Session: Advances in Mass Spectrometry:

Volatile extractables in medical devices are a potential concern because they are likely to diffuse from materials during use and possibly expose patients to toxic compounds. Such volatiles of potential toxicological concern include monomers, additives, processing aids, material impurities, byproducts and residual solvents. Identification and quantification of these compounds is a challenge due to an absence of qualified standard methods for the analysis of volatiles released from medical devices. One such potential methodology that is expected to improve the reliability of medical device volatiles analysis is headspace gas chromatography mass spectrometry (HS-GC/MS). International standards and regulatory bodies have developed HS-GC/MS methods for applications that include pharmaceuticals (ICH Q3C and USP<467>) and environmental (EPA method 5021A) analysis. However, current practice for HS-GC/MS of medical devices yields inconsistent results due to the lack of standardized/qualified methodology for thermal extraction conditions, sample handling and GC-MS analysis. Therefore, in this study, a modified headspace GC/MS analysis method with solvent-less extraction of medical devices was developed for the identification and quantification of volatile extractables. Instrument parameters and sample extraction conditions (equilibration time and temperature) were investigated on a variety of representative solid samples of medical device materials, such as ABS polymer, BUNA rubber -positive control, and HDPE -negative control. Furthermore, the resulting identifications of volatile extractables were compared with the typical chemical characterization method (solvent extraction) to evaluate the efficiency of the solvent-less HS-GC/MS analysis method. Preliminary data indicates that the solvent-less thermal extraction method yields a higher number of identifications for volatile extractables of ABS polymer, while comparable identifications were resulted for the other polymer materials. Quantification of the identified compounds are in progress. Overall, this study is aimed to characterize volatile extractables using simplified approaches and improve certainty of results that would otherwise be lost to analyses if current methods were used.

Milani Patabandige

US Food and Drug Administration

Appearances