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IAHCSMM Announces Board of Director Election Results

The International Association of Healthcare Central Service Materiel Management (IAHCSMM) announced the election results for four board of director positions.

Medtronic Recalls Valiant Navion Thoracic Stent Graft System

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Activ Surgical Announces FDA Clearance for ActivSight Intraoperative Imaging Module

Activ Surgical announced the U.S. Food and Drug Administration (FDA) 510(k) clearance of the company’s ActivSight Intraoperative Imaging Module for enhanced surgical visualization.

Metrex Surface Disinfectant Portfolio Secures EPA Approval

The U.S. Environmental Protection Agency (EPA) has approved all eight surface disinfectant products made by an infection prevention leader, Metrex, as effective against SARS-CoV-2, the novel coronavirus that causes COVID-19.

FDA Issues New Policy on Devices for ECMO Therapy During COVID-19

Today, the U.S. Food and Drug Administration (FDA) issued an immediately in effect guidance that allows manufacturers of certain FDA-cleared or FDA-approved extracorporeal membrane oxygenation (ECMO) and cardiopulmonary bypass devices to expand device indications or modify designs to increase device availability and facilitate long-term ECMO therapy.

Certain cardiopulmonary bypass devices used to pump blood or oxygenate blood can be used for longer periods of time than currently indicated and may help address urgent public health concerns by expanding the availability of devices to provide ECMO therapy for patients experiencing acute respiratory failure and/or acute cardiopulmonary failure.

This policy reflects FDA’s commitment to ease burdens on health care providers and facilities as they face COVID-19.

READ THE GUIDANCE »

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