I-DECIDED® – A decision tool for assessment and management of invasive devices in the hospital setting

Indwelling medical devices, including vascular access and urinary catheters, pose a risk for infection, and therefore daily assessment and consideration of their continued need is a patient safety priority. The I-DECIDED® device assessment and decision tool is an evidence-based checklist, designed to improve the assessment, care and timely removal of invasive devices in acute hospitalized patients. This paper explains each step of the tool, with rationale for inclusion.

More than a century ago, Osler took numerous syndrome descriptions of cardiac valvular infection that were incomplete and confusing and categorized them into the cardiovascular infections known as infective endocarditis. Because he was both a clinician and a pathologist, he was able to provide a meaningful outline of this complex disease. Technical advances have allowed us to better subcategorize infective endocarditis on the basis of microbiological etiology. More recently, the syndromes of infective endocarditis and endarteritis have been expanded to include infections involving a variety of cardiovascular prostheses and devices that are used to replace or assist damaged or dysfunctional tissues (Table 1). Taken together, infections of these novel intracardiac, arterial, and venous devices are frequently seen in medical centers throughout the developed world. In response, the American Heart Association’s Committee on Rheumatic Fever, Endocarditis, and Kawasaki Disease wrote this review to assist and educate clinicians who care for an increasing number of patients with nonvalvular cardiovascular device–related infections. Because timely guidelines1,2 exist that address the prevention and management of intravascular catheter–related infections, these device-related infections are not discussed in the present Statement. View this table: TABLE 1. Nonvalvular Cardiovascular Device–Related Infections This review is divided into two broad sections. The first section examines general principles for the evaluation and management of infection that apply to all nonvalvular cardiovascular devices. Despite the marked variability in composition, structure, function, and frequency of infection among the various types of nonvalvular cardiovascular devices reviewed in this article, there are several areas of commonality for infection of these devices. These include clinical manifestations, microbiology, pathogenesis, diagnosis, treatment, and prevention. The second section addresses each device and describes unique clinical features of infection. Each device is placed into one of 3 categories—intracardiac, arterial, or venous—for discussion. ### Clinical Manifestations The specific signs and symptoms associated with an infection of a …

Bacterial infections in healthcare settings are a frequent accompaniment to both routine procedures such as catheterization and surgical site interventions. Their impact is becoming even more marked as the numbers of medical devices that are used to manage chronic health conditions and improve quality of life increases. The resistance of pathogens to multiple antibiotics is also increasing, adding an additional layer of complexity to the problems of employing safe and effective medical procedures. One approach to reducing the rate of infections associated with implanted and indwelling medical devices is the use of polymers that resist the formation of bacterial biofilms. To significantly accelerate the discovery of such materials, we show how state of the art machine learning methods can generate quantitative predictions for the attachment of multiple pathogens to a large library of polymers in a single model for the first time. Such models facilitate design of polymers with very low pathogen attachment across different bacterial species that will be candidate materials for implantable or indwelling medical devices such as urinary catheters, cochlear implants, and pacemakers.

Background:Indwelling medical devices (IMDs) in critical patients are vulnerable to colonization by biofilm producing bacteria. Complex characteristics of bacterial biofilms promote antibiotic resistance, leading to the emergence of resistant device-related infections (DRI), which pose new challenges in their management.Materials and Methods:The study was done on 135 hospitalized (Intensive care units) pediatric patients with IMDs (intravascular catheter, urinary catheter, and endotracheal tube) to determine the device-specific infection rates. Biofilm formations were demonstrated by the tube method and by scanning electron microscopy (SEM). Bacteria in biofilms were identified by the standard conventional methods and tested for antibiotic resistance. We also detected the presence of extended spectrum β-lactamases (ESβLs), particularly, blaCTX-M, in gram-negative isolates.Results:The rates of biofilm-based catheter-related blood stream infections (CRBSI), catheter-associated urinary tract infections (CAUTI), and Ventilator Associated Pneumonia (VAP), in our study, were 10.4, 26.6, and 20%. Biofilm formation by the tube method correlated well with the SEM findings. A majority of infections were caused by Klebsiella pneumoniae followed by Staphylococcal biofilms. A high percentage (85.7%, 95% confidence interval 64.5 to 95.8%) of biofilm producing bacterial isolates, causing infection, were multidrug resistant. Many biofilm producing gram-negative isolates were ESβLs producers, and a majority particularly harbored blaCTX-M, among the ESβLs genotypes.Conclusion:The incidence of resistant device-related infections, predominantly caused by biofilm producing bacteria, is rising. The tube method is an effective screening method to test biofilm production, where sophisticated microscopy facilities are not available. The varying resistance pattern of organisms isolated in our setup, emphasizes the importance of studying the pattern of infection in every setting and providing antibiotic guidelines in the management of such infections.

