Regulations/Legal

Latest Issue of OR Manager
February 2025
Home Regulations/Legal

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…

Read More

By: Judy Mathias
September 1, 2022
Share

New Joint Commission Speak Up program on telehealth

Editor's Note The Joint Commission on August  31 announced a new patient safety campaign to help patients understand telehealth visits, titled: “Speak Up At Your Telehealth Visit.” Educational resources for the Speak Up program include: an infographic poster/flyer an animated video a distribution guide on how to provide the materials…

Read More

By: Judy Mathias
September 1, 2022
Share

FDA: Class I recall of Intera 3000 Hepatic Artery Infusion Pump

Editor's Note The Food and Drug Administration on August 29 identified the recall by Intera Oncology of its Intera 3000 Hepatic Artery Infusion Pump as Class I, the most serious. The company is recalling the pumps after receiving reports from clinicians that the pumps were delivering medication faster than expected.…

Read More

By: Judy Mathias
August 31, 2022
Share

Moderna sues Pfizer and BioNTech for COVID-19 vaccine patent infringement

Editor's Note On Friday, August 26, the vaccine manufacturer Moderna sued Pfizer and the German drugmaker BioNTech, accusing its competitors of copying technology that Moderna had developed prior to the pandemic, The New York Times August 26 reports. The patent infringement claims could result in a protracted and expensive legal battle…

Read More

By: Lauren McCaffrey
August 29, 2022
Share

Sponsored Message

FDA: Class I recall of Medtronic’s HeartWare HVAD system batteries

Editor's Note The Food and Drug Administration on August 25 identified the recall by Medtronic of its HeartWare Ventricular Assist Device (HVAD) system batteries as Class I, the most serious. Medtronic is recalling the batteries because they may experience electrical faults that cause them to unexpectedly fail. A similar recall…

Read More

By: Judy Mathias
August 29, 2022
Share

HHS releases two reports on long COVID-19 research, support

Editor's Note  On August 3, as directed by President Joe Biden in a briefing room release in April 2022, when he tasked the Department of Health and Human Services (HHS) “to coordinate the federal response to the long-term health effects of COVID-19,” as reported by OR Manager, HHS released a national…

Read More

By: Lauren McCaffrey
August 25, 2022
Share

Sponsored Message

FBI warns healthcare professionals about fraud scheme

Editor's Note The FBI on August 22 warned healthcare workers of ongoing fraud schemes where scammers impersonate law enforcement and government officials in an effort to extort money or steal personally identifiable information (PII), Healthcare Purchasing News August 24 reports. By researching a medical practice’s website or social media, scammers…

Read More

By: Lauren McCaffrey
August 25, 2022
Share

Study: Incubation period decreases with each COVID-19 variant

Editor's Note  New research in China, led by Min Liu of the Department of Epidemiology and Biostatistics at Peking University's School of Public Health in Beijing, shows that the incubation period is significantly shorter when people are infected with COVID-19 now than at the beginning of the pandemic, US News…

Read More

By: Lauren McCaffrey
August 23, 2022
Share

Dr Fauci plans to step down in December

Editor's Note On Monday, August 22, Dr Anthony Fauci announced he will step down as director of the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health and as chief medical adviser to President Joe Biden in December 2022. "While I am moving on from…

Read More

By: Lauren McCaffrey
August 22, 2022
Share

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…

Read More

By: Tarsilla Moura
August 18, 2022
Share

Join our community

Learn More
Video Spotlight
Live chat by BoldChat