Sterilization/Disinfection

Latest Issue of OR Manager
February 2020
Home Sterilization/Disinfection

Medline’s Illinois ethylene oxide sterilization facility hopes to reopen end of January

Editor's Note Medline Industries has not operated its Waukegan, Illinois, sterilization facility since December 13, 2019, when it was temporarily closed because it couldn’t meet Illinois’ new state standards for ethylene oxide, the January 21 MedTech Dive reports. A Lake County Health Department update on January 17 says Medline began…

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By: Judy Mathias
January 23, 2020
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Boston Scientific receives FDA clearance for single-use duodenoscope

Editor's Note Boston Scientific announced December 13 that it had received Food & Drug Administration (FDA) 510(k) clearance for the EXALT Model D Single-Use Duodenoscope for use in endoscopic retrograde cholangiopancreatography (ERCP) procedures. The EXALT Model D, which was granted Breakthrough Device Designation from the FDA, eliminates the need for…

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By: Judy Mathias
December 17, 2019
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Sterilization trumps high-level disinfection for semicritical items

In the never-ending quest to improve patient care, we are always seeking better ways to process medical devices. Many leading experts now recommend transitioning from high-level disinfection (HLD) to sterilization for semicritical items. Semicritical items are instruments or objects that contact mucous membranes or nonintact skin of a patient, but…

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By: Susan Klacik, BS, CRCST, ACE, CIS, FCS
November 18, 2019
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ECRI Institute opposes proposed ban of EtO sterilization

Editor's Note ECRI Institute on November 7 announced that it opposes a total ban of commercial ethylene oxide (EtO) sterilization operations because it could result in widespread shortages of sterile medical devices. Hospitals around the country reported device shortages after a large Illinois-based sterilization plant closed because of state environmental…

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By: Judy Mathias
November 12, 2019
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FDA of device shortages because of sterilization facility closures

Editor's Note The Food and Drug Administration (FDA) on October 25 released a statement warning of possible device shortages because of interruptions in ethylene oxide (EO) sterilization services due to facility closures in Illinois and Georgia. In the statement, the acting FDA Commissioner, Ned Sharpless, noted that “at this time…

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By: Judy Mathias
October 29, 2019
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EPA will require sterilization companies to provide data on EO emissions

Editor's Note Medtech sterilization companies were asked by the Environmental Protection Agency (EPA) to provide data that will help the agency craft new regulation of ethylene oxide emissions, the September 25 Medical Design & Outsourcing reports. The data will include specific sterilization facility characteristics, control devices, work practices, and costs…

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By: Judy Mathias
September 26, 2019
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Is point-of-use treatment an integral part of your sterilization process?

Providing sterile instrumentation for patient care is a basic fundamental of surgery, and ensuring sterility means that instrumentation must first be thoroughly cleaned, step by step. Point-of-use treatment, an important part of this process, is gaining the attention of accrediting agencies such as the Joint Commission, and it is included…

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By: Susan Klacik, BS, CRCST, CHL, CIS, ACE, FCS
September 23, 2019
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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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