B. Braun Medical today challenged infusion pump ratings out of the ECRI Institute after its Infusomat Space 2nd-generation large volume pump was given a 2-out-of-5 star rating.
The Bethlehem, Penn.-based company said that the ECRI Institute has “lax protocol test methods for rating infusion pumps” and strongly disagreed with the evaluation of the Infusomat.
The institute gave the Infusomat Space 2nd-gen large volume pump “good” ratings in 4 out of 5 categories, including safety, interoperability, performance and maintenance, but received a “fair” rating in the workflow category. Overall, the device was given a 2-star “fair” rating.
“ECRI is a well-respected institution and we recognize the important role it plays in shaping the opinion of medical device purchasers. That’s why it’s troubling that the institute doesn’t have a scientific, protocol-driven methodology for evaluating infusion pumps,” B. Braun marketing senior veep Rob Albert said in a prepared statement.
B. Braun said that the ECRI institute used a small review committee to asses the devices, after which consultants validated the ratings.
The company called for a redesign of ECRI Institute’s evaluation methods, saying the company need to establish a “scientific, protocol-driven methodology for evaluation infusion pumps.”
“Not only were we disappointed by ECRI’s rating, but we also were confused by it. 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,” B. Braun automation and infusion systems veep of marketing Mike Golebiowski said in a press release.
The company claims the device underwent more than 100 hours of usability testing with 100 registered nurses and anesthesiologists participating in 8 human factor tests, and said it was the 1st infusion pump cleared by the FDA through the new human factors and usability engineering process.
“This demonstrates the rigor that is necessary to ensure use-safety and user experience of a product. It’s difficult, if not impossible, to assess a product on these merits without a controlled usability test using actual intended clinical users,” Joseph Cafazzo of the University Health Network said in a prepared release.