Sterilization/Disinfection

Latest Issue of OR Manager
October 2019
Home Sterilization/Disinfection

FDA sets meeting to discuss EO sterilization

Editor's Note The Food & Drug Administration (FDA) announced September 4 that it will hold a Medical Devices Advisory Committee Meeting in November to discuss ethylene oxide (EO) sterilization of medical devices, including methods to reduce EO emissions. The committee also will provide recommendations on reducing infection risks from reprocessed…

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By: Judy Mathias
September 5, 2019
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NYT: Experts call for single-use, sterilization or redesign of duodenoscopes, bronchoscopes

Editor's Note Contaminated duodenoscopes have transmitted drug-resistant infections to hundreds of patients, and now some experts are urging the Food & Drug Administration to force manufacturers to develop duodenoscopes that can be properly sterilized or single-use duodenoscopes or take duodenoscopes off the market, the August 6 New York Times Reports.…

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By: Judy Mathias
August 6, 2019
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Research raises concerns about lubricants used in endoscopes

Current endoscope reprocessing methods are not consistently effective in eliminating organic soil or microbes, and the off-label use of products for defoaming, lubrication, and bleeding control may be contributing to reprocessing failures. Though endoscope manufacturers have cautioned against the use of these products, endoscopists still commonly use them, and many…

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By: Judith M. Mathias, MA, RN
July 24, 2019
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Joint Commission issues Quick Safety on disinfection of tonometers, other ophthalmology devices

Editor's Note The Joint Commission on May 21 issued Quick Safety 49: Disinfection of tonometers and other ophthalmology devices. The Joint Commission noted that the American Academy of Ophthalmology has reported that transmission of adenovirus and herpes simplex virus HIV, hepatitis C virus, enterovirus 70, Pseudomonas aeruginosa, methicillin-resistant Staphylococcus aureus,…

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By: Judy Mathias
May 23, 2019
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What should you do if your sterilizer fails?

A sterilization failure is a significant event. Receiving a positive biological indicator (BI) result from a sterilizer can be devastating and presents a patient safety concern because it could result in infection. This article addresses the proper action to take in the event of a positive BI result and biological…

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By: Susan Klacik, BS, CRCST, CHL, CIS, ACE, FCS
May 17, 2019
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Off-label use of simethicone, lubricants, and tissue glue contributes to endoscope reprocessing failures

Editor's Note The off-label use of defoaming agents, lubricants, and tissue glue is common, and these insoluable substances are not removed during reprocessing, this study finds. Of 69 fully reprocessed endoscopes examined in four hospitals, microbial cultures were positive for 50% or more. The researchers, led by Cori Ofstead, MSPH,…

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By: Judy Mathias
April 23, 2019
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FDA considering additional regulatory actions to reduce duodenoscope risks

Editor's Note The Food & Drug Administration on April 16 announced it is considering additional regulatory actions, including consulting with federal health experts for guidance, to reduce the risks of contamination and infections associated with duodenoscopes. The FDA is also working with manufacturers of disposable duodenoscopes that would make reprocessing…

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By: Judy Mathias
April 23, 2019
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'Coming clean' in the SPD requires collaboration and competency--Part 2

Contaminated surgical instruments pose a danger to patients and to an organization’s bottom line. In Part 1 of this two-part series, we discussed prevention strategies (OR Manager, April 2019, 14-15, 19). In Part 2, the focus is on investigating potential contamination, along with design considerations.   Detective work Despite best…

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By: Cynthia Saver, MS, RN
April 22, 2019
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FDA continues efforts to assess duodenoscope contamination risk

Editor's Note The Food & Drug Administration (FDA) on April 12 announced that it is taking steps to implement additional regulatory actions, including consulting with federal health experts, on how to reduce the risks of contamination and infections linked to duodenoscopes. The agency is also collaborating with manufacturers of disposable…

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By: Judy Mathias
April 18, 2019
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FDA issues statement on trach tube shortages

Editor's Note The Food & Drug Administration on April 12 issued a statement about the agency’s efforts to mitigate the shortage of Smiths Medical’s Bivona tracheostomy tubes, especially the pediatric tubes. The shortage is a result of the closure of a large ethylene oxide sterilization facility in Willowbrook, Illinois, and there…

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By: Judy Mathias
April 17, 2019
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