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  5. Virtual Public Workshop - 3D Printing in Hospitals: Veteran’s Health Administration’s Experiences in Point of Care 3D Printing of Device and Implementing a Quality Management System - 03/16/2022
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Workshop

Event Title
Virtual Public Workshop - 3D Printing in Hospitals: Veteran’s Health Administration’s Experiences in Point of Care 3D Printing of Device and Implementing a Quality Management System
March 16 - 17, 2022

Date:
March 16 - 17, 2022
Day1:
- ET
Day2:
- ET

The Food and Drug Administration (FDA) is announcing a virtual public workshop in collaboration with the Veteran’s Health Administration (VHA) to share VHA’s experiences using 3D printing/additive manufacturing in their hospitals. The workshop is also intended to provide a forum for VHA and other stakeholders to present and discuss their experience that could be useful for healthcare facilities considering 3D printing medical devices. 

BACKGROUND:

VHA’s Office of Advanced Manufacturing has worked diligently to evaluate how to safely 3D print devices at VHA hospitals and the VHA has successfully implemented a quality management system (QMS) per 21 CFR part 820 for 3D printing medical devices in three hospitals, with plans to implement a QMS in more hospitals in the future. The VHA speakers will share their perspective and lessons learned through that process. Speakers from other hospitals, professional societies, and medical device manufacturers will also share their experiences in these areas and each session will conclude with a group discussion and provide opportunity for the speakers to address audience questions. 

3D printing at the point of care (PoC) may serve an important public health purpose by providing for rapid and agile production of devices, such as patient-matched devices and anatomical models for surgical planning. This technology has the potential to help a healthcare facility quickly respond to patient needs, bring personalized care to patients in a timely manner, and lead to new innovations in patient care and treatment. Over the last two years during the COVID-19 pandemic for example, many hospitals have used 3D printing of devices to meet supply needs and address shortages. This workshop will help inform and spur additional discussion with the public on 3D printing at hospitals by sharing the VHA’s experiences, hearing from others in the field, and having an open dialogue with relevant stakeholders.

The FDA recently issued a discussion paper on 3D printing at the PoC, and while the discussion paper may provide helpful context in preparation for the workshop, it is not the focus of this workshop.

DATE and TIME 

This meeting will be held on March 16 and 17 2022, from 12:00 noon to 5:30 pm (ET) by webcast only. 

WEBCAST

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 archived webcast will be posted to this webpage for viewing after the public workshop.

We recommend using web browser “Chrome” to view the webcast. Click the webcast link then follow the instructions on screen to sign in using the “Register” section:

March 16 - Live webcast link: https://fda.yorkcast.com/webcast/Play/a9a4a0d21cf848fa8d85cf6c09ba39c21d
March 17 - Live webcast link: https://fda.yorkcast.com/webcast/Play/f4d1646c263e4c2da407bd3134ebc8cd1d

PRELIMINARY AGENDA

This agenda is preliminary and subject to change. More information will be made available as presenters are confirmed.

March 16, 2022 VHA 3D printing at PoC Experience

Time Subject Name of Speaker
12:00 noon Welcome/Opening Ryan Vega, MD; Chief Officer, Healthcare Innovation and Learning, VHA
12:10 pm Overview of FDA Discussion Paper Matthew Di Prima, PhD; Research Materials Scientist; Center for Devices and Radiological Health, FDA
12:20 pm Overview of VHA 3D Printing Activities Beth Ripley, MD, PhD; Deputy Chief Officer, Healthcare Innovation & Learning; Acting Director of VA Ventures; VA Puget Sound Healthcare System
12:30 pm 3D Printing at PoC Experience: Speaker 1 Dmitry Levin, Clinical Director; Advanced Manufacturing; VA Puget Sound Healthcare System
12:50 pm 3D Printing at PoC Experience: Speaker 2 Brian Laymam; Orthotist/Prosthetist; Southeast Louisiana VA Healthcare System
1:10 pm 3D Printing at PoC Experience: Speaker 3 Peter Liacouras, PhD; Director of Services, 3D Medical Application Center, Walter Reed National Military Medical Center
1:30 pm 3D Printing at PoC Experience: Group Q&A Moderator: Laura Gilmour, Principal Consultant, Additive Manufacturing and Regulatory Strategy, Office of Advanced Manufacturing, Veterans Health Administration
2:00 pm Break  
2:15 pm Clinical Ideas/Applications: Speaker 1 Nikki Beitenman, BSBME, BBA, CAM-F; Advanced Manufacturing Site Lead; Supervisory Biomedical Engineer; Ralph H. Johnson VA Healthcare System
2:35 pm Clinical Ideas/Applications: Speaker 2 Michael F. Amendola, MD, MEHP, FSVS, FACS; Professor of Surgery, VCU School of Medicine CRQS and 3D Printing Fellowship Program Director; Division Chair, Vascular Surgery; Director of the Arterial Duplex Laboratory; Central Virginia VA Healthcare System
2:55 pm Clinical Ideas/Applications: Speaker 3 Diana Otoya, MD, 3D Printing Fellow, Chief Resident in Quality, Safety Fellow, Central Virginia VA Healthcare System
3:15 pm Clinical Ideas/Applications: Group Q&A Moderator: William Corcuera, Innovations Program Coordinator and 3D Printing Lab Manager, VA Northeast Ohio Healthcare System
3:45 pm Break  
3:50 pm Outstanding Challenges: Speaker 1 Nikki Beitenman, BSBME, BBA, CAM-F; Advanced Manufacturing Site Lead; Supervisory Biomedical Engineer; Ralph H. Johnson VA Healthcare System
4:10 pm Outstanding Challenges: Speaker 2 Melissa Oliver, MS, OTR/L; Assistive Technology Program Director and AT Design Lab Director; Interim OAM Site Lead; Central Virginia VA Healthcare System
4:30 pm Outstanding Challenges: Speaker 3 Henry Pinchbeck, CEO, 3D Lifeprints
4:50 pm Outstanding Challenges: Group Q&A Moderator: Nicole Wake, Regional Director, Medical and Scientific Affairs, GE Healthcare, Executive Committee, Radiological Society of North America (RSNA) Special Interest Group on 3D Printing
5:20 pm Closing TBD

