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A new ASTM International standard will provide a test method for sacroiliac (SI) joint fusion devices. ASTM reported that the standard (F3574) was developed by the committee on medical and surgical materials and devices (F04).
Prior to this standard, SI joint fusion devices did not have standardized test methods. The lack of direction led to inconsistent testing methodologies used by spine companies, regulators and testing labs, said Nathan Wright, an ASTM International member.
“Sacroiliac joint fusion devices are fairly common in the orthopedic field for treating SI joint pain and instability,” Wright said. “The lack of standardized testing has resulted in significant inconsistency in regulatory testing, as well as unspecified expectations from regulators for mechanically evaluating SI joint fusion devices.”
Wright noted that the standard must meet reproducibility requirements to ensure its precision.
“We are seeking participating manufacturers and test labs to support these efforts through donating testing materials and/or test frame use to complete an interlaboratory study,” he said.
