Manufacturer's Instructions For Use Research Articles

A Novel Hybrid Injectable for Soft-tissue Augmentation: Analysis of Data and Practical Experience

Background: HA/CaHa (HArmonyCa, Allergan Aesthetics, an AbbVie Company) is a hybrid injectable filler developed for aesthetic purposes that contains calcium hydroxyapatite microspheres suspended in a hyaluronic acid gel. This review describes preclinical and clinical data, recommendations for use based on the primary author’s clinical experience, and case studies that illustrate implementation of product use recommendations and patient outcomes. Methods: Preclinical data on the lift capacity and tissue integration of the HA/CaHa hybrid injectable and clinical data on its safety, efficacy, and real-world use were extracted from poster presentations, published literature, manufacturer instructions for use, and proprietary data files. Case studies were presented based on clinical experience. Results: The HA component of HA/CaHa provides an immediate and noticeable filling and lifting effect, whereas CaHa microspheres result in neocollagenesis. In preclinical studies, HA/CaHa demonstrated higher lift capacity (P < 0.05) and faster tissue integration than a CaHa filler and led to collagen I gene and protein expression. Clinical studies showed clinical safety and effectiveness with high patient satisfaction. The most common adverse event was injection-site response. Clinician recommendations for achieving desired aesthetic results while minimizing or preventing adverse events are reviewed, including patient selection and assessment, treatment approaches based on face shape, injection technique, and postprocedure care. Conclusion: The novel hybrid injectable consisting of HA with incorporated CaHa microspheres in a single marketed product may help achieve aesthetic goals by immediately restoring volume and potentially improving skin architecture and soft-tissue quality over time.

Anatomical Suitability of Iliac Branch Devices for East Asian Patients with Abdominal Aortic Aneurysm

This study aimed to identify the iliac artery characteristics of East Asian patients with abdominal aortic aneurysms (AAAs) and to evaluate anatomical suitability rates with current iliac branch devices (IBDs). This was a single centre, retrospective, cross sectional study. Patients diagnosed with AAA between 2008 and 2023 were enrolled. The morphological parameters of the iliac arteries were measured, and their eligibility for four IBDs (Cook ZBIS, Gore IBE, E-Liac IBD, and G-Iliac IBD) was evaluated according to the manufacturer's latest instructions for use (IFU). Among 1 144 AAAs observed in the study, 45.5% (n= 521) presented with concurrent common iliac artery aneurysm (CIAA). In total, 304 patients (26.6%) and 371 iliac arteries necessitated internal iliac artery (IIA) reconstruction. The anatomical suitability rates for the Cook ZBIS, Gore IBE, E-Liac IBD, and G-Iliac IBD were 18.9%, 21.8%, 11.9%, and 22.6%, respectively. The E-Liac IBD exhibited a significantly lower anatomical suitability rate compared with the other three devices (p < .001). The primary IBD exclusion criteria were: a common iliac artery (CIA) length of < 50 mm for Cook ZBIS (n= 211, 56.9%); an IIA diameter of < 6.5 mm or > 13.5 mm for Gore IBE (n= 177, 47.7%); and a CIA bifurcation diameter of < 18 mm both for E-Liac IBD and G-Iliac IBD (n= 244, 65.8%). A total of 198 patients (53.4%) failed to meet the anatomical criteria for any device, while 112 (30.2%) qualified for just one device, 26 (7.0%) for two devices, 25 (6.7%) for three devices, and 10 (2.7%) for all four devices. A significant proportion of East Asian patients with AAA present with concurrent CIAA, necessitating substantial IIA reconstruction. IBD techniques show low anatomical suitability rates among the East Asian population, with 53.4% of patients failing to meet anatomical criteria for any IBD based on the manufacturer's IFU.

A cluster of three extrapulmonary Mycobacterium abscessus infections linked to well-maintained water-based heater-cooler devices.

