FDA Center for Devices and Radiological Health Presents- Virtual Public Workshop Extended Reality in Orthopedic Surgical Devices
The Food and Drug Administration (FDA) is announcing a virtual public workshop entitled “Extended Reality in Orthopedic Surgical Devices: Insights into User Experience and Adverse Event Reporting for Patient Safety.” The workshop will provide a public forum for engaging with orthopedic community, device manufacturers, regulatory affairs professionals, clinicians, patients and the general public. It will focus on stakeholders’ experiences associated with advanced surgical systems in orthopedic surgery that incorporate extended reality (XR) technologies, including stereotaxic navigation and robotic-assisted surgical systems. The workshop is intended to enhance the FDA’s understanding of user experience and initiates an exchange of ideas that may facilitate the development of innovative methods for assessing and monitoring device performance. The presentations will review current education, training, and adverse event reporting to promote patient safety.
To RegisterVirtual Public Workshop – Extended Reality in Orthopedic Surgical Devices: Insights into User Experience and Adverse Event Reporting for Patient Safety - November 2, 2023 - 11/02/2023 | FDA
In recent years, XR technology which includes Augmented Reality (AR), Virtual Reality (VR), and Mixed Reality (MR) has led to the development of new paradigms for diagnosis, preoperative planning, and surgical treatment for orthopedic extremities and spinal disorders. Compared to traditional stereotaxic systems these advancements are intended to improve ergonomics, precision, accuracy, patient outcomes and decrease surgical time.
Since 2019, when the first orthopedic surgical system with integrated XR technology received FDA clearance, there has been only limited information available on user experience. While there have been adverse events reported to FDA, there has been limited information available on training, education, and adverse event reporting by users of these systems. Reported adverse events include surgical delays, conversions to non-navigated (manual) techniques, and direct patient harms due to a myriad of factors such as inaccurate bone resection or implant misplacement. Transparency with regards to best practices employed by end users to assure the precision and accuracy of XR technologies is vital for ensuring safe and effective use of these systems.
For more information on adverse event reporting, please refer to the FDA website on Medical Device Reporting (MDR): How to Report Medical Device Problems at https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems
The Center for Devices and Radiological Health (CDRH) has initiated several efforts to facilitate the understanding of XR technologies. See Digital Health Center of Excellence, “Augmented Reality and Virtual Reality in Medical Devices” website at https://www.fda.gov/medical-devices/digital-health-center-excellence/augmented-reality-and-virtual-reality-medical-devices.
The information gathered through stakeholder engagement at this public workshop may also provide insight into potential best practices related to using XR technologies in orthopedic surgery and foster a collaborative approach to patient safety. The workshop is not intended to address non-orthopedic surgical devices.
This virtual meeting will be held on November 2, 2023, from 9:00 a.m. to 1:00 p.m. ET by webcast only.
The virtual public workshop will be a live webcast and the link will be provided in your confirmation email once you have registered. The link for the archived webcast will be posted to this webpage for viewing after the public workshop.