Sterilization & Disinfection

Latest Issue of OR Manager
February 2025
Home Sterilization & Disinfection

FDA: Nationwide recall of certain SterRx drug products

Editor's Note The Food and Drug Administration (FDA), on November 15, announced the nationwide recall by SterRx, LLC, of 240 lots of its drug products. The recall was initiated because of the lack of sterility assurance due to equipment and process issues. The recalled drugs include: l mg/ml Midazolam in…

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By: Judy Mathias
November 18, 2021
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Quality monitoring for decontamination process

The foundation of sterilization is cleaning. How can we be sure that the mechanical cleaning equipment being used is producing clean medical devices? There are methods available to verify that the mechanical equipment used to clean medical devices is functioning appropriately. ANSI/AAMI ST79:2017 Comprehensive guide to steam sterilization and sterility…

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By: Susan Klacik, BS, FCS, ACE, CHL, CIS, CRCST, AAMIf
November 17, 2021
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Researchers raise the alarm on splashing during reprocessing--Part 2

Part 1 of this two-part series discussed the splashes and the potential for exposure to pathogens that personnel face daily in sterile processing and endoscopy departments, as well as the current guidelines and strategies for reducing exposures (OR Manager, July 2021, pp 1, 9-11, 15). These risks were derived from…

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By: Judith M. Mathias, MA, RN
July 20, 2021
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New term clarifies instrument point-of-use treatment

What exactly is required to prepare instruments for transport to the decontamination room after a surgical procedure? Point-of-use cleaning, which may also be referred to as precleaning, has been used to describe instrument preparation at the point of use after a surgical procedure. But both point-of-use cleaning and precleaning have…

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By: Susan Klacik, BS, CRCST, ACE, CIS, FCS
July 20, 2021
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FDA revokes EUA for non-NIOSH-approved respirators

Editor's Note The Food and Drug Administration (FDA) on June 30 announced that it is revoking the Emergency Use Authorizations (EUAs) for non-NIOSH-approved disposable respirators (including N95s), effective July 6. The announcement also revokes EUAs for decontamination and bioburden reduction systems for disposable respirators, effective immediately. The FDA says the…

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By: Judy Mathias
July 1, 2021
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Researchers raise the alarm on splashing during reprocessing--Part 1

Does it really matter if surgical instruments are submerged in cleaning solution when technologists or nurses scrub them after a case? Is there a reason for the 3-foot separation between dirty and clean areas? Do germs stop at the red line? During the COVID-19 pandemic, much attention has been focused…

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By: Judith M. Mathias, MA, RN
June 22, 2021
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No such thing as downtime: CSP renovation does not stop surgery

Many of today’s medical facilities have been modernized, but some still have areas of aging infrastructure. The central sterile processing (CSP) department at Cleveland Clinic Mercy Hospital in Canton, Ohio, is one such example. The original Terrazzo floor from when the facility was built in 1953 had become hazardous. The…

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By: Barbara Underwood, MBA, BSN, RN, CNOR, CSSM
June 22, 2021
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FDA clears single-use flexible cystoscope from UroViu

Editor's Note UroViu Corporation, Bellevue, Washington, announced May 24 that it has received clearance from the Food and Drug Administration (FDA) for its portable, flexible single-use cystoscope. The Uro-G has a fully deflectable tip that enables physicians to perform interventional and diagnostic urologic procedures in various settings, without reprocessing.

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By: Judy Mathias
May 27, 2021
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ANSI/AAMI ST79 amendments refine sterilization practices

Amendments have been added to the Association for the Advancement of Medical Instrumentation (AAMI) standard ANSI/AAMI ST79, Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. The standard, which is used in healthcare facilities to guide their sterilization processes, is considered a useful resource to promote best…

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By: Susan Klacik, BS, CRCST, ACE, CIS, FCS
May 19, 2021
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The Joint Commission announces top 5 most challenging requirements for 2020

Editor's Note The Joint Commission, on May 12, listed the top 5 standards most frequently identified as “not compliant” during surveys and reviews from January 1 to December 31, 2020. The top five for accredited hospitals are: NPSG.15.01.01: Reduce the risk for suicide. EP1. IC.02.02.01: The hospital reduces the risk…

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By: Judy Mathias
May 13, 2021
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