Assessing operational readiness: Regulatory landscape and compliance in zimbabwe for medical devices and in vitro diagnostic medical devices.

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.

Optimización de la exploración eco Doppler mediante la manipulación de los controles del equipo (knobology); primera parte / Doppler ultrasound exploration optimization by manipulating the controls of the equipment: knobology; part one

La ecografía Doppler es una modalidad diagnóstica dependiente de un operador indispensable por disponibilidad, eficacia y costes. además de conocimientos anatómicos y clínicos, exige un mínimo conocimiento de sus principios físicos y tecnológicos. Conocer, practicar, ajustar las funciones del eco Doppler de forma ordenada y en función del paciente y de la exploración indicada harán que nuestras exploraciones sean más sencillas, rápidas, seguras y precisas. este artículo de formación intenta repasar y esquematizar cómo ajustar las principales aplicaciones del equipo mediante los botones y controles del dispositivo ("knobology").(AU)

doppler ultrasound is an operator-dependent diagnostic modality, essential due to its availability, efficacy and costs.in addition to anatomical and clinical knowledge, it requires a minimum knowledge of its physical and technologicalprinciples. the knowledge, training, and set up the functions of the duplex scan in a properly way depending onthe patient and kind of exploration, will make our examinations easier, faster, safer, and more precise. this papertries to review and outline how to adjust the main applications of the equipment using the buttons and controlsof the device (knobology).(AU)

[Discussion on Technical Evaluation of Tongue Diagnosis Equipment of Traditional Chinese Medicine].

This study briefly introduces the tongue diagnostic equipment of traditional Chinese medicine. It analyzes and discusses the key points of technical evaluation of tongue diagnostic equipment from the aspects of product name, performance parameters, image processing functions, product use methods, clinical evaluation, etc. It analyzes the safety risks and effectiveness indicators of tongue diagnostic equipment, hoping to bring some help to the gradual standardization of tongue diagnostic equipment and the registration of enterprises.

Accessible medical diagnostic equipment in primary care: Assessing its geographic distribution for disability equity.

BACKGROUND: Height adjustable examination tables, accessible weight scales, and lifts for transferring individuals on/off examination equipment enable delivery of equitable health care to persons with mobility impairment. Because most Medicaid-covered patients must utilize a managed care network, network providers with accessible medical diagnostic equipment (MDE) at proximate locations for travel time and distance are necessary. Network density and distribution of accessible MDE has not been studied. OBJECTIVE: This descriptive research examined geographic network adequacy by comparing the density of persons with mobility impairments and location of Medicaid managed care practices with accessible MDE in Los Angeles County. METHODS: Medicaid managed care practices with MDE were mapped by ZIP Codes shaded to indicate the number of persons with mobility impairment. Zero-inflated negative binomial regression examined ZIP Code population characteristics as potential predictors of accessible MDE presence. Data sources were: (1) 2013-2016 primary care facility audit of Medicaid managed care network providers in LA County, aggregated by ZIP Code, and (2) LA County ZIP Code characteristics from the 2016 American Community Survey. ArcGIS was used for mapping and MPlus for the regression analysis. RESULTS: No consistent association between the size of the mobility limited population, demographic characteristics, and presence of accessible MDE was observed or measured by regression. The observed low MDE density suggests network adequacy likely is not achieved in LA County. CONCLUSIONS: Actions by state and federal agencies are necessary to increase accessible MDE and network adequacy by enforcing existing non-discrimination law and Medicaid regulations.

Discussion on Technical Evaluation of Tongue Diagnosis Equipment of Traditional Chinese Medicine / 中国医疗器械杂志

This study briefly introduces the tongue diagnostic equipment of traditional Chinese medicine. It analyzes and discusses the key points of technical evaluation of tongue diagnostic equipment from the aspects of product name, performance parameters, image processing functions, product use methods, clinical evaluation, etc. It analyzes the safety risks and effectiveness indicators of tongue diagnostic equipment, hoping to bring some help to the gradual standardization of tongue diagnostic equipment and the registration of enterprises.

Novel Diagnosis Technologies for a Lack of Oil Lubrication in Gearmotor Systems, Based on Motor Current Signature Analysis.

Due to the wide use of gearmotor systems in industry, many diagnostic techniques have been developed/employed to prevent their failures. An insufficient lubrication of gearboxes of these machines could shorten their life and lead to catastrophic failures and losses, making it important to ensure a required lubrication level. For the first time in worldwide terms, this paper proposed to diagnose a lack of gearbox oil lubrication using motor current signature analysis (MCSA). This study proposed, investigated, and experimentally validated two new technologies to diagnose a lack of lubrication of gear motor systems based on MCSA. Two new diagnostic features were extracted from the current signals of a three-phase induction motor. The effectiveness of the proposed technologies was evaluated for different gear lubrication levels and was compared for three phases of motor current signals and for a case of averaging the proposed diagnostic features over three phases. The results confirmed a high effectiveness of the proposed technologies for diagnosing a lack of oil lubrication in gearmotor systems. Other contributions were as follows: (i) it was shown for the first time in worldwide terms, that the motor current nonlinearity level increases with the reduction of the sgearbox oil level; (ii) novel experimental validations of the proposed two diagnostic technologies via comprehensive experimental trials (iii) novel experimental comparisons of the diagnosis effectiveness of the proposed two diagnostic technologies.

National inventory of authorized diagnostic imaging equipment in Ghana: data as of September 2020.

