- November 2, 2023
- 9:00 AM - 1:00 PM ET
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.
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.
November 2nd webcast: https://fda.yorkcast.com/webcast/Play/762512358f8f4fd8856ec15ece9542341d
|Time||Subject||Name of Speaker|
|9:00 a.m. – 9:15 a.m.||Welcome and Opening Remarks||CAPT Raquel Peat, PhD, MPH, Director,
OHT6: Office of Orthopedic Devices, Office
of Product Evaluation and Quality (OPEQ), CDRH, FDA
|Master of Ceremony - Christopher Harner, MD, Deputy Director, OHT6: Office of Orthopedic Devices, OPEQ, CDRH|
|9:15 a.m. - 9:25 a.m.||Overview of Extended Reality Technology in Orthopedics||CDR Michel Janda, MS, Lead Reviewer, OHT6, OPEQ, CDRH, FDA|
|9:25 a.m. - 9:35 a.m.||FDA Perspectives on Training and Education||Bart Sachs, MD, MBA, FACHE, Medical Officer, OHT6: OPEQ, CDRH, FDA|
|9:35 a.m. - 9:45 a.m.||Industry Perspective on Training and Education||Kimberly Walker
Sr. Director Robotics Education, Stryker
|9:45 a.m. - 9:55 a.m.||Perspectives on Clinician Training and Education - Spine Procedures||Ronald A. Lehman Jr., MD
Professor of Orthopedics-Columbia Univ
|9:55 a.m. - 10:05 a.m.||Perspectives on Clinician Training and Education - Knee and Hip Replacement||Brett Levine, MD, MS, FAOA Professor of Orthopedic Surgery
Rush University Medical Center
|10:05 a.m. - 10:15 a.m.||Perspectives on Clinician- Shoulder Procedures||Danny P. Goel, MD, MBA, MSc, FRCSC
CEO & Clinical Professor of Orthopedics-PrecisionOS
|10:15 a.m. - 10:25 a.m.||Perspectives on Clinician - Training and Education on Trauma Procedures||Greg M. Osgood, MD, FACS, FAOA, FAAOS
Associate Professor, Johns Hopkins Department of Orthopaedic Surgery
|10:25 a.m. - 10:45 a.m.||FDA’s Infographics for Augmented Reality and Virtual Reality Devices; Critical Questions to Consider for Patients and Healthcare Professionals||
Leeda Rashid, MD, MPH, ABFM
Aubrey Shick MS, Sr. Digital Health Advisor, Digital Health Center of Excellence, Office of Strategic Partnerships and Technology Innovation, FDA
|10:45 a.m. - 11:00 a.m.||Clinical Discussion on Education and Training||Moderators: David Scott, MD, Medical Officer & Christopher Harner, MD, Clinical Deputy Director, OHT6: Office of Orthopedic Devices, OPEQ, CDRH, FDA|
|11:00 a.m. - 11:10 a.m.||BREAK|
|11:10 a.m. - 11:20 a.m.||Overview of Extended Reality Technologies||Mark Zhang, DO, MMsc
President, American Medical Extended Reality Association
|11:20 a.m. - 11:30 a.m.||Office of Science and Engineering Laboratories (OSEL) and Training Discussion||Ryan Beams, PhD, Physicist, Division of Imaging Diagnostics and Software Reliability, OSEL, CDRH, FDA|
|11:30 a.m. - 11:40 a.m.||Mixed Reality Operating Room||Beth Ann Ripley, MD, PhD
Deputy Chief, Healthcare Innovation & Learning, VHA
|11:40 a.m. - 11:50 a.m.||Standard Testing Facility||Zane Arp, PhD,
Director Division of Biomedical Physics, OSEL, CDRH, FDA
|11:50 a.m. - 12:10 p.m.||Technical Discussion||Moderators: David Scott, MD, Medical Officer, OHT6, OPEQ, and Ryan Beams, PhD, Physicist, OSEL, CDRH, FDA|
|12:10 p.m. - 12:20 p.m.||FDA Expectations for Mandatory and Voluntary Reporters||Shumaya Ali, MPH, Assistant Director, OHT6, OPEQ, CDRH, FDA|
|12:20 p.m. - 12:30 p.m.||Adverse Events in Action: Proactive Reporting and Best Practices||Madris Kinard, MBA
Founder and CEO Device Events
|12:30 p.m. - 12:40 p.m.||MAUDE and MedWatch Matter to My Practice: A Case-Series||Jonathan Dubin, MD Associate Professor of Orthopedic Surgery University of Missouri – Kansas City|
|12:40 p.m. - 12:50 p.m.||Clinical Discussion on Adverse Events||Moderators: David Scott, MD, Medical Officer and Christopher Harner, MD, Clinical Deputy Director, OHT6: Office of Orthopedic Devices, OPEQ, CDRH, FDA|
|12:55 p.m. - 1:00 p.m.||Closing Remarks||
Laurence D. Coyne, PhD, Division Director, OHT6: Office of Orthopedic Devices, OPEQ, CDRH, FDA
If you wish to attend this Workshop, you must register by 4:00 p.m. on November 1, 2023.
There is no fee to register for the Workshop. Registration will be on a first-come, first-served basis. When registering, you must provide the following information:
(4) Affiliation, Company or Organization
(5) E-mail address
(6) Telephone number
(7) Stakeholder Category (Academia, Clinician, Consultant, Government, Industry, Regulatory and Other)
Registrants will receive confirmation when requests for participation have been accepted.
If you require special accommodations due to a disability, or need additional information regarding registration, please contact Susan Monahan, Office of Communication and Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 32, Silver Spring, MD 20993, 301-796-5661, Susan.Monahan@fda.hhs.gov by October 27, 2023
Please submit your comments regarding the workshop to https://www.regulations.gov/, Docket No. FDA-2023-N-4298 by December 3, 2023.
Please refer to the Instructions for submitting comments to the docket to ensure that your feedback is received.
The resulting discussions from the workshop and comments received in the docket will be taken into consideration.
Please be advised that as soon as a transcript is available, it will be posted in the Dockets and accessible at https://www.regulations.gov/.
For questions regarding workshop content please contact:
CDR Randoshia Miller
Office of Health Technology 6
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, Maryland 20993-0002
|Instructions for Submitting Comments - Ortho Surgical Procedures Workshop||pdf (143.15 KB)|