Smithers Rapra: Can you give us a bit of background about your role at the FDA?
Keaton Nahan: My research is performed at the molecular analysis and mass spectrometry (MAMS) facility located in the Division of Biology, Chemistry, and Materials Science (DBCMS), Office of Science and Engineering (OSEL), Center for Devices and Radiological Health (CDRH). One of the goals of CDRH is to ensure medical device safety. As an ORISE postdoctoral fellow at the FDA, I use analytical methods to develop guidelines for medical device extractables and leachables studies as well as investigate contemporary chemical characterization approaches. Commercial as well as in-house extractables databases and accurate mass spectrometers are utilized for chemical characterization to further extractables and leachables studies on medical devices as well as support regulatory science research at the FDA.
Smithers Rapra: What projects are you involved in related to Extractables and Leachables?
Keaton Nahan: Investigation of E&L studies and method development
The current primary standard for assessing the biological safety of medical devices is ISO 10993 and a significant amount of this standard is recognized by the FDA. While extraction parameters in ISO 10993-Part 12 are used to support biocompatibility testing, they may not be optimal for chemical characterization of medical device leachables. Chemical characterization is cost-effective, high throughput, and capable of identifying individual extractables for toxicological risk assessment (TRA). Further, the ISO 10993-Part 18 standard for chemical characterization is not overly prescriptive; therefore, there are opportunities to improve the quality of information and analyses. Our goal is to determine an effective analytical workflow that is accurate as well as time efficient to address the challenges of chemical characterization.
Collaborative 3D Printing
From building artistic sculpture to producing affordable, in-house prostheses, additive manufacturing, otherwise known as 3-D printing, is a field bustling with possibilities in the field of medical devices. Vendors offer raw materials for 3-D printing that are advertised as biocompatible for medical devices even though differences in vendor raw materials, in-house manufacturing, and post-processing may alter the extractables profile. Our lab has characterized medical devices produced by the University of Maryland as well as their respective raw materials by both GC-MS and accurate mass LC-MS.
Smithers Rapra: What are the key findings you will be presenting and what are the next steps for your studies?
Keaton Nahan: The goals of our studies are to simplify the decisions of medical device manufacturers with regard to chemical characterization. In order to improve review time of medical device submissions, especially breakthrough devices, it must be ensured that the chemical characterization is performed in a least burdensome manner, while providing sufficient qualitative or semi-quantitative data with the highest accuracy possible. To address these concerns, my work investigated solvent selection, extraction temperature, deuterated internal standards, semi-quantitative reference standard selection, and data analysis. Each of these intricacies have been found to substantially affect the resulting qualitative as well as semi-quantitative results. These effects were attributed to differences in RF, internal standard adsorbtion to medical devices materials, vial closure and deconvolution software parameters. Our work has demonstrated that extraction conditions, analytical methods, and data analysis substantially impact the findings. Future work aims to address these gaps with the goal to improve chemical characterization consensus standards.
Smithers Rapra: What are you most looking forward to about the conference?
Keaton Nahan: The E&L conference has a number of knowledgeable, expert speakers. I am looking forward to hearing the experiences, criticisms, and unparalleled science they will share. I am enthusiastic to engage the speakers and conference attendees to gain further understanding of the field from an industry perspective and incorporate it into my future work.
Disclaimer: The views and opinions presented here represent those of the speaker and should not be considered to represent advice or guidance on behalf of the U.S. Food and Drug Administration.