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.