Various water-based heater-cooler devices (HCDs) have been implicated in nontuberculous mycobacteria outbreaks. Ongoing rigorous surveillance for healthcare-associated M. abscessus (HA-Mab) put in place following a prior institutional outbreak of M. abscessus alerted investigators to a cluster of 3 extrapulmonary M. abscessus infections among patients who had undergone cardiothoracic surgery. Investigators convened a multidisciplinary team and launched a comprehensive investigation to identify potential sources of M. abscessus in the healthcare setting. Adherence to tap water avoidance protocols during patient care and HCD cleaning, disinfection, and maintenance practices were reviewed. Relevant environmental samples were obtained. Patient and environmental M. abscessus isolates were compared using multilocus-sequence typing and pulsed-field gel electrophoresis. Smoke testing was performed to evaluate the potential for aerosol generation and dispersion during HCD use. The entire HCD fleet was replaced to mitigate continued transmission. Clinical presentations of case patients and epidemiologic data supported intraoperative acquisition. M. abscessus was isolated from HCDs used on patients and molecular comparison with patient isolates demonstrated clonality. Smoke testing simulated aerosolization of M. abscessus from HCDs during device operation. Because the HCD fleet was replaced, no additional extrapulmonary HA-Mab infections due to the unique clone identified in this cluster have been detected. Despite adhering to HCD cleaning and disinfection strategies beyond manufacturer instructions for use, HCDs became colonized with and ultimately transmitted M. abscessus to 3 patients. Design modifications to better contain aerosols or filter exhaust during device operation are needed to prevent NTM transmission events from water-based HCDs.

Health Economic Analysis of Two-Layer Bandage System for Treatment of Chronic Venous Insufficiency.

Background: Compression therapy is the gold standard for the treatment of chronic venous insufficiency (CVI). Two-layer bandage (2LB) systems have been shown to be a safe and effective treatment option. Objective: To estimate the total cost per response (CPR) for the resolution of edema and wounds in patients with CVI treated with a 2LB system as part of their overall wound healing regimen. Methods: A probabilistic decision tree model was developed to estimate the incremental CPR for a 2LB system. The model simulated 10 000 patients to estimate the CPR for the resolution of edema and wound healing. The analysis was performed using clinical data from a published single-arm, multicenter prospective study of CVI indicated for compression therapy. The response outcomes of interest were resolution of edema and rate of wound healing. The follow-up time was a maximum of 6 weeks, and the perspective of the study was a US outpatient treatment center. Economic data for compression therapy were based on the public prices of a 2LB system. Dressing changes occurred per manufacturer instructions for use. Results: The study comprised 702 patients (56% female), with a total of 414 wounds. The median duration of the wounds was 42 days, and the median size at the initial visit was 3.5 cm2. The average pain reduction fell by 67% using a visual analog score. Bandages were typically changed once or twice a week (51.7%). Wound healing occurred in 128 of the 414 wounds (30.9%). The expected incremental CPR of a 2LB system for the resolution of edema was $65.67 (range, $16.67-$124.32). The expected incremental CPR of a 2LB system for the healing of a wound was $138.71 (range, $35.71-$273.53). Conclusion: This economic evaluation complements previous clinical effectiveness and safety studies of 2LB systems for the treatment of CVI. The results demonstrate that the costs of incorporating 2LB into standard wound-healing protocols are negligible compared with overall treatment costs. Two-layer bandages may be considered a cost-effective first-line system for the treatment of wounds caused by CVI.

Health Economic Analysis of Two-Layer Bandage System for Treatment of Chronic Venous Insufficiency

Background: Compression therapy is the gold standard for the treatment of chronic venous insufficiency (CVI). Two-layer bandage (2LB) systems have been shown to be a safe and effective treatment option. Objective: To estimate the total cost per response (CPR) for the resolution of edema and wounds in patients with CVI treated with a 2LB system as part of their overall wound healing regimen. Methods: A probabilistic decision tree model was developed to estimate the incremental CPR for a 2LB system. The model simulated 10 000 patients to estimate the CPR for the resolution of edema and wound healing. The analysis was performed using clinical data from a published single-arm, multicenter prospective study of CVI indicated for compression therapy. The response outcomes of interest were resolution of edema and rate of wound healing. The follow-up time was a maximum of 6 weeks, and the perspective of the study was a US outpatient treatment center. Economic data for compression therapy were based on the public prices of a 2LB system. Dressing changes occurred per manufacturer instructions for use. Results: The study comprised 702 patients (56% female), with a total of 414 wounds. The median duration of the wounds was 42 days, and the median size at the initial visit was 3.5 cm2. The average pain reduction fell by 67% using a visual analog score. Bandages were typically changed once or twice a week (51.7%). Wound healing occurred in 128 of the 414 wounds (30.9%). The expected incremental CPR of a 2LB system for the resolution of edema was $65.67 (range, $16.67-$124.32). The expected incremental CPR of a 2LB system for the healing of a wound was $138.71 (range, $35.71-$273.53). Conclusion: This economic evaluation complements previous clinical effectiveness and safety studies of 2LB systems for the treatment of CVI. The results demonstrate that the costs of incorporating 2LB into standard wound-healing protocols are negligible compared with overall treatment costs. Two-layer bandages may be considered a cost-effective first-line system for the treatment of wounds caused by CVI.

