Speaker: Berk Oktem, Food and Drug Administration

Topic: Role of Mass Spectrometry in Chemical Analysis of Medical Device Extractables

Date: December 16, 2024

Time: 6:15 pm Dinner, 7:15 pm Presentation

Location: Shimadzu Scientific Instrument, Inc. Training Center 7100 Riverwood Drive, Columbia, MD 21046 (Directions)

Dinner: Please RSVP to Dingyin Tao (owendtao@gmail.com) by Friday, December 13 if you will be attending the dinner.

Abstract: Chemical analysis of medical device extracts has two main purposes: identification of unknown medical device constituents and quantification of known or unknown extractables. Mass spectrometry is an essential part of chemical analysis of medical device extractables. Identification of the extractables is an ongoing challenge with limited options. Quantification is also an important task in this field as the toxicologists, who need this chemical analysis data, make important decisions based on the both the identity and the reported quantities of the extractables. This presentation will attempt to offer a summary of the current status, ongoing research and challenges related to mass spectrometry in this field, and also lists future directions