Volatile extractables in medical devices are a particular concern because they are most likely to migrate out of implanted materials, associated with more toxic effects, and present an analytical challenge to current chemical characterization screening. Potential volatile extractables include monomers, processing aids, material impurities & byproducts, and residual solvents which may be introduced from starting materials and device manufacturing. Considering that these extractables can be present initially in high quantities, the level of exposure may present a toxicological concern if released into the patient.<br/>Current practice for volatile extractable characterization by gas chromatography/mass spectrometry (GC/MS) is technically challenging and non-uniform due to extraction conditions, sample vessel leaks, and limitations in standard GC/MS methods. While GC/MS use is widespread, lack of qualified methods for volatile analysis of medical device extractables is thought to reduce reliability of the data. There is currently no qualified volatiles method for medical devices, but standards that utilize headspace as sample introduction for GC have been developed by other fields including pharmaceuticals (ICH Q3C and USP &lt;467&gt;).<br/>A simplified, headspace method for analyzing medical devices was developed that required less sample preparation. Targeted and non-targeted analysis were used to chemical characterize volatile extractables in medical devices such as gas pathway devices. Further, a comparison was performed to determine the volatile extractables that are missing from standard chemical characterization methods to quantify the degree of uncharacterized volatiles. Preliminary work identified volatile extractables that were not determined by general screening separation by introducing a short period thermal extraction of medical device materials by headspace and conducting a chromatographic separation using a residual solvent column. This study aimed to characterize volatile extractables, improve certainty of results, leading to decrease patient risk in clinical trials, and reduce the costs for industry to produce safe and effective medical devices.

Investigating simplified approaches to characterize volatile extractables from polymeric medical devices

Macromolecular Chemistry: The Second Century

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ACS Spring 2020 National Meeting & Expo

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.