Tag: Rules and Regulations

WHO: Virus transmission airborne, not limited to droplets

Editor's Note In a move one expert calls “a complete U-turn,” the World Health Organization (WHO) has concluded that viruses transmit through primarily the air via inhalation of tiny suspended particles of saliva and mucus, KFF Health News reported on May 1. Until now, health authorities have relied on the…

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By: Matt Danford
May 6, 2024
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FDA medical device Class 1 recalls trend upward

Editor's Note The number of US Food and Drug Administration (FDA) Class 1 recalls—the most serious classification—for medical devices has been trending upwards. Regulatory News, a publication of the Regulatory Affairs Professional Society (RAPS), reported the news April 25.  According to the report, Anne Reid, program director of the Office…

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By: Matt Danford
April 29, 2024
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Federal regulations require written consent for pelvic exams at hospitals, medical schools

Editor's Note New federal guidelines require obtaining written informed consent before conducting pelvic and other sensitive medical examinations, according to an April 2 Associated Press report. The new guidance from the US Department of Health and Human Services focuses specifically on medical students, nurse practitioners, and physician assistants performing breast,…

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By: Matt Danford
April 15, 2024
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EPA rule to limit dangerous emissions from medical sterilization plants

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Editor's Note The Environmental Protection Agency (EPA) has finalized a rule to reduce chloroprene and ethylene oxide emissions that will impact over 200 chemical plants across the nation, including medical sterilization plants, according to an April 10 report from USA Today. Under the new rule, the EPA will cut more…

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By: Brita Belli
April 11, 2024
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FDA approves new antibiotic for staph, other infections

Editor's Note The US Food and Drug administration approved Zevtera for treating Staphylococcus aureus bacteremia (SAB) bloodstream infections, which are often acquired in healthcare settings. In the April 3 announcement, the agency notes the new antibiotic Zevtera (ceftobiprole medocaril sodium for injection) is effective for SAB-infected patients with right-sided infective…

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By: Matt Danford
April 4, 2024
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Private payers profit by delaying medical claims

Editor's Note Private payers initially deny reimbursement on 15% of claims, only to later approve more than half of those initial denials, according to a national survey of healthcare institutions published March 21 by Premiere, Inc. Additionally, the denied claims on average tend to be more prevalent for higher-cost treatments…

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By: Matt Danford
April 4, 2024
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FDA warning: unapproved topical analgesics potentially dangerous

Editor's Note The US Food and Drug Administration (FDA) advises consumers to avoid topical analgesics marketed in violation of federal law by six different companies, including: TKTX Company: TKTX Numb Maximum Strength Pain Reliever, Mithra+ 10% Lidocaine, TKTX During Procedure Numbing Gel 40% and J-CAIN cream [LIDOCAINE] 29.9% SeeNext Venture,…

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By: Matt Danford
March 29, 2024
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Proposed federal rule would require hospitals, health systems to report cyberattacks

Editor's Note The Department of Homeland Security's Cybersecurity and Infrastructure Security Agency (CISA) proposed a new rule that would require hospitals and health systems to report any cyberattacks or ransomware attacks to the agency within 72 hours and any ransomware payments within 24 hours.  The healthcare sector is one of…

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By: Brita Belli
March 28, 2024
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How data puts the ‘value’ in value-based care

What if a surgeon decided to perform a procedure on a patient that was not totally necessary? It happens more often that one might realize. As recently as August 2023, Forbes published an article that cited a Harvard Business Review report stating that over 50% of lumbar spine surgeries are…

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By: David Cotriss
March 22, 2024
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New EPA standards to reduce ethylene oxide emissions

Editor's Note New standards from The Environmental Protection Agency promise to cut nationwide emissions of ethylene oxide—employed to sterilize more than half of US medical devices—by more than 90 percent. According to a March 15 MedPage Today report, the aim is to reduce cancer risk among the 13 to 14…

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By: Matt Danford
March 18, 2024
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