Stress reactions and health problems in hospital personnel during the COVID-19 pandemic-A longitudinal, multicenter study

Background: The overarching aim of the study was to (1) investigate how working with COVID-19 patients has impacted work environment, and (2) to identify how factors in the work environment impact adverse health outcomes among hospital personnel (HP), throughout the four waves of the pandemic. Material(s) and Method(s): In a web-based survey altogether 2472 HP participated from four large university hospitals in Norway, whereof N = 680 in April-June 2020 (T1), N = 1073 in December-January 2020/2021 (T2), N = 818 in April-May 2021 (T3), and N = 972 in December 2021-February 2022 (T4). At each time point participants reported on pandemic related work tasks, work environment and adverse health outcomes. Somatic symptoms, psychological distress, posttraumatic stress symptoms and burnout served as outcomes of multivariable linear regression models. The percentage of responders involved in ICU treatment of COVID-19 patients varied between 21% and 40% from T1-T4. Result(s): Reported stressors altered in strength during the 4 waves. Preliminary results indicate that exposure to patients with COVID-19 was associated with more frequent experience of work environmental factors. Compared to colleagues not working with patients with COVID-19 HP reported challenges related to professional competency and training, predictability in teams and work environment, manageable workload, adequate help and support for work stress management, user-friendliness of Personal Protection Equipment and infection protection safety. Furthermore, these environmental factors were associated with symptoms of psychological unhealth on at least one timepoint. Conclusion(s): The results may help guide organizational efforts to maintain professional competency and to reduce stress more efficiently among hospital personnel at different stages in response to long-term crises.

Applying blockchain technology to ensure compliance with sustainability standards in the PPE multi-tier supply chain

Because of the Covid-19 pandemic, urgent surging demand for healthcare products such as personal protective equipment (PPE) has caused significant challenges for multi-tier supply chain management. Although a given firm may predominantly focus on an arms-length solution by targeting the first-tier supplier, the firm can still struggle with extended multi-tier suppliers it cannot choose which use unsustainable practices. One key goal is compliance across various dimensions with production, environmental and labour standards across the multi-tier supply chain, a goal that blockchain technology can be applied to manage. Based on a comprehensive literature review, this research develops a system architecture of blockchain-based multi-tier sustainable supply chain management in the PPE industry designed to identify and coordinate standards in production and social and environmental sustainability in multi-tier PPE supply chains. The architecture was validated by theoretical basis, expert opinions and technical solutions. We conclude with managerial implications for implementing blockchain technology to advance sustainable multi-tier supply chain practices.

Analyzing the research trends of COVID-19 using topic modeling approach

PurposeThe COVID-19 pandemic has impacted 222 countries across the globe, with millions of people losing their lives. The threat from the virus may be assessed from the fact that most countries across the world have been forced to order partial or complete shutdown of their economies for a period of time to contain the spread of the virus. The fallout of this action manifested in loss of livelihood, migration of the labor force and severe impact on mental health due to the long duration of confinement to homes or residences.Design/methodology/approachThe current study identifies the focus areas of the research conducted on the COVID-19 pandemic. s of papers on the subject were collated from the SCOPUS database for the period December 2019 to June 2020. The collected sample data (after preprocessing) was analyzed using Topic Modeling with Latent Dirichlet Allocation.FindingsBased on the research papers published within the mentioned timeframe, the study identifies the 10 most prominent topics that formed the area of interest for the COVID-19 pandemic research.Originality/valueWhile similar studies exist, no other work has used topic modeling to comprehensively analyze the COVID-19 literature by considering diverse fields and domains.

