What standards can (and can't) tell us about a spinal device
Standards are important tools in evaluating and predicting the performance of medical
devices prior to implantation. There are three types of standards that are available: a …
devices prior to implantation. There are three types of standards that are available: a …
[BOOK][B] Spinal implants: are we evaluating them appropriately?
MN Melkerson, SL Griffith, JS Kirkpatrick - 2003 - books.google.com
A November 2001 symposium sought to assess the knowledge base for the testing of spinal
implants, improve published standards, encourage new standards activities, and determine …
implants, improve published standards, encourage new standards activities, and determine …
Clinical research: is the spine field a mine field?
Spinal surgery for infection, tumor, and major traumatic disruption may avert catastrophic
outcomes such as paralysis, major deformity, or death. Recent research on decompression …
outcomes such as paralysis, major deformity, or death. Recent research on decompression …
Test protocols for evaluation of spinal implants
VK Goel, MM Panjabi, AG Patwardhan, AP Dooris… - JBJS, 2006 - journals.lww.com
Prior to implantation, medical devices are subjected to rigorous testing to ensure safety and
efficacy. A full battery of testing protocols for implantable spinal devices may include many …
efficacy. A full battery of testing protocols for implantable spinal devices may include many …
Testing criteria for spinal implants: recommendations for the standardization of in vitro stability testing of spinal implants
HJ Wilke, K Wenger, L Claes - European spine journal, 1998 - Springer
New implants and new surgical approaches should be tested in vitro for primary stability in
standardized laboratory tests in order to decide the most appropriate approach before being …
standardized laboratory tests in order to decide the most appropriate approach before being …
[BOOK][B] Spine technology handbook
SM Kurtz, A Edidin - 2006 - books.google.com
Over the past decade, there has been rapid growth in bioengineering applications in the
field of spine implants. Spine Technology Handbook explains the technical foundation for …
field of spine implants. Spine Technology Handbook explains the technical foundation for …
[HTML][HTML] Market approval processes for new types of spinal devices: challenges and recommendations for improvement
A Bisschop, MW van Tulder - European Spine Journal, 2016 - Springer
Background Spinal pathology and related symptoms are among the most common health
problems and are associated with high health care costs and productivity losses. Due to the …
problems and are associated with high health care costs and productivity losses. Due to the …
Scientific evaluation of spinal implants: an ethical necessity
WA Moojen, AL Bredenoord, RF Viergever, WC Peul - Spine, 2014 - journals.lww.com
The clinical introduction of novel medical devices often occurs without evidence of good
methodological quality and with relatively little oversight and regulation. As a consequence …
methodological quality and with relatively little oversight and regulation. As a consequence …
Healthcare technology and technology assessment
JH Herndon, R Hwang, KH Bozic - European Spine Journal, 2007 - Springer
New technology is one of the primary drivers for increased healthcare costs in the United
States. Both physician and industry play important roles in the development, adoption …
States. Both physician and industry play important roles in the development, adoption …
New products and standards
SA BROWN, JE LEMONS, NB MATEO - Biomaterials science, 1996 - Elsevier
Publisher Summary Surgical implant standards within the United States are based on
consensus organizations with the American Society for Testing and Materials CommitteeF-4 …
consensus organizations with the American Society for Testing and Materials CommitteeF-4 …