Dynamic Headspace GC–MS Method to Detect Volatile Extractables from Medical Device Materials

This study addresses the critical issue of detecting volatile extractables released during the clinical use of medical devices which can pose a serious threat to patient health. ISO 10993-18:2020 introduces the concept of the Analytical Evaluation Threshold (AET) to determine the necessary analytical sensitivity for detecting these extractables. Compounds at or above the AET must be reported for toxicological risk assessment. Currently, Static Headspace (SHS) analysis serves as a supplementary technique for volatile analysis, but its variable signal responses and limited sensitivity have hindered the establishment of a defined AET. In response to this challenge, this study explores the potential of Dynamic Headspace (DHS) gas chromatography-mass spectrometry (GC–MS) analysis to achieve the required sensitivity levels for robust toxicological risk assessment of volatile compounds from medical devices. The development of the DHS method involves optimizing several parameters, including incubation temperature, trapping volume/time, adsorbent type, and drying time. The study rigorously evaluates DHS extraction performance and compares it to traditional SHS and Stir Bar Sorptive Extraction (SBSE) GC–MS methods. By applying these newly developed methods to saline extracts from various medical devices and materials, the study demonstrates that DHS achieves over a tenfold increase in sensitivity compared to conventional volatile organic compound (VOC) analysis methods. This enhanced sensitivity enables the quantification of a significantly greater number of VOCs, thereby improving safety assessments for volatiles present in medical devices. With optimized conditions and robust data, DHS methods emerge as a valuable tool for VOC analysis to support comprehensive toxicological risk assessments in the context of medical device safety evaluation.