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Requirements and Test Methods for Injectable Solutions and Medical Devices
Published in Thomas A. Barber, Control of Particulate Matter Contamination in Healthcare Manufacturing, 1999
Many of the particles associated with medical devices originate at process assembly points; typically, a much smaller number comes from the environment. Each component part assembled into devices typically contributes some variable level of unique particles. Interestingly, because of the distinct sources of particles found in devices, mixed particle populations composed of subvisible 1—50 μm particles (representing the inherent burden of components), and small numbers of larger particles of visible size (predominantly process related) may occur. Currently manufactured parenteral-type devices span a range of complexity from single administration sets and extension sets to blood oxygenators, extracorporeal circuits, blood warmers, and autotransfusion devices. Large numbers of individual component parts may be included in devices of the latter types. Even simple devices may incorporate parts made from several different types of polymeric material; many manufacturers test individual components as a means of qualifying processes or vendors.
Interval analysis of blood filtration efficacy in novel device for autotransfusion in postpartum hemorrhage
Published in Journal of Medical Engineering & Technology, 2019
Gardner Yost, Olivia Murray, Pam Kutz-McClain, Abby Koch, Mary L. Delaney, Andrea M DuBois, Andrew B. Onderdonk, Stacie Geller, Valerie Dobiesz
Future study will be focussed on determining whether the contemporary device may be safely and practically utilised in an animal model for PPH in which autotransfusion of filtered blood will be implemented. Each leukocyte depletion filter is designed to filter a single unit of blood. PPH, by definition, occurs when there is greater than 1000 ml or more of bleeding, roughly the equivalent of two units of blood. Considering that our device incorporates multiple filters in series and that post-partum blood can become highly contaminated, a feasibility study investigating the maximum volume of blood, the device is capable of filtering while maintaining current standards of microbial filtration is required.