Disinfection, Decontamination, Cleaning & Sterilization

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 19, 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 11, 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 21, 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...
November 14, 2019
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Has That IFU Actually Been Validated? (Part I)

The most misunderstood and overlooked aspect of any reusable device manufacturer’s instructions for disinfecting, cleaning and sterilizing their product is whether those instructions for use (IFUs) have been ‘validated’ by...
November 7, 2019
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The Problem of Sterilization Indicator Tape Fading in Sterile Storage

In a previous blog we addressed issues surrounding the proper operation and maintenance of steam sterilizers, including the use of monitoring tools. These monitoring tools should include process challenge...
October 31, 2019
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Maintaining Quality Control With “Table-Top” Sterilizers Part II

In Part I of this blog  we pointed out that over the past 30 years, there has been a very significant increase in the number of outpatient surgical procedures....
October 24, 2019
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Maintaining Quality Control With “Table-Top” Sterilizers Part I

Over the past 30 years, there has been a tremendous increase in the number of outpatient surgical procedures done in the United States. The number of outpatient procedures surpassed 54...
October 17, 2019
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Just Because An Instrument Is ‘Sterile’ Doesn’t Mean It Is ‘Safe!’

According to the CDC, over 30,000 patients die every year in the U.S. from a surgical infection. Among hospital acquired infections (HAIs), surgical site infections (SSIs) are associated with greater...
September 13, 2019
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Update on the Problems and Challenges with Duodenoscopes Part II

In Part I we reviewed the FDA’s latest Safety Communication on duodenoscopes that was issued on April 12, 2019. In that Safety Communication the FDA listed the patient infection...
August 23, 2019
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