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.

Durability of Flexible Ureteroscopes: A Prospective Evaluation of Longevity, the Factors that Affect it, and Damage Mechanisms.

BACKGROUND: Flexible ureteroscopy is an established treatment modality for evaluating and treating abnormalities in the upper urinary tract. Reusable ureteroscope (USC) durability is a significant concern. OBJECTIVE: To evaluate the durability of the latest generation of digital and fiber optic reusable flexible USCs and the factors affecting it. DESIGN, SETTING, PARTICIPANTS: Six new flexible USCs from Olympus and Karl Storz were included. The primary endpoint for each USC was its first repair. Data on patient and treatment characteristics, accessory device use, ureteroscopy time, image quality, USC handling, disinfection cycles, type of damage, and deflection loss were collected prospectively. INTERVENTION: Ureteroscopy. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: USC durability was measured as the total number of uses and ureteroscopy time before repair. USC handling and image quality were scored. After every procedure, maximal ventral and dorsal USC deflection were documented on digital images. RESULTS AND LIMITATIONS: A total of 198 procedures were performed. The median number of procedures was 27 (IQR 16-48; 14h) for the six USCs overall, 27 (IQR 20-56; 14h) for the digital USCs, and 24 (range 10-37; 14h) for the fiber optic USCs. Image quality remained high throughout the study for all six USCs. USC handling and the range of deflection remained good under incremental use. Damage to the distal part of the shaft and shaft coating was the most frequent reason for repair, and was related to intraoperative manual forcing. A limitation of this study is its single-center design. CONCLUSIONS: The durability of the latest reusable flexible USCs in the current study was limited to 27 uses (14h). Damage to the flexible shaft was the most important limitation to the durability of the USCs evaluated. Prevention of intraoperative manual forcing of flexible USCs maximizes their overall durability. PATIENT SUMMARY: Current flexible ureteroscopes proved to be durable. Shaft vulnerability was the most important limiting factor affecting durability.

Cuff Leak Test for the Diagnosis of Post-Extubation Stridor: A Multicenter Evaluation Study.

BACKGROUND:: Cuff leak test was developed to predict the occurrence of post-extubation stridor (PES). This study evaluated the diagnostic performance of this test in unselected critically ill patients. METHODS:: Multicenter prospective study including unselected ventilated patients at the time of their first planned extubation. The diagnostic performance of 4 different cuff leak tests was assessed. RESULTS:: Post-extubation stridor occurred in 34 (9.4%) of 362 included patients. Compared to patients without PES, patients with PES required more frequently reintubation (6 [17.6%] vs 26 [7.9%], P = .041), prolonged duration of ventilation (6 [3-13] vs 5 [2-9] days, P = .029), and longer intensive care unit (ICU) stay (12 [6-17.5] vs 7.5 [4-13] days, P = .018). However, ICU mortality was similar in both groups (1 [2.9%] vs 23 [7.0%], P = .61). The 4 cuff leak tests display poor diagnostic accuracy: sensitivities ranging from 27% to 46%, specificities from 70% to 88%, positive predictive values from 14% to 19%, and negative predictive values from 92% to 93%. CONCLUSION:: Post-extubation stridor occurs in less than 10% of unselected critically ill patients. The several cuff leak tests display limited diagnostic performance for the detection of PES. Given the high rate of false positives, routine cuff leak test may expose to undue prolonged mechanical ventilation.

Point-Counterpoint: Meningitis/Encephalitis Syndromic Testing in the Clinical Laboratory.

INTRODUCTIONSyndromic panels were first FDA cleared for detection of respiratory pathogens in 2008. Since then, other panels have been approved by the FDA, and most recently, the FilmArray meningitis/encephalitis panel (BioFire, Salt Lake City, UT) has become available. This assay detects 14 targets within 1 h and includes pathogens that typically cause different manifestations of infection, although they infect the same organ system. Several studies have reported both false-positive and false-negative results with this test, and all agree that the cost is significant. As with other panels, health care systems have adopted different strategies for offering this assay. Some have implemented strategies to limit the use of the test to certain patient populations, others have elected not to offer the test, and others have elected not to offer the test and instead request that providers order specific PCRs for the pathogens that best fit the patient's symptoms. In this Point-Counterpoint, Jennifer Dien Bard of the Department of Pathology and Laboratory Medicine, Children's Hospital Los Angeles, and of the Keck School of Medicine at the University of Southern California explains why laboratories should offer these assays without restriction. Kevin Alby of the University of Pennsylvania explains the concerns about the use of these assays as first-line tests and why some limitations on their use might be appropriate.