Connecting the Dots for Pharma

A major driver for innovation within the bio/pharma sector has been the COVID-19 pandemic, which propelled advances such as the approval of messenger RNA (mRNA) vaccines at record-breaking speeds and led to many companies pivoting to deal with the urgent requirements for capacity and supply chain flexibility needed to overcome pandemic challenges. "Before deciding on a location, we conducted extensive market research, and it quickly became clear, just by the sheer proximity of so many biopharmaceutical companies, associations, and research centres, that the event had to be in Geneva. Organized as four half-days, they will each address a theme related to the four main areas of the supply chain present in the exhibition area: pharmaceutical packaging (primary and secondary), medical devices, pharmaceutical sub-contracting, and pharmaceutical equipment. The dream scenario, the real measure of success, is when a product comes to market that happened as a result of a meeting or discussion that took place at our event.

Learning Regulatory Lessons in Times of a Crisis

The bio/pharma sector is an industry that has probably been most affected by the pandemic, not only is there an expectation for bio/pharma companies to step up and develop appropriate treatments quickly, resulting in regulatory flexibility and unprecedented collaborations, but there have also been concerns around supply chain security. Agencies have prioritized protocol consultations, shortened the timelines for clinical trial application review and approvals, and there is some focus on implementing fast-track and priority review processes for the evaluation of marketing authorization applications. Marton (Arriello): Authorities that have more experience in evaluation of data adapted quickly, while other authorities, such as those in the Commonwealth of Independent States area, stopped all activities for a period of time or adapted along the way. Gross (ProductLife): There is already some cooperation between the US and Europe, especially in the regulatory development process and in the evaluation process, so it's possible the current situation could reinforce those efforts and lead to some further joint assessments for clinical trial protocols and marketing authorization reviews.

Factors Influencing Work Satisfaction and Compliance of Using Ppe among Shop Assistants during Covid-19

Objectives: The objectives of the study was to assess the level of work satisfaction, assess compliance of using PPE among shop assistants during COVID-19 and to find the factors influencing work satisfaction. Method(s): A quantitative approach with descriptive design was used for the study. Eighty samples were selected by using convenient sampling technique. The study was conducted in 4 districts of Kerala through online platform as well as through offline mediums. Result(s): From the study, it is evident that majority of the subjects (55%) were satisfied with their work at the time of COVID-19 and more than half (55%) of the samples have enough compliance with the use of PPE and only 7.5% have less compliance with the use of PPE. Demographic variables such age, relationship status, and work experience were found to be statically significant (p<0.05) with work satisfaction, and other variables did not have a significant association. Conclusion(s): This study provides a baseline for assessing the level of work satisfaction and compliance of PPE among shop assistants in selected areas. Periodic reinforcements, proper education, availability and trainings on the use of PPE can reduce the spread of Corona Virus and improve PPE compliance to an extend. Good working environment support from family and good rapport with colleagues can help to improve work satisfaction .Copyright © 2023 The Authors.

The Pandemic as a Catalyst for Digital Pathology Adoption as an LDT

Whole-slide images (WSI) are the basis for the application of artificial intelligence/machine learning and other informatics methods to histological diagnosis and will further blur the line separating anatomic and clinical pathology. FDA classified WSI systems for primary diagnosis as class III (highest risk) medical devices until 2017. This discouraged anatomic pathology laboratories at risk-averse domestic institutions like mine from investing in these digital pathology (DP) platforms. In 2017, FDA downgraded WSI to class II (moderate risk) when they de-novo approved a system marketed by Philips. We were not interested in that system at my institution, but the downgrade caused us to reset our perception of the risk of validating a RUO system for primary diagnosis. Cost remained a barrier. In April 2020, FDA issued temporary guidance stating they would not enforce premarket approval of WSI systems to facilitate pathologists working remotely during the SARS-CoV-2 pandemic. The guidance included a statement that "laboratories and hospitals consider performing a validation study.” In January 2021, FDA proposed making the temporary non-enforcement guidance permanent. So, in a little more than three years, WSI for primary diagnosis had gone from class III to exempted from pre-market approval! This nicely aligned the approval framework for WSI with the approval framework for our conventional optical microscopes, which are statutorily exempted from approval, and further reset our perception of risk. In April 2021, FDA withdrew the proposal to make non-enforcement permanent, but the temporary non-enforcement guidance is still in effect at the time of writing. Amid all this FDA activity, the College of American Pathologists updated and reissued their consensus guidelines for validating WSI systems for diagnostic purposes in March 2021. The narrative mentions the FDA's recent approval of a few WSI systems and anticipates more, but the expert panel recommendations do not include any related to the approval status of systems. The reissue of this document reminded us that, as clinical laboratorians, we are capable of safely validating WSI as a laboratory-developed test and are supported in doing so by consensus guidelines from one of our leading professional organizations. In early 2021 we committed to funding a DP initiative to make WSI part of our routine histological process for 10% of our anatomic pathology cases. The initial capital investment is $1.5M. When realized, the microscope slides for designated pathology services will be transported directly from the cover slipper to a slide scanner and electronically distributed to pathologists using a clinical-grade image management system that we share with our radiology department. We made the decision to fund this in the context of the regulatory (decreased perception of risk), sociological (demand for remote telepathology), and technological (availability of scalable WSI systems) changes that occurred during the pandemic.