BackgroundEstablishing patient safety priorities in psychiatry has received less international attention than in other areas of health care. This study aimed to identify safety issues as described by people in the United Kingdom identifying as mental health service users, carers and professionals.MethodsA cross‐sectional online survey was distributed via social media. Identified safety issues were mapped onto the Yorkshire Contributory Factors Framework (YCFF) which categorizes factors that contribute to patient safety incidents in general hospital settings. Service user and carer responses were described separately from professional responses using descriptive statistics.ResultsOne hundred and eighty‐five responses from 95 service users and carers and 90 professionals were analysed. Seventy different safety issues were identified. These were mapped onto the 17 existing categories of the YCFF and two additional categories created to form the YCFF‐MH. Most frequently identified issues were as follows: “Individual characteristics” (of staff) which included competence and listening skills; “Service process” that contained concerns about waiting times; “Management of staff and staffing levels” dominated by staffing levels; and “External policy context” which included the overall resourcing of services. Professionals identified staffing levels and inadequate community provision more frequently than service users and carers, who in turn identified crisis care more frequently.ConclusionsThis study updates knowledge on stakeholder perceived safety issues across mental health care. It shows a far broader range of issues relating to safety than has previously been described. The YCFF was successfully modified to describe these issues and areas for further coproduced research are suggested.

Indwelling medical devices, such as urinary catheters, often experience bacterial colonization, forming biofilms that resist antibiotics and the host's immune defenses through quorum sensing (QS), a chemical communication system. This study explores the development of antimicrobial coatings by immobilizing acylase, a quorum-quenching enzyme, on sandblasted polydimethylsiloxane (PDMS) surfaces. PDMS, commonly used in medical devices, was sandblasted to increase its surface roughness, enhancing acylase attachment. FTIR analysis confirmed that acylase retained its three-dimensional structure upon immobilization, preserving its enzymatic activity. The antibacterial efficacy of the coatings was tested against Pseudomonas aeruginosa (P. aeruginosa) (a common biofilm-forming pathogen), Staphylococcus aureus (S. aureus), and Escherichia coli (E. coli). The results showed that sandblasted PDMS surfaces had improved bacterial adhesion due to increased focal adhesion points, but acylase-functionalized surfaces had significantly reduced bacterial attachment and biofilm formation. Notably, the coatings inhibited P. aeruginosa growth by 40% under static conditions, demonstrating the potential of acylase-functionalized PDMS for medical applications. This approach offers a promising strategy for creating antimicrobial surfaces that prevent biofilm-related infections in urinary catheters and other medical devices. The findings highlight the dual role of surface roughness in enhancing enzyme attachment while reducing bacterial adhesion through effective QS inhibition.

Diabetes mellitus is becoming increasingly prevalent worldwide. Additionally, there is an increasing number of patients receiving implantable devices such as glucose sensors and orthopedic implants. Thus, it is likely that the number of diabetic patients receiving these devices will also increase. Even though implantable medical devices are considered biocompatible by the Food and Drug Administration, the adverse tissue healing that occurs adjacent to these foreign objects is a leading cause of their failure. This foreign body response leads to fibrosis, encapsulation of the device, and a reduction or cessation of device performance. A second adverse event is microbial infection of implanted devices, which can lead to persistent local and systemic infections and also exacerbates the fibrotic response. Nearly half of all nosocomial infections are associated with the presence of an indwelling medical device. Events associated with both the foreign body response and implant infection can necessitate device removal and may lead to amputation, which is associated with significant morbidity and cost. Diabetes mellitus is generally indicated as a risk factor for the infection of a variety of implants such as prosthetic joints, pacemakers, implantable cardioverter defibrillators, penile implants, and urinary catheters. Implant infection rates in diabetic patients vary depending upon the implant and the microorganism, however, for example, diabetes was found to be a significant variable associated with a nearly 7.2% infection rate for implantable cardioverter defibrillators by the microorganism Candida albicans. While research has elucidated many of the altered mechanisms of diabetic cutaneous wound healing, the internal healing adjacent to indwelling medical devices in a diabetic model has rarely been studied. Understanding this healing process is crucial to facilitating improved device design. The purpose of this article is to summarize the physiologic factors that influence wound healing and infection in diabetic patients, to review research concerning diabetes and biomedical implants and device infection, and to critically analyze which diabetic animal model might be advantageous for assessing internal healing adjacent to implanted devices.

