B. Braun Receives FDA Clearance for SpaceStation MRI: Allows Space® Infusion Pumps to Continuously Deliver Medications Within the MRI Suite

BETHLEHEM, Pa., Aug. 27, 2020 /PRNewswire/ -- B. Braun Medical Inc. (B. Braun), a leader in infusion therapy and pain management, announced today that it 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:

• Each station holds up to 4 Space pumps, including the Infusomat^® Space^® Large Volume Pump, Perfusor^® Space^® Syringe Pump, and the Perfusor^® PCA Syringe Pump.
• Integrated TeslaSpy^® continuously monitors magnetic field strength to provide proper placement and positioning of the SpaceStation MRI.
• Pump status window allows for visibility of all infusion pumps with a centralized alarm display to continuously monitor the status on all infusions during imaging.
• Standard Space infusion lines can be used with the Infusomat Space Large Volume Infusion Pump and non-dedicated disposables are available for the Perfusor Space Syringe Infusion Pump.
• Full drug library software available with DoseGuardtm (Dose Error Reduction Software) Drug Library Development Software, powered by FDB Infusion Knowledgetm allowing online collaboration, access to FDB reference materials, and customizable drug hard and soft limits.

B. Braun offers a full-line of infusion pumps, drug library management, dose error reduction, and interoperability software. The company has a space efficient design which safely integrates with major EMR systems, asset tracking devices, alarm management technologies, and follows the IHE PCD standards in communication and integration. Their integration solution has been shown to improve IV pump utilization by 167%, resulting in $1M immediate capital savings through reduced inventory requirements¹.

B. Braun's DoseGuard Software is the only drug library development solution available that fully integrates FDB's Infusion Knowledge Portal². This provides robust evidence-based drug limits with frequent content updates, collaborative authoring tools, and companion audit trails that enable site administrator customization of drug library records for streamlined upload and incorporation into smart pump software.

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.  

About B. Braun 

B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pennsylvania and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap^® and CAPS^®.

Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise^® philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, explore our website.

¹Versustm Locating Advantages for Healthcaretm: Asset Management Case Study: McLauren Flint, 2017
² Director of Strategic Alliance, FBD Infusion Knowledgetm (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.

SOURCE B. Braun Medical Inc.