental) or UCT (control) arms. Transducers were swabbed and inserted into the SystemSURE Plus Adenosine Triphosphate (ATP) Luminometer to calculate Relative Light Units (RLU). We performed a cost analysis of requiring sterile covers for USPIVs.ResultsThe UCT and SCT arms contained 35 and 38 patients, respectively. The SCT group had a mean of 0.34 compared to the UCT group mean of 2.29. Each sterile cover costs $8.49, and over 3000 USPIVs are placed annually by the "PICC" team.ConclusionContamination rates were similar among the UCT and SCT groups after LLD. 254 inpatient USPIVs are performed monthly, not including failed attempts or covers used in the ED where USPIV placement is an essential part of ED workflow. This study suggests that the use of SCT does not significantly affect transducer contamination rates. These findings question burdensome regulatory hospital policies that are not evidence-based.
| S-EPMC10850037 | biostudies-literature
Project description:A surgical site infection (SSI) is one of the most common surgical complications. This study analyzed different sources of microorganisms in the air, on reusable surgical instruments, and the outer surface of sterile packaging systems during the use and reprocessing of sterile goods (from the operating room (OR) to the Central Sterile Supply Department (CSSD)). The microbial load in the air was analyzed via active air sampling and settle plates. Furthermore, the airborne particle load was measured by a particle counter. Contact agar plates were used to determine the microbial load on surgical instruments and sterile packaging systems. The highest average microbial and particle load was measured in the air of the OR (active air sampling: max. 56 CFU/m3; settle plates: max. 9 CFU; ≥0.3 μm particles in size: 1,958,403 no./m3). However, no microbial load (0 CFU) was detected on surgical instruments sampled in the OR. The outer surface of stored sterile packaging systems showed a maximal microbial load of 64 CFU. The most common identified pathogen was coagulase-negative staphylococci. Compared to properly reprocessed reusable surgical instruments and sterile packaging systems, the air still seems to be the primary potential source of microbial contamination, especially within the OR.
| S-EPMC9858816 | biostudies-literature
Project description:Flexible endoscopes are widely used to examine, diagnose, and treat medical disorders. While the risk of endoscopy-related transmission of infection is estimated to be very low, more health care-associated infections are related to contaminated endoscopes than to any other medical device. Flexible endoscopes can get highly contaminated with microorganisms, secretions and blood during use. The narrow lumens and multiple internal channels make the cleaning of flexible endoscopes a complex and difficult task. Despite the availability of international, national and local endoscope reprocessing guidelines, contamination and transmission of microorganisms continue to occur. These transmissions are mostly related to the use of defective equipment, endoscope reprocessing failures, and noncompliance with recommended guidelines. This article presents an overview of publications about case reports and outbreaks related to contamination of flexible endoscopes.
| S-EPMC4554517 | biostudies-other
Project description:BackgroundEndoscopic retrograde cholangio-pancreatography (ERCP) is commonly performed in the management of pancreatic and biliary disease. Duodenoscopes are specialized endoscopes used to perform ERCP, and inherent to their design, a high rate of persistent bacterial contamination exists even after automated reprocessing and disinfection. Consequently, in recent years, ERCP has been associated with infection transmission, leading to several fatal patient outbreaks. Due to increasing fears over widespread future duodenoscope-related outbreaks, regulatory bodies have called for alterations in the design of duodenoscopes. A duodenoscope has recently been developed that employs a disposable cap. This novel design theoretically eliminates the mechanism behind persistent bacterial contamination and infection transmission. However, there are no data demonstrating persistent bacterial contamination rates, technical success rates, or clinical outcomes associated with these duodenoscopes.MethodsA parallel arm randomized controlled trial will be performed for which 520 patients will be recruited. The study population will consist of consecutive patients undergoing ERCP procedures for any indication at a high-volume tertiary care centre in Calgary, Alberta, Canada. Patients will be randomized to an intervention group, that will undergo ERCP with a novel duodenoscope with disposable cap, or to a control group who will undergo ERCP with a traditional duodenoscope. Co-primary outcomes will include persistent bacterial contamination rates (post automated reprocessing) and ERCP technical success rates. Secondary outcomes include clinical success rates, overall and specific early and late adverse event rates, 30-day mortality and healthcare utilization rates, procedure and reprocessing times, and ease of device use.DiscussionThe ICECAP trial will answer important questions regarding the use of a novel duodenoscope with disposable cap. Specifically, persistent bacterial contamination, technical performance, and relevant clinical outcomes will be assessed. Given the mortality and morbidity burden associated with ERCP-related infectious outbreaks, the results of this study have the capacity to be impactful at an international level.Trial registrationThis trial was registered on clinicaltrials.gov (NCT04040504) on July 31, 2019.
| S-EPMC7066768 | biostudies-literature
Project description:Personal protective equipment, used extensively during the COVID-19 pandemic, heavily burdened the environment due to improper waste management. Owing to their fibrous structure, layered non-woven polypropylene (PP) disposable masks release secondary fragments at a much higher rate than other plastic waste types, thus, posing a barely understood new form of ecological hazard. Here we show that PP mask fragments of different sizes induce morphogenic responses in plants during their early development. Using in vitro systems and soil-filled rhizotrons, we found that several PP mask treatments modified the root growth of Brassica napus (L.) regardless of the experimental system. The environment around the root and mask fragments seemed to influence the effect of PP fabric fragment contamination on early root growth. In soil, primary root length was clearly inhibited by larger PP mask fragments at 1 % concentration, while the two smallest sizes of applied mask fragments caused distinct, concentration-dependent changes in the lateral root numbers. Our results indicate that PP can act as a stressor: contamination by PP surgical masks affects plant growth and hence, warrants attention. Further investigations regarding the effects of plastic pollution on plant-soil interactions involving various soil types are urgently needed.
| S-EPMC9158377 | biostudies-literature