An imported case of Bundibugyo virus disease in Kenya raises questions about airport screening, clinical recognition, and potential exposures, highlighting the importance of coordinated contact tracing and hospital infection prevention readiness.
|Articles|September 7, 2014
CareFusion Completes Post-Market Surveillance for Positive Displacement Needleless Connectors
Advertisement
CareFusion announces that the Food and Drug Administration (FDA) has notified the company that it has fully completed its obligations for post-market surveillance studies for the MaxPlus® line of positive displacement needleless connectors.
In an Aug. 6 letter to CareFusion, FDA officials cited multiple studies conducted by CareFusion that showed MaxPlus positive displacement needleless connectors had no evidence of higher infection rates as compared to other neutral or negative displacement needleless connectors. The letter highlighted an analysis of the CMS’ Hospital Compare database suggesting that in 2013, hospitals using MaxPlus positive displacement needleless connectors had lower unadjusted central line associated blood stream infection (CLABSI) rates, as well as lower standardized infection ratios, compared to hospitals not using MaxPlus. These assessments were based on data from 3,074 hospitals, accounting for nearly 11,000 CLABSIs associated with approximately 10 million catheter days.
“We have always believed in the design of the MaxPlus needleless connector,” says Jim Paloyan, vice president of Americas Infusion Specialty Disposables for CareFusion. “The data from nearly 10 million catheter days suggesting lower infection rates for hospitals using MaxPlus are a powerful testament to the design and function of our product.”
All manufacturers of positive displacement connectors were required by the FDA to perform post-market surveillance. Manufacturers were asked to provide data to show that the rate of bloodstream infections for patients receiving a positive displacement needleless connector for central line access is statistically non-inferior to the rates seen in subjects receiving other needleless connectors for central line access, given comparable patient populations. Through the completion of this study, CareFusion has no further post-market surveillance requirements from the FDA concerning the MaxPlus needleless connector.
Source: CareFusion Corporation
Advertisement
Related to this article
Florida’s dengue outbreak highlights the importance of recognizing symptoms, identifying warning signs, and preventing mosquito bites. Ubong Johnson, MD, explains local transmission, diagnostic testing, treatment, and practical prevention measures.
Understanding current water quality is a starting point for ST108 implementation. John Kimsey, vice president of processing optimization and customer success for STERIS, spoke about his HSPA presentation on assessing readiness, distinguishing system qualification from routine testing, and understanding where water samples should be collected.
An unexplained death at a Russian plague research institute has prompted international scrutiny. The incident raises questions about laboratory safety, transparent reporting, and infection prevention preparedness while the cause remains unconfirmed.
Behind every landmark in infection prevention, from antimicrobial stewardship guidelines to the COVID-19 town halls that reached flight attendants and teachers, is a generation of physician-scientists who led SHEA through crises, organizational change, and scientific breakthroughs. Infection Control Today traces 30 years of SHEA presidents and the lasting mark they left on the field.
Missing instruments and processing delays can strain OR–SPD relationships. At AORN 2026, John Kimsey, vice president of processing optimization and customer success for STERIS, discusses understanding root causes, exploring off-site reprocessing for ambulatory surgical centers, and using hands-on simulation to help surgical teams see sterile processing from a different perspective.
This week's coverage in Infection Control Today centered on a common thread: the systems, partnerships, and data that let infection prevention teams catch problems before patients are harmed.
UPMC’s genomic surveillance initiative earned national recognition for patient safety. Alexander Sundermann, DrPH, CIC, FAPIC, AL-CIP, explains how the award could help infection preventionists secure leadership support and sustainable funding for earlier outbreak detection.
Advertisement
Advertisement