FDA's STeP Program Embraces Pneuma Systems' Next-Gen Infusion Pump Control

Pneuma Systems, a US-based fluid control company, has been accepted into the FDA's Safer Technologies Program (STeP) for Medical Devices, thanks to its PneumaFlow Controller system. This program aims to accelerate the approval of technologies and device combinations that are expected to enhance the safety of existing treatments or diagnostics for specific diseases or conditions. Pneuma's PneumaFlow Controller and Administration Sets have received an expedited review as part of this initiative.

Since its inception in 2021, the STeP program has welcomed only 35 devices, indicating the selective nature of its admissions. The FDA will collaborate closely with Pneuma Systems, which is addressing a critical safety concern for clinicians, as over 50 infusion system recalls have occurred in the past decade. The PneumaFlow Controller is engineered to streamline infusion systems and minimize the complexity associated with using infusion pumps. In related news, Smiths Medical has issued a correction for its CADD-Solis and CADD-Solis VIP infusion pumps due to software issues. Older models will receive an update to resolve operational failures associated with these devices.

Peggy McDaniel, Pneuma’s director of clinical support, said in a statement, “I have been in the trenches with infusion devices, fellow nurses, and patients for decades. Our team is ready to prove and quantify significant improvements in patient care, infusion safety, and nurse efficiency. We are grateful the FDA has given us the chance to verify this innovative approach.”