ZOLL to Support Customers Affected by the FDA Final Order at EMS Today 2020

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ZOLL TO SUPPORT CUSTOMERS AFFECTED BY THE FDA FINAL ORDER AT EMS TODAY 2020

Experts On-hand to Discuss the FDA Order on Defibrillators without Premarket Approval (PMA)

 

   

February 28, 2020 — CHELMSFORD, MASS. — ZOLL® Medical Corporation, an Asahi Kasei Group Company that manufactures medical devices and related software solutions, will offer EMS Today 2020 attendees the opportunity to experience the company's portfolio of advanced CPR and acute critical care technologies, along with its integrated data solutions. ZOLL will also have experts on-hand to discuss FDA regulations for defibrillators set to take effect in February 2021. Visit ZOLL in Booth 601 March 4–6 at the Tampa Convention Center in Florida.

Important Changes to FDA Regulations for Defibrillators

In September 2019, the U.S. Food and Drug Administration (FDA) notified all AED and professional defibrillator owners, users, and prescribers that, effective February 3, 2021, medical device manufacturers can no longer provide support for monitor/defibrillators without FDA Premarket Approval (PMA).

This regulation will impact ZOLL® M Series® and E Series® monitor/defibrillator customers. In accordance with the FDA requirement, effective February 3, 2021, accessories (including, but not limited to, batteries, cables, hardware, and therapy electrodes) and service will no longer be available for these devices. Customers with products that are not FDA Premarket Approved are encouraged to visit the booth to learn how ZOLL can assist them in making the transition to an FDA-approved device.

Additional attractions at the ZOLL exhibit include:

ZOLL Bundle of Care

Achieving high-quality CPR is essential to improving outcomes, and compressions are critical to all resuscitation efforts. ZOLL’s Bundle of Care includes the X Series® monitor/defibrillator, the AutoPulse® Resuscitation System, the ResQPOD® ITD, and RescueNet® CaseReview. Visitors to the booth can learn more about the unique integration of the X Series monitor with the AutoPulse Resuscitation System, how the ResQPOD ITD (impedance threshold device) improves blood flow to the brain and vital organs, and how RescueNet CaseReview can help teams improve system-wide performance for their toughest cases.

ZOLL AED 3 BLS: The AED for First Responders

The new ZOLL AED 3® BLS will also be on display. This AED was specifically designed for professional rescuers and offers a defibrillation platform of unmatched support. It features an 8-second shock pause — one of the shortest pauses among AEDs. Enhanced Real CPR Help® gives rescuers the power to know when they are providing high-quality chest compressions. The ZOLL AED 3 BLS also offers pediatric mode and is the only AED to provide pediatric CPR metrics using the CPR Dashboard™.

Take the BVM Challenge with the Z Vent

ZOLL will be hosting the BVM (bag-valve-mask) Challenge in Booth 601. Attendees can test their BVM skills unaided for the first minute, and then aided with the help of a simulator. Visitors can also see the Z Vent® transport ventilator deliver precise volume at a set rate, removing the uncertainties of manual ventilation.

555 Fitness Assault on CPR

Using the ZOLL X Series monitor/defibrillator, show attendees will have a chance to test their CPR skills following an intense one-minute workout on an Assault Air Bike. During two minutes of CPR, attendees will have the benefit of Real CPR Help, ZOLL's real-time CPR feedback technology. And ZOLL's RescueNet CaseReview software will provide participants with a detailed analysis of their CPR performance. 555 Fitness, a nonprofit whose mission is to help reduce line-of-duty deaths in first responders by promoting a healthier lifestyle, will be in the booth assisting with the challenge.

About ZOLL Medical Corporation

ZOLL Medical Corporation, an Asahi Kasei Group company, develops and markets medical devices and software solutions that help advance emergency care and save lives, while increasing clinical and operational efficiencies. With products for defibrillation and monitoring, circulation and CPR feedback, data management, fluid resuscitation, therapeutic temperature management, and ventilation, ZOLL provides a comprehensive set of technologies that help clinicians, EMS and fire professionals, as well as lay rescuers, treat victims needing resuscitation and acute critical care. For more information, visit www.zoll.com.

About Asahi Kasei 

The Asahi Kasei Group is a diversified group of companies led by holding company Asahi Kasei Corporation, with operations in the material, homes, and health care business sectors. Its health care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, transfusion, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents. With more than 30,000 employees around the world, the Asahi Kasei Group serves customers in more than 100 countries. For more information, visit www.asahi-kasei.co.jp/asahi/en/.

Copyright © 2020 ZOLL Medical Corporation. All rights reserved. AutoPulse, CPR Dashboard, E Series, M Series, Real CPR Help, RescueNet, ResQPOD, X Series, Z Vent, ZOLL, and ZOLL AED 3 are trademarks or registered trademarks of ZOLL Medical Corporation in the United States and/or other countries. Asahi Kasei is a registered trademark of Asahi Kasei Corporation. All other trademarks are the property of their respective owners.

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