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

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(Natural News) When you think of a pandemic, global disease outbreaks like the Spanish flu that killed 50 million in the early 1900s or the more recent HIV/AIDS pandemic are what usually come to mind. However, some experts are warning that the next pandemic will come from an unexpected source – and it’s something that...
Source: NaturalNews.com - Category: Consumer Health News Source Type: news
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Source: Genome Medicine - Category: Genetics & Stem Cells Source Type: research
Publication date: Available online 10 November 2018Source: Computational and Structural Biotechnology JournalAuthor(s): Maytham Hussein, Mei-Ling Han, Yan Zhu, Elena K. Schneider-Futschik, Xiaohan Hu, Qi Tony Zhou, Yu-Wei Lin, Dovile Anderson, Darren J. Creek, Daniel Hoyer, Jian Li, Tony VelkovAbstractPolymyxins are amongst the most important antibiotics in modern medicine, in recent times their clinical utility has been overshadowed by nosocomial outbreaks of polymyxin resistant MDR Gram-negative ‘superbugs’. An effective strategy to surmount polymyxin resistance is combination therapy with FDA-approved non-an...
Source: Computational and Structural Biotechnology Journal - Category: Biotechnology Source Type: research
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Source: MDDI - Category: Medical Devices Authors: Tags: IVD Source Type: news
Abstract An alarming rise in hospital outbreaks implicating hand-washing sinks has led to widespread acknowledgement that sinks are a major reservoir of antibiotic resistant pathogens in patient-care areas. An earlier study using a GFP-expressing Escherichia coli (GFP-E. coli) as a model organism demonstrated dispersal from drain biofilm in contaminated sinks. The present study further characterizes the dispersal of microorganisms from contaminated sinks. Replicate hand-washing sinks were inoculated with GFP-E. coli, and dispersion was measured using qualitative (settle plates) and quantitative (air sampling) meth...
Source: Applied and Environmental Microbiology - Category: Microbiology Authors: Tags: Appl Environ Microbiol Source Type: research
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Source: Journal of Hospital Infection - Category: Infectious Diseases Source Type: research
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Source: Journal of Hospital Infection - Category: Infectious Diseases Source Type: research
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Source: the Mail online | Health - Category: Consumer Health News Source Type: news
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Source: BBC News | Health | UK Edition - Category: Consumer Health News Source Type: news
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Source: Forbes.com Healthcare News - Category: Pharmaceuticals Authors: Source Type: news
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