Safety/Quality

Latest Issue of OR Manager
September 2024
Home Safety/Quality

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…

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By: Judy Mathias
August 29, 2022
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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…

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By: Lauren McCaffrey
August 25, 2022
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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…

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By: Lauren McCaffrey
August 25, 2022
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COVID-19 outbreak in acute care hospital linked to vaccine breakthrough

Editor's Note This study by researchers in South Korea analyzes a COVID-19 outbreak caused by vaccine breakthrough infections in a hospital where 91.9% of healthcare workers were vaccinated. In addition, it was mandatory that all healthcare workers and caregivers wear masks or respirators at all times except when eating. During…

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By: Judy Mathias
August 25, 2022
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ANSI/AAMI ST98 provides cleaning validation requirements for device manufacturers

Editor's Note The Association for the Advancement of Medical Instrumentation (AAMI) on August 24 announced the publication of a new standard: “ANSI/AAMI ST98:2022, Cleaning validation of health care products—Requirements for development and validation of a cleaning process for medical devices.” The new standard not only provides manufacturers with a formalized…

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By: Judy Mathias
August 25, 2022
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Regular physical activity linked to lower risk of COVID-19 infection, adverse outcomes

Editor's Note This meta-analysis led by researchers in Spain finds that regular physical activity is associated with a lower risk of COVID-19 infection, severity, and mortality. The analysis included 1,853,610 adults from multiple countries worldwide—54% were women, and the average age was 53. Compared with physically inactive individuals, those who…

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By: Judy Mathias
August 24, 2022
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Impact of COVID-19 on surgical cases for urology resident training

Editor's Note This study from researchers at the Urology Institute, University Hospitals Cleveland Medical Center, examines the impact of COVID-19 on surgical cases for urology residents and finds that despite widespread disruptions in surgical care, there will likely be minimal detriment to training over time. Using data from the Accreditation…

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By: Judy Mathias
August 24, 2022
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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…

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By: Lauren McCaffrey
August 23, 2022
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Association of masking policies with mask adherence, distancing during COVID-19

Editor's Note This study led by researchers at Kaiser Permanente, Southern California, Pasadena, finds that masking mandates had a significant role in influencing people to wear masks during COVID-19. A total of 109,999 individuals in 126 US cities were included in the analysis. Data were collected by 231 students affiliated with…

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By: Judy Mathias
August 23, 2022
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FDA: Hospira recalls another lot of Propofol

Editor's Note The Food and Drug Administration (FDA) on August 22 posted the Hospira Inc (a Pfizer company) recall of one lot of Propofol Injectable Emulsion (containing Benzyl alcohol), 100 mL single patient use glass fliptop vials, lot EA7470. The recall was initiated because of visible particulates observed in two…

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By: Judy Mathias
August 23, 2022
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