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Citing numerous reports of infections associated with reprocessed urological endoscopes, the FDA wants providers to pay extra attention to careful cleaning and inspection following use of these devices.
In a Dear Health Care Provider letter dated Thursday, the FDA said it is currently investigating the potential causes and contributing factors associated with the reported infections and contamination issues. While some reports indicate possible inadequate reprocessing or maintenance issues (for example, device failed leak testing) as a potential cause, the FDA is also evaluating other potential issues including reprocessing instructions in the labeling and device design, the letter added.
Iora Health co-founder Rushika Fernandopulle, MD (Photo courtesy Iora Health)
Many startup companies in healthcare are entrepreneurial or innovative, but true disruptors in the field are harder to come by. These are the companies that are actually shaking the pillars of an established system. MedPage Today Editor-in-Chief Marty Makary, MD, MPH, of Johns Hopkins University in Baltimore, selected several companies that fit the profile of a real disruptor; we re profiling them in an ongoing series.
It s the Holy Grail of healthcare: improving quality while cutting costs. But how to do it?
Rushika Fernandopulle, MD, co-founder and CEO of Boston-based Iora Health, thinks he knows the answer double down on primary care.
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A topical atopic dermatitis (AD) treatment derived from skin bacteria demonstrated safety and preliminary evidence of clinical activity in a proof-of-principle study.
After seven days of treatment, MSB-0221 significantly reduced
Staphylococcus aureus colonization in
S. aureus toxin PSM-alpha. The compound inhibited inflammation-inducing toxin irrespective of its activity against
S. aureus. A post hoc evaluation limited to patients with confirmed
S. aureus killing suggested improvement in local eczema severity.
Patients treated with MSB-0221 had fewer AD-related adverse events (AEs) as compared with patients treated with a topical delivery substance (vehicle) without
S. hominis (
ShA9), a naturally occurring skin bacteria incorporated into MSB-0221, reported Richard L. Gallo, MD, PhD, of the University of California San Diego, and colleagues in