Devices

FDA Monitoring Covid Ventilator Splitters

FDA says it is monitoring clinical experience with ventilator splitters (multiplexing ventilator tubing connectors) in situations in which no alternatives for invasive ventilatory support are available. Splitters are intended to divide the gas flow from a single mechanical ventilator to deliver a tidal volume to more than one patient and collect expiration from the patients. FDA 3/25/2020 issued an Emergency Use Authorization for certain ventilators and ventilator accessories for treating patients to address the observed and anticipated shortages of ventilators and ventilator accessories.

“Although the FDA has not received any adverse event reports related to the use of ventilator splitters authorized for emergency use during the Covid-19 pandemic, recent literature describes risks that may be associated with using certain ventilator splitters,” an agency notice says. It says the literature indicates that certain features are associated with better performance, such as:

One-way valves in the breathing circuit,
Flow restrictors or pressure regulators at each inspiratory limb of the circuit,
Individual positive end-expiratory pressure valves,
Inspiratory and expiratory tidal volume sensors, and
Pressure sensors.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome