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In March 2018, the US Food and Drug Administration (FDA), US Centers for Disease Control and Prevention, California Department of Public Health, Los Angeles County Department of Public Health and Pennsylvania Department of Health initiated an investigation of an outbreak of Burkholderia cepacia complex (Bcc) infections. Sixty infections were identified in California, New Jersey, Pennsylvania, Maine, Nevada and Ohio. The infections were linked to a no-rinse cleansing foam product (NRCFP), produced by Manufacturer A, used for skin care of patients in healthcare settings. FDA inspected Manufacturer A's production facility (manufacturing site of over-the-counter drugs and cosmetics), reviewed production records and collected product and environmental samples for analysis. FDA's inspection found poor manufacturing practices. Analysis by pulsed-field gel electrophoresis confirmed a match between NRCFP samples and clinical isolates. Manufacturer A conducted extensive recalls, FDA issued a warning letter citing the manufacturer's inadequate manufacturing practices, and federal, state and local partners issued public communications to advise patients, pharmacies, other healthcare providers and healthcare facilities to stop using the recalled NRCFP. This investigation highlighted the importance of following appropriate manufacturing practices to minimize microbial contamination of cosmetic products, especially if intended for use in healthcare settings.
One in six nursing home residents and staff with positive SARS-CoV-2 tests ≥90 days after initial infection had specimen cycle thresholds (Ct) <30. Individuals with specimen Ct<30 were more likely to report symptoms but were not different from individuals with high Ct value specimens by other clinical and testing data.
The purpose of this document is to highlight practical recommendations to assist acute care hospitals to prioritize and implement strategies to prevent ventilator-associated pneumonia (VAP), ventilator-associated events (VAE), and non-ventilator hospital-acquired pneumonia (NV-HAP) in adults, children, and neonates. This document updates the Strategies to Prevent Ventilator-Associated Pneumonia in Acute Care Hospitals published in 2014. This expert guidance document is sponsored by the Society for Healthcare Epidemiology (SHEA), and is the product of a collaborative effort led by SHEA, the Infectious Diseases Society of America, the American Hospital Association, the Association for Professionals in Infection Control and Epidemiology, and The Joint Commission, with major contributions from representatives of a number of organizations and societies with content expertise.
In 2015, an international outbreak of Mycobacterium chimaera infections among patients undergoing cardiothoracic surgeries was associated with exposure to contaminated LivaNova 3T heater-cooler devices (HCDs). From June 2017 to October 2020, the Centers for Disease Control and Prevention was notified of 18 patients with M. chimaera infections who had undergone cardiothoracic surgeries at 2 hospitals in Kansas (14 patients) and California (4 patients); 17 had exposure to 3T HCDs. Whole-genome sequencing of the clinical and environmental isolates matched the global outbreak strain identified in 2015.
Investigations were conducted at each hospital to determine the cause of ongoing infections. Investigative methods included query of microbiologic records to identify additional cases, medical chart review, observations of operating room setup, HCD use and maintenance practices, and collection of HCD and environmental samples.
Onsite observations identified deviations in the positioning and maintenance of the 3T HCDs from the US Food and Drug Administration (FDA) recommendations and the manufacturer’s updated cleaning and disinfection protocols. Additionally, most 3T HCDs had not undergone the recommended vacuum and sealing upgrades by the manufacturer to decrease the dispersal of M. chimaera–containing aerosols into the operating room, despite hospital requests to the manufacturer.
These findings highlight the need for continued awareness of the risk of M. chimaera infections associated with 3T HCDs, even if the devices are newly manufactured. Hospitals should maintain vigilance in adhering to FDA recommendations and the manufacturer’s protocols and in identifying patients with potential M. chimaera infections with exposure to these devices.
