Regulations/Legal

Latest Issue of OR Manager
March 2018
Home Regulations/Legal

FDA: Class I recall of HeartStart MRx Defibrillator

Editor's Note The Food & Drug Administration (FDA) on February 9 classified the recall by Philips Electronics (Andover, Massachusetts) of its HeartStart MRx Defibrillator as Class I, the most serious. The recall was initiated because of micro cracks in the gas discharge tube that allow internal gasses to escape and…

Read More

By: Judy Mathias
February 13, 2018
Share

Budget deal includes big changes for healthcare

Editor's Note The US Congress on February 9 passed a budget deal that will have a significant impact across nearly every sector of the healthcare industry, the March 9 Business Insider reports. Among the initiatives are: $2 billion for the National Institutes of Health $6 billion to combat the opioid…

Read More

By: Judy Mathias
February 9, 2018
Share

FDA: New imaging technology promises stable supply of imaging isotope

Editor's Note The Food & Drug Administration (FDA) Commissioner, Scott Gottlieb, MD, on February 8 announced the role the FDA played in the groundbreaking effort to develop a new imaging technology−the RadioGenix System. The technology, which resulted from a collaboration across the federal government and industry, has the potential to…

Read More

By: Judy Mathias
February 9, 2018
Share

Joint Commission seeking comments on credentialing, privileging standards

Editor's Note The Joint Commission on February 7 announced that it is seeking comments on proposed revisions to its credentialing and privileging standards for contract services in Hospital, Critical Access Hospital, Ambulatory Health Care, Office-based Surgery, Nursing Care Center, and Behavioral Health Care accreditation programs. The revisions clarify or consolidate existing…

Read More

By: Judy Mathias
February 8, 2018
Share

FDA clears updated design, labeling for Pentax duodenoscope

Editor's Note The Food and Drug Administration (FDA) on February 7 announced that it had cleared the updated design and labeling for Pentax Medical's duodenoscope Model ED-3490TK. Pentax replaced the forceps elevator mechanism, O-ring seal, and distal end cap, and updated the Operation Manual to recommend annual maintenance. The design…

Read More

By: Judy Mathias
February 7, 2018
Share

New brochure focuses on HAI prevention

Editor's Note The Joint Commission on January 31 announced that a new brochure is available to help healthcare organizations inform patients about healthcare-associated infections (HAIs) and prevention. The brochure, titled, “For Our Patients and Their Visitors: Help Prevent Infections,” is derived from the resource, “Compendium of Strategies to Prevent Healthcare-Associated…

Read More

By: Judy Mathias
February 6, 2018
Share

FDA: Class I recall of AirLife Humidification Chamber, Heated Breathing Circuit Kits

Editor's Note The Food and Drug Administration (FDA) on January 31 classified the recall by Vyaire Medical (Mettawa, Illinois) of its AirLife Humidification Chamber and Heated Breathing Circuit Kits as Class I, the most serious. The recall was initiated because of a manufacturing error that may cause parts of the…

Read More

By: Judy Mathias
February 6, 2018
Share

CMS: Two exercises of emergency operations plan required annually

Editor's Note The Joint Commission reported on January 31 that it had confirmed with the Centers for Medicare & Medicaid Services (CMS) that organizations are required to have two exercises of their emergency operations plan annually. Among the organizations to which the requirement applies are: deemed hospitals critical access hospitals…

Read More

By: Judy Mathias
February 5, 2018
Share

Physicians negatively affected by EHRs

Editor's Note Physicians are more likely to leave the profession or reduce their hours if they are uncomfortable using electronic health records (EHRs), the January 24 Medical Economics reports. Although EHRs have the potential to enhance quality of care and clinical coordination, they also increase risk of physician burnout, reduce…

Read More

By: Judy Mathias
January 25, 2018
Share

Joint Commission Quick Safety reports on supporting second victims

Editor's Note The Joint Commission on January 24 announced that its January Quick Safety examines second victim experiences and safety actions to consider, and it also includes an anonymous, personal story of a Joint Commission employee who is a second victim. Though the patient and family are the priority for…

Read More

By: Judy Mathias
January 25, 2018
Share
Upcoming Webinars
Live chat by BoldChat