Standardization News

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.”

Estes says the new standard has broad appeal among different groups involved with surgical implants. Testing laboratories and manufacturers will find that the standard removes ambiguity that exists in current spinal device testing standards by specifying good practices for inspection and failure documentation that applies to all of these standards.

He adds that the standard could also remove uncertainties for regulatory bodies since it establishes minimum inspection and failure documentation practices for testing reports that would be included in regulatory submissions. Finally, consumers – orthopedic surgeons and neurosurgeons – will have the benefit of being able to compare products, knowing that implants were assessed for failure with the same degree of rigor.

ASTM International’s committee on medical and surgical materials and devices (F04) developed the standard, soon to be published as F3292. To purchase standards, contact customer relations (tel +1.877.909.ASTM; sales@astm.org).

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