Rules and Regulations

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May 2025
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AHA urges EPA to ensure proposed EtO standards don’t disrupt healthcare delivery

Editor's Note In a June 27 letter, the American Hospital Association (AHA) urged the Environmental Protection Agency (EPA) “to avoid disrupting healthcare delivery through the unintentional fracturing” of the medical device supply chain with its proposed ethylene oxide (EtO) standards. The EPA proposes: reducing EtO emissions by 80% adding new…

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By: Judy Mathias
June 29, 2023
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Compliance with CMS Hospital Price Transparency Rule linked to financial penalties

Editor's Note This study from Harvard Medical School, Boston, and Georgetown University, Washington, DC, finds that hospital compliance with the Centers for Medicare & Medicaid Services (CMS) 2021 Price Transparency Rule is increasing since financial penalties were enforced. Data from 4,377 acute care hospitals operating in 2021 and 2022 were…

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By: Judy Mathias
June 28, 2023
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The Joint Commission starts new voluntary Health Care Equity Certification

Editor's Note The Joint Commission, on June 27, announced that it is starting a new voluntary Health care Equity Certification Program, effective July 1. The advanced certification recognizes hospitals for excellence in their efforts to provide equitable care, treatment, and services and builds on longstanding accreditation requirements that support healthcare…

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By: Judy Mathias
June 28, 2023
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FDA: Class I recall of Arrow Endurance Extended Dwell Peripheral Catheter System

Editor's Note The Food and Drug Administration (FDA), on June 26, identified the recall by Teleflex, and their subsidiary Arrow International, of the Arrow Endurance Extended Dwell Peripheral Catheter System as Class I, the most serious. The recall was initiated because of the risk of catheter separation and leakage. If…

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By: Judy Mathias
June 27, 2023
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ASA, APSF update recommendations for elective surgery after COVID-19 infection

Editor's Note Because of recent studies, the evolving nature of COVID-19, and widespread vaccination, the American Society of Anesthesiologists (ASA) and Anesthesia Patient Safety Foundation (APSF) on June 20 released a joint statement providing updated recommendations for the timing of elective surgery and anesthesia after COVID-19 infection. The recommendations include:…

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By: Judy Mathias
June 21, 2023
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National Time Out Day is June 14

Editor's Note National Time Out Day on June 14 renews attention on the surgical team to prevent wrong-site surgery by pausing before a surgical procedure begins to make sure it is the right site, right procedure, and right person, a June 7 joint statement by The Joint Commission and AORN…

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By: Judy Mathias
June 12, 2023
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The Joint Commission revises CAH requirements to align with CMS

Editor's Note The Joint Commission, on May 31, announced that it has added several new and revised elements of performance (EPs) for critical access hospitals (CAHs) that address restraint and seclusion, the complaint process, and unified and integrated structures for CAHs that are part of a multihospital system, effective June…

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By: Judy Mathias
June 1, 2023
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SHEA: Strategies to prevent SSIs updated

Editor's Note The Society for Healthcare Epidemiology of America (SHEA) has updated the Strategies to Prevent Surgical Site Infection in Acute Care Hospitals, which was published in 2014. The update highlights practical recommendations designed to assist acute-care hospitals in implementing and prioritizing their surgical site infection (SSI) prevention efforts. Among…

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By: Judy Mathias
May 26, 2023
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AAMI releases updated protective barriers standard

The Association for the Advancement of Medical Instrumentation (AAMI) has revised the ANSI/AAMI PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities. This revised standard provides healthcare professionals with a better understanding of the barrier protection properties of available protective apparel. The…

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By: Susan Klacik, BS, FCS, ACE, CHL, CIS, CRCST, AAMIF
May 23, 2023
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FDA finalizes recommendations for blood donations

Editor's Note The Food and Drug Administration (FDA), on May 11, finalized its recommendations for assessing blood donor eligibility, which uses individual risk-based questions to reduce the risk of transmitting HIV. The questions will be the same for all donors, regardless of sexual orientation, sex, or gender. The new policy…

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By: Judy Mathias
May 22, 2023
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