Articles by Sumeet Dharkar


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Articles by Sumeet Dharkar

Facts behind IFU validation: Here’s the who, what, where, when, why and how (including how much)

The No. 1 responsibility of everyone involved in reusable medical device reprocessing is to minimize the risk of patient harm caused by a device that remains contaminated with organic debris...
January 14, 2021
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Latest Update on COVID-19 and the Vaccines

America has entered a whole new phase of the COVID-19 pandemic. As of January 8, 2021, over 2 million U.S. citizens have been vaccinated with the Pfizer/BioNTech’s vaccine or with...
January 11, 2021
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FDA Announces EUA for Second COVID-19 Vaccine

On Friday, December 18, 2020 the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for a second vaccine for the prevention of COVID-19 to Moderna. This...
December 21, 2020
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Breaking News on COVID-19 Vaccines

On Friday, November 20, 2020, Pfizer and BioNTech submitted a request to the US Food and Drug Administration (FDA) for emergency use authorization for their coronavirus vaccine candidate. This request...
November 21, 2020
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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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