Regulations/Legal

Latest Issue of OR Manager
November 2025
Home Regulations/Legal

FDA: Class I recall of Medtronic’s Valiant Navion Thoracic Stent Graft System

Editor's Note The Food & Drug Administration (FDA), on April 9, identified the recall of Medtronic’s Valiant Navion Thoracic Stent Graft System as Class I, the most serious. The recall was initiated because of the risk of stent fractures and endoleak concerns. The system is used to repair lesions of…

Read More

By: Judy Mathias
April 12, 2021
Share

Better masks, ventilation needed to curb spread of COVID-19 in enclosed spaces

Editor's Note Findings in this study, by researchers at the Indian Institute of Technology Bhubaneswar, show the need for new mask designs that reduce side and bottom droplet leakage and good ventilation systems that take into account the aerosolized particle leakage that occurs with breathing and normal conversation as a…

Read More

By: Judy Mathias
April 8, 2021
Share

The Joint Commission creates new requirements addressing patient admission, discharge, transfer

Editor's Note In response to a May 2020 Centers for Medicare & Medicaid Services final rule on interoperability and patient access, The Joint Commission has created new requirements that address patient admission, discharge, and transfer notifications. The new requirements, which apply to hospitals and critical access hospitals, address the electronic…

Read More

By: Judy Mathias
April 8, 2021
Share

The Joint Commission launches SAFER Dashboard

Editor's Note The Joint Commission, on April 6, launched the SAFER Dashboard for its accredited healthcare organizations. The dashboard, which is accessible on an organization’s Joint Commission Connect extranet site, is a data analytic tool that allows organizations to view their survey data and national comparison data in one place.…

Read More

By: Judy Mathias
April 8, 2021
Share

Sponsored Message

CDC: Risk of getting COVID-19 from surfaces is low

Editor's Note In a science brief based on the Centers for Disease Control and Prevention’s (CDC’s) analysis of the latest available data, the agency says the risk of getting COVID-19 from surfaces “is generally considered to be low.” The CDC noted that: The risk of COVID-19 infection via surface transmission…

Read More

By: Judy Mathias
April 6, 2021
Share

CDC: Fully vaccinated people are safe for domestic travel

Editor's Note The Centers for Disease Control and Prevention (CDC), on April 2, updated its information for travelers to say people who are fully vaccinated can travel safely within the US. The update notes that fully vaccinated travelers do not have to be tested before or after travel unless required…

Read More

By: Judy Mathias
April 5, 2021
Share

Sponsored Message

FDA: Class I recall of Medtronic Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface

Editor's Note The Food and Drug Administration (FDA), on March 24, identified the recall by Medtronic of its Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface as Class I, the most serious. The recall was issued because of potentially elevated levels of harmful bacterial endotoxins. Use of a device…

Read More

By: Judy Mathias
March 25, 2021
Share

The Joint Commission releases 2020 sentinel event statistics

Editor's Note The Joint Commission, on March 24, released its sentinel event statistics for 2020, which totaled 794. The top five most frequently reported events were: Falls: 170 Unintended retention of a foreign object: 106 Suicide: 81 Delay in treatment: 76 Wrong-site surgery: 68. The Joint Commission’s Office of Quality…

Read More

By: Judy Mathias
March 25, 2021
Share

Kentucky is third state to enact legislation on surgical smoke evacuation

Editor's Note AORN announced on March 24 that Kentucky Governor Andy Beshear had signed into law new legislation that will require licensed hospitals and ambulatory surgery centers to adopt and implement policies to prevent human exposure to surgical smoke. AORN’s government affairs team and Kentucky AORN members worked closely with…

Read More

By: Judy Mathias
March 24, 2021
Share

Survey: Healthcare workers’ intentions to receive COVID-19 vaccine

Editor's Note This survey by researchers at the Geisinger Health System, Danville, Pennsylvania, shows a trend of increased intention by healthcare workers to receive a COVID-19 vaccine. A total of 16,292 employees completed the survey, for a response rate of 68.5%. During the period of survey data collection, the researchers…

Read More

By: Judy Mathias
March 23, 2021
Share

Join our community

Learn More
Video Spotlight
Live chat by BoldChat