- Federal regulators last Thursday issued final rules regarding the cleaning and disinfecting of reusable medical devices such as the endoscopes that have been responsible for outbreaks of drug-resistant bacteria at a number of hospitals. Product makers will be required, under the new guidance, to validate that the disinfecting instructions for their medical devices are effective before they can get Food and Drug Administration approval. Also recommended is that healthcare providers routinely test medical scopes for bacterial growth after they have been disinfected, something a number of hospitals have begun to do in light of the recent contamination involving the devices. The guidance also recommends that manufacturers consider reprocessing challenges early in device design, an issue in the case of duodenoscopes.
- The University of Illinois board of trustees voted unanimously last Thursday to establish an engineering-based medical college at its Urbana-Champaign campus in partnership with the Carle Foundation, an Urbana-based integrated-care network. University of Illinois President Robert Easter endorsed the concept Wednesday, choosing it over a counterproposal for a “translational bioengineering institute” based in Chicago.
- HealthCare.gov's special enrollment window for some consumers to get 2015 coverage started Sunday, just as many people realized they owed a tax penalty for failing to get health insurance last year. The fee for the 2014 tax year is set at $95 for each uninsured person in the filing or 1% of household income (whichever is greater), and scheduled to rise in upcoming tax years: $325 or 2% for 2015; and $695 or 2.5% of household income for 2016. But many Americans remain unaware of the penalties associated with not having health insurance. Acting CMS Administrator Andy Slavitt cited a McKinsey & Co. study showing 40% of uninsured consumers who are liable for the penalty don't know about it.
Endoscope cleaning rules issued by FDA after deadly outbreaks, and other briefs
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