Rules and Regulations
FDA issues warning letters to endoscope manufacturer
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…
The Joint Commission raises healthcare equity standard to NPSG
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…
FDA: Class I recall of Arrow central venous access and catheter kits
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…
The Joint Commission announces standards reductions, revisions for 2023
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…
FDA: Exela Pharma Sciences, LLC, expands recall of Sodium Bicarb
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…
Federal judge declines challenge to vaccination mandate by 14 states
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…
The Joint Commission joins White House pledge to decarbonize healthcare
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…
CMS releases safety expectations on workplace violence
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…
FDA: Class I recall of Baxter Hillrom WatchCare IMS for RF interference risk
Editor's Note The Food and Drug Administration, on November 23, identified the recall by Baxter Hillrom of its WatchCare Incontinence Management System (IMS) as Class I, the most serious. The recall was initiated because of the risk for radiofrequency (RF) emissions from WatchCare devices that may interfere with other devices,…
FDA: Class I recall of Insulet Omnipod DASH PDM
Editor's Note The Food and Drug Administration (FDA) on November 16 identified the recall by Insulet of its Omnipod DASH Insulin Management System Personal Diabetes Manager (PDM) as Class I, the most serious. The recall was initiated because of PDM battery issues, including: Battery swelling Fluid leakage from the battery…
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