FDA clears Custom Ultrasonics to resume manufacturing System 83 endoscope washer-disinfector

Custom Ultrasonics said yesterday that the FDA inspected and cleared its manufacturing facility in Ivyland, Penn, reinstating the manufacturing, packing and distribution of the company’s System 83 Plus washer and disinfector for use with non-duodenoscope endoscopes. The Philadelphia-based company said that it was required to perform independent validation testing for its System 83 Plus water filtration system and its inline disc filter, which the FDA approved with no changes to the design. New validations were also required for processing bronchoscopes and non-GI endoscopes which all met specified performance criteria, the company said. Custom Ultrasonics said it is still working with the FDA to validate the System 83 Plus for duodenoscopes, after the agency said last August that the system should not be used with the devices in light of a number of “superbug” outbreaks. “Custom Ultrasonics has undergone many changes in the past several years.  The leadership of our new president and CEO has taken Custom Ultrasonics into a new era of progress.  Custom Ultrasonics has significantly expanded its quality, regulatory and engineering departments, as evidenced by the company passing a recent inspection of its facility and quality system with no Form 483s, in preparation for Custom Ultrasonics’ re-entry into the automated endoscope reprocessing market and beyond,” the company wrote in a press release. The post FDA clears Custom Ultr...
Source: Mass Device - Category: Medical Devices Authors: Tags: Endoscopic / Arthroscopic Food & Drug Administration (FDA) Sterilization / Calibration Custom Ultrasonics Source Type: news

Related Links:

Conclusion This study revealed that Enterococcus species with biofilm potentials and extracellular virulence properties extensively occur in retail RTE shrimps. A significant number of isolated strains are resistant to antibiotics and harbor resistant and virulent genes, denoting a significant route of resistance and virulence dissemination to bacteria in humans. There is an inadequate understanding of the intricacies of antibiotic-resistant enterococci of food origin that belong to enterococci aside from E. faecium and E. faecalis. Findings from this study reveal detailed antibiotic resistance of E. durans, E. casselifla...
Source: Frontiers in Microbiology - Category: Microbiology Source Type: research
This study examined one of the first sustained hospital outbreaks of a multidrug-resistant bacterium, Enterococcus faecalis, which occurred from the early through the mid-1980s, causing over 60 outbreak strains.
Source: EurekAlert! - Medicine and Health - Category: International Medicine & Public Health Source Type: news
In this study, the multivariate linear mixed model (LMM) was used to calculate the P-value to determine interesting SNPs at each time point using GEMMA software v0.97 (Zhou and Stephens, 2014). Growth data from both untreated and vancomycin-treated group formed the bivariate phenotype, which differs hugely from the univariate phenotype. Therefore, LMM developed for univariate phenotype cannot be applied to analyze correlated phenotype directly; methods allowing LMM algorithm specific to multivariate and correlated phenotype [multivariate LMMs (mvLMMs)] are in urgent need. GEMMA software could extend a standard LMM to mvLMM...
Source: Frontiers in Microbiology - Category: Microbiology Source Type: research
This study was supported by the Israel Institute for Biological Research, Ness Ziona, Israel. Conflict of Interest Statement The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. Acknowledgments We thank Dr. Vered Caspi (Ben-Gurion University) for assisting with the bioinformatics and statistical analyses of the Agilent DNA microarray results. Supplementary Material The Supplementary Material for this article can be found online at: https://www.frontiersin.org/articles/10.3389/fmicb.2019.00754/full#s...
Source: Frontiers in Microbiology - Category: Microbiology Source Type: research
In this study, a BER homolog encoded by cj0595c (named nth) in C. jejuni was analyzed for endonuclease III activity and for its role in maintaining genomic stability. It was found that inactivation of nth resulted in elevated frequencies of spontaneous fluoroquinolone-resistant (FQR) and oxidative stress resistant (OXR) mutants, compared with the wild-type strain in C. jejuni. Sequencing analysis of the FQR and OXR mutants revealed that the elevated mutation rates were associated with C → T or G → A transition in gyrA (FQR mutants) or perR (for OXR mutants). In an in vitro assay, a purified recombinant C. jejuni ...
Source: Frontiers in Microbiology - Category: Microbiology Source Type: research
The objective of this research was to determine changes to lettuce phyllosphere microbiota, inoculated ARB, and the resistome (profile of ARGs) following washing with a sanitizer, gamma irradiation, and cold storage. To simulate potential sources of pre-harvest contamination, romaine lettuce leaves were inoculated with compost slurry containing antibiotic-resistant strains of pathogenic (Escherichia coli O157:H7) and representative of spoilage bacteria (Pseudomonas aeruginosa). Various combinations of washing with sodium hypochlorite (50 ppm free chlorine), packaging under modified atmosphere (98% nitrogen), irradiating (1...
Source: Frontiers in Microbiology - Category: Microbiology Source Type: research
ConclusionvB-SdyS-ISF003 is a novel virulent T1virus phage and has the appropriate potential for being used in bio controlling of S. dysenteriae in different condition.
Source: Microbial Pathogenesis - Category: Infectious Diseases Source Type: research
ConclusionUse of EpiSeq solution allowed fast demonstration of the polyclonal profile of the MSSA population in neonates, and enabled the suspicion of a global outbreak to be ruled out. However, wgSNP analysis showed the transmission and persistence of one sequence type for over six months in the NICU, and enabled the infection control team to adapt its response.
Source: Journal of Hospital Infection - Category: Infectious Diseases Source Type: research
Abstract Mupirocin is an antibiotic from monocarboxylic acid class used as antibacterial agent against methicillin-resistant Staphylococcus aureus (MRSA) and can be obtained as a mixture of four pseudomonic acids by Pseudomonas fluorescens biosynthesis. Nowadays improving antibiotics occupies an important place in the pharmaceutical industry as more and more resistant microorganisms are developing. Mupirocin is used to control the MRSA outbreaks, for infections of soft tissue or skin and for nasal decolonization. Due to its wide use without prescription, the microorganism's resistance to Mupirocin increased from u...
Source: Biotechnology Letters - Category: Biotechnology Authors: Tags: Biotechnol Lett Source Type: research
Abstract Vancomycin-resistant enterococci (VRE) have been responsible for numerous outbreaks of serious infections in humans worldwide. Enterococcus faecium and Enterococcus faecalis are the principal species that are frequently associated with vancomycin resistance determinants, thus usually implicated in hospital- and community-acquired infections in humans. The study aim was to determine the antibiotic resistance and virulence profiles of VREs isolated from surface and groundwater samples that are used by humans in the North West Province, South Africa. A total of 170 water samples were collected and analyzed. ...
Source: Environmental Science and Pollution Research International - Category: Environmental Health Authors: Tags: Environ Sci Pollut Res Int Source Type: research
More News: Arthroscopy | Bronchoscopy | Infectious Diseases | Outbreaks | Superbugs