B. Braun's Space® Infusion Pump Systems Earn UL 2900-2-1 Certification

Friday, December 02, 2022

B. Braun Medical Inc. (B. Braun), a leader in infusion therapy and pain management, today announced that the wireless devices of the Space Infusion Pump System* earned certification to UL 2900-2-1** through UL Cybersecurity Assurance Program (UL CAP). The UL 2900-2-1 standard is published as a U.S. national consensus standard by the American National Standards Institute (ANSI) and a recognized consensus standard by the U.S. Food and Drug Administration (FDA) supporting their pre- and post-market cybersecurity guidance.

Based on the UL 2900 series of Standards created with input from cybersecurity experts in government, academia and industry, UL Solutions rigorously tests and evaluates connected devices and software. Specifically, the CAP program tests products and evaluates software development activities and the internal operational processes that enable organizations to address cybersecurity challenges and mitigate security risks.

The technical experts at UL Solutions explored all facets of the UL 2900-2-1 Standard requirements in their evaluation of the Space Infusion Pump Systems for CAP certification. This included establishing the strength of encryption used, analyzing the source code in each of the devices and applications and conducting penetration and fuzz testing to identify any vulnerabilities.

"The value of integrated systems must never be taken at face value without also remembering that cyberattacks are a serious threat in any clinical setting," said Jonathan Stapley, Senior Director Marketing - Active Devices at B. Braun. "The importance of taking proactive steps to minimize risk cannot be overstated. We sought third-party experts at UL Solutions to evaluate our Wireless Space Infusion Pumps and the processes that support them to confirm that B. Braun's stringent and demanding requirements for security and performance were met. Every component is crucial in any infusion system."

As part of the evaluation, UL Solutions' technical experts reviewed all of B. Braun's software development processes according to the requirements of UL 2900-2-1 to assess whether they reflect cybersecurity best practices and a security-minded approach. Notably, UL Solutions also evaluated B. Braun's internal processes and its ability to quickly inform customers of any cybersecurity issues, mitigate them and provide software updates.

"Medical device product security impacts patient safety. At B. Braun, the U.S. Product Cybersecurity Team is ready to provide reactive support because new security vulnerabilities are reported daily," said Robert Smigielski, Senior Cybersecurity Architect at B. Braun. "We hold to the belief that an unavailable medical device is useless to patient care. We embrace our design which provides a path for innovation and security in a replaceable wireless communication component while keeping the infusion system consistent and stable for your long-term investment."

In addition to receiving certification to the UL 2900-2-1 Standard, Perfusor® Syringe Pump, within B. Braun's Space Infusion Pump Systems platform, is the first in the industry with medical ground and/or air transport in the FDA cleared indications for use. B. Braun also received a 2021 Best in KLAS Award for Infusomat® Space® Large Volume Pump based on numerous features including the ability to integrate with EMR system, real-time location systems and alarm management technologies.

"The ability to seamlessly and wirelessly integrate our Space Infusion Pump Systems with our advanced infusion software and the myriad of systems used in hospitals today is designed to enable caregivers to administer crucial therapies faster and more effectively than ever before," said Stapley.