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AimThere are no studies comparing tests performed at home with those carried out in the laboratory, using the same device. The only studies that have been performed have compared the device used at home with the standard polygraph used in the laboratory. The purpose of this study was therefore to verify the accuracy of the home diagnosis of obstructive sleep apnea syndrome (OSAS) via unassisted type 2 portable polysomnography, compared with polysomnography using the same equipment in a sleep laboratory.MethodsTo avoid any possible order effect on the apnea-hypopnea index (AHI), we randomly created two groups of 20—total 40 patients, according to the test sequence. One of the groups had the first test at home and the second test in the laboratory (H-L); the other group had the first test in the laboratory and the second at home (L-H). The second test always took place on the night immediately following the first test. All polysomnographic monitoring was undertaken with the same equipment, an Embletta X100 system (Embla, Natus Inc., Middleton, USA). The Embletta X100 is a portable polygraph that records eleven polygraph signs: (1) electroencephalogram C4/A; (2) electroencephalogram O2/M1; (3) submental EMG; (4) electrooculogram of the right side; (5) nasal cannula (air flow); (6) respiratory effort against a plethysmographic chest strap; (7) respiratory effort against an abdominal plethysmographic belt; (8) heart rate; (9) saturation of oxyhemoglobin; (10) snoring; and (11) body position.ResultsThere was no difference in sleep efficiency between the group monitored in the laboratory and the group tested at home (p = 0.30). There was no difference in total sleep time (p = 0.11) or sleep latency (p = 0.52), or in the latency in phases N2 and N3 between the monitoring in the laboratory and at home (N2 p = 0.24; N3 p = 0.09). Some differences occurred regarding the PSG that took place at home, with longer duration of wake after sleep onset (WASO) and longer latency for REM sleep, due to failure of the patient to start the monitoring by pressing the “events” button on the device. In the distribution of sleep phases, there was no difference between the group monitored in the laboratory and the group tested at home.ConclusionResults from home sleep monitoring correlate well with the laboratory “gold standard” and may be an option for diagnosing OSAS in selected patients.

The regulation of medical devices and In Vitro Diagnostic (IVD) medical devices have lagged significantly, especially in low- and middle-income countries. Disparities in regulating medical and IVD medical devices in Africa are below the global average. This may translate to poor access to quality-assured medical and IVD devices, resulting in undesirable health outcomes. Operational readiness to regulate medical and IVD devices at the Medicines Control Authority of Zimbabwe (MCAZ) was assessed. The aim was to determine the strengths and gaps and propose an action plan that can be monitored and evaluated to assess progress over time. We used the World Health Organization (WHO) Global Benchmarking Tool for medical devices and IVDs methodology to evaluate regulatory oversight of these products. Purposive sampling was used for data collection using researcher-administered global benchmarking tool factsheets and document reviews to evaluate the implementation of the regulatory functions. The regulatory functions assessed were the National Regulatory System, Registration and Market Authorization, Vigilance, Market Surveillance and Control, Licensing Establishment, Regulatory Inspection, Laboratory Testing, and Clinical Trials Oversight. The MCAZ attained maturity level 1, with a regulatory system score of 79%, registration and market authorization 44%, vigilance 27%, market surveillance and control 40%, licensing establishment 62%, regulatory inspection 68%, laboratory testing 88%, and clinical trials 18%. Condoms and gloves were the only regulated medical devices in Zimbabwe. IVDs were not regulated by the MCAZ. This review showed that the regulatory system is not robust, fit for purpose, responsive, transparent, or proportionate to the risk classification of medical devices and IVDs. It is crucial to amend the Medicines and Allied Substance Control Act to incorporate the definition and classification of medical devices and IVDs, regulatory authority establishment, licensing and registration, quality management system, conformity assessment, post-market surveillance, labeling and instructions for use, capacity building and training, and international harmonization.

