Sarcouncil Journal of Engineering and Computer Sciences

Abstract: Mechanical testing is fundamental to establishing the safety and performance of infusion and drug-delivery medical devices (IDDs) within the United States regulatory framework. These systems, including infusion pumps, tubing assemblies, connectors, vascular access devices, and intravascular catheters, depend on mechanical integrity to maintain functional reliability under clinically relevant loading and environmental conditions. This review examines mechanical testing practices for IDDs in the United States through the perspectives of FDA regulatory expectations, FDA-recognized consensus standards, and representative experimental literature. Prevailing methodologies, including tensile and bond strength testing, fatigue and cycling loading assessment, burst pressure and leakage evaluation, environmental conditioning, and simulated-use protocols, are synthesized and critically analysed. The review identifies substantial methodological variability in test configurations, boundary conditions, environmental parameters, and definitions of mechanical failure. Inconsistent procedural reporting and limited disclosure of test implementation strategies emerge as recurrent limitations that constrain reproducibility and cross-study comparability. These challenges reflect the inherent flexibility of performance-based regulatory and standards frameworks rather than regulatory absence. Strengthening procedural transparency, clarifying failure criteria, and expanding system-level and interface-focused evaluation strategies represent practical opportunities to enhance the interpretability and translational relevance of mechanical testing evidence while preserving the innovation-enabling character of the U.S. device evaluation paradigm.