Leak verification method for additively manufactured medical devices
摘要
During the COVID-19 pandemic, supply shortages drove innovation in additively manufactured (AM) personal protective equipment, such as face masks that create barriers against infectious body fluids like blood, mucus, and respiratory droplets. However, printing defects including pores and flaws may occur during AM fabrication, potentially compromising effectiveness. This study advances AM quality assurance by providing a novel leak verification approach specifically targeting defects that may arise from AM processes. This article presents a verification method for manufacturers to assess defect impacts on device performance. A vessel mimicking an AM face mask with artificial defects underwent pressure decay testing to characterize air leakage. Fluid infiltration susceptibility was studied using synthetic blood, while aerosol leakage effects were investigated with sodium chloride testing. Combining these results established allowable pressure decay limits, enabling estimation of critical pressure decay responses where manufacturing defects can hinder the mask’s performance. For the designed face mask pressure vessel, we found that an equivalent flaw size less than 70,686 µm2 would likely ensure no blood infiltration of the mask frame at a heavy breathing pressure differential. This translated to a pressure decay test criteria requiring no more than a 1.3 psi air pressure drop over 2 s when the vessel is charged to 5 psi. The approach can be adapted for other AM components, providing a framework for developing verification methods ensuring AM part quality and reliability across various industries.