Abstract The recent SARS-CoV-2 outbreak has placed immense pressure on supply chains, including shortages in nasopharyngeal (NP) swabs. Here, we report our experience of using 3D-printing to rapidly develop and deploy custom-made NP swabs to address supply shortages at our healthcare institution.

In recent years, the increasing availability of instruments and laboratory tests has significantly influenced the diagnostic work in primary healthcare. This study aimed to map the availability of diagnostic equipment and point-of-care tests (POCTs) in Norwegian emergency primary healthcare clinics and examine the demographic and organisational factors influencing their availability. This cross-sectional study utilised the National Out-of-Hours Services Registry (NOOHR) survey across all Norwegian emergency primary healthcare clinics in early 2024. Clinic managers provided data on diagnostic equipment and POCTs. Clinics were categorised by population size, hospital proximity, co-location with general practitioner (GP) offices, and total equipment available. All 167 Norwegian emergency primary healthcare clinics responded. The median number of diagnostic equipment and POCTs was 17 (Interquartile range (IQR) 16-20). Clinics with the most equipment were often smaller, co-located with a GP office, and over 40 km from a hospital. Almost all clinics had a repertoire of CRP, urinary dipstick, haemoglobin, glucose, strep A test, SARS-CoV-2 rapid test, urinary HCG test, pulse oximeter, and ECG. Clinics far from hospitals more frequently had tests like D-dimer and troponin. Of the clinics with troponin tests, 69% had a low-sensitive POCT. Norwegian emergency primary healthcare clinics are well equipped, especially if co-located with a GP office or far from a hospital. Further research is needed to enlighten how availability influences use and the possible impact on patient trajectories. Clinic leaders should pave the way for sustainable practices and high-value care when deciding their diagnostic equipment and POCTs repertoire.

Diagnostic radiology is recognised as a key component of modern healthcare. However there is marked inequality in global access to imaging. Rural populations of low- and middle-income countries (LMICs) have the greatest need. Carefully coordinated healthcare planning is required to meet the ever increasing global demand for imaging and to ensure equitable access to services. However, meaningful planning requires robust data. Currently, there are no comprehensive published data on radiological equipment resources in low-income countries. The aim of this study was to conduct the first detailed analysis of registered diagnostic radiology equipment resources in a low-income African country and compare findings with recently published South African data. The study was conducted in Tanzania in September 2014, in collaboration with the Tanzanian Atomic Energy Commission (TAEC), which maintains a comprehensive database of the country's registered diagnostic imaging equipment. All TAEC equipment data were quantified as units per million people by imaging modality, geographical zone and healthcare sector. There are 5.7 general radiography units per million people in the public sector with a relatively homogeneous geographical distribution. When compared with the South African public sector, Tanzanian resources are 3-, 21- and 6-times lower in general radiography, computed tomography and magnetic resonance imaging, respectively. The homogeneous Tanzanian distribution of basic public-sector radiological services reflects central government's commitment to equitable distribution of essential resources. However, the 5.7 general radiography units per million people is lower than the 20 units per million people recommended by the World Health Organization.

Kidney transplant recipients have high cardiovascular risk, and vascular inflammation may play an important role. We explored whether the inflammatory state in the vessel wall was related to carotid intima-media thickness (c-IMT) and patient survival following kidney transplantation. In this prospective observational cohort study we measured c-IMT and expression of proinflammatory cytokines and adhesion molecules in the inferior epigastric artery in 115 kidney transplant candidates. Another c-IMT measurement was done 1-year post-transplantation in 107. By stepwise multiple regression analysis we explored factors associated with baseline c-IMT and their changes over time. Multivariate Cox regression analysis was constructed to identify risk factors for mortality. A worse cardiovascular profile (older age, smoker, diabetic, carotid plaque, systolic blood pressure and vascular calcification) and higher VCAM-1 levels were found in patients in the highest baseline c-IMT tertile, who also had a worse survival. Factors independently related to baseline c-IMT were age (β=0.369, P<0.0001), fasting glucose (β=0.168, P=0.045), smoking (β=0.228, P=0.003) and VCAM-1 levels (β=0.244, P=0.002). Independent factors associated with c-IMT measurement 1-year post-transplantation were baseline c-IMT (β=-0.677, P<0.0001), post-transplant diabetes (β=0.225, P=0.003) and triglycerides (β=0.302, P=0.023). Vascular VCAM-1 levels were associated with increased risk of mortality in bivariate and multivariate Cox regression. Notably, nearly 50% of patients showed an increase or maintenance of high c-IMT 1 year post-transplantation and these patients experienced a higher mortality (13 versus 3.5%; P=0.021). A worse cardiovascular profile and a higher vascular VCAM-1 protein levels at time of KT are related to subclinical atheromatosis. This could lead to a higher post-transplant mortality. Pre-transplant c IMT, post-transplant diabetes and triglycerides at 1-year post-transplantation may condition a high c-IMT measurement post-transplantation, which may decrease patient survival.

