It has previously been found that, compared with cigarette smoke, the aerosols generated by heated tobacco products contain fewer and lower harmful and potentially harmful constituents (HPHCs) and elicit lower biological activity in in vitro models and lower smoking-related exposure biomarker levels in clinical studies. It is important to accumulate such scientific evidences for heated tobacco products with a novel heating system, because different heating system may affect the quantitative aspect of the amount of HPHCs and the qualitative aspect of the biological activity of the aerosol generated. Here, the chemical properties of, and toxicological responses to aerosols emitted by DT3.0a, a new heated tobacco product with a novel heating system, and cigarette smoke (CS) were compared, using chemical analyses, in vitro battery (standardized genotoxicity and cytotoxicity) assays, and mechanistic (ToxTracker and two-dimensional cell culture) assays. Regular- and menthol-flavored DT3.0a and standard 1R6F reference cigarettes were tested. Selected HPHC yields were lower in DT3.0a aerosol than 1R6F CS. The genotoxicity-related assays indicated that DT3.0a aerosol was not genotoxic, regardless of metabolic activation. The other biological assays indicated that less cytotoxicity induction and oxidative stress response were elicited by DT3.0a aerosol compared with 1R6F CS. Similar results were found for both regular and menthol DT3.0a. Like previous reports for heated tobacco products with other heating systems, the results of this study indicated that DT3.0a aerosols have chemical and biological properties less likely to be harmful than 1R6F CS.

A face shield is a secondary personal protective equipment (PPE) for healthcare workers (HCW). Worn with the appropriate face masks/respirators, it provides short term barrier protection against potentially infectious droplet particles. Coronavirus disease 2019 (COVID-19) caused a spike in demand for PPE, leading to a shortage and risking the safety of HCW. Transport restrictions further challenged the existing PPE supply chain which has been reliant on overseas-based manufacturers. Despite the urgency in demand, PPE must be properly tested for functionality and quality. We describe the establishment of local face shields manufacture in Western Australia to ensure adequate PPE for HCW. Ten thousand face shields for general use (standard) and for ear, nose and throat (ENT) specialist use were produced. Materials and design considerations are described, and the face shields were vigorously tested to the relevant Standards to ensure their effectiveness as a protective barrier, including splash and impact resistance. Comparative testing with traditional and other novel face shields was also undertaken. Therapeutic Goods Administration (TGA) licence was obtained to manufacture and supply the face shields as a Class I medical device. The swiftness of process is a credit to collaboration from industry, academia and healthcare.

The EU In-Vitro Diagnostic Device Regulation (IVDR) aims for transparent risk-and purpose-based validation of diagnostic devices, traceability of results to uniquely identified devices, and post-market surveillance. The IVDR regulates design, manufacture and putting into use of devices, but not medical services using these devices. In the absence of suitable commercial devices, the laboratory can resort to laboratory-developed tests (LDT) for in-house use. Documentary obligations (IVDR Art 5.5), the performance and safety specifications of ANNEX I, and development and manufacture under an ISO 15189-equivalent quality system apply. LDTs serve specific clinical needs, often for low volume niche applications, or correspond to the translational phase of new tests and treatments, often extremely relevant for patient care. As some commercial tests may disappear with the IVDR roll-out, many will require urgent LDT replacement. The workload will also depend on which modifications to commercial tests turns them into an LDT, and on how national legislators and competent authorities (CA) will handle new competences and responsibilities. We discuss appropriate interpretation of ISO 15189 to cover IVDR requirements. Selected cases illustrate LDT implementation covering medical needs with commensurate management of risk emanating from intended use and/or design of devices. Unintended collateral damage of the IVDR comprises loss of non-profitable niche applications, increases of costs and wasted resources, and migration of innovative research to more cost-efficient environments. Taking into account local specifics, the legislative framework should reduce the burden on and associated opportunity costs for the health care system, by making diligent use of existing frameworks.

