Ethical and regulatory implications of the COVID-19 pandemic for the medical devices industry and its representatives

The development and deployment of medical devices, along with most areas of healthcare, has been signifcantly impacted by the COVID-19 pandemic. This has had variable ethical implications, two of which we will focus on here. First, medical device regulations have been rapidly amended to expedite approvals of devices ranging from face masks to ventilators. Although some regulators have issued cessation dates, there is inadequate discussion of trig‑ gers for exiting these crisis standards, and evidence that this may not be feasible. Given the relatively low evidence standards currently required for regulatory approval of devices, this further indefnite reduction in standards raises serious ethical issues. Second, the pandemic has disrupted the usual operations of device representatives in hospi‑ tals, providing an opportunity to examine and refne this potentially ethically problematic practice. In this paper we explain and critically analyse the ethical implications of these two pandemic-related impacts on medical devices and propose suggestions for their management. These include an endpoint for pandemic-related adjustments to device regulation or a mechanism for continued refnement over time, together with a review of device research conducted under crisis conditions, support for the removal and replacement of emergency approved devices, and a review of device representative credentialling.Brette Blakely, Wendy Rogers, Jane Johnson, Quinn Grundy, Katrina Hutchison, Robyn Clay, Williams, Bernadette Richards, and Guy Madder

The landscape of gifted and talented education in England and Wales: How are teachers implementing policy?

This is an Author's Accepted Manuscript of an article published in Research Papers in Education, 27(2), 167-186, 2012, copyright Taylor & Francis, available online at: http://www.tandfonline.com/10.1080/02671522.2010.509514.This paper explores the evidence relating to how primary schools are responding to the ‘gifted and talented’ initiative in England and Wales. A questionnaire survey which invited both closed and open-ended responses was carried out with a national sample of primary schools. The survey indicated an increasing proportion of coordinators, compared with a survey carried out in 1996, were identifying their gifted and talented children as well as having associated school policies. However, the survey also highlighted a number of issues which need addressing if the initiative is to achieve its objective of providing the best possible educational opportunities for children. For example, it was found that a significant number of practitioners were not aware of the existence of the National Quality Standards for gifted and talented education, provided by the UK government in 2007, and the subject-specific criteria provided by the UK’s Curriculum Authority for identification and provision have been largely ignored. The process of identifying children to be placed on the ‘gifted and talented’ register seems haphazard and based on pragmatic reasons. Analysis of teachers’ responses also revealed a range of views and theoretical positioning held by them, which have implications for classroom practice. As the ‘gifted and talented’ initiative in the UK is entering a second decade, and yet more significant changes in policy are introduced, pertinent questions need to be raised and given consideration

VPR-Bench: An Open-Source Visual Place Recognition Evaluation Framework with Quantifiable Viewpoint and Appearance Change

Visual place recognition (VPR) is the process of recognising a previously visited place using visual information, often under varying appearance conditions and viewpoint changes and with computational constraints. VPR is related to the concepts of localisation, loop closure, image retrieval and is a critical component of many autonomous navigation systems ranging from autonomous vehicles to drones and computer vision systems. While the concept of place recognition has been around for many years, VPR research has grown rapidly as a field over the past decade due to improving camera hardware and its potential for deep learning-based techniques, and has become a widely studied topic in both the computer vision and robotics communities. This growth however has led to fragmentation and a lack of standardisation in the field, especially concerning performance evaluation. Moreover, the notion of viewpoint and illumination invariance of VPR techniques has largely been assessed qualitatively and hence ambiguously in the past. In this paper, we address these gaps through a new comprehensive open-source framework for assessing the performance of VPR techniques, dubbed “VPR-Bench”. VPR-Bench (Open-sourced at: https://github.com/MubarizZaffar/VPR-Bench) introduces two much-needed capabilities for VPR researchers: firstly, it contains a benchmark of 12 fully-integrated datasets and 10 VPR techniques, and secondly, it integrates a comprehensive variation-quantified dataset for quantifying viewpoint and illumination invariance. We apply and analyse popular evaluation metrics for VPR from both the computer vision and robotics communities, and discuss how these different metrics complement and/or replace each other, depending upon the underlying applications and system requirements. Our analysis reveals that no universal SOTA VPR technique exists, since: (a) state-of-the-art (SOTA) performance is achieved by 8 out of the 10 techniques on at least one dataset, (b) SOTA technique in one community does not necessarily yield SOTA performance in the other given the differences in datasets and metrics. Furthermore, we identify key open challenges since: (c) all 10 techniques suffer greatly in perceptually-aliased and less-structured environments, (d) all techniques suffer from viewpoint variance where lateral change has less effect than 3D change, and (e) directional illumination change has more adverse effects on matching confidence than uniform illumination change. We also present detailed meta-analyses regarding the roles of varying ground-truths, platforms, application requirements and technique parameters. Finally, VPR-Bench provides a unified implementation to deploy these VPR techniques, metrics and datasets, and is extensible through templates

Are late hernia mesh complications linked to Staphylococci biofilms?

