B. Braun Medical Inc. Calls for ECRI Institute to Establish a Scientific, Protocol-Driven Methodology for Evaluating Infusion Pumps
Company disputes institute’s rating for the 2nd generation Infusomat® Space Pump
BETHLEHEM, PA – May 10, 2016 – Citing the rigorous human factors testing B. Braun Medical Inc. used to help redesign its Infusomat® Space second-generation large volume pump, the company is challenging ECRI Institute’s lax protocol test methods for rating infusion pumps and strongly disagrees with the organization’s recent evaluation of the medical device company’s latest large volume pump.
“ECRI is a well-respected institution and we recognize the important role it plays in shaping the opinion of medical device purchasers,” said Rob Albert, Senior Vice President of Marketing at B. Braun Medical. “That’s why it’s troubling that the institute doesn’t have a scientific, protocol-driven methodology for evaluating infusion pumps.”
According to ECRI, a small review committee assesses the advantages and disadvantages of individual pump features and category ratings on a case-by-case basis with no specific testing protocol. Consultants then validate the ratings.
B. Braun’s second-generation Infusomat Space Pump recently received a “good” rating from ECRI in four out of five categories – Safety, Interoperability, Performance, Maintenance – and “fair” in the Workflow category. However the Institute assigned the pump only a “fair” overall rating.
“Not only were we disappointed by ECRI’s rating, but we also were confused by it,” said Mike Golebiowski, Vice President of Marketing, Automation and Infusion Systems at B. Braun Medical. “A major focus of the Space pump redesign centered on workflows and navigation to make it more intuitive for the user. We achieved this by designing for the needs of clinicians and validating that design with the rigor of human factors and usability testing.”
According to Golebiowski, the second-generation Infusomat Space Pump was one of the first infusion pumps to be cleared by the Food and Drug Administration by applying the new human factors and usability engineering process. To direct the pump’s redesign, B. Braun worked with Healthcare Human Factors, a global leader in developing best practices for human factors testing in healthcare. During design and validation, the device underwent more than 100 hours of usability testing with a total of 100 registered, practicing nurses and anesthesiologists participating in eight human factors tests – four formative evaluations and four summative usability tests.
“This demonstrates the rigor that is necessary to ensure use-safety and user experience of a product,” said Joseph Cafazzo, PhD PEng, Executive Director of Medical Engineering and Healthcare Human Factors, University Health Network, and Associate Professor, University of Toronto. “It’s difficult, if not impossible, to assess a product on these merits without a controlled usability test using actual intended clinical users.”
Healthcare Human Factors’ scientific methodology is in stark contrast to ECRI’s approach, Albert said. “ECRI does not have adequate experience or scientific research to support its evaluation of infusion pump workflow. Opinion is not science.”
“This may explain why ECRI’s track record for assessing infusion pumps is concerning,” he said, noting that over the past six years, two competitor pumps that received “acceptable” or “recommended” ratings from ECRI faced FDA-imposed import bans, recalls, discontinuation or destruction affecting a total of more than 200,000 individual devices.
Learn more about B. Braun’s second-generation Infusomat Space Pump. For information on human factors and usability testing, visit the Healthcare Human Factors website.
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. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is part of the B. Braun Group of Companies in the U.S., which is headquartered in Bethlehem, Pa., and includes B. Braun Interventional Systems, Aesculap® and CAPS®.
Globally, the B. Braun Group of Companies employs more than 56,000 employees in more than 60 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, visit www.BBraunUSA.com.