Rapid exchange of a percutaneous gastrostomy tube during an early episode of COVID-19

We retrospectively report a case of rapid exchange of a percutaneous radiologic gastrostomy tube (balloon-occluded type catheter) via off-label use of a pigtail catheter for nutrition supply during a very early episode of coronavirus disease 2019 (COVID-19) in an outpatient clinic. This case demonstrates that minimally invasive percutaneous procedures might be provided safely and effectively under appropriate precautions for preventing COVID-19 transmission during the pandemic.Copyright © 2023, Society of Gastrointestinal Intervention.

Face Mask Detector for Raspberry Pi Based on Computer Vision and Edge Computing

The pandemic of the coronavirus disease 2019 has shown weakness and threats in various fields of human activity. In turn, the World Health Organization has recommended different preventive measures to decrease the spreading of coronavirus. Nonetheless, the world community ought to be ready for worldwide pandemics in the closest future. One of the most productive approaches to prevent spreading the virus is still using a face mask. This case has required staff who would verify visitors in public areas to wear masks. The aim of this paper was to identify persons remotely who wore masks or not, and also inform the personnel about the status through the message queuing telemetry transport as soon as possible using the edge computing paradigm. To solve this problem, we proposed to use the Raspberry Pi with a camera as an edge device, as well as the TensorFlow framework for pre-processing data at the edge. The offered system is developed as a system that could be introduced into the entrance of public areas. Experimental results have shown that the proposed approach was able to optimize network traffic and detect persons without masks. This study can be applied to various closed and public areas for monitoring situations. © 2022 Copyright for this paper by its authors. Use permitted under Creative Commons License Attribution 4.0 International (CC BY 4.0).

The UK's public health response to covid-19

Too little, too late, too flawed

A Project to Distribute Personal Protective Equipment to Homecare Agencies during the COVID-19 Pandemic: Its Association with the Sense of Security Improvement among Homecare Nurses/Helpers

During the early period of COVID-19 pandemic, there was a serious shortage of personal protective equipments (PPEs), which caused difficulty in homecare agencies to make home visits to those (possible) positive COVID-19 cases. An organization with the help of several foundations started a special program to distribute PPEs to those agencies in which there was a possible case or those cases that had close contact with the positive cases. This study examined whether this voluntary activity contributed to increasing the sense of security in providing care among homecare workers. We conducted a survey with homecare agencies that received PPEs from the program between July 2020 and February 2021. The participants were agency managers who applied for PPEs. We conducted the survey twice, before and after receiving PPEs. In the questionnaire, we asked about the overall sense of security in providing care for those infected with COVID-19, reasons for applying for PPE, symptoms of the client or his/her family who caused the PPE request, and the agency's and clients' characteristics. We analyzed the data from 802 responses. Before PPE distribution, the sense of security was associated with the focal client having a cognitive impairment (β = −0.096), having cough (β = −0.088), fatigue (β = −0.085), or headache (β = −0.078). Agencies that did not visits those (possibly) positive cases (β = −0.123) had lower sense of security. Overall, the mean sense of security increased after receiving PPE. Factors that contributed to the increase in sense of security included a lower sense of security before the application (β = −0.529), visiting clients without dyspnoea (β = −0.109), the agency that did not visit positive cases before the application (β = −0.089), and with higher satisfaction with the days of PPEs received (β = 0.144). These results underline the benefit of the special PPsE distribution program.

