Stir-bar sorptive extraction combined with online supercritical fluid extraction and chromatography - mass spectrometry: A new approach to analyze migrating plastic additives from medical devices.

Plastic materials are composed of polymers with small-molecule additives introduced in the composition during manufacturing to adapt the properties of the final product to its intended use. However, plastic additives may migrate into contact matrices. In the case of medical devices, the contact matrices may be biofluids or medical solutions to be infused to the patient. However, among plastic additives, some have recognized toxicity. Their possible migration is therefore a significant health concern. In this work, a method using Stir-Bar Sorptive Extraction (SBSE) was developed to extract and concentrate leachables from medical solutions. The stir-bar with adsorbed compounds was then placed in a supercritical fluid extraction system, to desorb the analytes with supercritical CO2 and transfer them to supercritical fluid chromatography hyphenated to mass spectrometry (SFE-SFC-MS). Different medical solutions and devices were examined as nutritive bags, saline solution bottle, pipette, pre-filled syringe and an infusion tubing. Using this method, different plastic additives leaching from the packaging were found in medical solutions, including lubricants (oleamide and erucamide), plasticizers (DIBP, DBP, DEHP and DINCH) and antioxidants (Irgafos 168 and its oxide). In addition, a closed circuit was set up to imitate the process of patient infusion, to extract and detect leachables from plastic tubing used in infusion devices. A rinsing and contamination checking method was developed using the same SFE-SFC-MS system to easily reuse the SBSE device from one experiment to another and to facilitate sample preparation steps. Finally, the greenness of the sample preparation technique was evaluated with CACI and AGREEprep green scores.