Dräger Evita V800/V600, Babylog VN800 and Savina 300 obtain Authority to Operate (ATO) under Risk Management Framework
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 (RMF) eMASS #3984. Additionally, the Savina 300 series received ATO certification under eMASS #3957. Both certifications are effective from January 23, 2025, and expire on January 21, 2028.
This certification follows Dräger's previous achievement with the V500 series ventilators in 2020. The ATO certification represents the highest level of security for medical devices, offering benefits such as enhanced data protection, compliance assurance, and faster integration with hospital systems. These certifications demonstrate Dräger's commitment to cybersecurity and patient data protection.
Dräger ha annunciato che la sua famiglia di ventilatori meccanici Evita V800/V600 e Babylog VN800 ha ricevuto la certificazione di Autorità Operativa (ATO) nell'ambito del Risk Management Framework (RMF) del Dipartimento della Difesa, con eMASS #3984. Inoltre, la serie Savina 300 ha ottenuto la certificazione ATO con eMASS #3957. Entrambe le certificazioni sono valide dal 23 gennaio 2025 e scadranno il 21 gennaio 2028.
Questa certificazione segue il successo precedente di Dräger con i ventilatori della serie V500 nel 2020. La certificazione ATO rappresenta il più alto livello di sicurezza per i dispositivi medici, offrendo vantaggi come una maggiore protezione dei dati, garanzia di conformità e una più rapida integrazione con i sistemi ospedalieri. Queste certificazioni dimostrano l'impegno di Dräger per la cybersecurity e la protezione dei dati dei pazienti.
Dräger anunció que su familia de ventiladores mecánicos Evita V800/V600 y Babylog VN800 ha recibido la certificación de Autoridad para Operar (ATO) bajo el marco de gestión de riesgos (RMF) del Departamento de Defensa, con eMASS #3984. Además, la serie Savina 300 recibió la certificación ATO con eMASS #3957. Ambas certificaciones son efectivas desde el 23 de enero de 2025 y expiran el 21 de enero de 2028.
Esta certificación sigue al logro anterior de Dräger con los ventiladores de la serie V500 en 2020. La certificación ATO representa el más alto nivel de seguridad para dispositivos médicos, ofreciendo beneficios como una mejor protección de datos, garantía de cumplimiento e integración más rápida con los sistemas hospitalarios. Estas certificaciones demuestran el compromiso de Dräger con la ciberseguridad y la protección de datos de los pacientes.
Dräger는 Evita V800/V600 및 Babylog VN800 기계 환기 장치가 국방부의 위험 관리 프레임워크(RMF) eMASS #3984에 따라 운영 권한(ATO) 인증을 받았다고 발표했습니다. 또한, Savina 300 시리즈는 eMASS #3957에 따라 ATO 인증을 받았습니다. 두 인증서는 2025년 1월 23일부터 유효하며 2028년 1월 21일에 만료됩니다.
이번 인증은 Dräger가 2020년에 V500 시리즈 환기 장치로 달성한 이전 성공에 이어진 것입니다. ATO 인증은 의료 기기에서 가장 높은 수준의 보안을 나타내며, 데이터 보호 강화, 준수 보장 및 병원 시스템과의 빠른 통합 등의 이점을 제공합니다. 이러한 인증은 Dräger의 사이버 보안 및 환자 데이터 보호에 대한 약속을 보여줍니다.
Dräger a annoncé que sa famille de ventilateurs mécaniques Evita V800/V600 et Babylog VN800 a reçu la certification d'Autorité d'Exploitation (ATO) selon le Cadre de Gestion des Risques (RMF) du Département de la Défense, sous eMASS #3984. De plus, la série Savina 300 a reçu la certification ATO sous eMASS #3957. Ces deux certifications sont valables à partir du 23 janvier 2025 et expirent le 21 janvier 2028.
Cette certification fait suite à la réalisation antérieure de Dräger avec les ventilateurs de la série V500 en 2020. La certification ATO représente le plus haut niveau de sécurité pour les dispositifs médicaux, offrant des avantages tels qu'une meilleure protection des données, une garantie de conformité et une intégration plus rapide avec les systèmes hospitaliers. Ces certifications démontrent l'engagement de Dräger envers la cybersécurité et la protection des données des patients.
Dräger kündigte an, dass seine Familie von modernen Beatmungsgeräten, Evita V800/V600 und Babylog VN800, die Genehmigung zur Nutzung (ATO) gemäß dem Risikomanagementrahmen (RMF) des Verteidigungsministeriums unter eMASS #3984 erhalten hat. Darüber hinaus erhielt die Savina 300 Serie die ATO-Zertifizierung unter eMASS #3957. Beide Zertifizierungen sind ab dem 23. Januar 2025 gültig und laufen am 21. Januar 2028 ab.
Diese Zertifizierung folgt auf Drägers vorherigen Erfolg mit den Beatmungsgeräten der V500-Serie im Jahr 2020. Die ATO-Zertifizierung stellt die höchste Sicherheitsstufe für medizinische Geräte dar und bietet Vorteile wie verbesserten Datenschutz, Gewährleistung der Compliance und schnellere Integration in Krankenhaus-Systeme. Diese Zertifizierungen demonstrieren Drägers Engagement für Cybersicherheit und den Schutz von Patientendaten.
- Obtained highest level security certification (ATO) for multiple ventilator product lines
- Certifications valid for 3 years (2025-2028)
- Enhanced product integration capabilities with hospital systems
- Improved market positioning for government and military contracts
- None.
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
"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,
Contact
Communications: Melanie Kamann, Tel. +49 451 882-3202, melanie.kamann@draeger.com
Press Contact North America: Laura Edwards, Tel. +1 215 565-5868, laura.edwards@draeger.com
Investor Relations: Thomas Fischler, Tel. +49 451 882-2685, thomas.fischler@draeger.com
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SOURCE Draeger
FAQ
When do the new ATO certifications for Dräger's Evita V800/V600 and Babylog VN800 ventilators expire?
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