Rapid, point-of-care antigen tests for diagnosis of SARS-CoV-2 infection.

Rapid, point-of-care antigen tests for diagnosis of SARS-CoV-2 infection.

“Large Diameter” Aortic Endografts are Associated With Aneurysm Sac Expansion

The purpose of this study was to evaluate the association between aortic endograft diameter and long-term outcomes following endovascular aneurysm repair (EVAR) performed in accordance with manufacturer instructions for use (IFU). A retrospective review of consecutive patients undergoing on-IFU EVAR (2000-2018) was performed to facilitate a comparative analysis of long-term patient outcomes based on device diameter. "Large diameter" devices were defined as >34mm. The primary outcome of interest was freedom from sac expansion throughout long-term follow-up. Analyses included standard bivariate analyses, Kaplan-Meier with log-rank comparison, and Cox proportional hazards multivariate analysis. A total of 1,099 underwent on-IFU EVAR from 2000-2018. Follow-up data were available for 980 patients. Of these, 75 patients (7.6%) were treated with >34-mm devices. There were no significant differences in demographics or comorbidities between the 2 groups, although preoperative abdominal aortic aneurysm size was greater in patients undergoing implantation of >34-mm devices (58±8.5mm vs. 56±17.4mm; P=0.05). Median follow-up was 10.3years. Patients with grafts >34mm had reduced freedom from sac expansion throughout follow-up (P=0.038). There were no significant differences in reintervention rates, open conversion, or rupture when stratified by graft diameter. A multivariate Cox regression identified patient age, preoperative abdominal aortic aneurysm size, need for reintervention, and use of >34-mm endografts as independent factors associated with expansion. The use of large diameter aortic endografts is associated with higher rates of sac expansion during long-term follow-up. Although there is undoubtedly a role for large diameter graft use in selected patients, it is important to recognize that these devices were typically approved post hoc without the same regulatory scrutiny of smaller endografts. These findings underscore the importance of ongoing surveillance for patients treated with >34-mm grafts, irrespective of compliance with manufacturer IFU.

Large-Scale SARS-CoV-2 Antigen Testing With Real-World Specimens.

Real-world data are needed to establish SARS-CoV-2 rapid antigen testing (RAT) as an effective and reliable approach for SARS-CoV-2 screening. This study included 1,952,931 individuals who provided upper respiratory specimens during SARS-CoV-2 screening at CityMD urgent care locations in the New York metropolitan area from October 2020 to March 2021. Positive and negative results, as determined by the BD Veritor™ System for Rapid Detection of SARS-CoV-2 antigen (Veritor), were obtained for all individuals, with reflex reverse transcriptase-polymerase chain reaction (RT-PCR) testing performed on a case-by-case basis, per standard of care. Using verification bias adjustment, two alternative model assumptions were utilized for RAT results with missing reflex RT-PCR results. The worst antigen diagnostic performance estimates asserted that missing RT-PCR results would show a distribution similar to those RT-PCR results actually obtained, based on symptom category. The best antigen diagnostic performance estimates asserted that individuals without RT-PCR results had a clinical presentation consistent with RAT results, and, therefore, missing RT-PCR results would agree with RAT results. For patients with symptoms or high-risk exposure, 25.3% (n = 86,811/343,253) of RAT results were positive; vs. 3.4% (n = 53,046/1,559,733) positive for asymptomatic individuals without high-risk exposure. Reflex RT-PCR results were obtained from 46.3% (n = 158,836/343,253) and 13.8% (n = 215,708/1,559,733) of symptomatic and asymptomatic individuals, respectively. RT-PCR confirmed 94.4% (4,265/4,518) of positive and 90.6% (139,759/154,318) of negative RAT results in symptomatic individuals; and confirmed 83.4% (6,693/8,024) of positive and 95.3% (197,955/207,684) of negative RAT results in asymptomatic individuals. Applied assumptions for missing reflex RT-PCR results led to worst performance sensitivity estimates of 77.2 and 38.5% in the symptomatic and asymptomatic populations, respectively; assumptions for best performance estimates led to sensitivity values of 85.6 and 84.2%, respectively. Specificity values, regardless of assumptions or symptom category, ranged from 97.9–99.9%. At 10% SARS-CoV-2 prevalence, RAT positive predictive value was 86.9 and 99.0% for worst and best performance estimates across the total population, respectively; negative predictive values were >95% regardless of the applied assumption. Veritor test performance was consistent with that listed in the manufacturer instructions for use for symptomatic individuals. Real-world evidence should be gathered on RATs to support their efficacy as SARS-CoV-2 persists.

