Articles by Sumeet Dharkar

Articles by Sumeet Dharkar

February 6, 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...
January 20, 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 9, 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 2, 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...
December 19, 2019
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FDA’s Validated IFU Requirements For “High Risk” Devices (Part II)

In Part I of this blog  we pointed out that “The #1 responsibility of everyone involved in reusable medical device processing is to minimize the risk of patient harm...
December 11, 2019
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FDA’s Validated IFU Requirements For “High Risk” Devices (Part I)

The #1 responsibility of everyone involved in reusable medical device processing is to minimize the risk of patient harm caused by a device that remains contaminated with organic debris after...
December 5, 2019
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The Growing Concerns Over Robotic Surgery (Part II)

In Part I of this blog  we discussed how the use of robotic-assisted surgery systems has grown steadily in the U.S. over the past twenty years. This growth has...
November 28, 2019
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The Growing Concerns Over Robotic Surgery (Part I)

The use of robotic-assisted surgery systems has been growing steadily in the U.S. over the past two decades. In an effort to keep up with competition from other hospitals and...
November 21, 2019
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1st Duodenoscope with Disposable Elevator Approved by FDA

Over the past several years this blog has frequently addressed the many problems caused by contaminated duodenoscopes. According to a recent study, data from three major hospitals documented the fact...
November 14, 2019
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Has That IFU Actually Been Validated? (Part II)

In Part I of this blog we discussed the fact that several reusable device manufacturers claim that their cleaning and sterilization IFUs are ‘validated.’ We then raised two important...
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