COVID-19 and The Surgical Neonate

COVID-19 pandemic in 2020-2021 affected millions of people including children. Though uncommon, there are few reports of COVID in neonates also. COVID is primarily managed by pediatricians;however, they are involved when providing anesthesia to these neonates for surgery. The role of anesthetists, besides during surgery, has proven to be vital in COVID pandemic for their expertise in airway and ventilatory management, also putting them to the highest risk of exposure. Various testing methods are available, and TrueNAT and RTPCR have emerged as most reliable. Most neonates remain asymptomatic or have mild symptoms;however, RTPCR testing should be done in all at least 72 h of preoperative. Utmost care should be taken during the preoperative evaluation, and in the perioperative period, goal is to prevent transmission of COVID to noninfected HCW involved in the perioperative period, to other newborns and neonates, and also to avoid increasing the severity of the diseases in the positive neonates, while keeping in mind the vulnerability of these babies in combination with their surgical disease and the changing neonatal physiology. COVID care protocols should be followed at all times. Anesthetic considerations remain the same as described in other chapters in the book, in newborns and neonates, both term and preterm. All OT personnel need to don the PPE, which can be problematic especially for the anesthetist, as it restricts the normal unhindered movements, use of stethoscope for chest auscultation for heart rate, respiration, and ETT positioning. Hence, one needs to be very meticulous in IV line and ET placement and their securing to prevent accidental dislodging during positioning and under the drapes. All disposable and non-disposable equipment used for the covid positive baby, should be adequately treated or discarded, as the case may be, after each surgery. Only emergency surgery should be undertaken in COVID-positive neonates to prevent high postoperative morbidity and mortality. There is not much data available in neonates, and most guidelines have been introduced for children and adolescents. Neonatal care has emerged from the experience of the anesthesiologist and from extrapolation of the available pediatric guidelines. Here, we will be discussing COVID in neonates and anesthetic management in COVID-positive neonates undergoing surgery. © The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd. 2023.

Covid-19 disruption, resilience and industrial policy: the automotive sector in the West Midlands

The Covid-19 pandemic and Brexit have focused attention on the resilience of key sectors and firms. This paper explores the financial resilience of the 50 largest automotive firms in the West Midlands region of the UK in their response to disruption and economic shocks. The findings demonstrate that 22 firms are at high risk due to poor current liquidity ratios, with Coventry and Birmingham emerging as locations most susceptible to firm closures. High-risk firms include key flagship original equipment manufacturers operating at the downstream end of supply chains. If these firms were to fail, there would be a significant destructive impact on both the industry and the local economy. We assert an effective subnational industrial policy is required in order to support economic resilience in regions such as the West Midlands where a few firms account for a disproportionate share of employment and value-added.

Effect of COVID-19 Pandemic on Awareness on Prevention of Spread of Infective Respiratory Secretions among Resident Doctors