Introduction: to address the challenge of inadequate and non-equitable distribution of diagnostic imaging equipment, countries are encouraged to evaluate the distribution of installed systems and undertake adequate monitoring to ensure equitability. Ghana´s medical imaging resources have been analyzed in this study and evaluated against the status in other countries. Methods: data on registered medical imaging equipment were retrieved from the database of the Nuclear Regulatory Authority and analyzed. The equipment/population ratio was mapped out graphically for the 16 regions of Ghana. Comparison of the equipment/population ratio was made with the situation in other countries. Results: six hundred and seventy-four diagnostic imaging equipment units from 266 medical imaging facilities (2.5 units/facility), comprising computed tomography (CT), general X-ray, dental X-ray, single-photon emission computed tomography (SPECT) gamma camera, fluoroscopy, mammography and magnetic resonance imaging (MRI) were surveyed nationally. None of the imaging systems measured above the Organization for Economic Co-operation and Development (OECD) average imaging units per million populations (u/mp). The overall equipment/population ratio estimated nationally was 21.4 u/mp. Majority of the imaging systems were general X-ray, installed in the Greater Accra and Ashanti regions. The regional estimates of equipment/population ratios were Greater Accra (49.6 u/mp), Ashanti (22.4 u/mp), Western (21.4 u/mp), Eastern (20.6 u/mp), Bono East (20.0 u/mp), Bono (19.2 u/mp), Volta (17.9 u/mp), Upper West (16.7 u/mp), Oti (12.5 u/mp), Central (11.9 u/mp), Northern (8.9 u/mp), Ahafo (8.9 u/mp), Upper East (6.9 u/mp), Western North (6.7 u/mp), Savannah (5.5 u/mp) and North-East (1.7 u/mp). Conclusion: medical imaging equipment shortfall exist across all imaging modalities in Ghana. A wide inter-regional disparity in the distribution of medical imaging equipment exists contrary to WHO´s recommendation for equitable distribution. A concerted national plan will be needed to address the disparity.

Comparación entre el análisis automático y manual de 301 poligrafías respiratorias domiciliarias con ApneaLink / Comparison between automatic and manual scoring of 301 home respiratory polygraphs with ApneaLink device

Resumen Introducción: El síndrome de apnea obstructiva del sueño (SAOS) se asocia a aumento de morbimortalidad cardiovascular y metabólica, y a mala calidad de vida. Su diagnóstico y tratamiento eficaz mejora la salud individual y pública. Objetivo: evaluar concordancia entre análisis automático versus manual del dispositivo ApneaLink para diagnosticar y clasificar SAOS en pacientes con sospecha clínica. Material y Método: Evaluación retrospectiva de 301 poligrafías respiratorias del HOSCAR. Se mide correlación, acuerdo general y concordancia entre parámetros obtenidos manual y automáticamente usando coeficiente de Pearson, coeficiente de correlación intraclase y gráfico de Bland y Altman. Resultados: En 11,3% de casos el análisis automático interpreto erróneamente la señal de flujo. No hubo diferencias significativas entre índices de apnea-hipopnea automático (AHIa 18,9 ± 17,5) y manual (AHIm 20,8 ± 19,4) r + 0,97 (95% CI: 0,9571 a 0,9728; p < 0,0001) y tampoco entre la saturación mínima de oxígeno automática (82,1 ± 7,6) y manual (83,1 ± 6,8) r + 0,85 (95% CI: 0,8108 a 0,8766; p < 0,0001). No hubo buena correlación entre análisis automático y manual en clasificación de apneas centrales, r + 0,51 (95% CI: 0,4238 a 0,5942; p < 0,0001). Hubo subestimación de gravedad de SAOS por análisis automático: en 11% de casos. Conclusión: El diagnóstico entregado automáticamente por ApneaLink podría aceptarse sin confirmación manual adicional solamente en casos clasificados como severos. Para AHI menores se requeriría confirmación mediante análisis manual de experto.

Abstract Introduction: Obstructive sleep apnea syndrome (OSAS) is associated with increased cardiovascular and metabolic morbidity and mortality, and poor quality of life. Its effective diagnosis and treatment improve individual and public health. Aim: To evaluate concordance between automatic versus manual analysis of the ApneaLink device to diagnose and classify OSAS in patients with clinical suspicion. Material and Method: Retrospective evaluation of 301 respiratory polygraphs from HOSCAR. Correlation, general agreement and concordance between parameters obtained manually and automatically are measured using Pearson's coefficient, intraclass correlation coefficient, and Bland and Altman graph. Results: In 11.3% of cases, the automatic analysis misinterpreted the flow signal. There were no significant differences between automatic (AHIa 18.9 ± 17.5) and manual (AHIm 20.8 ± 19.4) apnea-hypopnea indices r + 0.97 (95% CI:0.9571 to 0.9728, p < 0.0001) and nor between automatic (82.1 ± 7.6) and manual (83.1 ± 6.8) minimum oxygen saturation r + 0.85 (95% CI: 0.8108 to 0.8766, p < 0.0001). There was no good correlation between automatic and manual analysis in the classification of central apneas, r + 0.51(95% CI:0.4238 to 0.5942, p < 0.0001). There was an underestimation of the severity of OSAS by automatic analysis in 11% of cases. Conclusion: The diagnosis delivered automatically by ApneaLink could be accepted without additional manual confirmation only in cases classified as severe. For minors AHI, confirmation through manual expert analysis would be required.

Ecografía clínica multiventana: diagnóstico inusual en la UCIP / Unusual diagnostic in PICU by POCUS head-to-toe

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