Dräger’s Evita V800/V600, Babylog VN800, and Savina 300 ventilators have received ATO certification under the Department of Defense’s Risk Management Framework, meeting federal cybersecurity standards for medical devices.

Summary:

Dräger announced that its Evita V800/V600, Babylog VN800, and Savina 300 series mechanical ventilators have received Authority to Operate (ATO) certification under the Department of Defense’s Risk Management Framework (eMASS #3984 and #3957), a certification that ensures that the ventilators meet stringent federal cybersecurity and compliance standards, protecting patient data and improving device security. Dräger emphasized its ongoing investment in cybersecurity, noting that this certification builds on the previous ATO approval of the Dräger V500 ventilator series in 2020. Hospitals using ATO-certified ventilators benefit from enhanced security, regulatory compliance, improved interoperability, and reduced cyberattack risks, the company notes.

Key Takeaways:

  1. Dräger’s ventilators have received ATO certification from the Department of Defense, confirming compliance with federal cybersecurity standards.
  2. The certification enhances patient data security, ensuring ventilators meet strict risk management and compliance requirements.
  3. Hospitals using ATO-certified ventilators gain benefits such as improved cybersecurity, streamlined system integration, and reduced cyberattack risks, according to Dräger.

Dräger 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 Risk Management Framework eMASS #3984. 

In addition, the Savina 300 series of mechanical ventilators received ATO certification under the Department of Defense’s Risk Management Framework eMASS #3957.

“At Dräger, our mission extends beyond clinical technology,” says Lothar Thielen, president and CEO of Draeger Inc, in a release. “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.”

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 March 3, 2026. 

Benefits of ATO-Certified Ventilators

Medical devices that have achieved an ATO under the Risk Management Framework offer 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.
  • Interoperability: Devices with ATO are often designed to integrate seamlessly with other systems within the healthcare network.
  • 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,” according to a press release from Dräger.

Photo caption: Evita V800

Photo credit: Dräger