Introduction: Respiratory infections including Coronavirus Disease-2019 (COVID-19) infection spread through droplet infections. Hence standard precautionary measures like handwashing and use of masks are essential to prevent transmission of these infections in healthcare setting. Aim: To determine the effect of COVID-19 pandemic on awareness level of resident doctors on prevention of spread of infective respiratory secretions. Materials and Methods: This cross-sectional study was conducted among two subsequent batches (year 2019-20 and 2020-21) of resident doctors at a medical college hospital, from February 2020 to September 2020. The 2019-2020 batch of resident doctors worked as residents from March 2019 to March 2020 and were considered as pre-COVID-19 batch. The 2020-2021 batch of resident doctors had their training period from April 2020 to April 2021 and were considered the COVID-19 batch. A pretested semi-structured questionnaire consisting of 14 questions to evaluate the awareness on prevention of spread of infective respiratory secretions was administered. The responses were evaluated, marks awarded and summated. Results: The response rate of pre-COVID-19 batch was 85% and that of COVID-19 batch was 86%. The mean (standard deviation) score obtained by the COVID-19 batch was 9.91 +/- 3.42 which was significant higher than that obtained by the pre-COVID-19 batch which was 7.1 +/- 1.83. The score obtained by COVID-19 batch for 11/14 questions was significantly higher compared to the pre-COVID-19 batch. Conclusion: A significant improvement was seen in the knowledge level in prevention of spread of infective respiratory secretions among resident doctors after the onset of the COVID-19 pandemic.

Protecting the NHS from Cyber Attacks

Given that cyber security underwrites public trust in digital services and technologies, the new cyber strategy sets out a vision for reducing the cyber security risk to health and social care organizations across the Department of Health and Social Care (DHSC), National Health Service (NHS) organizations, local authorities, independent social care providers, and suppliers-which includes pharmaceutical manufacturers. [...]attacks can cause a complete loss of access to clinical and administrative information technology (IT) systems, resulting in significant disruption in day-to-day operations. According to the NCSC, ransomware attacks are increasingly seen to include data theft and extortion with a threat of data leaks (3). According to the UK government's recently published policy paper outlining the new cyber security strategy, "all these threats pose risk not just to patient and staff safety, but also to public trust in a health and social care system that can and must safeguard people's data" (2).

Enhanced Role of EMA in EU Crisis Response

The regulation also sets out obligations on marketing authorization holders (MAHs) and medical devices manufacturers, authorized representatives, importers, distributors, and notified bodies duties to: * Provide information that will assist with the monitoring by the MSSG/MDSSG of shortages of medicinal products and devices contained in the critical medicines list and updating this when necessary * Provide a justification for any failure to provide the requested information by the established deadlines * Immediately provide any evidence of an actual or potential shortage of medicinal products or devices * Provide information to EMA by 2 Sep. 2022 that will enable the establishment of a Single Point of Contact (SPOC) network, and the industry Single Point of Contact (iSPOC) network, with mandates to updating this when necessary (7). Enhanced advisory role In addition to the measures designed to address medicinal and medical device shortages, an Emergency Task Force (ETF) will also be established within EMA to provide scientific advice and review evidence on medicines that have the potential to address public health emergencies, offer scientific support to facilitate clinical trials, and support existing EMA committees with their authorization and safety monitoring of medicines (8). According to the document published by EMA on Crisis Preparedness and Management, the key benefits for EMA of having these responsibilities include: * Accelerated evaluation and access to safe and effective medicines which could treat or prevent a disease causing, or likely to cause, a public health emergency * Improved quality of data and the effective use of resources through increased support at EU level towards the conducting of clinical trials in preparation for, and during a public health emergency * Improved coordination and harmonization at EU level in preparation for and during a public health emergency (7).

NEW STRUCTURES TO TACKLE NEW CHALLENGES IN EUROPEAN HEALTHCARE

At the official level, the EU has already acknowledged the need for some closer alignment between its distinct but overlapping institutions, with the emergence of declarations of intent to create a European Health Union and promises of a radical review of EU rules on pharmaceuticals-all predating the arrival of COVID's additional impact of concentrating minds. [...]there is support within the European Parliament and the European Commission for more ambitious official EU engagement in health policy and a corresponding extension of EU competences into traditionally national government territory-although as a telling demonstration of the sort of divisions that dominate Europe, this is viewed by many of the member states in the EU's Council with extreme caution and has even provoked some downright resistance. According to its just-released manifesto, collaboration is needed between European policymakers, member states, and all other actors across the health community-and even more so in the wake of COVID.

