Application of Accelerated Stress Testing to the Design of Pressure Injectable Central Venous Catheters

Rudy Drobnick

Central venous catheters (CVCs) are medical devices used to gain access to a patient’s vascular system for administration of various therapies including pressure injection of contrast media. Catheter lumens are designed to withstand more than one injection at their rated flow and may survive hundreds of injections before failure. Testing to estimate expected cycles to failure can be prohibitively expensive and time consuming. An accelerated stress method is presented that appears useful in decreasing the amount of testing required to predict cycles to failure. The failure mode under consideration is bursting of the catheter lumen and the stress used to accelerate failure is volume flow rate. Selection of stress levels, test methodology and data analysis results are presented. Accelerated stress testing is shown to reduce the number of required injections by up to 80% corresponding to a potential savings of $42,000 for a typical catheter development project.