Dräger Evita V800/V600, Babylog VN800 and Savina 300 obtain Authority to Operate (ATO) under Risk Management Framework

New certifications follow Dräger's previous ATO certification for a critical care ventilator

• Dräger Evita V800/V600 and Babylog VN800 family of devices, effective 1/23/2025 and expiring on 1/21/2028 under eMASS System ID 3984
• Dräger Savina 300 series, effective 1/23/2025 and expiring on 1/21/2028 under eMASS System ID 3957

TELFORD, Pa., Feb. 11, 2025 /PRNewswire/ -- Dräger, an international leader in medical and safety technologies, today announced that its Evita V800/V600 and Babylog VN800 family of mechanical ventilators received Authority to Operate (ATO) certification under the Department of Defense's (DoD) Risk Management Framework (RMF) eMASS #3984. In addition, the Savina 300 series of mechanical ventilators received ATO certification under the DoD's RMF eMASS #3957.

"At Dräger, our mission extends beyond clinical technology," said President and CEO for Draeger, Inc., Lothar Thielen. "In our quest to improve patient outcomes and health equity, we are also committed to protecting patient data. That's why we invest significant resources in cybersecurity, which has culminated in ATO certification – the highest level of security a device can hold."

Dräger was one of the first companies to obtain an ATO for a critical care ventilator
Certification of Dräger's latest-technology ventilators follows that of the Dräger V500 series of ventilators, which achieved this level of security in 2020 under eMASS System ID 2510 and extends to 3/3/2026. With this ATO certification of a critical care ventilator – as well as many ATOs for other medical devices before 2020 – Dräger broke new ground in patient data security.

Benefits of ATO-certified ventilators
Medical devices that have achieved an Authority to Operate (ATO) under the Risk Management Framework (RMF) offer significant advantages to hospitals, including:

• Enhanced security: Rigorous security assessments ensure that these devices meet high standards for protecting sensitive patient data and maintaining the integrity of medical operations
• Compliance assurance: Devices that comply with federal regulations and standards reduce the risk of legal and regulatory issues
• Reliability and trust: Hospitals can trust that these devices have been thoroughly vetted for security and performance, leading to greater confidence in their use in critical environments
• Interoperability: Devices with ATO are often designed to integrate seamlessly with other systems within the healthcare network, enhancing overall efficiency and effectiveness
• Continuous monitoring: Ongoing monitoring and updates continually address new security threats, ensuring that devices remain secure over time
• Faster installation: ATO-certified devices streamline the process of integrating ventilator data with electronic medical records, centralized alarm stations, and remote notifications

In short, ventilators that offer this level of security have stronger patient data protection and carry a lower risk of cyberattacks.

More information:
Dräger Evita V800/V600 family of devices [link]
Dräger Babylog VN800 ventilator [link]
Dräger Savina 300 series of ventilators [link]

Dräger Evita V800
The Evita V800 combines high performance ventilation with an ergonomic design, enabling intuitive and efficient operation. This integrated, patient-centered ventilation workplace enables caregivers to care for patients with various acuity levels – efficiently and cost effectively.

D-3636-2019

Dräger Babylog VN800
Designed specifically for fragile neonates, the Babylog VN800 has an intuitive user interface that helps make it safe and easy to operate. The system supports lung and brain protective ventilation modes throughout the baby's whole respiratory cycle, supporting a seamless transition from O₂ therapy to non-invasive ventilation to invasive ventilation.

D-12091-2019

Dräger Savina 300
The Savina 300 is designed to be as non-invasive as possible, yet as invasive as necessary. The ventilator has automatic leak compensation to effectively support non-invasive ventilation. The built-in turbine has a rapid response time and an external battery enables it to be operated independently from the central gas supply.

D-14953-2019

You can find more information and pictures in our press center:
https://www.draeger.com/en-us_us/Newsroom/Press-Center

Dräger. Technology for Life.
Dräger is a leading international medical and safety technology company. Our products protect, support and save lives. Founded in Lübeck, Germany in 1889, Dräger generated global sales of around EUR 3 billion in 2022. The Lübeck-based company is represented in more than 190 countries and employs more than 14,000 people worldwide. For more information, visit www.draeger.com.

Contact
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SOURCE Draeger