Recently, venovenous extracorporeal life support (VVECLS) using a double lumen catheter has been clinically used to avoid neurologic complications in the treatment of respiratory failure for neonates. However, recirculation, which is a limiting factor for oxygen delivery, still exists, and thus it does not contribute to oxygenation of the patient. We developed a newly designed double lumen catheter with a double balloon (DBDL) catheter for ECLS vascular access and performed two animal preliminary experiments in normal and hypoxic dog models (normal ventilation and one lung ventilation experiments) to investigate whether the DBDL catheter could prevent recirculation and maintain oxygen delivery to systemic circulation. The DBDL catheter (JCT Co., Hiroshima, Japan) of 15 Fr was fabricated from silicone. It consists of two lumens for drainage and return of blood with two balloons (distal and proximal balloons) that prevent oxygenated blood mixing with unoxygenated blood. VVECLS using a DBDL catheter was performed in 13 mongrel dogs (8 dogs for normal ventilation experiment weighing 12.9 +/- 1.6 kg [mean +/- SD], 5 dogs for one lung ventilation experiment weighing 16.6 +/- 2.5 kg [mean +/- SD]) under anesthesia in the two experiments. The bypass flow ranged from 10-40 ml/kg per minute in the normal ventilation experiment. VVECLS in the one lung ventilation experiment was performed with maximal bypass flow for 6 hours (ranged from 25.2 +/- 8.0-28.3 +/- 8.7 ml/kg per minute at balloon inflation and deflation). Recirculation and oxygen transfer of artificial lung with or without balloon inflation during VVECLS were studied. Recirculation decreased with balloon inflation at varied bypass flows during VVECLS in the normal ventilation experiment (varied from 1.5 +/- 14.6-12.8 +/- 16.7%) and for 6 hours after VVECLS initiation in the one lung ventilation experiment (varied from 12.2 +/- 12.2-19.2 +/- 6.5%). In particular, the values at 3 and 6 hours were significantly lower than that of balloon deflation in the one lung ventilation experiment. The difference in O2 content between inlet and outlet in the artificial lung with balloon inflation was significantly higher than that of balloon deflation (varied from 3.7 +/- 1.8-4.8 +/- 1.9 ml/dl, p < 0.05) at the bypass flow of 10-30 ml/kg per minute in the normal ventilation experiment and at 5 hours after VVECLS initiation in the one lung ventilation experiment (varied from 10.6 +/- 1.6-11.7 +/- 1.8 ml/dl). The blood gas analysis of systemic circulation with balloon inflation revealed that the values of PaO2 (varied from 83.8 +/- 11.4-96.9 +/- 23.4 mm Hg) and PaCO2 (37.7 +/- 9.2-40.4 +/- 11.8 mm Hg) were higher and lower, respectively, compared with balloon deflation. In particular, PaO2 level was significantly higher than that of the preECLS value at the bypass flow of 20-40 ml/kg per minute (varied from 83.8 +/- 11.4-96.9 +/- 23.4 mm Hg, p < 0.05). In the one lung ventilation experiment, systemic PaO2 and PaCO2 levels at balloon inflation were higher and lower, respectively, compared with balloon deflation during VVECLS for 6 hours. At balloon inflation, the value of PaO2 at 6 hours after VVECLS initiation was significantly higher than that at balloon deflation. A newly designed DBDL catheter for ECLS vascular access successfully reduced recirculation and maintained oxygen delivery to systemic circulation during VVECLS. These results suggest that a high bypass flow may not be necessarily required in terms of oxygen delivery to systemic circulation when the DBDL catheter was used as an ECLS vascular access.

