Spinal Implant Inspection Practices Established in New Standard

A new ASTM International standard will help manufacturers of surgical implants inspect their products for potential mechanical failure. 

“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 chief operating officer 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.” 

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