For you hard-core spinal device folks who couldn’t make the long trip to Vancouver, here are a few items of potential interest from the most recent ASTM standards committee meeting. Of the 50-plus attendees, several spine companies with a local presence were represented, including DePuy Spine, Facet Solutions and Orthofix Spinal Implants.
Most exciting to me is that we began planning for a follow-up symposium to our 2001 “Spinal Implants: Are We Evaluating Them Appropriately?” seminar. However, for the under-employed orthopedic engineers out there, you may be interested to know that Mark Melkerson (director, division of general, restorative and neurological devices for the Office of Device Evaluation within the Center for Devices and Radiological Health) mentioned that the FDA is currently hiring reviewers.
We also discussed starting work on two potential standards: Combinatory anterior/posterior non-fusion devices and quasi-static testing in an in vitro model. Work on the facet replacement standard has been completed and it will move forward to the main committee for final approval.
Finally, work is ongoing on multiple device standards, including those related to testing total disc replacements, posterior fusion devices, annular repair devices, fusion cages, posterior non-fusion devices and spinal terminology.
Several of our members were honored for their hard work on the standards process, including Elliott Sanders of Nitinol Devices & Components, Brad Estes of Duke University and David Rosler, formerly of Archus Orthopedics. Kudos to you guys and thanks again for all of your assistance.
Our next meeting will be held immediately prior to the North American Spine Society annual meeting Nov. 10-14 in San Francisco. Hope to see you there.
