Braun Medical Inc. (B. Braun), a leader in infusion therapy and pain management, has received 510(k) clearance from the US Food and Drug Administration for the SpaceStation MRI to allow Space® infusion pumps to continuously deliver medications to patients within the MRI suite.
"This clearance allows us to expand our infusion therapy portfolio by providing seamless infusion management across multiple care settings," said Jonathan Stapley, Director of Marketing for Infusion Systems at B. Braun Medical. "Our Space Infusion System allows standardization of large volume and syringe pumps on the same workflow with one integration," Stapley continued.
The SpaceStation MRI is designed to shield Space infusion pumps against 1.5-T and 3.0-T magnetic fields to protect the MR scanner and provide interference-free images. Long infusion lines are no longer needed and hospital-wide Space infusion pumps are now able to safely transition patients into the imaging suite with the SpaceStation MRI.
"Clearance of the SpaceStation MRI represents a significant development for patients and healthcare providers," said Angela Karpf, MD, Corporate Vice President, Medical Affairs at B. Braun Medical. "It will allow patients to be safely transitioned into the MRI suite without the interruption of infusion therapy since there is no need to switch to an alternative pump. The versatility of the SpaceStation MRI accommodates adult, pediatric, and neonatal patients."
Key features of the SpaceStation MRI include:
In addition, B. Braun offers DoseTrac® Software that provides real-time data for consistent documentation and recognition of issues that may lead to an adverse event. DoseTrac Software and Analysis Service have helped clients achieve up to 100% DL compliance, up to 99% reduction in alerts and significant reduction in infusion related medication errors3.
1Versus™ Locating Advantages for Healthcare™: Asset Management Case Study: McLauren Flint, 2017
2 Director of Strategic Alliance, FBD Infusion Knowledge™ (personal communication, October 3, 2018)
3 Vitoux R, Chang H, Lehr J. Establishing benchmarks and identifying opportunities to reduce alert fatigue associated with smart infusion pumps. Poster presentation at the American Society of Health-System Pharmacists Midyear Clinical Meeting, December 2015.
B Braun Earns FDA Approval for SpaceStation MRI Infusion Technology. Appl Radiol.