In 2020 a group of U.S. healthcare leaders formed the National Organization to Prevent Hospital-Acquired Pneumonia (NOHAP) to issue a call to action to address non–ventilator-associated hospital-acquired pneumonia (NVHAP). NVHAP is one of the most common and morbid healthcare-associated infections, but it is not tracked, reported, or actively prevented by most hospitals. This national call to action includes (1) launching a national healthcare conversation about NVHAP prevention; (2) adding NVHAP prevention measures to education for patients, healthcare professionals, and students; (3) challenging healthcare systems and insurers to implement and support NVHAP prevention; and (4) encouraging researchers to develop new strategies for NVHAP surveillance and prevention. The purpose of this document is to outline research needs to support the NVHAP call to action. Primary needs include the development of better models to estimate the economic cost of NVHAP, to elucidate the pathophysiology of NVHAP and identify the most promising pathways for prevention, to develop objective and efficient surveillance methods to track NVHAP, to rigorously test the impact of prevention strategies proposed to prevent NVHAP, and to identify the policy levers that will best engage hospitals in NVHAP surveillance and prevention. A joint task force developed this document including stakeholders from the Veterans’ Health Administration (VHA), the U.S. Centers for Disease Control and Prevention (CDC), The Joint Commission, the American Dental Association, the Patient Safety Movement Foundation, Oral Health Nursing Education and Practice (OHNEP), Teaching Oral-Systemic Health (TOSH), industry partners and academia.
Background: Peritoneal dialysis is a type of dialysis performed by patients in their homes; patients receive training from dialysis clinic staff. Peritonitis is a serious complication of peritoneal dialysis, most commonly caused by gram-positive organisms. During March‒April 2019, a dialysis provider organization transitioned ~400 patients to a different manufacturer of peritoneal dialysis equipment and supplies (from product A to B). Shortly thereafter, patients experienced an increase in peritonitis episodes, caused predominantly by gram-negative organisms. In May 2019, we initiated an investigation to determine the source. Methods: We conducted case finding, reviewed medical records, observed peritoneal dialysis procedures and trainings, and performed patient home visits and interviews. A 1:1 matched case–control study was performed in 1 state. A case had ≥2 of the following: (1) positive peritoneal fluid culture, (2) high peritoneal fluid white cell count with ≥50% polymorphonuclear cells, or (3) cloudy peritoneal fluid and/or abdominal pain. Controls were matched to cases by week of clinic visit. Conditional logistic regression was used to estimate univariate matched odds ratios (mOR) and 95% confidence intervals (CIs). We conducted microbiological testing of peritoneal dialysis fluid bags to rule out product contamination. Results: During March‒September 2019, we identified 157 cases of peritonitis across 15 clinics in 2 states (attack rate≍39%). Staphylococcus spp (14%), Serratia spp (12%) and Klebsiella spp (6.3%) were the most common pathogens. Steps to perform peritoneal dialysis using product B differed from product A in several key areas; however, no common errors in practice were identified to explain the outbreak. Patient training on transitioning products was not standardized. Outcomes of the 73 cases in the case–control study included hospitalization (77%), peritoneal dialysis failure (40%), and death (7%). The median duration of training prior to product transition was 1 day for cases and controls (P = .86). Transitioning to product B (mOR, 18.00; 95% CI, 2.40‒134.83), using product B (mOR, 18.26; 95% CI, 3.86‒∞), drain-line reuse (mOR, 4.67; 95% CI, 1.34‒16.24) and performing daytime exchanges (mOR, 3.63; 95% CI, 1.71‒8.45) were associated with peritonitis. After several interventions, including transition of patients back to product A (Fig. 1), overall cases declined. Sterility testing of samples from 23 unopened product B peritoneal dialysis solution bags showed no contamination. Conclusions: Multiple factors may have contributed to this large outbreak, including a rapid transition in peritoneal dialysis products and potentially inadequate patient training. Efforts are needed to identify and incorporate best training practices, and product advances are desired to improve the safety of patient transitions between different types of peritoneal dialysis equipment.
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