Bloodstream Infection Prevention in ESRD: Forging a Pathway for Success

Indwelling medical devices such as catheters are a ubiquitous and indispensable component in modern medical practice for improving therapeutic outcomes for patients. Yet at the same time, they can be a cause of healthcare-associated infections contributing to patient morbidity and mortality, and healthcare costs. Other surface-related complications can also arise from interactions of the catheter with biological components in the in vivo environment. This review summarizes the progress made in the development of antimicrobial surfaces, and the application of surface modification strategies to three important classes of catheters: urinary catheters, intravascular catheters and peritoneal dialysis catheters. The review also provides a perspective on the challenges in translating favorable developments from in vitro studies into similar clinical outcomes.

Healthcare-associated infections (HAIs) are a major threat to patient safety, and are associated with mortality rates varying from 5% to 35%. Important risk factors associated with HAIs are the use of invasive medical devices (e.g. central lines, urinary catheters and mechanical ventilators), and poor staff adherence to infection prevention practices during insertion and care for the devices when in place. There are specific risk profiles for each device, but in general, the breakdown of aseptic technique during insertion and care for the device, as well as the duration of device use, are important factors for the development of these serious and costly infections. To assess the effectiveness of different interventions, alone or in combination, which target healthcare professionals or healthcare organisations to improve professional adherence to infection control guidelines on device-related infection rates and measures of adherence. We searched the following electronic databases for primary studies up to June 2012: the Cochrane Effective Paractice and Organisation of Care (EPOC) Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, and CINAHL. We searched reference lists and contacted authors of included studies. We also searched the Cochrane Database of Systematic Reviews and Database of Abstracts of Reviews of Effectiveness (DARE) for related reviews. We included randomised controlled trials (RCTs), non-randomised controlled trials (NRCTs), controlled before-after (CBA) studies and interrupted time series (ITS) studies that complied with the Cochrane EPOC Group methodological criteria, and that evaluated interventions to improve professional adherence to guidelines for the prevention of device-related infections. Two review authors independently extracted data and assessed the risk of bias of each included study using the Cochrane EPOC 'Risk of bias' tool. We contacted authors of original papers to obtain missing information. We included 13 studies: one cluster randomised controlled trial (CRCT) and 12 ITS studies, involving 40 hospitals, 51 intensive care units (ICUs), 27 wards, and more than 3504 patients and 1406 healthcare professionals. Six of the included studies targeted adherence to guidelines to prevent central line-associated blood stream infections (CLABSIs); another six studies targeted adherence to guidelines to prevent ventilator-associated pneumonia (VAP), and one study focused on interventions to improve urinary catheter practices. We judged all included studies to be at moderate or high risk of bias.The largest median effect on rates of VAP was found at nine months follow-up with a decrease of 7.36 (-10.82 to 3.14) cases per 1000 ventilator days (five studies and 15 sites). The one included cluster randomised controlled trial (CRCT) observed, improved urinary catheter practices five weeks after the intervention (absolute difference 12.2 percentage points), however, the statistical significance of this is unknown given a unit of analysis error. It is worth noting that N = 6 interventions that did result in significantly decreased infection rates involved more than one active intervention, which in some cases, was repeatedly administered over time, and further, that one intervention involving specialised oral care personnel showed the largest step change (-22.9 cases per 1000 ventilator days (standard error (SE) 4.0), and also the largest slope change (-6.45 cases per 1000 ventilator days (SE 1.42, P = 0.002)) among the included studies. We attempted to combine the results for studies targeting the same indwelling medical device (central line catheters or mechanical ventilators) and reporting the same outcomes (CLABSI and VAP rate) in two separate meta-analyses, but due to very high statistical heterogeneity among included studies (I(2) up to 97%), we did not retain these analyses. Six of the included studies reported post-intervention adherence scores ranging from 14% to 98%. The effect on rates of infection were mixed and the effect sizes were small, with the largest median effect for the change in level (interquartile range (IQR)) for the six CLABSI studies being observed at three months follow-up was a decrease of 0.6 (-2.74 to 0.28) cases per 1000 central line days (six studies and 36 sites). This change was not sustained over longer follow-up times. The low to very low quality of the evidence of studies included in this review provides insufficient evidence to determine with certainty which interventions are most effective in changing professional behaviour and in what contexts. However, interventions that may be worth further study are educational interventions involving more than one active element and that are repeatedly administered over time, and interventions employing specialised personnel, who are focused on an aspect of care that is supported by evidence e.g. dentists/dental auxiliaries performing oral care for VAP prevention.