UNASSIGNED: Verifying new reagent or calibrator lots is crucial for maintaining consistent test performance. The Institute for Quality Management in Healthcare (IQMH) conducted a patterns-of-practice survey and follow-up case study to collect information on lot verification practices in Ontario.
UNASSIGNED: The survey had 17 multiple-choice questions and was distributed to 183 licensed laboratories. Participants provided information on materials used and approval/rejection criteria for their lot verification procedures for eight classes of testing systems. The case study provided a set of lot comparison data and was distributed to 132 laboratories. Responses were reviewed by IQMH scientific committees.
UNASSIGNED: Of the 175 laboratories that responded regarding reagent lot verifications, 74% verified all tests, 11% some, and 15% none. Of the 171 laboratories that responded regarding calibrator lot verifications, 39% verified all calibrators, 4% some, and 57% none. Reasons for not performing verifications ranged from difficulty performing parallel testing to high reagent cost. For automated chemistry assays and immunoassays, 23% of laboratories did not include patient-derived materials in reagent lot verifications and 42% included five to six patient materials; 58% of laboratories did not include patient-derived materials in calibrator lot verifications and 23% included five to six patient materials. Different combinations of test-specific rules were used for acceptance criteria. For a failed lot, 98% of laboratories would investigate further and take corrective actions. Forty-three percent of laboratories would accept the new reagent lot in the case study.
UNASSIGNED: Responses to the survey and case study demonstrated variability in lot verification practices among laboratories.

UNASSIGNED: Even after decades of intensive research, an ideal heart valve prosthesis remains elusive. Shortcomings of conventional devices include reduced durability of bioprostheses and the thrombogenicity of mechanical substitutes, necessitating anticoagulation and resulting in imperfect hemodynamics. Here we present in vivo results of a novel mechanical heart valve prosthesis aiming for freedom from anticoagulation.
UNASSIGNED: Four female sheep had their aortic valves replaced using the novel mechanical heart valve (size 21 mm), with no postoperative anticoagulation treatment. This trileaflet heart valve was designed with the pivots in the systolic central flow. Hemodynamics, biochemistry, hematology, and macroscopy and microscopy were studied at 90 days in 2 sheep and at 1 year in the other 2 sheep.
UNASSIGNED: Mean (<6 mm Hg) and peak (<10 mm Hg) aortic transvalvular gradients remained low during the study period. Aortic regurgitation was trivial, and central traces were only rarely observed. The rate of thrombotic events was very low, with none macroscopically and microscopically visible thrombotic material on the device. Biochemistry and hemotology were unchanged without hemolysis. In 3 sheep, the fibrous pannus and mitral leaflet were partially folded over the edge of the annular body. Apart from organic/inorganic deposits on the leaflets after 1 year, the ultrastructurally evaluated leaflets were similar to those of nonimplanted controls.
UNASSIGNED: The preliminary in vivo results of this novel anticoagulation-free aortic mechanical heart valve are promising with excellent hemodynamics and a very low risk of thrombotic events.

Multiple sclerosis (MS) is an inflammatory autoimmune disease associated with genetic and environmental factors. Cigarette smoking is harmful to health and may be one of the risk factors for MS. However, there have been no systematic investigations under controlled experimental conditions linking cigarette smoke (CS) and MS. The present study is the first inhalation study to correlate the pre-clinical and pathological manifestations affected by different doses of CS exposure in a mouse experimental autoimmune encephalomyelitis (EAE) model. Female C57BL/6 mice were whole-body exposed to either fresh air (sham) or three concentrations of CS from a reference cigarette (3R4F) for 2 weeks before and 4 weeks after EAE induction. The effects of exposure on body weight, clinical symptoms, spinal cord pathology, and serum biochemicals were then assessed. Exposure to low and medium concentrations of CS exacerbated the severity of symptoms and spinal cord pathology, while the high concentration had no effect relative to sham exposure in mice with EAE. Interestingly, the clinical chemistry parameters for metabolic profile as well as liver and renal function (e.g. triglycerides and creatinine levels, alkaline phosphatase activity) were lower in these mice than in naïve controls. Although the mouse EAE model does not fully recapitulate the pathology or symptoms of MS in humans, these findings largely corroborate previous epidemiological findings that exposure to CS can worsen the symptoms and pathology of MS. Furthermore, the study newly highlights the possible correlation of clinical chemistry findings such as metabolism and liver and renal function between MS patients and EAE mice.

To date, skin wounds are still an issue for healthcare professionals. Although numerous approaches have been developed over the years for skin regeneration, recent advances in regenerative medicine offer very promising strategies for the fabrication of artificial skin substitutes, including 3D bioprinting, electrospinning or spraying, among others. In particular, skin sprays are an innovative technique still under clinical evaluation that show great potential for the delivery of cells and hydrogels to treat acute and chronic wounds. Skin sprays present significant advantages compared to conventional treatments for wound healing, such as the facility of application, the possibility to treat large wound areas, or the homogeneous distribution of the sprayed material. In this article, we review the latest advances in this technology, giving a detailed description of investigational and currently commercially available acellular and cellular skin spray products, used for a variety of diseases and applying different experimental materials. Moreover, as skin sprays products are subjected to different classifications, we also explain the regulatory pathways for their commercialization and include the main clinical trials for different skin diseases and their treatment conditions. Finally, we argue and suggest possible future trends for the biotechnology of skin sprays for a better use in clinical dermatology.

