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  5. Public Workshop - Orthopedic Device-Related Infections - 11/13/2020 - 11/13/2020
  1. Workshops & Conferences (Medical Devices)


Event Title
Public Workshop - Orthopedic Device-Related Infections
November 13, 2020

November 13, 2020
8:00 AM - 1:00 PM ET

The Food and Drug Administration (FDA) is announcing a public workshop entitled "Orthopedic Device-Related Infections." This is intended to be a series of workshops envisioned to improve public understanding of infections related to orthopedic devices and appropriate mitigation measures for protecting and promoting public health in this clinical area. The focus of this inaugural workshop is the role of medical devices in orthopedic infections, specifically exploring new and ongoing research, discussing potential strategies to address associated challenges, developing innovative solutions, and catalyzing collaboration among the orthopedic community stakeholders to identify regulatory science challenges related to orthopedic device-related infections.


The inaugural workshop will provide a forum to facilitate information exchange among academic centers, health care professionals, governmental agencies, and device manufacturers interested in developing products and gathering individual opinions on strategies to address infections related to orthopedic devices. The public workshop is not intended to communicate any new policies, processes or interpretations regarding medical device marketing authorizations. The topics for discussion include 1) Current state of the science regarding technologies that are linked to infections associated with orthopedic devices, 2) Critical gaps in research related to infections in joint arthroplasty and orthopedic trauma devices, including medical device technologies not currently available in the United States, to address the critical gaps in understanding, 3) Novel technologies and factors that impact innovation, 4) Potential new technologies that could impact public health in the fields of joint arthroplasty and trauma care, and 5) Potential opportunties for appropriate collaboration between device manufacturers, physician community, patients, government agencies and regulators to mitigate infections related to orthopedic devices.

Date and Time

This public workshop will be held November 13, 2020, from 8:00 a.m. to 1:00 p.m. ET by webcast only.


Webcast Workshop Link: http://fda.yorkcast.com/webcast/Play/8cd0cdbe08ea4b0088fe139199e733181d

Internet Explorer and Firefox are the preferred web browsers to view this webcast.

The link for archived webcast will be posted on the webpage for viewing after the public workshop.





8:00 AM – 8:01 AM


CAPT Raquel Peat, PhD, MPH
Director, OHT6: Office of Orthopedic Devices, Office of Product Evaluation and Quality, CDRH

8:01 AM – 8:06 AM

Opening Remarks

William H. Maisel, MD, MPH
Director, Office of Product Evaluation and Quality, CDRH

Master of Ceremony- James Bertram, PhD

Session 1: Orthopedic Infections and the Role of Medical Devices in Orthopedic Infections
Moderators: Vincent Devlin, MD and Richard Iorio, MD

 8:06 AM – 8:15 AM

Overview of Orthopedic Infections Involving the Appendicular Skeleton

Javad Parvizi, MD
Vice Chairman of Research
Thomas Jefferson University

8:15 AM – 8:20 AM

Orthopedic Infections- Current Medical Treatment Recommendations and Associated Concerns

John Segreti, MD
Professor, Department of Internal Medicine
Rush Medical College

8:20 AM – 8:30 AM

Systemic and Local Toxicity Associated with Delivery Technologies

 Bryan Springer, MD
OrthoCarolina Hip and Knee Center

8:30 AM – 8:35 AM

Current State of Periprosthetic Joint Infections of the Hip and Knee

  Yale Fillingham, MD
Rothman Orthopaedic Institute at Thomas Jefferson University

8:35 AM- 8:45 AM

Current State of Infections Related to Orthopedic Trauma Surgery

Peter Giannoudis, MD
Professor and Chairman of Orthopaedics
School of Medicine, University of Leeds

8:45 AM – 9:05 AM

Presenter Discussion

9:05AM – 9:10 AM


Session 2:  Total Joint Arthroplasty Devices: Knowledge Gaps and Development of Device Technologies to Address Unmet Needs Related to Orthopedic Infections
Moderators:  Javad Parvizi, MD and Edward Schwarz, PhD

9:10 AM – 9:20AM

Safety and Effectiveness Data Related to the Use of Polymethylmethacrylate Bone Cements in Infection

Chad Krueger, MD
Rothman Orthopaedic Institute

9:20 AM – 9:25 AM

PMMA Spacers: Effectiveness and Utilization

Carlos Higuera, MD, FAAOS
Regional Director, Orthopaedic and Rheumatologic Institute
Cleveland Clinic

9:25 AM – 9:35 AM

Current Evidence Regarding Device Coatings

Stuart Goodman, MD, PhD
Stanford Health Care

9:35 AM – 9:45 AM

Current Evidence for Surface Modifications of Arthroplasty Devices

Noreen Hickok, PhD
Professor, Dept. of Orthopaedic Surgery Sidney Kimmel Medical College of Thomas Jefferson University

