Regulations/Legal

Latest Issue of OR Manager
January 2025
Home Regulations/Legal

FDA: Class I recall of Getinge Flow-c, Flow-e Anesthesia Systems

Editor's Note The Food and Drug Administration (FDA) on July 6 identified the recall by Getinge USA Sales Inc of its Flow-c and Flow-e Anesthesia Systems as Class I, the most serious. The recall was initiated after reports of cracked or broken on/off switchs on the systems’ suction units. If…

Read More

By: Judy Mathias
July 12, 2022
Share

The Joint Commission: New toolkit helps find survey, review resources

Editor's Note The Joint Commission, on July 6, announced a new online toolkit, the “Readiness Roadmap,” that will help organizations locate resources for survey or review based on where they are in their accreditation, certification, or verification process. The toolkit, which is available on The Joint Commission’s Connect extranet site…

Read More

By: Judy Mathias
July 11, 2022
Share

New study: Disposable gowns may expose clinicians to infection

Editor's Note After this October 2020 peer-reviewed study, titled “Disposable versus reusable medical gowns: A performance comparison,” found that “isolation gowns commonly worn in medical units or intensive care units ripped too easily and allowed about four to 14 times the expected amount of liquid to seep through when sprayed…

Read More

By: Tarsilla Moura
July 8, 2022
Share

CMS physician fee schedule proposes 4.43% cut in 2023

Editor's Note The Centers for Medicare & Medicaid Services (CMS) released its Medicare physician fee schedule proposed rule for 2023, “which suggests further cuts to physician pay while inflation and the cost of running an independent practice continue to rise,” Becker’s ASC Review July 8 reports. The proposed rule would…

Read More

By: Tarsilla Moura
July 8, 2022
Share

Sponsored Message

FDA allows for pharmacists to prescribe Paxlovid to treat COVID-19

Editor's Note The US Food and Drug Administration (FDA) announced on July 6 that it would alter its emergency use authorization for the Paxlovid pill—Pfizer’s oral antiviral pill used by some to treat COVID-19—to allow pharmacists to prescribe the treatment to recently affected individuals directly. According to Fierce Pharma July…

Read More

By: Tarsilla Moura
July 8, 2022
Share

Justice Department showing closer inspection of ASC, anesthesia provider arrangements

Editor's Note According to a June 20 article published by JDSupra from law firm Waller Lansden Dortch & Davis, recent government action out of the Justice Department involving ambulatory surgery centers (ASCs) and anesthesia provider arrangements points "to a need to carefully vet these partnerships,” Becker’s ASC Review June 21…

Read More

By: Tarsilla Moura
July 6, 2022
Share

Sponsored Message

CMS updates ASC guidance, revisions for surveyors

Editor's Note The Centers for Medicare & Medicaid Services (CMS) has recently updated its State Operations Manual (SOM) Appendix L—Guidance for Surveyors: Ambulatory Surgical Centers (ASCs), making conforming revisions to the regulatory tags and interpretive guidelines, as well as clarifications and technical corrections to other guidance areas including medical history…

Read More

By: Tarsilla Moura
July 6, 2022
Share

HHS orders 2.5 million more doses of monkeypox vaccine

Editor's Note The US Department of Health and Human Services (HHS) on July 1 announced it ordered an additional 2.5 million doses of the FDA-licensed Bavarian Nordic's JYNNEOS vaccine in response to current or future monkeypox outbreaks and as part of US smallpox preparedness, Healthcare Purchasing News (HPN) July 5…

Read More

By: Tarsilla Moura
July 5, 2022
Share

Legislation to improve medical device cybersecurity introduced, supported by AHA

Editor's Note On Friday, June 24, the American Hospital Association (AHA) voiced support for the Protecting and Transforming Cyber Health Care Act (PATCH Act)—legislation that would “require medical device manufacturers to meet certain cybersecurity requirements when seeking approval for devices that are internet connected or include software” in order to…

Read More

By: Tarsilla Moura
June 30, 2022
Share

The Joint Commission extends application deadline for Tyson Award

Editor's Note The Joint Commission on June 29 announced that the application deadline for the "Bernard J. Tyson National Award for Excellence in Pursuit of Healthcare Equity" has been extended through July 14. The Tyson Award was established in partnership with Kaiser Permanente in honor of Bernard J. Tyson, the…

Read More

By: Judy Mathias
June 30, 2022
Share

Join our community

Learn More
Video Spotlight
Live chat by BoldChat