Virtual Public Workshop – 3D Printing in Hospitals: Veterans Health Administration Experiences in 3D Printing Point-of-Care Devices and Implementing a Quality Management System – 03/16 /2022

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Dated:
March 16 – 17, 2022
Day 1 :


HEY
Day 2:


HEY

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

CONTEXT:

VHA’s Office of Advanced Manufacturing has worked diligently to assess how to safely 3D print devices in VHA hospitals and 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 quality management system in more hospitals in the future. VHA speakers will share their perspective and lessons learned through this process. Speakers from other hospitals, professional societies and medical device manufacturers will also share their experiences in these areas and each session will end with a panel discussion and provide an opportunity for speakers to answer questions from the audience.

Point-of-care (PoC) 3D printing can serve an important public health purpose by enabling rapid and agile production of devices, such as patient-specific devices and anatomical models for surgical planning. This technology has the potential to help a healthcare facility respond quickly to patient needs, deliver personalized patient care in a timely manner, and lead to new innovations in patient care and treatment. Over the past 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 stimulate further discussion with the public about 3D printing in hospitals by sharing VHA experiences, listening to others in the field, and having an open dialogue with relevant stakeholders. .

The FDA recently released a discussion paper on 3D printing at the PoC, and while the discussion paper may provide useful background for workshop preparation, that is not the focus of this workshop.


date and time

This meeting will take place on March 16 and 17, 2022, from 12:00 p.m. to 5:30 p.m. (ET) by webcast only.

WEBCAST

The virtual public workshop will be webcast live and the link will be provided in your confirmation email once you register. The archived webcast link will be posted on this webpage for viewing after the public workshop.

We recommend using a web browser”Chromium” to watch the webcast. Click on the webcast link then follow the on-screen instructions to connect 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 HAV 3D printing at the PoC Experience

Time Topic Speaker’s name
12:00 p.m. Home/Opening Ryan Vega, MD; CEO, Healthcare Innovation and Learning, VHA
12:10 p.m. Overview of the FDA Discussion Paper Matthew Di Prima, PhD; Research Materials Scientist; Center for Devices and Radiological Health, FDA
12:20 p.m. Presentation of VHA 3D printing activities Beth Ripley, MD, Ph.D.; Deputy CEO, Healthcare Innovation and Learning; Acting Director of VA Ventures; VA Puget Sound Health Care System
12:30 p.m. 3D printing at the PoC experience: Speaker 1 Dmitry Levin, clinical director; advanced manufacturing; VA Puget Sound Health Care System
12:50 p.m. 3D printing at the PoC experience: Speaker 2 Brian Laymam; orthotist/prosthetist; Southeast Louisiana VA Health System
1:10 p.m. 3D printing at the PoC experience: Speaker 3 Pierre Liacouras, PhD; Director of Services, 3D Medical Applications Center, Walter Reed National Military Medical Center
1:30 p.m. 3D Printing at the PoC Experience: Group Questions and Answers Moderator: Laura Gilmour, Senior Consultant, Additive Manufacturing and Regulatory Strategy, Office of Advanced Manufacturing, Veterans Health Administration
2:00 p.m. Break
2:15 p.m. Clinical Ideas/Applications: Speaker 1 Nikki Beitenman, BSBME, BBA, CAM-F; Head of advanced manufacturing site; Supervising biomedical engineer; Ralph H. Johnson VA Health System
2:35 p.m. Clinical Ideas/Applications: Speaker 2 Michael F. Amendola, MD, MEHP, FSVS, FACS; Professor of Surgery, VCU School of Medicine CRQS and Director of the 3D Printing Fellowship Program; Division Director, Vascular Surgery; director of the arterial duplex laboratory; Central Virginia Health System in Virginia
2:55 p.m. Clinical Ideas/Applications: Speaker 3 Diana Otoya, MD, 3D Printing Fellow, Chief Quality Resident, Safety Fellow, Central Virginia VA Healthcare System
3:15 p.m. Ideas/Clinical Applications: Group Q&A Moderator: William Corcuera, Innovations Program Coordinator and 3D Printing Lab Manager, VA Northeast Ohio Healthcare System
3:45 p.m. Break
3:50 p.m. Outstanding Challenges: Speaker 1 Nikki Beitenman, BSBME, BBA, CAM-F; Head of advanced manufacturing site; Supervising biomedical engineer; Ralph H. Johnson VA Health System
4:10 p.m. Outstanding Challenges: Speaker 2 Melissa Oliver, MS, OTR/L; Assistive Technology Program Director and AT Design Lab Director; Acting OAM Site Manager; Central Virginia Health System in Virginia
4:30 p.m. Exceptional Challenges: Responder 3 Henry Pinchbeck, CEO, 3D Lifeprints
4:50 p.m. Exceptional Challenges: Group Q&A Moderator: Nicole Wake, Regional Director, Medical and Scientific Affairs, GE Healthcare, Executive Committee, Radiological Society of North America (RSNA) 3D Printing Special Interest Group
5:20 p.m. Closing To be determined