Five-year outcomes of the Bi- versus Trimodular EndurantTM stent-graft in 100 patients with infrarenal abdominal aortic repair

Recent studies on the Endurant™ endografts mainly compared outcomes of the bimodular stent-graft to other manufacturer's endografts or reported results for cases outside manufacturer's instructions for use (IFU), while data on the experience of standard endovascular aortic repair (EVAR) of infrarenal abdominal aortic aneurysms (AAA) inside manufacturer's IFU comparing the bi- with the trimodular device is limited. Inclusion criteria were: 1) infrarenal aneurysms (>50 mm diameter) treated by EndurantTM II (END II) or EndurantTM IIs (END IIs) stent-graft inside manufacturer's IFU; 2) available CTA with 1 mm reconstruction of the entire aorta prior to intervention. Endpoints comparing the devices included technical success, 30-day mortality, rate of complications (bleeding with conversion to open repair, stent-graft stenosis/occlusion, acute distal embolism, infection or postprocedural necessity of dialysis), endoleaks and reinterventions (5-year follow-up). Aneurysm sac diameters were compared between baseline preinterventional CTA and last post-interventional CTA. One hundred patients (90% male, mean age 74 years) treated with END II (N.=66) or END IIs (N.=34) were included. Technical success was 99%. One procedure-related active bleeding occurred ending up in surgical conversion (END II N.=1). 30d mortality was 0%. No initial type I/III endoleaks were present. Re-interventions were required in 19/100 (19%) of patients (END II N.=10; END IIs N.=9, P=0.17). The outcome of EVAR including technical success, 30d mortality, rate of complications, endoleaks and re-interventions showed no significant differences comparing END II/IIs. Five-year outcomes of EVAR show consistently safe and effective results for either END II or IIs device.

“Large Diameter” Aortic Endografts Are Associated With Aneurysm Sac Expansion

<h3>INTRODUCTION AND OBJECTIVES</h3> This study's purpose was to evaluate the association between aortic endograft diameter and long-term outcomes following endovascular aneurysm repair (EVAR) performed in accordance with manufacturer instructions for use (IFU). <h3>METHODS</h3> Retrospective review of consecutive patients undergoing on-IFU EVAR (2000-2018) was performed to compare long-term patient outcomes based on device diameter. "Large diameter" devices were defined as >34mm. The primary outcome was freedom from sac expansion throughout long-term follow-up. Analyses included bivariate analyses, Kaplan Meier with log-rank comparison, and multivariate Cox regression.Figure 1Figure 1 <h3>RESULTS</h3> A total of 1099 patients underwent on-IFU EVAR from 2000-2018. Follow-up data were available for 980 patients. Of these, 75 (7.6%) were treated with >34 mm devices. There were no significant differences in demographics or co-morbidities between the two groups, although pre-operative AAA size was greater in the large diameter group (58 ± 8.5 mm vs. 56 ± 17.4 mm; p=0.05). Median follow-up was 10.3 years. Patients with grafts >34 mm had decreased freedom from sac expansion (p=0.038) (Figure 1). Multivariate Cox regression identified independent factors associated with sac expansion, including age, pre-operative AAA size, reinterventions, and >34 mm endografts (Table 1). <h3>CONCLUSION</h3> Large diameter aortic endografts are associated with higher rates of sac expansion during long-term follow-up. While there is a role for large diameter grafts in select patients, it is important to recognize that these devices were often approved <i>post-hoc</i> without the same regulatory scrutiny of smaller endografts. These findings underscore the importance of surveillance for patients treated with >34 mm grafts.

