Infusion Platform Gets FDA Clearance

Smiths Medical has received 510(k) clearance from the US FDA for the CADD-Solis Ambulatory Infusion System, a clinically and technologically advanced next generation ambulatory infusion platform that enhances patient safety and personalized care for pain management patients.

Ambulatory infusion systems, like the CADD-Solis system, administer pain management medications, including narcotics, via a variety of delivery routes including intravenous and epidural. It is critical for these devices to have safeguards such as safety software and intuitive programming options to help clinicians care for their pain management patients.

"Improving patient safety and the quality of care is our first priority," says Jim Stitt, president of Smiths Medical MD. "By involving both clinicians and the Human Factors Engineering team at the University Health Network in Toronto in all phases of the development process, we worked to design a safe, easy-to-use system that brings exceptional value in helping hospitals reduce the risk of programming medication errors while providing better patient care management."

The CADD-Solis Ambulatory Infusion System includes:

• CADD-Solis ambulatory infusion pump;
• CADD-Solis medication safety software; and
• CADD medication cassette reservoirs and administration sets.

The CADD-Solis Ambulatory Infusion Pump is small and lightweight to promote patient mobility and clinician convenience. The versatile pump can be used for a variety of pain management therapies and patients. Its large color graphic display screen helps clinicians view and verify pump programs, identify and respond to alarms, and interpret delivery trends and patient activity. The pump's task-based software and cell-phone design is familiar to users, promoting ease of use and safety. The scalable, adaptable platform is designed to satisfy hospital's current and future clinical requirements and health information technology initiatives.

The CADD-Solis medication safety software is an innovative therapybased medication safety system designed to deploy the customer's current best practice pain management protocols, helping to reduce the risk of adverse drug events (ADEs) and promote clinician confidence. The safety software allows hospitals to create their own standardized pain management protocols, including, "hard" and "soft" programming limits to help prevent medication errors. The protocols are downloaded directly into each CADSolis pump so a clinician can easily select the specific pain management protocol for each patient's individual therapy needs. By allowing clinicians to select only the standard protocol information that is pre-determined by hospital administrators, the risk of programming and medication errors can be greatly reduced.

CADD medication cassette reservoirs are unique to CADD ambulatory infusion systems, providing a compact, durable, self-contained medication reservoir to promote patient mobility and drug security. CADD administration sets are also available for medication delivery from an IV bag.

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