Going faster, going greener, going safer – a student led approach for safety management

© 2020 The Author(s). This an open access work distributed under the terms of the Creative Commons Attribution Licence (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.Peer reviewedFinal Published versio

Analysis of FDA warning letters issued to US medical device companies for CAPA related issues between 2013 and 2019

© Journal of Medical Device Regulation – 2023. This is the accepted manuscript version of an article which has been published in final form at https://globalregulatorypress.com/product/may-2023-volume-20-issue-2/ ​​​​​​

FDA Medical Device Warning Letters and Trends Pre and Post COVID 2013-2022

© 2023 Anderson R, et al. This is an open access article distributed under the terms of the Creative Commons Attribution License (CC BY), https://creativecommons.org/licenses/by/4.0/The United States Food & Drug Administration requires under Title 21 of the Code of Federal Regulations (21 CFR) Part 820.100, that medical device manufacturers must establish a system to address Corrective And Preventive Actions (CAPAs) to meet regulatory standards. This article provides insight into medical device quality issues relating to CAPA through the evaluation of warning letters issued by the US Food and Drug Administration (FDA) between 2013 and 2022. The results of this study indicate that despite the medical device regulations being in place since 1976 violations of 21 CFR 820.100 (CAPA related violations) continues to be a significant issue for medical device companies.Peer reviewe

Electromagnetic Actuated Stiring in Microbioreactor Enabling Easier Multiplexing and Flexible Device Design

The development of a novel electromagnetically (EM) actuated stirring method, for use in microbioreactors, is reported. Mixing in microbioreactors is critical to ensure even distribution of nutrients to microorganisms and cells. Magnetically driven stirrer bars or peristaltic mixing are the most commonly utilised mixing methods employed in completely liquid-filled microbioreactors. However the circular reactor shape required for mixing with a stirrer bar and frequently used for peristaltically mixed microbioreactors presents difficulties for bubble-free priming in a microfluidic bioreactor. Moreover the circular shape and the hardware required for both types of mixing reduces the potential packing density of multiplexed reactors. We present a new method of mixing, displaying design flexibility by demonstrating mixing in circular and diamond-shaped reactors and a duplex diamond reactor and fermentation of the gram-positive bacteria S. carnosus in a diamond-shaped microbioreactor system. The results of the optimisation of this mixing method for performing fermentations alongside both batch and continuous culture fermentations are presentedPeer reviewe

Dean flow focusing and separation of small microspheres within a narrow size range.

Copyright The Author(s) 2014. This article is published with open access at Springerlink.com. This article is distributed under the terms of the Creative Commons Attribution License which permits any use, distribution, and reproduction in any medium, provided the original author(s) and the source are creditedRapid, selective particle separation and concentration within the bacterial size range (1–3 μm) in clinical or environmental samples promises significant improvements in detection of pathogenic microorganisms in areas including diagnostics and bio-defence. It has been proposed that microfluidic Dean flow-based separation might offer simple, efficient sample clean-up: separation of larger, bioassay contaminants to prepare bioassay targets including spores, viruses and proteins. However, reports are limited to focusing spherical particles with diameters of 5 μm or above. To evaluate Dean flow separation for (1–3 μm) range samples, we employ a 20 μm width and depth, spiral microchannel. We demonstrate focusing, separation and concentration of particles with closely spaced diameters of 2.1 and 3.2 μm, significantly smaller than previously reported as separated in Dean flow devices. The smallest target, represented by 1.0 μm particles, is not focused due to the high pressures associated with focussing particles of this size; however, it is cleaned of 93 % of 3.2 μm and 87 % of 2.1 μm microparticles. Concentration increases approaching 3.5 times, close to the maximum, were obtained for 3.2 μm particles at a flow rate of 10 μl min−1. Increasing concentration degraded separation, commencing at significantly lower concentrations than previously predicted, particularly for particles on the limit of being focused. It was demonstrated that flow separation specificity can be fine-tuned by adjustment of output pressure differentials, improving separation of closely spaced particle sizes. We conclude that Dean flow separation techniques can be effectively applied to sample clean-up within this significant microorganism size range.Peer reviewedFinal Published versio

Fully integrated digital microfluidics platform for automated immunoassay; a versatile tool for rapid, specific detection of a wide range of pathogens

