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Covid-19 and the Need for Validated IFUs

COVID-19 represents the single largest pandemic to hit the world in the past 100 years. By the end of October, 2020, the pandemic will have taken the lives of over...
October 28, 2020
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Nearly 70% of KN95 Masks Fail To Meet Minimum U.S. Standards

PLYMOUTH MEETING, PA—“An analysis by the nation’s largest patient safety organization shows that up to 70 percent of KN95 masks it tested do not meet U.S. standards for effectiveness, raising...
October 6, 2020
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Risk of Misinterpreting Hydrogen Peroxide Indicators: FDA Letter Concerning the Safety Risk to Patients

Earlier this year the U.S. Food and Drug Administration (FDA) was made aware of the potential to misinterpret colored hydrogen peroxide indicator strips used to validate vapor sterilization of medical...
September 15, 2020
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FDA’s Emergency Use Authorizations for PPE

Beginning in March of this year, the FDA has issued several Emergency Use Authorizations (EUAs) to help healthcare personnel and facilities in their fight against the COVID-19 epidemic. Over the...
September 1, 2020
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Have you Validated your Instrument Cleaning Instructions?

There has been increased scrutiny on sterile processing departments regarding their practices for cleaning and sterilizing reusable surgical instruments and other medical devices.. The situation is complicated by the variances...
July 19, 2020
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2019-nCoV Crisis

On January 30, 2020 the World Health Organization (WHO) declared the recent outbreak of the novel coronavirus (2019-nCoV)
February 13, 2020
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Skipping An IFU Step?

The importance of following a manufacturer’s validated cleaning and sterilization Instructions for Use (IFU) cannot be over emphasized. As readers of this blog know, the issue of adhering to all...
February 6, 2020
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CST Certification

Central Service Technicians (CSTs) can have as much impact on reducing surgical infections as the surgical team in the operating room does. A surgical instrument that remains contaminated with organic...
January 20, 2020
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FDA to Focus on Lowering Ethylene Oxide Emissions

Recently the FDA conducted a public advisory committee meeting to comment on the feasibility of various strategies to reduce (or completely eliminate) ethylene oxide (EtO) emissions from large-scale, medical device...
January 9, 2020
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A Few Ideas To Help Reduce Surgical Infections In 2020

The primary responsibility of everyone involved in reusable medical device reprocessing is to minimize the risk of a surgical infection caused by a device that remains contaminated with organic debris...
January 2, 2020
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