The authors of the editorial are members of a workgroup established by the American Orthotic and Prosthetic Association “to meet the emerging regulatory requirements and support innovators.” They wrote that the US Food and Drug Administration is “considering closer alignment for prosthetic devices and other similar medical devices, as well as with the European Medical Device Regulation.” The goal of the workgroup is to provide evidence-based best practices, develop consensus for methods for prosthetic socket structural analysis, and identify knowledge gaps.
Its members will publish “Mechanical testing of transtibial prosthetic sockets: A discussion paper from the American Orthotic & Prosthetic Association Socket Guidance Workgroup” to address the knowledge gaps it discovered with the intent of developing standards in consensus clinicians, clinical researchers, academia, and financial stakeholders.
To read the editorial, “Toward standardized methods for prosthetic socket mechanical testing,” visit Prosthetics and Orthotics International.