776. Reducing Central Line Associated Bloodstream Infections (CLABSI) in a High-Risk Cohort of Patients by Standardizing Skin Preparation Prior to Pulmonary Artery Catheter Insertion

BackgroundCentral line associated bloodstream infections (CLABSI) are a recognized complication of all central venous access devices including pulmonary artery catheters (PAC). At our institution, PACs are utilized frequently, often for prolonged durations, for patients with advanced heart failure in the cardiac care unit (CCU) who are awaiting heart transplant. In early summer 2018, our hospital infection prevention (IP) department detected an uptick in CLABSI attributable to the CCU. After 9 months of zero CLABSI, two CLABSIs attributable to the CCU were identified during a 3 month period from November 2017-January 2018. Four additional CLABSIs were identified between May-July 2018 prompting an investigation by IP. Review of the 9 CLABSIs attributed to the CCU from May 2018 – June 2019 led IP to prioritize improving PAC insertion practices in our cardiac catheterization lab as a mean to reducing CLABSI (see table 1). MethodsIP performed 5 observations of PAC insertion in the cath lab. During the observations of skin preparation, the prep time was performed correctly 40% of the time, correct application 60% of the time and dry time 60% of the time (see table 2, Figure1). Interventions included scheduling a training day for all cath lab staff with the skin prep vendor, performing competency check-offs, and identifying super-users to train future staff. Furthermore, skin antiseptic utilization according the manufacturer's instructions for use was implemented, the coverage area for the applicator was reviewed and a chart for reference was provided.The staff was provided with posters on correct skin prep technique as a visual cue in the procedure room. ResultsSince the project was implemented in September 2019, there has been 1 CLABSI identified that was possibly related to a PAC inserted in the cath lab. During this time 3 CLABSIs were identified in the CCU but were felt to be unrelated to cath lab insertion. ConclusionSince the project was implemented in September 2019, there has been 1 CLABSI identified that was possibly related to a PAC inserted in the cath lab. During this time 3 CLABSIs were identified in the CCU but were felt to be unrelated to cath lab insertion.Disclosures All Authors: No reported disclosures

S970 New Automated Cleaning System Is More Effective in Reducing Bioburden vs Standard Manual Clean in Duodenoscopes

Introduction: Multiple recent outbreaks of multidrug resistant organisms (MDRO) related to contaminated duodenoscopes have led to increased scrutiny of duodenoscope standard reprocessing methods. A key component of duodenoscope reprocessing is the cleaning step that occurs before high-level disinfection (HLD) or sterilization. Perfect adherence to manufacturer Instructions for Use (IFU) for manual cleaning can be difficult to achieve due to technical complexity and is open to human factor error. Adequate cleaning is measured against FDA and industry maximum allowed contaminants post cleaning of protein < 6.4 ug/cm^2 and carbohydrates < 2.2 ug/cm^2. Inadequate cleaning increases the risk for inadequate high-level disinfection and the possibility of procedures being performed with contaminated duodenoscopes. A new cleaning process has been developed to fully automate the cleaning step using turbulent flow technology. Methods: A total of 48 therapeutic ERCP procedures were performed utilizing Olympus TJF-Q180V duodenoscopes. After bedside point of use cleaning, 21 duodenoscopes were manually cleaned by trained technicians following the manufacturer IFU. 27 duodenoscopes were cleaned using the automated cleaning system. Duodenoscope instrument channels and distal elevator areas were sampled for residual protein and carbohydrates after cleaning. Results: The automated cleaning process resulted in a lower average level of residual protein and carbohydrate compared to standard manual cleaning (Table 1). Using FDA and industry standards as a benchmark, the automated cleaning process reduced levels of protein and carbohydrate below safety threshold levels on all study duodenoscopes, while manual cleaning resulted in 4/21 (19%) duodenoscopes having protein or carbohydrate levels above FDA standards (p = 0.03). Conclusion: Recent outbreaks of MDRO organisms transmitted after ERCP have brought to light the risk to patients when reusable duodenoscopes are not sufficiently reprocessed. The complex design of the device – involving multiple channels and an elevator mechanism at the distal tip – makes proper cleaning difficult. Without sufficient cleaning, subsequent HLD or sterilization can fail to adequately remove contaminants. As seen in this study, manual cleaning can be prone to error. With no incidents of elevated bioburden post cleaning, a fully automated cleaning technology appears to be a viable alternative for replacement of manual cleaning of duodenoscopes.Table 1.: Residual Protein and Carbohydrate Post Manual Versus Automated Clean *One manually cleaned duodenoscope had levels of both protein and carbohydrate above FDA threshold.

