Design and testing of the Baxter Integrated Disconnect Systems (IDS)

Area of Science:

• Nephrology
• Medical Devices
• Infection Control

Background:

• Continuous ambulatory peritoneal dialysis (CAPD) requires reliable systems to prevent complications like peritonitis.
• Existing CAPD disconnect systems often involve multiple components with varied sterilization methods, increasing contamination risks.
• Patient assembly of some CAPD systems can further compromise sterility.

Purpose of the Study:

• To describe the design and evaluation of the Baxter Integrated Disconnect System (IDS).
• To assess the safety, effectiveness, and contamination rates of the novel IDS.
• To determine the peritonitis-free probability associated with using the IDS.

Main Methods:

• A multidisciplinary approach was used to design and evaluate the IDS.
• The IDS features preassembled, disposable components, including fresh dialysate and drainage bags, connected in a Y-fashion.
• The entire IDS unit is steam-sterilized as one piece, unlike conventional systems.

Main Results:

• The IDS simplifies the connection process for patients, requiring only one connection.
• Clinical testing over 765 patient-months demonstrated the system to be simple, safe, and effective.
• The system yielded a 63% probability of peritonitis-free patients at 24 months.

Conclusions:

• The Baxter Integrated Disconnect System (IDS) offers a unique, preassembled, and fully sterilized solution for CAPD.
• The IDS design inherently warrants lower rates of contamination compared to traditional systems.
• The IDS is a safe and effective tool for improving patient outcomes in CAPD, significantly reducing peritonitis risk.