Published online: 14 March 2022Purpose: The purpose of this study was to investigate the link between bacterial biofilms and negative outcomes of hernia repair surgery. As biofilms are known to play a role in mesh-related infections, we investigated the presence of biofilms on hernia meshes, which had to be explanted due to mesh failure without showing signs of bacterial infection. Methods: In this retrospective observational study, 20 paraffin-embedded tissue sections from explanted groin hernia meshes were analysed. Meshes have been removed due to chronic pain, hernia recurrence or mesh shrinkage. The presence and bacterial composition of biofilms were determined. First, specimens were stained with fluorescence in situ hybridisation (FISH) probes, specific for Staphylococcus aureus and coagulase-negative staphylococci, and visualised by confocal laser scanning microscopy. Second, DNA was extracted from tissue and identified by S. aureus and S. epidermidis specific PCR. Results: Confocal microscopy showed evidence of bacterial biofilms on meshes in 15/20 (75.0%) samples, of which 3 were positive for S. aureus, 3 for coagulase-negative staphylococci and 9 for both species. PCR analysis identified biofilms in 17/20 (85.0%) samples, of which 4 were positive for S. aureus, 4 for S. epidermidis and 9 for both species. Combined results from FISH/microscopy and PCR identified staphylococci biofilms in 19/20 (95.0%) mesh samples. Only 1 (5.0%) mesh sample was negative for bacterial biofilm by both techniques. Conclusion: Results suggest that staphylococci biofilms may be associated with hernia repair failure. A silent, undetected biofilm infection could contribute to mesh complications, chronic pain and exacerbation of disease.P. Patiniott, A. Jacombs, L. Kaul, H. Hu, M. Warner, B. Klosterhalfen, A. Karatassas, G. Maddern, K. Richte

Beyond Controlled Environments: 3D Camera Re-Localization in Changing Indoor Scenes

Long-term camera re-localization is an important task with numerous computer vision and robotics applications. Whilst various outdoor benchmarks exist that target lighting, weather and seasonal changes, far less attention has been paid to appearance changes that occur indoors. This has led to a mismatch between popular indoor benchmarks, which focus on static scenes, and indoor environments that are of interest for many real-world applications. In this paper, we adapt 3RScan - a recently introduced indoor RGB-D dataset designed for object instance re-localization - to create RIO10, a new long-term camera re-localization benchmark focused on indoor scenes. We propose new metrics for evaluating camera re-localization and explore how state-of-the-art camera re-localizers perform according to these metrics. We also examine in detail how different types of scene change affect the performance of different methods, based on novel ways of detecting such changes in a given RGB-D frame. Our results clearly show that long-term indoor re-localization is an unsolved problem. Our benchmark and tools are publicly available at waldjohannau.github.io/RIO10Comment: ECCV 2020, project website https://waldjohannau.github.io/RIO1

Olorinab (APD371), a peripherally acting, highly selective, full agonist of the cannabinoid receptor 2, reduces colitis-induced acute and chronic visceral hypersensitivity in rodents

