Cytotoxic Evaluation of Ultra High Molecular Weight Polyethylene for Medical Device Applications

Objectives: This study evaluates the cytotoxicity of ultra-high molecular weight polyethylene (UHMWPE) using the Neutral Red Uptake (NRU) assay and examines whether any leachable substances affect cell health. The findings add to the evidence that UHMWPE is safe for long-term use in medical implants. Method: The Elution Method was used to evaluate the cytotoxic effects of UHMWPE extract by ISO 10993-5:2009 in Balb/c 3T3 using Neutral Red Uptake method. Findings: The extract of UHMWPE did not induce any cytotoxicity effects using the qualitative and quantitative methods. In the qualitative method the cultures treated at different concentrations (30% to 100%) appeared normal without any change in their morphology (grade 0). In the quantitative method, the viability was greater than 90 %, indicating no cytotoxicity. Novelty: This study evaluated the cytotoxicity of unmodified UHMWPE using ISO 10993-5/-12 compliant protocols under GLP conditions. By generating concentration-dependent viability data, it offers strong evidence for the baseline biocompatibility of UHMWPE, supporting its continued use in implantable medical devices. Keywords: Ultrahigh molecular weight polyethylene, Polymer, Cytotoxicity, Elution Method, Neutral Red Uptake