Workshop
Event Title
Public Workshop - Orthopedic Device-Related Infections
November 13, 2020
- Date:
- November 13, 2020
- Time:
- 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.
Background
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
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.
Agenda
Time |
Title |
Speaker |
---|---|---|
8:00 AM – 8:01 AM |
Welcome |
CAPT Raquel Peat, PhD, MPH |
8:01 AM – 8:06 AM |
Opening Remarks |
William H. Maisel, MD, MPH |
Master of Ceremony- James Bertram, PhD |
||
Session 1: Orthopedic Infections and the Role of Medical Devices in Orthopedic Infections |
||
8:06 AM – 8:15 AM |
Overview of Orthopedic Infections Involving the Appendicular Skeleton |
Javad Parvizi, MD |
8:15 AM – 8:20 AM |
Orthopedic Infections- Current Medical Treatment Recommendations and Associated Concerns |
John Segreti, MD |
8:20 AM – 8:30 AM |
Systemic and Local Toxicity Associated with Delivery Technologies |
Bryan Springer, MD |
8:30 AM – 8:35 AM |
Current State of Periprosthetic Joint Infections of the Hip and Knee |
Yale Fillingham, MD |
8:35 AM- 8:45 AM |
Current State of Infections Related to Orthopedic Trauma Surgery |
Peter Giannoudis, MD |
8:45 AM – 9:05 AM |
Presenter Discussion |
|
9:05AM – 9:10 AM |
Break |
|
Session 2: Total Joint Arthroplasty Devices: Knowledge Gaps and Development of Device Technologies to Address Unmet Needs Related to Orthopedic Infections |
||
9:10 AM – 9:20AM |
Safety and Effectiveness Data Related to the Use of Polymethylmethacrylate Bone Cements in Infection |
Chad Krueger, MD |
9:20 AM – 9:25 AM |
PMMA Spacers: Effectiveness and Utilization |
Carlos Higuera, MD, FAAOS |
9:25 AM – 9:35 AM |
Current Evidence Regarding Device Coatings |
Stuart Goodman, MD, PhD |
9:35 AM – 9:45 AM |
Current Evidence for Surface Modifications of Arthroplasty Devices |
Noreen Hickok, PhD |
9:45 AM – 10:05 AM |
Presenter Discussion |
|
10:05 AM – 10:10 AM |
Break |
|
Session 3: Orthopedic Trauma Devices: Knowledge Gaps and the Development of Device Technologies to Address Unmet Needs |
||
10:10 AM – 10:20 AM |
Evidence Gaps and Emerging Solutions for Use in Acute Orthopedic Trauma |
Michael Bosse, MD |
10:20 AM – 10:30 AM |
Evidence Gaps and Emerging Solutions for Use in Chronic Osteomyelitis |
|
10:30 AM – 10:40 AM |
Biodegradable Delivery Systems |
J. Tracy Watson, MD |
10:40 AM – 11:00 AM |
Presenter Discussion |
|
11:00 AM – 11:05 AM |
Break |
|
Session 4: Advance Development of Needed Orthopedic Device Technologies: (Physician Community, Device Manufacturers, Academia, Governmental Agencies, Regulators and Patients) |
||
11:05 AM – 11:15 AM |
FDA Perspective: Emerging Concepts Related to Orthopedic Device Technologies |
Laurence Coyne, PhD |
11:15 AM – 11:25 AM |
Developing Protocols and Guidelines to Minimize Infection Related to Orthopedic Devices |
Richard Iorio, MD |
11:25 AM – 11:35 PM |
Scientist’s Perspective: Translating a Technology from Bench to Bedside |
Joseph Wenke, PhD |
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 |
11:45 PM – 11:55 PM |
Joint Arthroplasty Devices-Industry Perspective: Orthopedic Device and Regulatory Challenges in the United States |
Robert E. Durgin, JD |
11:55 PM – 12:00 PM |
Clinician’s Perspective – Priorities Related to Orthopedic Trauma Devices |
Paul Tornetta III, MD |
12:00 PM – 12:05 PM |
Trauma Devices-Industry Perspective: Orthopedic Device and Regulatory Challenges in the United States |
Joseph Ferrante, BSME |
12:05 PM – 12:10 PM |
Patient Perspective on Orthopedic Medical Devices and Potential Solutions |
Michael Daley, PhD |
12:10 PM – 12:15 PM |
Patient Perspective on Orthopedic Infection |
Michael Egge |
12:15 PM - 12:50 PM |
Presenter Discussion |
|
12:50 PM - 1:00 PM |
Closing Remarks |
CAPT Raquel Peat, PhD, MPH |
Registration
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, Peggy.Roney@fda.hhs.gov by October 23, 2020.
Comments
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.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before the date shown in the Docket. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of the date shown in the Docket. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
- Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
- If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see "Written/Paper Submissions" and "Instructions").
Written/Paper Submissions
Submit written/paper submissions as follows:
- Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
- For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in "Instructions."
Instructions: All submissions received must include the Docket No. FDA-2020-N-1762 for "Public Workshop - Orthopedic Device-Related Infections." Received comments, those filed in a timely manner, will be placed in the docket and, except for those submitted as "Confidential Submissions," publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
- Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states "THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION." The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as "confidential." Any information marked as "confidential" will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the "Search" box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
The meeting transcript will be posted in the Docket as soon as it is available, and accessible at https://www.regulations.gov.
Contact
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
301-796-6838
CDRHpublicmeetings@fda.hhs.gov