A growing number of public health bodies, regulators and governments around the world consider electronic vapor products a lower risk alternative to conventional cigarettes. Of critical importance are rapid new approach methodologies to enable the screening of next generation products (NGPs) also known as next generation tobacco and nicotine products. In this study, the activity of conventional cigarette (3R4F) smoke and a range of NGP aerosols (heated tobacco product, hybrid product and electronic vapor product) captured in phosphate buffered saline, were screened by exposing a panel of human cell-based model systems using Biologically Multiplexed Activity Profiling (BioMAP® Diversity PLUS® Panel, Eurofins Discovery). Following exposure, the biological activity for a wide range of biomarkers in the BioMAP panel were compared to determine the presence of toxicity signatures that are associated with specific clinical findings. NGP aerosols were found to be weakly active in the BioMAP Diversity PLUS Panel (≤3/148 biomarkers) whereas significant activity was observed for 3R4F (22/148 biomarkers). Toxicity associated biomarker signatures for 3R4F included immunosuppression, skin irritation and thrombosis, with no toxicity signatures seen for the NGPs. BioMAP profiling could effectively be used to differentiate between complex mixtures of cigarette smoke or NGP aerosol extracts in a panel of human primary cell-based assays. Clinical validation of these results will be critical for confirming the utility of BioMAP for screening NGPs for potential adverse human effects.

Smoking is a cause of serious diseases in smokers including chronic respiratory diseases. This study aimed to evaluate the tobacco harm reduction (THR) potential of an electronic vapor product (EVP, myblu™) compared to a Kentucky Reference Cigarette (3R4F), and assessed endpoints related to chronic respiratory diseases. Endpoints included: cytotoxicity, barrier integrity (TEER), cilia function, immunohistochemistry, and pro-inflammatory markers. In order to more closely represent the user exposure scenario, we have employed the in vitro 3D organotypic model of human airway epithelium (MucilAir™, Epithelix) for respiratory assessment. The model was repeatedly exposed to either whole aerosol of the EVP, or whole 3R4F smoke, at the air liquid interface (ALI), for 4 weeks to either 30, 60 or 90 puffs on 3-exposure-per-week basis. 3R4F smoke generation used the ISO 20778:2018 regime and EVP aerosol used the ISO 20768:2018 vaping regime. Exposure to undiluted whole EVP aerosol did not trigger any significant changes in the level of pro-inflammatory mediators, cilia beating function, barrier integrity and cytotoxicity when compared with air controls. In contrast, exposure to diluted (1:17) whole cigarette smoke caused significant changes to all the endpoints mentioned above. To our knowledge, this is the first study evaluating the effects of repeated whole cigarette smoke and whole EVP aerosol exposure to a 3D lung model at the ALI. Our results add to the growing body of scientific literature supporting the THR potential of EVPs relative to combustible cigarettes and the applicability of the 3D lung models in human-relevant product risk assessments.

UNASSIGNED: Besides diagnostic imaging devices, in particular computed tomography (CT) and magnetic resonance imaging (MRI), numerous reading workstations contribute to the high energy consumption of radiological departments. It was investigated whether switching off workstations after core working hours can relevantly lower energy consumption considering both ecological and economical aspects.
UNASSIGNED: Besides calculating different theoretical energy consumption scenarios, we measured power consumption of 3 workstations in our department over a 6-month period under routine working conditions and another 6-month period during which users were asked to switch off workstations after work. Staff costs arising from restarting workstations manually were calculated.
UNASSIGNED: Our approach to switching off workstations after core working hours reduced energy consumption by about 5.6 %, corresponding to an extrapolated saving of 3.2 tons in carbon dioxide (CO2) emissions and 2100.70 USD/year in electricity costs for 227 workstations. Theoretical calculations indicate that consistent automatic shutdown after core working hours could result in a potential total reduction of energy consumption of 38.6 %, equaling 22.2 tons of CO2 and 14,388.28 USD/year. However, staff costs resulting from waiting times after manually restarting workstations would amount to 36,280.02 USD/year.
UNASSIGNED: Switching off workstations after core working hours can considerably reduce energy consumption and costs, but varies with user adherence. Staff costs caused by waiting time after manually starting up workstations outweigh energy savings by far. Therefore, an energy-saving plan with automated shutdown/restart besides enabling an energy-saving mode would be the most effective way of saving both energy and costs.