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FDA Updates
01/06/2022

The following is a listing of recent U.S. Food and Drug Administration (FDA) updates and activities: Medtronic Recalls Synergy Cranial and ...

Sources:
  • Food and Drug Administration
Relevant To:
  • All Healthcare Organizations

The U.S. Department of Health and Human Services (HHS) recently sent a letter to health care professionals about the uptick in cyberattacks over the h...

Sources:
  • Department of Health and Human Services
Relevant To:
  • All Healthcare Organizations

The SARS-CoV-2 Omicron variant has quickly become the dominant variant of concern in the United States and is present in all 50 st...

Sources:
  • Centers for Disease Control and Prevention
Relevant To:
  • All Healthcare Organizations

The U.S. Food and Drug Administration (FDA) has amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to: Expan...

Sources:
  • Food and Drug Administration
Relevant To:
  • All Healthcare Organizations
Happy New Year
12/31/2021

  The MCN Healthcare StayAlert! Team wishes you a Happy New Year!  ...

Sources:
  • Miscellaneous
Relevant To:
  • All Healthcare Organizations

On November 5, 2021, Centers for Medicare and Medicaid Services (CMS) published an interim final rule with comment period (IFC), “Medicare and M...

Sources:
  • Centers for Medicare and Medicaid Services
Relevant To:
  • All Healthcare Organizations
FDA Updates
12/29/2021

The following is a listing of recent U.S. Food and Drug Administration (FDA) updates and activities: Padagis Issues Voluntary Nationwide Recall ...

Sources:
  • Food and Drug Administration
Relevant To:
  • All Healthcare Organizations

The U.S. Centers for Disease Control and Prevention (CDC) has updated recommendations for isolation and quarantine period for the general population. ...

Sources:
  • Centers for Disease Control and Prevention
Relevant To:
  • All Healthcare Organizations

Due to the increased transmissibility of the SARS-CoV-2 Omicron variant and concerns about potential impacts on the healthcare system, the C...

Sources:
  • Centers for Disease Control and Prevention
Relevant To:
  • All Healthcare Organizations

Wishing you a joyous holiday season with peace and cheer in the New Year. Happy Holidays from the StayAlert! Compliance Team...

Sources:
  • Miscellaneous
Relevant To:
  • All Healthcare Organizations
FDA Updates
12/23/2021

The following is a listing of recent U.S. Food and Drug Administration (FDA) updates and activities: ASPR Pauses Shipping of Bamlanivimab and Et...

Sources:
  • Food and Drug Administration
Relevant To:
  • All Healthcare Organizations

The U.S. Centers for Disease Control and Prevention (CDC) is encouraging healthcare providers to recommend to their patients to perform COVI...

Sources:
  • Centers for Disease Control and Prevention
Relevant To:
  • Assisted Living,
  • Urgent Care,
  • Medical Office,
  • Critical Access Hospitals,
  • Home Health,
  • Hospitals,
  • Long Term Care,
  • Ambulatory Care,
  • Rural Health Clinics

The U.S. Department of Health and Human Services' (HHS) Office for Civil Rights (OCR) has issued guidance to help clarify how the Health Insu...

Sources:
  • Health Insurance Portability and Accountability Act
Relevant To:
  • All Healthcare Organizations
FDA Updates
12/20/2021

The following is a listing of recent U.S. Food and Drug Administration updates and activities: Possible False RPR Reactivity with BioPlex 2200 S...

Sources:
  • Food and Drug Administration
Relevant To:
  • All Healthcare Organizations

The Joint Commission’s (TJC) new and revised workplace violence prevention standards are effective January 1, 2022 and apply to TJC-accredited h...

Sources:
  • The Joint Commission
Relevant To:
  • Critical Access Hospitals,
  • Hospitals