Mycobacterium abscessus Surgical Site Infections Due to Modular Cooler-Heater Units in Cardiac Surgery

Background: In the spring of 2020, we identified 3 patients with organ-space surgical site infections (SSIs) secondary to Mycobacterium abscessus (Table 1). All 3 patients underwent cardiac surgery in the same operating room (OR) during which the CardioQuip Modular Cooler-Heaters (MCHs) were used. We describe key aspects of our cluster investigation, which ultimately led to release of a national safety alert by the Food and Drug Administration (FDA). Methods: For environmental cultures, we obtained samples from 9 MCHs in circulation; 2 scrub sink samples; ice from the OR ice machine; water samples from sinks in the cardiovascular critical care unit, and water samples from floors above the cardiac ORs. All samples were sent for molecular genotyping. For pathway studies, an external environmental engineering team was consulted who conducted smoke pathway tests in 3 different ORs. The team also conducted a particle generator experiment, simulating the set-up of a cardiac bypass surgery case. To assess disinfection practices, we reviewed the manufacturer instructions for use (IFU) protocol of the MCHs and audited our own policies and procedures to ensure compliance. Results: For environmental cultures, molecular typing from 5 of 9 MCHs and all 3 patient SSI isolates returned positive for the identical hybrid species M. abscessus bolleti. All other samples with mycobacterial growth returned with different species. For pathway studies, the particle-generator experiment demonstrated particle movement from the MCH to the sterile field with facilities-guidelines–compliant OR ventilation and despite MCH manufacturing design. For disinfection practices, despite compliance with the stated IFU, and in consultation with experts, we implemented disinfection of associated Quick-connect devices (otherwise not stated in the IFU), and we also initiated a precleaning step prior to disinfection. Conclusions: Our investigation concluded that 3 patients developed SSIs with Mycobacterium abscessus that was aerosolized from the CardioQuip MCH. This finding led to the national FDA safety report alerting providers to risks associated with the device and the need for continued vigilance around disinfection. In addition, we implemented other control measures including placement of MCHs outside all ORs; creation of a separate MCH fleet for non-OR use; and use of modified disinfection protocols. To date, no additional cases have been identified.Funding: NoDisclosures: None

Rapid, point-of-care antigen and molecular-based tests for diagnosis of SARS-CoV-2 infection.

Rapid, point-of-care antigen and molecular-based tests for diagnosis of SARS-CoV-2 infection.

Usability and acceptability of a multimodal respiratory rate and pulse oximeter device in case management of children with symptoms of pneumonia: A cross-sectional study in Ethiopia.

AimPneumonia is the leading infectious cause of death among children under five globally. Many pneumonia deaths result from inappropriate treatment due to misdiagnosis of signs and symptoms. This study aims to identify whether health extension workers (HEWs) in Ethiopia, using an automated multimodal device (Masimo Rad‐G), adhere to required guidelines while assessing and classifying under five children with cough or difficulty breathing and to understand device acceptability.MethodsA cross‐sectional study was conducted in three districts of Southern Nations, Nationalities, and Peoples' Region, Ethiopia. Between September and December 2018, 133 HEWs were directly observed using Rad‐G while conducting 599 sick child consultations. Usability was measured as adherence to the World Health Organization requirements to assess fast breathing and device manufacturer instructions for use. Acceptability was assessed using semi‐structured interviews with HEWs, first‐level health facility workers and caregivers.ResultsAdherence using the Rad‐G routinely for 2 months was 85.3% (95% CI 80.2, 89.3). Health workers and caregivers stated a preference for Rad‐G. Users highlighted a number of device design issues.ConclusionWhile demonstrating high levels of acceptability and usability, the device modifications to consider include better probe fit, improved user interface with exclusive age categories and simplified classification outcomes.