March 17, 2022: Implementing a Quality Management Systems (QMS) at Point of Care (PoC)

Time Subject Name of Speaker
12:00 noon Day 2 Opening TBD
12:10 pm VHA Experience: Speaker 1 Joe Beedle, CPA; Chief Financial Officer, VA Puget Sound Health Care System
12:30 pm VHA Experience: Speaker 2 Gregory Voss, BS, MBA; Biomedical Research Engineer, MADE Lab; Minneapolis VA Healthcare System
12:50 pm VHA Experience: Speaker 3 Arrianna Willis, MGEL; Director of Operations; Advanced Manufacturing; VA Puget Sound Healthcare System
1:10 pm VHA Experience: Panel Q&A Moderator: Laura Gilmour, Principal Consultant, Additive Manufacturing and Regulatory Strategy, Office of Advanced Manufacturing, Veterans Healthcare Administration
1:40 pm Break  
1:45 pm Non-PoC QMS Experience: Speaker 1 Patricia Fleenor, Director Global Quality Healthcare, 3D Systems
2:05 pm Non-PoC QMS Experience: Speaker 2 Alain Fortuney, Director, Scan2Health and 3DP at Point of Care Engineering, Johnson and Johnson
2:25 pm Non-PoC QMS Experience: Speaker 3 Phil Pontikos; Medical Device National Expert Investigator; Office of Regulatory Affairs, FDA
2:45 pm Non-PoC QMS Experience: Group Q&A Moderator: Kim Torluemke, Regulatory Affairs Consultant, KT Regulatory Consulting, LLC
3:15 pm Break  
3:20 pm PoC QMS Gaps and Needs: Speaker 1 Brian Strzelecki; Director of Quality and New Products; Advanced Manufacturing; VA Puget Sound Healthcare System
3:40 pm PoC QMS Gaps and Needs: Speaker 2 Amy Alexander; Unit Head, Biomechanical Development & Applied Computational Engineering, Mayo Clinic Division of Engineering
4:00 pm PoC QMS Gaps and Needs: Speaker 3 Lauralyn McDaniel; Strategy & Engagement at Metrix Connect, an ASME Company
4:20pm PoC QMS Gaps and Needs: Speaker 4 Shane Collins, Senior Associate Consultant, Wohlers Associates, ASTM
4:40 pm PoC QMS Gaps and Needs: Panel Q&A Moderator: Andy Christensen, Adjunct Faculty, Department of Radiology, University of Cincinnati, Executive Committee 2022 Chair, Radiological Society of North America (RSNA) Special Interest Group on 3D Printing
5:20 pm Closing TBD

REGISTRATION

Registration is closed as of March 15, 2022.

SUBMIT COMMENTS

Please submit your comments regarding the workshop to https://www.regulations.gov/, Docket No. FDA-2022-N-0145 by April 18, 2022.    

Please refer to the Instructions for submitting comments (include the hyperlink) 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 http://www.regulations.gov.  

CONTACT

For questions regarding workshop content please contact:

Matthew Di Prima 
Center for Devices and Radiological Health
U.S. Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993
E mail: [email protected].

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