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Abstracts Invited for ASTM International Virtual Workshop on Fast-Tracking PPE Standards Development

Abstracts for presentation are invited for the ASTM International virtual workshop on Fast-Tracking Standards Development to Address Personal Protective Equipment (PPE) Shortages Due to the COVID-19 Pandemic, Sept. 9-10, 2020. ASTM International’s committees on...

340 Organizations Send Letter to Congress Urging Action on Telehealth

On Tuesday 340 organizations signed a letter urging Congressional leaders to make telehealth flexibilities created during the COVID-19 pandemic permanent. Those signing this multi-stakeholder letter include national and regional organizations representing a full range...

AAAHC Enhances Standards in New Accreditation Handbook

The Accreditation Association for Ambulatory Health Care (AAAHC) is moving forward with enhanced Standards in version 41 of its Accreditation Handbook for Ambulatory Health Care. For more than 40 years, AAAHC has provided facilities with relevant standards and...

New Plastic Biomaterials Could Lead To Tougher Medical Implants

A new thermoplastic biomaterial, which is tough and strong but also easy to process and shape has been developed by researchers at the University of Birmingham (UAB). A type of nylon, the material’s shape memory properties enable it to be stretched and moulded but...

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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