March 17, 2022: Implementation of a quality management system (QMS) at the point of service (PoC)

Time Topic Speaker’s name
12:00 p.m. Day 2 Opening To be determined
12:10 p.m. VHA Experience: Speaker 1 Joe Beedle, CPA; Chief Financial Officer, VA Puget Sound Health Care System
12:30 p.m. VHA Experience: Speaker 2 Gregory Voss, BS, MBA; Biomedical Research Engineer, MADE Laboratory; Minneapolis Virginia Health System
12:50 p.m. VHA Experience: Speaker 3 Arrianna Willis, MGEL; Operations Manager; advanced manufacturing; VA Puget Sound Health Care System
1:10 p.m. VHA Experience: Questions and Answers from the Panel Moderator: Laura Gilmour, Senior Consultant, Additive Manufacturing and Regulatory Strategy, Office of Advanced Manufacturing, Veterans Healthcare Administration
1:40 p.m. Break
1:45 p.m. Non-PoC QMS Experience: Speaker 1 Patricia Fleenor, Director of Global Healthcare Quality, 3D Systems
2:05 p.m. Non-PoC QMS Experience: Speaker 2 Alain Fortuney, Director, Scan2Health and 3DP at Point of Care Engineering, Johnson and Johnson
2:25 p.m. Non-PoC QMS Experience: Speaker 3 Phil Pontikos; National expert researcher of medical devices; Office of Regulatory Affairs, FDA
2:45 p.m. Non-PoC QMS experience: group questions and answers Moderator: Kim Torluemke, Regulatory Affairs Consultant, KT Regulatory Consulting, LLC
3:15 p.m. Break
3:20 p.m. QMS PoC Gaps and Needs: Stakeholder 1 Brian Strzelecki; Quality and New Products Director; advanced manufacturing; VA Puget Sound Health Care System
3:40 p.m. QMS PoC Gaps and Needs: Stakeholder 2 Amy Alexander; Unit Head, Biomechanical Development and Applied Computer Engineering, Mayo Clinic Engineering Division
4:00 p.m. QMS PoC Gaps and Needs: Stakeholder 3 Lauralyn McDaniel; Strategy and Engagement at Metrix Connect, an ASME Company
4:20 p.m. QMS PoC Gaps and Needs: Speaker 4 Shane Collins, Senior Associate Consultant, Wohlers Associates, ASTM
4:40 p.m. QMS PoC Gaps and Needs: Questions and Answers from the Panel Moderator: Andy Christensen, Adjunct Professor, Department of Radiology, University of Cincinnati, Chair of the 2022 Executive Committee, Radiological Society of North America (RSNA) 3D Printing Special Interest Group
5:20 p.m. Closing To be determined

REGISTRATION

Registrations have been closed since March 15, 2022.

SUBMIT COMMENTS

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

Please refer to the instructions for submitting comments (include hyperlink) on file to ensure your comments are received.

The discussions resulting from the workshop and the comments received in the dossier will be taken into consideration.

Please note that as soon as a transcript is available, it will be posted to the records and accessible at http://www.regulations.gov.

CONTACT

For any questions regarding the content of the workshop, please contact:

Matthew DiPrima
Center for Devices and Radiation Health
US Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993
Email: [email protected]

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