Introduction The prevalence of catheter-associated bloodstream infections (CLABSI) is high and is a severe health problem associated with an increase in mortality and elevated economic costs. There are discrepancies related to the risk factors of CLABSI since the results published are very heterogeneous and there is no synthesis in the description of all the predisposing factors. Objective We aimed to perform a systematic review and meta-analysis to synthesize and establish the risk factors predisposing to CLABSI reported in the literature. Method This is a systematic review of observational studies following the PRISMA recommendations. MEDLINE and CINAHL databases were searched for primary studies from 2007 to 2021. The protocol was registered in PROSPERO CRD42018083564. Results A total of 654 studies were identified, 23 of which were included in this systematic review. The meta-analysis included 17 studies and 9 risk factors were analyzed (total parenteral nutrition (TPN), chemotherapy, monolumen and bilumen catheters, days of catheterization, immunosuppression, kidney disease and diabetes mellitus) due to the homogeneity of their definitions and measurements. The risk factors found to increase the probability of developing CLABSI were TPN, multilumen devices, chemotherapy treatment, immunosuppression and the number of days of catheterization. On the other hand, monolumen devices presented a lower likelihood of triggering this infection.

/pdf/risk-factors-of-catheter-associated-bloodstream-infection-1kyro1ep.pdf

Risk factors of catheter- associated bloodstream infection: Systematic review and meta-analysis

RATIONALE: Fever is frequently an early indicator of infection and often requires rigorous diagnostic evaluation. OBJECTIVES: This is an update of the 2008 Infectious Diseases Society of America and Society (IDSA) and Society of Critical Care Medicine (SCCM) guideline for the evaluation of new-onset fever in adult ICU patients without severe immunocompromise, now using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology. PANEL DESIGN: The SCCM and IDSA convened a taskforce to update the 2008 version of the guideline for the evaluation of new fever in critically ill adult patients, which included expert clinicians as well as methodologists from the Guidelines in Intensive Care, Development and Evaluation Group. The guidelines committee consisted of 12 experts in critical care, infectious diseases, clinical microbiology, organ transplantation, public health, clinical research, and health policy and administration. All task force members followed all conflict-of-interest procedures as documented in the American College of Critical Care Medicine/SCCM Standard Operating Procedures Manual and the IDSA. There was no industry input or funding to produce this guideline. METHODS: We conducted a systematic review for each population, intervention, comparison, and outcomes question to identify the best available evidence, statistically summarized the evidence, and then assessed the quality of evidence using the GRADE approach. We used the evidence-to-decision framework to formulate recommendations as strong or weak or as best-practice statements. RESULTS: The panel issued 12 recommendations and 9 best practice statements. The panel recommended using central temperature monitoring methods, including thermistors for pulmonary artery catheters, bladder catheters, or esophageal balloon thermistors when these devices are in place or accurate temperature measurements are critical for diagnosis and management. For patients without these devices in place, oral or rectal temperatures over other temperature measurement methods that are less reliable such as axillary or tympanic membrane temperatures, noninvasive temporal artery thermometers, or chemical dot thermometers were recommended. Imaging studies including ultrasonography were recommended in addition to microbiological evaluation using rapid diagnostic testing strategies. Biomarkers were recommended to assist in guiding the discontinuation of antimicrobial therapy. All recommendations issued were weak based on the quality of data. CONCLUSIONS: The guidelines panel was able to formulate several recommendations for the evaluation of new fever in a critically ill adult patient, acknowledging that most recommendations were based on weak evidence. This highlights the need for the rapid advancement of research in all aspects of this issue—including better noninvasive methods to measure core body temperature, the use of diagnostic imaging, advances in microbiology including molecular testing, and the use of biomarkers.

Society of Critical Care Medicine and the Infectious Diseases Society of America Guidelines for Evaluating New Fever in Adult Patients in the ICU

This study evaluated the questionnaire testing nurses’ knowledge about the maintenance of a central venous catheter (CVC) and assessed it with regard to age, work experience, type of ward, frequency of trainings, and postgraduate education. There were 1,180 questionnaires (N = 784; 66.4% of the total sample) distributed in several regions of Poland for a period of 7 months. The difficulty level for each question ranged from 0.22-0.88.

Prevention of Central Line-Associated Bloodstream Infections.