The purpose of this research was to determine if cortical metrics-a unique set of sensory-based assessment tools-could be used to characterize and differentiate concussed individuals from nonconcussed individuals. Cortical metrics take advantage of the somatotopic relationship between skin and cortex, and the protocols are designed to evoke interactions between adjacent cortical regions to investigate fundamental mechanisms that mediate cortical-cortical interactions. Student athletes, aged 18 to 22 years, were recruited into the study through an athletic training center that made determinations of postconcussion return-to-play status. Sensory-based performance tasks utilizing vibrotactile stimuli applied to tips of the index and middle fingers were administered to test an individual's amplitude discrimination, temporal order judgment, and duration discrimination capacity in the presence and absence of illusion-inducing conditioning stimuli. Comparison of the performances in the presence and absence of conditioning stimuli demonstrated differences between concussed and nonconcussed individuals. Additionally, mathematically combining results from the measures yields a unique central nervous system (CNS) profile that describes an individual's information processing capacity. A comparison was made of CNS profiles of concussed vs. nonconcussed individuals and demonstrated with 99% confidence that the two populations are statistically distinct. The study established solid proof-of-concept that cortical metrics have significant potential as a quantitative biomarker of CNS status.

The Human Gene Mutation Database (HGMD®) constitutes a comprehensive collection of published germline mutations in nuclear genes that are thought to underlie, or are closely associated with human inherited disease. At the time of writing (June 2020), the database contains in excess of 289,000 different gene lesions identified in over 11,100 genes manually curated from 72,987 articles published in over 3100 peer-reviewed journals. There are primarily two main groups of users who utilise HGMD on a regular basis; research scientists and clinical diagnosticians. This review aims to highlight how to make the most out of HGMD data in each setting.

Background Over 75% of the medical devices used in India are imported. Often, they are costly and maladapted to low-resource settings. We have prepared case studies of six firms in Bangalore that could contribute to solving this problem. They have developed (or are developing) innovative health care products and therefore are pioneers in the Indian health care sector, better known for its reverse engineering skills. We have sought to understand what enablers and barriers they encountered. Methods Information for the case studies was collected through semi-structured interviews. Initially, over 40 stakeholders of the diagnostics sector in India were interviewed to understand the sector. However the focus here is on the six featured companies. Further information was obtained from company material and other published resources. Results In all cases, product innovation has been enabled by close interaction with local medical practitioners, links to global science and technology and global regulatory requirements. The major challenges were the lack of guidance on product specifications from the national regulatory agency, paucity of institutionalized health care payers and lack of transparency and formalized Health Technology Assessment in coverage decision-making. The absence of national evidence-based guidelines and of compulsory continuous education for medical practitioners were key obstacles in accessing the poorly regulated and fragmented private market. Conclusions Innovative Indian companies would benefit from a strengthened capacity and interdisciplinary work culture of the national device regulatory body, institutionalized health care payers and medical councils and associations. Continuous medical education and national medical guidelines for medical practitioners would facilitate market access for innovative products.