EU PLANNING TO RESPOND EU PLANNING TO RESPOND SMARTER REGULATION BY 2025

The results should be greater leverage of non-clinical models and optimized capabilities in modeling, simulation, and extrapolation, as well as investment in initiatives for special populations, and the conduct of environmental risk assessments in line with the latest scientific knowledge. "Developments in basic science, in medicine, in information technology, and data analytics in particular, continue to pour forth at an astonishing rate," the agenda says, and the network "must have the capacity and knowledge to regulate new types of medicine, making them available to pa- tients with unmet needs while continuing to ensure that any risks are outweighed overall by the benefits." Inevitably, the experience of the pandemic will play into the planning-as will the EU's specific health plans announced in recent months, including its new "EU4Health" health program and the so-called "rescEU" program to build a strategic European reserve of critical medicines and to encourage production of active pharmaceutical ingredients in Europe.

Manufacturing Innovation

(ProQuest: ... denotes non-USASCII text omitted.) The annual Global Innovation Index released in September 2021 ranked China twelfth, surpassing developed economies such as Japan, Israel, and Canada and raising fears in the United States amidst sluggish growth in North America and strong growth in the Asia Pacific region.1 Interestingly, the United States government responded by boycotting the Beijing Olympic Games, citing human rights abuses as the main reason.2 A tech war between China and the United States brewed beneath the diplomatic rancor over the attendance at the Olympic Games. Part I documents how the United States has assisted China's tech and intellectual property domination through President Nixon's historic visit to China, giving China Most Favorite Nation (MFN) status and ascending China to the World Trade Organization (WTO). [...]under Deng Xiaoping's leadership during the reform period, China rapidly developed its special economic zones (SEZs), laying the foundation for subsequent tech innovation and production. [...]broadcasting, telecommunications, office machines, computers, integrated circuits, and cell phones are among China's notable exports to the world.9 China dominates in commodities and raw materials, exporting refined petroleum, cotton, plywood, and tea.10 For agricultural products, China occupies the perch as the world's largest producer. Shenzhen rose as the largest among the four.18 Shenzhen, a small fishing locale in the southern part of China's southern province, Guangdong, served as the pioneer of Deng Xiaoping's embrace of economic reforms.19 A market-oriented economy took root in Shenzhen, allowing foreign companies and entities from Hong Kong and Macau to operate and allowing Chinese talents the freedom to leave their hometowns and move into the SEZs.20 Cheap labor proved to be another significant factor facilitating China's rise as a global manufacturer.21 In the 1980s, multinational corporations from Taiwan, Japan, and South Korea, as well as domestic Chinese companies, opened their factories in the SEZs and other cities in China to take advantage of the cheap and plentiful labor force.22 Indeed, when Deng Xiaoping began his pilot SEZs, China's young workers who wished to lift themselves out of poverty descended into the economic zones in search of better opportunities.23 Shenzhen grew from a population of 59,000 in 1980 to a population of 12,357,000 in 2020.24 The new migrants became the workers, participants, and stakeholders in the global manufacturing frontier.25 Because of the abundance of cheap labor, manufacturers in China have no difficulty keeping production prices low and pleasing consumers and businesses worldwide.26 China's currency manipulation is another factor propelling China to its domination in global manufacturing.27 The United States Congress attempted numerous times to introduce legislation to combat China's currency manipulation.28 China artificially devalued its currency through government control of the exchange rate and refused to let the Chinese Renminbi (RMB) float.29 Despite strong criticisms from the United States, China refuses to allow its currency to freely float.30 China's currency manipulations, according to critics, caused the widening of trade deficits between the United States and China.31 China's currency manipulation allows products to be manufactured at lower prices, hampering competitors and thereafter replacing them.32 In order to cope with China's currency practices, United States manufacturers facing their own existential crises must decide to either outsource jobs overseas or face large risks, including financial ruin.33 The United States lost millions of manufacturing jobs due to massive job outsourcing as the trade deficits between the United States and China continued to persist.34 Geopolitically, in shaping post-Cold-War powers, the United States decided to assist China in its transformation from a poverty-stricken country to a global manufacturer.