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ASTM International Establishes New Standard for Spinal Implant Inspection Practices

A new ASTM International standard will help manufacturers of surgical implants inspect their products for potential mechanical failure. Soon to be published as F3292, the standard was developed by ASTM's F04 committee on medical and surgical materials and devices.

“The objective of this standard was to prescribe uniform inspection practices that would apply to all existing spinal device testing standards so that end users can reliably inspect parts for mechanical failure,” says ASTM International member Brad Estes, Ph.D., President and COO at Cytex Therapeutics. “Prior to the creation of this standard, inspection practices had to be determined by the end user/lab, and by standardizing the inspection process, we leveled the playing field, so all users of the standard will inspect the spinal implants in the same way before and after testing. Not only does the standard detail good inspection practices for the user, it will also help reduce interlaboratory variation and bias.”

While the standard benefits testing labs and manufacturers, it may also remove uncertainties for regulatory bodies by establishing minimum inspection and failure documentation practices for testing reports that would be included in regulatory submissions.

Orthopedic and neurosurgeons will also be able to compare products, knowing that implants were assessed for failure with the same degree of rigor.

Source: ASTM International