The Gram-negative opportunistic pathogen, Klebsiella pneumoniae, is responsible for causing a spectrum of community-acquired and nosocomial infections and typically infects patients with indwelling medical devices, especially urinary catheters, on which this microorganism is able to grow as a biofilm. The increasingly frequent acquisition of antibiotic resistance by K. pneumoniae strains has given rise to a global spread of this multidrug-resistant pathogen, mostly at the hospital level. This scenario is exacerbated when it is noted that intrinsic resistance to antimicrobial agents dramatically increases when K. pneumoniae strains grow as a biofilm. This review will summarize the findings about the antibiotic resistance related to biofilm formation in K. pneumoniae.

IntroductionStaphylococcus epidermidis is currently the most frequent pathogen of opportunistic and nosocomial infections worldwide. Most cases of Staphylococcus epidermidis infections are associated with indwelling medical devices and/or immunocompromised conditions. Community-acquired urinary tract infections are rare, particularly among pediatric populations, and clinicians often do not consider Staphylococcus epidermidis as a uropathogen.Case presentationA previously healthy Japanese boy developed pyelonephritis caused by Enterococcus faecalis at 10 months of age. Subsequently, he was diagnosed with severe bilateral vesicoureteral reflux (right side grade V, left side grade III), and was administered trimethoprim/sulfamethoxazole as the prophylaxis. At 18 months of age, he presented with fever. Gram staining of urine obtained through catheterization revealed gram-positive cocci. We suspected pyelonephritis caused by enterococci, and administered oral fluoroquinolone empirically. The fever promptly resolved, and eventually, methicillin-resistant Staphylococcus epidermidis was detected at significant levels in the urine. Thus, our final diagnosis was pyelonephritis caused by community-acquired methicillin-resistant Staphylococcus epidermidis.ConclusionsOur case indicated that even immunocompetent children without a urinary catheter can develop Staphylococcus epidermidis pyelonephritis. Staphylococcus epidermidis can be underdiagnosed or misdiagnosed as sample contamination in community-acquired urinary tract infections. Therefore, when Gram staining of appropriately obtained urine samples reveals gram-positive cocci, clinicians should take into consideration not only the possibility of enterococci but also staphylococci, including Staphylococcus epidermidis, particularly in children with urinary abnormalities and/or those receiving continuous antibiotic prophylaxis.

Compliance with hand hygiene is an effective way of reducing the incidence of healthcare acquired infections (HCAI). At one London National Health Service (NHS) Trust, improving hand hygiene compliance (HHC) was a patient safety priority in response to non-compliance and ongoing occurrences of HCAI. The objective of this study was to co-design a behavioural science informed intervention to improve HHC. To obtain a baseline level of HHC and understand associated behaviours, 18 hours of observation were undertaken on three inpatient wards. These focused upon Moment 1 and 5 of the World Health Organisation's moments for hand hygiene. The intervention was co-designed with clinical staff and took the form of "visual primes". Three different stickers designed to create a motivational "nudge" were placed at key points where HHC had been observed to fail. Following implementation, a further 18 hours of observation took place. A Chi-squared statistical analysis compared proportions of HHC pre- and post-intervention. Our intervention led to an 11% increase in HHC across the three study wards for both Moments (X2 (1, N = 1,285) = 13.711, p = <0.001) in the six weeks following the intervention. The intervention had a more marked effect on Moment 1, (with an increase of 15%, X2 (1, N = 667) = 17.091, p = <0.001 when compared to the change in compliance with Moment 5 (11%, X2 (1, N = 652) = 7.449, p = 0.06). This study demonstrated that utilising behavioural science in the co-design and placement of visual motivational nudges can significantly improve compliance with hand hygiene practices. We highlight the benefit of co-design when designing interventions-both in terms of engagement with and efficacy of the intervention.

ObjectiveIdentifying patient safety priorities in mental healthcare is an emerging issue. A variety of aspects of patient safety in medical care apply for patient safety in mental care as well....