Smiths Medical Gets FDA OK for New Infusion Pump

Smiths Medical has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its CADD-Solis pain management system version 3.0 with Programmed Intermittent Bolus (PIB) and Patient Controlled Analgesics (PCA) delivery.

The new customizable, infusion system is designed to help healthcare providers overcome challenges in maintaining effective epidural analgesia during labor and delivery or with post-operative pain management.

Epidural analgesia traditionally has been provided to patients using a pump that delivers manual bolus injections from a clinician, continuous infusions, or intermittent doses of medication controlled by the patient. All of these techniques can result in inconsistent and/or ineffective pain relief, as well as frequent clinician interventions.

“The new CADD®-Solis system with PIB and PCA combines programmed intermittent boluses and patient-controlled doses in an integrated, innovative delivery system,” said Tommy Johns, vice president of Global Product Management for Smiths Medical. “The PIB programming parameters and the delivery pressure provided by the CADD®-Solis system offer flexible drug delivery and reliable distribution of medication, which can help overcome some of the challenges associated with epidural analgesia.”

The CADD-Solis ambulatory infusion system is a management system that meets industry-recognized standards for advanced error-reduction features in PCA pumps. The platform is designed for nurses, anesthesiologists, pharmacists and other hospital personnel involved in pain management infusion therapy.

The system has a large color graphic display screen to help clinicians view and verify pump programs, identify and respond to alarms and interpret therapy trends and patient activity. The pump’s task-based software and therapy-based drug protocol library is familiar to users, enhancing usability and safety. The scalable platform is designed to satisfy hospital’s current and future clinical requirements and health information technology initiatives.

Smiths Medical develops medication delivery, vital care and safety devices market segments. It is part of Smiths Group that develops technology for threat and contraband detection, energy, medical devices, communications and engineered components. Smiths Group employs around 23,000 people in more than 50 countries.

Smiths Medical worldwide headquarters are located in St. Paul, Minn.