Tag: Rules & Regulations

FDA designates Class 1 recalls for balloon catheters, radiographic markers

Editor's Note Balloon catheters for atrial fibrillation patients and implantable radiographic markers were the subjects of separate US Food and Drug Administration (FDA) Class 1 recalls—the most severe category indicating risk of serious injury or death—announced on December 18. The first recall involves Boston Scientific’s POLARx Cryoablation devices. Higher-than-anticipated reports…

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By: Matt Danford
December 19, 2024
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Practice updates ease steam sterilization balancing act

Reliable and robust enough for daily use on most medical devices, steam is the most common sterilant in healthcare facilities. However, using steam properly requires a balancing act. For example, too much moisture can lead to wet packs, while steam that is too dry might not be sufficient to achieve…

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By: Susan Klacik, BS, FCS, ACE, CHL, CIS, CRCST, AAMIF
November 20, 2024
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AHA's Congressional "wish list" calls for financial relief, patient access, workforce protections

Editor's Note   In a November 12 letter to Congress, the American Hospital Association (AHA) outlined its priorities for the lame-duck legislative session, focusing on measures to stabilize hospitals and health systems facing significant financial and operational pressures. If enacted, these recommendations would support the nation’s healthcare infrastructure amid rising…

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By: Matt Danford
November 14, 2024
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OR “megafloor” combines inpatient, outpatient procedures

Editor's Note A newly constructed surgical “megafloor” that connects inpatient and outpatient ORs promises to aid workflow and add flexibility for perioperative teams at The University of California Irvine (UCI) Health—Irvine campus, Healthcare Design reported October 7. As detailed in the article, the academic center must accommodate a variety of…

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By: Matt Danford
October 21, 2024
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Feds take action on Hurricane-wracked medical supply chain with wartime powers, drug compounding guidance

Editor's Note The Biden administration has invoked wartime powers to speed rebuilding of intravenous fluid (IV) manufacturing capacity, CBS News reported October 15, four days after the US Food and Drug Administration (FDA) took steps to combat drug shortages. Both efforts are in response to devastation wrought by Hurricane Helene,…

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By: Matt Danford
October 16, 2024
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FDA designates Class 1 recall for infusion pumps due to air bubble risk

Editor's Note The US Food and Drug Administration (FDA) has deemed Zyno Medical’s recall of Z-800, Z-800F, Z-800W, and Z-800WF infusion pumps a Class 1, the most severe designation indicating serious risk of injury or death. According to FDA’s October 11 announcement, the recall was due to  a defect in…

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By: Matt Danford
October 14, 2024
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FDA announces Class 1 recall for pediatric resuscitator

Editor's Note The US Food and Drug Administration (FDA) has deemed Mercury Medical’s recall of Neo-Tee Resuscitators a Class 1, the most severe category indicating serious risk of injury or death. According to the agency’s October 7 announcement, the recall was motivated by potential for the inline controller to come…

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By: Matt Danford
October 7, 2024
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AAMI, CTA partners to develop healthcare AI standards

Editor's Note The Association for the Advancement of Medical Instrumentation (AAMI) has entered into a partnership with the Consumer Technology Association (CTA) to develop new standards for the integration of artificial intelligence and machine learning in healthcare, according to an October 1 report in DOTmed. Formalized through a memorandum of…

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By: Matt Danford
October 3, 2024
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Why nurse travelers are more friends than foes

Many are quick to blame travelers for the poor state of hospital finances. However, isn’t there a difference between a traveler in the OR—an interim staff member in the hospital’s profit center—and an interim RN in an area financially supported by OR profits? What about the argument that travelers can…

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By: Josiah Whitman
September 25, 2024
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How perioperative staff can combat human trafficking—Part 2

Human trafficking (HT) is a hidden-in-plain-sight crime—victims walk among the public at large, yet they remain essentially invisible. Lack of education and knowledge on HT and anti-trafficking measures is particularly egregious in healthcare. In fact, the literature shows the majority of people being trafficked access the system without being identified…

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By: Dr Francine Bono-Neri, PhD, RN, APRN, PNP
September 25, 2024
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