Published on 17 April 2021Abdominal pain is a key symptom of inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS), for which there are inadequate therapeutic options. We tested whether olorinab-a highly selective, full agonist of the cannabinoid receptor 2 (CB2)-reduced visceral hypersensitivity in models of colitis and chronic visceral hypersensitivity (CVH). In rodents, colitis was induced by intrarectal administration of nitrobenzene sulfonic acid derivatives. Control or colitis animals were administered vehicle or olorinab (3 or 30 mg/kg) twice daily by oral gavage for 5 days, starting 1 day before colitis induction. CVH mice were administered olorinab (1, 3, 10, or 30 mg/kg) twice daily by oral gavage for 5 days, starting 24 days after colitis induction. Visceral mechanosensitivity was assessed in vivo by quantifying visceromotor responses (VMR) to colorectal distension (CRD). Ex vivo afferent recordings determined colonic nociceptor firing evoked by mechanical stimuli. Colitis and CVH animals displayed significantly elevated VMRs to CRD and colonic nociceptor hypersensitivity. Olorinab treatment significantly reduced VMRs to control levels in colitis and CVH animals. Additionally, olorinab reduced nociceptor hypersensitivity in colitis and CVH states in a concentration- and CB2-dependent manner. In contrast, olorinab did not alter VMRs nor nociceptor responsiveness in control animals. CB2 mRNA was detected in colonic tissue, particularly within epithelial cells, and dorsal root ganglia, with no significant differences between healthy, colitis, and CVH states. These results demonstrate olorinab reduces visceral hypersensitivity via CB2 agonism in animal models, suggesting that olorinab may provide a novel therapy for IBD- and IBS-associated abdominal pain.Joel Castro, Sonia Garcia-Caraballo, Jessica Maddern, Gudrun Schober, Amanda Lumsden, Andrea Harrington, Shirdi Schmiel, Beatriz Lindstrom, John Adams, Stuart M. Brierle

End-to-End Learning of Driving Models with Surround-View Cameras and Route Planners

For human drivers, having rear and side-view mirrors is vital for safe driving. They deliver a more complete view of what is happening around the car. Human drivers also heavily exploit their mental map for navigation. Nonetheless, several methods have been published that learn driving models with only a front-facing camera and without a route planner. This lack of information renders the self-driving task quite intractable. We investigate the problem in a more realistic setting, which consists of a surround-view camera system with eight cameras, a route planner, and a CAN bus reader. In particular, we develop a sensor setup that provides data for a 360-degree view of the area surrounding the vehicle, the driving route to the destination, and low-level driving maneuvers (e.g. steering angle and speed) by human drivers. With such a sensor setup we collect a new driving dataset, covering diverse driving scenarios and varying weather/illumination conditions. Finally, we learn a novel driving model by integrating information from the surround-view cameras and the route planner. Two route planners are exploited: 1) by representing the planned routes on OpenStreetMap as a stack of GPS coordinates, and 2) by rendering the planned routes on TomTom Go Mobile and recording the progression into a video. Our experiments show that: 1) 360-degree surround-view cameras help avoid failures made with a single front-view camera, in particular for city driving and intersection scenarios; and 2) route planners help the driving task significantly, especially for steering angle prediction.Comment: to be published at ECCV 201

Electrolytic ablation of the rat pancreas: a feasibility trial

BACKGROUND: Pancreatic cancer is a biologically aggressive disease with less than 20% of patients suitable for a "curative" surgical resection. This, combined with the poor 5-year survival indicates that effective palliative methods for symptom relief are required. Currently there are no ablative techniques to treat pancreatic cancer in clinical use. Tissue electrolysis is the delivery of a direct current between an anode and cathode to induce localised necrosis. Electrolysis has been shown to be safe and reliable in producing hepatic tissue and tumour ablation in animal models and in a limited number of patients. This study investigates the feasibility of using electrolysis to produce localised pancreatic necrosis in a healthy rat model. METHOD: Ten rats were studied in total. Eight rats were treated with variable "doses" of coulombs, and the systemic and local effects were assessed; 2 rats were used as controls. RESULTS: Seven rats tolerated the procedure well without morbidity or mortality, and one died immediately post procedure. One control rat died on induction of anaesthesia. Serum amylase and glucose were not significantly affected. CONCLUSION: Electrolysis in the rat pancreas produced localised necrosis and appears both safe, and reproducible. This novel technique could offer significant advantages for patients with unresectable pancreatic tumours. The next stage of the study is to assess pancreatic electrolysis in a pig model, prior to human pilot studies

Single-Image Depth Prediction Makes Feature Matching Easier

Good local features improve the robustness of many 3D re-localization and multi-view reconstruction pipelines. The problem is that viewing angle and distance severely impact the recognizability of a local feature. Attempts to improve appearance invariance by choosing better local feature points or by leveraging outside information, have come with pre-requisites that made some of them impractical. In this paper, we propose a surprisingly effective enhancement to local feature extraction, which improves matching. We show that CNN-based depths inferred from single RGB images are quite helpful, despite their flaws. They allow us to pre-warp images and rectify perspective distortions, to significantly enhance SIFT and BRISK features, enabling more good matches, even when cameras are looking at the same scene but in opposite directions.Comment: 14 pages, 7 figures, accepted for publication at the European conference on computer vision (ECCV) 202