Trials and Tribulations of Implementing a Quality Management System at the Point-of-care

Point-of-care medical 3D printing has become more popular and accessible to healthcare facilities. The implementation of digital software in conjunction with additive manufacturing technology into healthcare facilities has allowed healthcare professionals to provide patient-specific care to their patients. As this integration continues more standards, regulations, and internal management systems are needed to control the design and manufacturing processes. Healthcare facilities have quality control measures in place for their treatment processes; however, most healthcare facilities are not fully equipped to control design and manufacturing processes since they currently are not required to follow the same regulations as industry.

The 3D Medical Applications Center (3D MAC) at Walter Reed National Military Medical Center has worked diligently to implement a quality management system (QMS) for their highest-risk devices. During the implementation, development of validation protocols and strategies was mandatory to consistently control the design and manufacturing processes. To fully implement, it was necessary for 3D MAC to leverage many internal hospital/DOD departments as well as external resources and companies. The purpose of the presentation will be to explain realistic expectations of QMS implementation at the POC, discuss the main trials and tribulations of the implementation process, and where “gaps” exist.