Dear Colleague,
In this issue of Trends, we provide several articles on the topic of medical device safety.
Our first article provides an overview of recent updates to the International Organization for Standardization (ISO) 10993-1 standard and their far-reaching implications. ISO 10993-1 is the international standard guiding the evaluation of medical device biocompatibility. The second article explores a screening approach to identify and mitigate potential health risks from medical device extractables. The third article discusses the importance of choosing an appropriate analytical method when assessing chemical “extractables” in medical devices. Our fourth article is co-written by Kelly Coleman of Medtronic and takes a closer look at how the newly released ISO 10993-1:2025 standard is redefining the assessment of “material-mediated pyrogenicity” (i.e., the ability to produce a febrile/fever response) in medical devices, including by significantly reducing animal testing.
Gradient contributors to this Trends issue include Daysi Diaz-Diestra, Ph.D., DABT; Lindsey Borton, M.P.H., DABT; Stephanie Kearing, M.S.; Katie Roach, Ph.D., M.P.H., DABT; and Brigitte Cronin.
We hope this issue of Trends gives you an insightful look at the current landscape of medical device testing.
Yours truly,
Chris Long, Sc.D., DABT, and Kurt Herman, M.Eng., P.G.
Chris.Long@gradientcorp.com Kurt.Herman@gradientcorp.com
The next issue of Trends will focus on:
Mining
Do you have a scientific topic that you would like Gradient to write about in Trends? Send us your ideas for future Trends topics: trends@gradientcorp.com.
