Regulations/Legal
FDA: Class I recall of Alaris Infusion Pump System and Modules
Editor's Note The Food and Drug Administration (FDA) on March 6 identified the recall by Becton Dickinson (BD)/CareFusion 303 of its Alaris System Infusion Pumps and Modules as Class I, the most serious. The recall was initiated because of multiple system errors, software errors, and use-related errors. The errors can…
Study: Anesthetic management of patients with suspected COVID-19 during emergency surgical procedures
Editor's Note This retrospective, multicenter study from four hospitals in Wuhan, China, found that Novel Coronavirus 2019 (COVID-19) specific guidelines for emergency surgical procedures in patients with confirmed or suspected COVID-19 infection can effectively prevent cross-infection in the OR. The guidelines include: negative pressure ORs level 3 protective measures for…
CMS issues call to action to healthcare providers aimed at limiting spread of COVID-19
Editor's Note In a March 4 press release, the Centers for Medicare & Medicaid Services (CMS) called on all healthcare providers to make sure they are implementing infection control practices, which they are required to maintain at all times, in an effort to limit the spread of the Novel Coronavirus…
FDA, CDC increase access to respirators during COVID-19 outbreak
Editor's Note The Food & Drug Administration (FDA) on March 2 announced that it had joined with the Centers for Disease Control and Prevention (CDC) to make more respirators, including certain N95s, available to healthcare personnel during the coronavirus (COVID-19) outbreak. Currently, the majority of respirators are used in industrial…
FDA: Class I recall of King Systems’ video laryngoscope adapter
Editor's Note The Food & Drug Administration (FDA) on February 27 identified the recall by King Systems of its King Vision Video Laryngoscope Adapter (size ½) as Class I, the most serious. The recall was initiated because all devices from the affected lots show a reversed image on the display,…
CDC updates coronavirus guidance
Editor's Note The Centers for Disease Control and Prevention (CDC) on February 27 updated its guidance for healthcare professionals evaluating and reporting patients under investigation for the novel coronavirus (COVID-19). The CDC has developed clinical criteria to guide patient evaluation based on what is known about Middle East Respiratory Syndrome…
Joint Commission makes minor modifications to on-site survey process
Editor's Note The Joint Commission on February 26 announced that it had made minor modifications to its on-site survey process that will go into effect March 1, 2020. The modifications were made to better accommodate critical survey activities for all accreditation programs, except for laboratory services accreditation. The modifications also…
CDC urges communities, hospitals to prepare for spread of coronavirus
Editor's Note In a February 25 telebriefing, the Centers for Disease Control and Prevention (CDC) warned that the novel coronavirus (COVID-19) will spread in the US, and hospitals and communities should begin ramping up their preparedness efforts, AHA Today reports. The CDC urged communities to implement non-pharmaceutical interventions or community…
FDA: Class I recall of Abbott coronary dilatation catheters
Editor's Note The Food & Drug Administration on February 19 identified the recall by Abbott Vascular of its NC Trek RX and NC Traveler RX Coronary Dilatation Catheters (diameter 4.0 mm, 4.5 mm, and 5.00 mm) as Class I, the most serious. The recall was initiated because of failure of…
Effect of total joint bundled payment program on patient selection
Editor's Note In this study, researchers found little to no significant change in the characteristics of patients having total hip and knee replacement surgery after the Centers for Medicare & Medicaid Services introduced the mandatory bundled payment programs in selected metropolitan statistical areas. The analysis included a matched set of…
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