© 2018 Elsevier Ltd. All rights reserved. This manuscript is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International Licence http://creativecommons.org/licenses/by-nc-nd/4.0/.With the tangible threat posed by the release of chemical and biological warfare (CBW) agents, detection of airborne pathogens is a critical military and security concern. Recent air sampling techniques developed for biocollection take advantage of Electrowetting on Dielectric (EWOD) to recover material, producing highly concentrated droplet samples. Bespoke EWOD-based digital microfluidics platforms are very well suited to take full advantage of the microlitre concentrated droplet resulting from this recovery process. In this paper we present a free-standing, fully automated DMF platform for immunoassay. Using this system, we demonstrate the automated detection of four classes of CBW agent simulant biomolecules and organisms each representing credible threat agents. Taking advantage of the full magnetic separation process with antibody-bound microbeads, rapid and complete separation of specific target antigen can be achieved with minimal washing steps allowing for very rapid detection. Here, we report clear detection of four categories of antigens achieved with assay completion times of between six and ten minutes. Detection of HSA, Bacillus atrophaeus (BG spores), MS2 bacteriophage and Escherichia coli are demonstrated with estimated limit of detection of respectively 30 ng ml -1, 4 × 10 4 cfu ml -1, 10 6 pfu ml -1 and 2 × 10 7 cfu ml -1. The fully-integrated portable platform described in this paper is highly compatible with the next generation of electrowetting-coupled air samplers and thus shows strong potential toward future in-field deployable biodetection systems and could have key implication in life-changing sectors such as healthcare, environment or food security.Peer reviewe

Electrowetting-Based Digital Microfluidics Platform for Automated Enzyme-linked Immunosorbent Assay

Electrowetting is the effect by which the contact angle of a droplet exposed to a surface charge is modified. Electrowetting-on-dielectric (EWOD) exploits the dielectric properties of thin insulator films to enhance the charge density and hence boost the electrowetting effect. The presence of charges results in an electrically induced spreading of the droplet which permits purposeful manipulation across a hydrophobic surface. Here, we demonstrate EWOD-based protocol for sample processing and detection of four categories of antigens, using an automated surface actuation platform, via two variations of an Enzyme-Linked Immunosorbent Assay (ELISA) methods. The ELISA is performed on magnetic beads with immobilized primary antibodies which can be selected to target a specific antigen. An antibody conjugated to HRP binds to the antigen and is mixed with H 2O 2/Luminol for quantification of the captured pathogens. Assay completion times of between 6 and 10 min were achieved, whilst minuscule volumes of reagents were utilized.Peer reviewe

Shake till you break – bilateral neck of humerus fracture post seizure

Fractures may occur after an episode of seizures. Although rare, with a high index of suspicion and proper physical examination, delay of diagnosis and treatment can be avoided. We report a case of near missed bilateral proximal humerus fracture after an episode of generalized tonic-clonic seizure. A 58-year-old lady with a background history of epilepsy complained of generalized body ache after a generalized tonic-clonic seizure which happened few hours before presentation to our Emergency Department. On assessment, she was in pain and unable to move all four limbs. After given analgesia, patient was reassessed whereby she complained of bilateral shoulder stiffness and pain. Examination of the upper limbs revealed restricted range of movement in all directions with no shoulder squaring. X-ray showed bilateral proximal humerus fracture. Proximal humeral fractures rarely occur by itself following seizures; they are almost always associated with dislocation of the glenohumeral joint

The Design of an Innovative Research Led, Undergraduate Programme for Effective Development of R&D Skills and Learning.

Daniel McCluskey, Christabel Tan, Mark Tracey, Ian Johnston, Loic Coudron, ‘The Design of an Innovative Research Led, Undergraduate Programme for Effective Development of R&D Skills and Learning’, paper presented at the 1st ASEAN Innovation Conference, Vientiane, Lao People’s Democratic Republic, 25-26 October, 2016.Engineering education has suffered a shift in focus between research led fundamental engineering and vocational training that has resulted in many graduate engineers equipped without a thorough grasp of either skill set. Furthermore the belief that these two components of education can be explicitly separated appears to undermine the notion of what a graduate engineer is. The purpose of this paper is to outline the development of a research informed, undergraduate, module that incorporates the principles of the Massachusetts Institute of Technology developed approach to engineering education where the core components of study are formed around the concept of CDIO (Conceive, Design, Implement, Operate). We outline our initial starting concept for the taught module and systematically break down the CDIO approach, applying the outcomes of this process to the design of the engineering module. The resultant module structure incorporates the majority of the CDIO principles, and highlights the mechanisms by which research can inform undergraduate teaching without straying away from the development of practical skills required by the graduate engineer. This work suggests that the CDIO approach, with minor modification, can be tailored to a single isolated module structure as well as a whole curriculum provided that there is a clear objective outlined at the start

Evaluating Knowledge Gaps in Sea-Level Rise Assessments From the United States

There have been many scientific advances regarding future sea-level projections, however it is unclear if these have been transferred to assessment reports used by stakeholders. Here, we present a first-of-its-kind comprehensive analysis of regional sea-level rise (SLR) assessments for the United States (U.S.). We identify variations in time horizons over which regions plan for SLR, with 25 projections from the U.S. Northeast and West that extend to 2150 or beyond, but no projections from the U.S. South beyond 2100. The majority of 2100 projections from the U.S. Northeast (77%) and West (83%) include ranges of future SLR, while 88% of projections from the U.S. South include only single estimates. At least 56% of U.S. communities in the database underestimate the upper end of future SLR compared to the regional projections of the Intergovernmental Panel on Climate Change Sixth Assessment Report