9:45 AM – 10:05 AM

Presenter Discussion

10:05 AM – 10:10 AM


Session 3: Orthopedic Trauma Devices: Knowledge Gaps and the Development of Device Technologies to Address Unmet Needs
Moderators: Paul Tornetta III, MD and J. Tracy Watson, MD

10:10 AM – 10:20 AM

Evidence Gaps and Emerging Solutions for Use in Acute Orthopedic Trauma

 Michael Bosse, MD
Emeritus Professor, Atrium Health Musculoskeletal Institute

10:20 AM – 10:30 AM

Evidence Gaps and Emerging Solutions for Use in Chronic Osteomyelitis

David W. Lowenberg, MD
Clinical Professor of Orthopaedic Surgery
Stanford University School of Medicine


10:30 AM – 10:40 AM

Biodegradable Delivery Systems

J. Tracy Watson, MD
Professor, Orthopaedic Surgery
Saint Louis University School of Medicine

10:40 AM – 11:00 AM

Presenter Discussion

11:00 AM – 11:05 AM


Session 4:  Advance Development of Needed Orthopedic Device Technologies: (Physician Community, Device Manufacturers, Academia, Governmental Agencies, Regulators and Patients)
Moderators: Kenneth Urish, MD and James Bertram, PhD

11:05 AM – 11:15 AM

FDA Perspective: Emerging Concepts Related to Orthopedic Device Technologies

Laurence Coyne, PhD
Director, Division of Restorative, Repair and Trauma Devices, OHT6: Office of Orthopedic Devices, Office of Product Evaluation and Quality, CDRH

11:15 AM – 11:25 AM

Developing Protocols and Guidelines to Minimize Infection Related to Orthopedic Devices

Richard Iorio, MD
Chief, Adult Reconstruction and TJA
Vice Chair of Clinical Effectiveness
Brigham and Women’s Hospital of Orthopaedic Surgery Richard D. Scott, MD Distinguished Chair in Orthopaedic Surgery

11:25 AM – 11:35 PM

Scientist’s Perspective: Translating a Technology from Bench to Bedside

Joseph Wenke, PhD
U.S. Army Institute of Surgical Research

11:35 PM – 11:45 PM

Clinician’s Perspective – Joint Arthroplasty Devices: Analysis of Clinical Worth and Advances of a Technology to the Market

Javad Parvizi, MD
Vice Chairman of Research
Thomas Jefferson University

11:45 PM – 11:55 PM

Joint Arthroplasty Devices-Industry Perspective: Orthopedic Device and Regulatory Challenges in the United States

Robert E. Durgin, JD
Worldwide VP, Regulatory Affairs
DePuy Synthes Companies of Johnson & Johnson

11:55 PM – 12:00 PM

Clinician’s Perspective – Priorities Related to Orthopedic Trauma Devices

Paul Tornetta III, MD
Chief, Department of Orthopedic Surgery
Boston University School of Medicine

12:00 PM – 12:05 PM


Trauma Devices-Industry Perspective: Orthopedic Device and Regulatory Challenges in the United States

Joseph Ferrante, BSME
Vice President Research & Development Trauma/Extremities and Limb Restoration
Smith and Nephew

12:05 PM – 12:10 PM

Patient Perspective on Orthopedic Medical Devices and Potential Solutions

Michael Daley, PhD
Co-President, Co-CEO and Founder
OrthogenRx, Inc.

12:10 PM – 12:15 PM

Patient Perspective on Orthopedic Infection

Michael Egge
Father of Osteosarcoma Survivor Olivia Egge
Partner, Latham & Watkins LLP

12:15 PM - 12:50 PM

Presenter Discussion

12:50 PM - 1:00 PM

Closing Remarks

CAPT Raquel Peat, PhD, MPH
Director, OHT6: Office of Orthopedic Devices, Office of Product Evaluation and Quality, CDRH


Registration is closed as of November 12, 2020.

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 Peggy Roney, 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, 301-796-5671, [email protected] by October 23, 2020.


Please submit your comments regarding the workshop to https://www.regulations.gov/, Docket No. # FDA-2020-N-1762 by December 14, 2020. 

Please refer to the following instructions for submitting comments to the docket to ensure that your feedback is taken into consideration.

The meeting transcript will be posted in the Docket as soon as it is available, and accessible at https://www.regulations.gov


For questions regarding workshop content please contact:

LCDR Randoshia Miller
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave.
Bldg. 66, Rm 4510
Silver Spring, MD 20993
[email protected]

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