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

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

Anatomical feasibility of a new off-the-shelf inner branch stent graft (E-nside) for endovascular treatment of thoraco-abdominal aneurysms.

The aim of this study was to evaluate the proportion of thoraco-abdominal aortic aneurysms (TAAAs) that could theoretically be treated with the JOTEC® E-nside® Thoracoabdominal Branch Endoprosthesis off-the-shelf multibranched endograft. Preoperative computed tomography scans of patients with atherosclerotic TAAA treated between 2007 and 2019 were reviewed, and the anatomical feasibility of the E-nside graft was verified by a retrospective study (clinicaltrials.gov: NCT03959670) based on the investigational manufacturer instructions for use. The anatomical factors determining overall feasibility were divided into vascular access (AC) feasibility, aortic (AO) feasibility and visceral vessels (VV) feasibility. Two hundred sixty-eight patients with thoraco-abdominal aneurysms were analysed: the overall treatment feasibility was 43%. AC feasibility was 78%, AO feasibility 60% and VV feasibility 79%. An iliac diameter <8.5 mm excluded 21% of the patients. Aortic feasibility was limited by infrarenal aortic diameter (16%) and size of aortic lumen at the level of visceral vessels (14%). Visceral vessels feasibility was mainly limited by inadequate number (8%) or diameter (12%) of target vessels. Height and orientation of target vessels were adequate in 97% of the cases. Overall feasibility was negatively influenced by female gender (Odds ratio: 3.89; 95% confidence interval 2.03-7.44; P < 0.001): the limiting factors in this subgroup being iliac diameter, infrarenal aortic diameter and visceral vessels diameter. The E-nside off-the-shelf stent graft can be theoretically employed in almost half of the cases from an all-comers cohort of patients with TAAA. Improvement of device profile and creation of a dedicated infrarenal component are warranted to increase overall feasibility. Female gender significantly affects the overall feasibility. NCT03959670.

Rapid, point-of-care antigen and molecular-based tests for diagnosis of SARS-CoV-2 infection.

Rapid, point-of-care antigen and molecular-based tests for diagnosis of SARS-CoV-2 infection.

Demystifying theoretical concerns involving respirators with exhalation valves during COVID-19 pandemic

Demystifying theoretical concerns involving respirators with exhalation valves during COVID-19 pandemic

Partnering with Central Sterile Processing Department Experts to Advance Infection Prevention Competency

<h3>Background</h3> The Central Sterile Processing Department (CSPD) manages the cleaning, disinfection, and sterilization of reprocessed devices and instruments. Infection Preventionists (IP) work closely with CSPD to ensure devices and instruments are reprocessed and stored according to the recommendations of manufacturer, regulatory, and expert guidelines. A large healthcare system surveyed their IP and identified opportunities related to the updated Association for Professionals in Infection Control and Epidemiology (APIC) Competency Model (2019) domains. Cleaning, Disinfection and Sterilization falls under the Operations domain and was identified as an area in which IP wanted to enhance their expertise. <h3>Methods</h3> IP partnered with CSPD experts throughout the healthcare system to provide an in-depth education workshop to grow IP competency in CSPD. IP within our system are responsible for CSPD in a range of settings, including adult and pediatric acute care, critical access hospitals, ambulatory surgery centers, and over 120 physician offices or outpatient care areas. The workshop was divided into 4 sessions that consisted of oral presentations, hands-on learning, and discussion of examples and real-life scenarios. Manufacturer instructions for use (MIFU) were addressed, and a review of standard work and best practices due to sterilization failures were discussed. <h3>Results</h3> 32 attendees from 12 settings participated in the workshop, including Infectious Diseases (ID) physicians, IP, Occupational Health (OH) practitioners, and CSPD technicians. Attendees were asked to evaluate the quality of the educational sessions. 20 attendees completed their evaluations. The 4 sessions each received either an Agree (12) or a Strongly Agree (68) approval rating. The overall quality of the program received an Excellent (16) or a Good (4). <h3>Conclusions</h3> By partnering with CSPD subject matter experts (SME) from their healthcare facilities, IP, ID Physicians and OH Specialists increased their knowledge about the cleaning, disinfection, and sterilization of reusable devices and instruments and enhanced their professional relationships with their CSPD team.