Catalog of Regulatory Science Tools to Help Assess New Medical Devices
This regulatory science tool presents a lab method that helps determine the extractables profile of additive-manufactured orthopedic casts produced by fused filament fabrication method. Please see appendix.
Technical Description
This tool describes the details on screening for extractables in additive-manufactured (AM) acrylonitrile butadiene styrene (ABS) pre- and post- processed materials and orthopedic cast as described in the peer-reviewed publication [1]. Filaments used included the United States Pharmacopeia (USP) Class VI ABS filaments, as well as consumer grade ABS filaments. Forearm casts (used as medical devices) were manufactured from USP Class VI (USPF) and consumer grade filaments (CGF) using fused filament fabrication (FFF) method. This tool provides a methodology for sample extraction and extract analyses by gas chromatography/mass spectrometry (GC/MS) and liquid chromatography/ mass spectrometry (LC/MS) techniques. Details of data processing including identification and semi-quantification information for the compounds identified in the extracts are also included to facilitate the ease of tool application.
Intended Purpose
This tool provides a method to determine the extractables profile of AM orthopedic casts produced by fused filament fabrication method.
Testing
Appendices A [2] and B [3] provide stepwise guidelines on how to execute the screening for extractables in medical device materials. The method has been tested with USP Class VI ABS filaments and consumer grade ABS filaments as well as orthopedic casts manufactured using the same filaments by fused fabrication method [1]. The method has been tested with USP Class VI ABS filaments and consumer grade ABS filaments as well as orthopedic casts manufactured using the same filaments by fused fabrication method. Sample preparation and analysis methods described in this tool have been adapted internally to conduct multiple research projects related to chemical characterization including an ISO 10993-12 round robin studyExternal Link Disclaimer.
Limitations
- Only tested with AM ABS materials generated by fused fabrication method. Different manufacturing and processing parameters along with other device materials would require optimization and validation.
- Tool does not include methodologies to screen for elemental impurities.
- Lack of available spectral database for extractables and leachables in medical device materials hinders the comprehensive identifications of the compounds extracted.
Supporting Documentation
- The paper linked here describes the process of screening of extractables in medical devices using additive manufactured devices in alignment with ISO 10993-18 (2020) recommendations. https://doi.org/10.1016/j.talanta.2019.120464External Link Disclaimer
- Appendix A: Protocol for sample extraction
- Appendix B: Protocol for Chemical Analysis
Contact
Tool Reference
- In addition to citing relevant publications please reference the use of this tool using RST24OP03.01