Editor's Note The Association for the Advancement of Medical Instrumentation (AAMI) on January 18 released a revised American National Standard that includes new information for manufacturers and users of personal protective equipment (PPE). The new edition of “ANSI/AAMI PB70:2022, Liquid barrier performance and classification of protective apparel and drapes intended…

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Editor's Note The American Society of Anesthesiologists (ASA) has updated its 2017 guidelines for preoperative fasting and the use of pharmacologic agents to reduce the risk of pulmonary aspiration. The new 2023 guidance focuses on topics not addressed in the previous guideline, including ingestion of carbohydrate-containing clear liquids with or…

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Editor's Note The Food and Drug Administration (FDA) on January 10 announced that it had recently issued two warning letters to Olympus Medical Systems Corporation and one of its subsidiaries, Aizu Olympus Co, Ltd, after facility inspections. The letters addressed violations related to medical device reporting (MDR) requirements and quality…

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Editor's Note The Joint Commission on January 10 announced that it had elevated the Leadership (LD) Standard LD.04.03.08, which addresses healthcare disparities as a quality and safety priority, to a National Patient Safety Goal (NPSG), effective July 1, 2023. Current requirements for accreditation will not change, and the intent behind…

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Editor's Note The Food and Drug Administration (FDA) on December 16 identified the recall by Teleflex and Arrow International, LLC, of its Arrow MAC Two-Lumen Central Venous Access Kits and Arrow Pressure Injectable Arrowg+ard Blue Plus Three-Lumen Central Venous Catheter (CVC) Kits as Class I, the most serious. The recall…

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Editor's Note The Joint Commission announced on December 21 that they are eliminating 168 standards (14%) and revising 14 other standards across its accreditation programs in the new year. The Joint Commission additionally announced that it will not raise accreditation fees for domestic hospitals in the coming year due the…

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Editor's Note The Food and Drug Administration (FDA) on November 29 posted Exela Pharma Sciences’ expansion of its recall of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial, 20-count carton. The product poses a safety concern because of vial breakage with flying glass when pressurized while preparing the product for…

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Editor's Note A federal judge in Louisiana declined a case brought by 14 states that challenged the Biden administration’s mandate requiring COVID-19 vaccination for eligible staff at healthcare facilities participating in Medicare and Medicaid Programs, the December 8 Becker’s Hospital Review reports. The states have 60 days to appeal the…

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Editor's Note The Joint Commission announced on December 7 that it was recognized by the Department of Health and Human Services at the 2022 United Nations Climate Change Conference for its actions to decarbonize the healthcare sector and make healthcare facilities more resilient to climate change. The Joint Commission formally…

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Editor's Note  The Centers for Medicare & Medicaid Services (CMS) released a new memorandum on November 28 emphasizing the importance of enforcing regulations and expectations to create a safe environment for hospital staff when delivering patient care, the American Hospital Association reported on November 28. According to the memo, the…

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