Rules and Regulations

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May 2025
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Funding for pandemic prevention, preparedness, response established

Editor's Note  The Financial Intermediary Fund (FIF) Governing Board established the new FIF for pandemic prevention, preparedness, and response (PPR) at its inaugural meeting from September 8-9, World Health Organization (WHO) September 9 reports. The goal is to provide long-term financing to strengthen PPR capabilities in low- and middle-income countries…

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By: Lauren McCaffrey
September 12, 2022
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FDA: Class I recall of Hamilton-C6 Intensive Care Ventilator

Editor's Note The Food and Drug Administration (FDA) on August 29 identified the recall by Hamilton Medical AG of its Hamilton-C6 Intensive Care Ventilator as Class I, the most serious. The recall was initiated because of potential water ingress between the indicator board and the ventilator’s main board that may…

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By: Judy Mathias
September 1, 2022
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CDC plans to overhaul structure, recover reputation

Editor's Note On Wednesday, August 18, Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky shared planned changes with CDC leadership and staff to “transform” the agency and its  culture, with the goal of "improving how the agency shares information, develops public health guidance, and communicates with the American…

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By: Tarsilla Moura
August 18, 2022
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CDC updates COVID-19 guidance

Editor's Note The Centers for Disease Control and Prevention (CDC) on August 11 updated its guidelines for COVID-19. The new recommendations focus on helping people better understand their risks, how to protect themselves and others, what actions to take if exposed, and what actions to take if they test positive…

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By: Judy Mathias
August 15, 2022
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COVID-19 infection risk on airlines

Editor's Note In this study, researchers from the Massachusetts Institute of Technology, Cambridge, calculate the chances of catching COVID-19 on a US plane flight. The study estimates that from June 2020 through February 2021, the probability of getting COVID-19 on a totally full flight lasting 2 hours was more than…

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By: Judy Mathias
August 4, 2022
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FDA adds AEDs, chest drains to device shortage list

Editor's Note The Food and Drug Administration (FDA) on July 19 added automated external defibrillators (AEDs) and chest drains/suction canisters and autotransfusion systems to its list of medical device shortages during COVID-19. The shortage of chest drains/suction canisters and autotransfusion systems is because of increased demand. The shortage of AEDs…

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By: Judy Mathias
July 26, 2022
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AAMI's response to GI societies' statement on ST91

Editor's Note The Association for the Advancement of Medical Instrumentation (AAMI), in June, published a response rebuking a joint statement issued by several GI societies opposing the "ANSI/AAMI ST91:2021, Flexible and semi-rigid endoscope processing in health care facilities." Many of the ST91 working group were dismayed that the GI society’s…

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By: Judy Mathias
July 21, 2022
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CDC advisers endorse ‘more traditional’ COVID-19 vaccine for unvaccinated

Editor's Note On July 19, Centers for Disease Control and Prevention (CDC) advisers said the 26 to 37 million adults in the US who have yet to get a COVID-19 vaccination should consider the “more traditional” vaccine Novavax, Modern Healthcare July 19 reports. Novavax is the “first so-called protein vaccine”…

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By: Lauren McCaffrey
July 20, 2022
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COVID-19 vaccination perspectives, infections among first responders

Editor's Note This study, led by the University of Miami and sponsored by the CDC, finds that unvaccinated first responders (eg, law enforcement officers, firefighters, and others) were more likely to develop COVID-19 and less likely to believe in the effectiveness and safety of vaccines than their vaccinated counterparts. Of…

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By: Judy Mathias
July 20, 2022
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CMS issues proposed rule for hospital outpatient, ASC payment rates for CY 2023

Editor's Note The Centers for Medicare & Medicaid Services (CMS) on July 15 released its Outpatient Prospective Payment System (OPPS) proposed rule that would raise rates by a net 2.7% in CY 2023. This update is based on the projected hospital market basket percentage increase of 3.1%, reduced by 0.4%…

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By: Judy Mathias
July 19, 2022
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