Risk factors associated with increased incidences of catheter-related bloodstream infection

Biomedical devices provide a critical role in the healthcare system to positively impact patient well-being. This paper aims to provide the current classifications and subclassifications of hardware and software medical devices according to the Food and Drug Administration (FDA) guidelines. An overview of the FDA regulatory pathway for medical device development such as radiation-emitting electronic product verification, product classification database, Humanitarian Use Device (HUD), premarket approval, premarket notification and clearance, post-market surveillance, and reclassification is provided. Current advances and the advantages of implementing human factors engineering in biomedical device development to reduce the risk of user error, product recalls and effective safe use are discussed. This paper also provides a review of evolving topics such as the Internet of Things (IoT), software as medical devices, artificial intelligence (AI), machine learning (ML), mobile medical devices, and clinical decision software support systems. A comprehensive discussion of the first FDA-approved AI-medical device for the diagnosis of diabetic retinopathy is presented. Further, potential cybersecurity-related risks associated with software-driven AI/ML and IoT medical devices are discussed with an emphasis on government regulations. Futuristic trends in biomedical device development and their implications on patient care and the healthcare system are elucidated. 

A Review of Biomedical Devices: Classification, Regulatory Guidelines, Human Factors, Software as a Medical Device, and Cybersecurity

Niccolò Buetti MD, MSc, PhD12a , Jonas Marschall MD, MSc34a , Marci Drees MD, MS56 , Mohamad G. Fakih MD, MPH7 , Lynn Hadaway MEd, RN, NPD-BC, CRNI8, Lisa L. Maragakis MD, MPH9, Elizabeth Monsees PhD, MBA, RN, CIC1011 , Shannon Novosad MD MPH12, Naomi P. O’Grady MD13, Mark E. Rupp MD14 , Joshua Wolf MBBS, PhD, FRACP1516 , Deborah Yokoe MD, MPH17 and Leonard A. Mermel DO, ScM1819 1Infection Control Programme, University of Geneva Hospitals and Faculty of Medicine, Geneva, Switzerland, 2University of Paris, Paris, France, 3Department of Infectious Diseases, Bern University Hospital and University of Bern, Bern, Switzerland, 4Division of Infectious Diseases, Department of Medicine, Washington University School of Medicine, St. Louis, Missouri, United States, 5ChristianaCare, Wilmington, Delaware, United States, 6Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania, United States, 7Ascension Healthcare and Wayne State University School of Medicine, Detroit, Michigan, United States, 8Lynn Hadaway Associates, Milner, Georgia, United States, 9Johns Hopkins University School of Medicine, Baltimore, Maryland, United States, 10Children’s Mercy Hospital, Kansas City, Missouri, United States, 11University of Missouri–Kansas City School of Medicine, Kansas City, Missouri, United States,, 12Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia, United States, 13National Institutes of Health, Bethesda, Maryland, United States, 14University of Nebraska Medical Center, Omaha, Nebraska, United States, 15Department of Infectious Diseases, St. Jude Children’s Research Hospital, Memphis, Tennessee, United States, 16Department of Pediatrics, University of Tennessee Health Science Center, Memphis, Tennessee, United States, 17University of California–San Francisco, San Francisco, California, United States, 18Warren Alpert Medical School of Brown University, Providence, Rhode Island, United States and 19Rhode Island Hospital, Providence, Rhode Island, United States

/pdf/strategies-to-prevent-central-line-associated-bloodstream-221e4k5v.pdf

Strategies to prevent central line-associated bloodstream infections in acute-care hospitals: 2022 Update

A nationwide tuberculosis outbreak linked to a viable bone allograft product contaminated with Mycobacterium tuberculosis was identified in June 2021. Our subsequent investigation identified 73 healthcare personnel with new latent tuberculosis infection following exposure to the contaminated product, product recipients, surgical instruments, or medical waste.

https://academic.oup.com/cid/advance-article-pdf/doi/10.1093/cid/ciad029/49158959/ciad029.pdf

Transmission of Mycobacterium tuberculosis to healthcare personnel resulting from contaminated bone graft material, United States, June 2021- August 2022.

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Strategies to prevent central line-associated bloodstream infections in acute-care hospitals: 2022 Update

Transmission of Mycobacterium tuberculosis to healthcare personnel resulting from contaminated bone graft material, United States, June 2021- August 2022.

ICE volume 43 issue 1 Cover and Front matter