3D Printing in Hospitals: Veteran’s Health Administration’s Experiences in Point of Care 3D Printing of Device and Implementing a Quality Management System

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.