Neurosensory Assessments of Concussion.

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.

Determining peripheral skin temperature: subjective versus objective measurements.

AIM: Diseases that affect peripheral vasculature or neurological function can manifest with peripheral skin temperature abnormalities. This pilot study investigates the accuracy of current physical examination techniques and determines whether a hand-held infrared device can be used to estimate peripheral skin temperature and detect temperature disparities. METHODS: Comparison between traditional physical examination of hands/feet by 30 healthcare professionals and a hand-held infrared device was made in 12 individuals (ages 4-25 years; 5 with disorders affecting peripheral skin temperature). Thermal camera measurements served as the reference temperature for comparison. RESULTS: A total of 231 extremity examinations by healthcare professionals were analysed. Healthcare professionals correctly identified subjects with colder or warmer than normal peripheral temperature. Hand-held device measurements were significantly different than reference measurements, with the size of the temperature difference diverging significantly between hands (1.20°C) and feet (0.78°C). When analysing temperature disparities, healthcare professionals identified fewer clinically significant disparities (≥3.0°C) than the hand-held device (76% vs. 99%). CONCLUSION: Although different from reference temperatures, the hand-held infrared device provided a more accurate and objective method than traditional physical exam in identifying peripheral skin temperature asymmetries that may be related to chronic paediatric illness.

Disposable optics for microscopy diagnostics.

The point-of-care testing (POCT) is having increasing role on modern health care systems due to a possibility to perform tests for patients conveniently and immediately. POCT includes lot of disposable devices because of the environment they are often used. For a disposable system to be reasonably utilized, it needs to be high in quality but low in price. Optics based POCT systems are interesting approach to be developed, and here we describe a low-cost fabrication process for microlens arrays for microscopy. Lens arrays having average lens diameter of 222 µm with 300 µm lens pitch were fabricated. The lenses were characterized to have standard deviation of 0.06 µm in height and 4.61 µm in diameter. The resolution limit of 3.9µm is demonstrated with real images, and the images were compared with ones made with glass and polycarbonate lens arrays. The image quality is at the same level than with the glass lenses and the manufacturing costs are very low, thus making them suitable for POCT applications.

Tolerance and Relative Utility: Two Proposed Indices for Comparing Change in Clinical Measurement Noise Between Different Populations (Repeatability) or Measurement Methods (Agreement).

Reaching a consensus in terms of interchangeability and utility (i.e., disease detection/monitoring) of a medical device is the eventual aim of repeatability and agreement studies. The aim of the tolerance and relative utility indices described in this report is to provide a methodology to compare change in clinical measurement noise between different populations (repeatability) or measurement methods (agreement), so as to highlight problematic areas. No longitudinal data are required to calculate these indices. Both indices establish a metric of least to most effected across all parameters to facilitate comparison. If validated, these indices may prove useful tools when combining reports and forming the consensus required in the validation process for software updates and new medical devices.

Does customer information fulfill MEDDEV criteria in cases of product problems of in vitro diagnostics for infection testing?

The European Directive 98/79/EC on in vitro diagnostics (IVD) regulates marketing and post market surveillance of IVD in the European Economic Area. In cases of incidents and field safety corrective actions (FSCA) manufacturers have to inform responsible competent authority (CA) and public by field safety notices (FSN). We analyzed FSCA and FSN of IVD for infection testing (culture media, reagents, kits, control materials, as well as culture-based analyzers and their general consumables) published by the Federal Institute for Drugs and Medical Devices (BfArM) in Bonn, Germany in 2005-2012 in regard to the European Regulatory Framework of Medical Devices (MEDDEV). One hundred and sixty-nine FSCA were published and German and English FSN were found in 157 and 154 cases, respectively. FSN were clearly characterized as FSN in 110 German and 134 English cases and product names were provided in 157 and 154 cases, respectively. Lot numbers and other information for product characterization were available in 146 and 137 cases, respectively. The information regarding FSCA and product malfunction was provided in 157 and 151 and 144 and 136 cases and that regarding the product related risks with continued use of affected IVD in 116 and 116 cases, respectively. In 156 German and 152 English cases, manufacturers provided the information for risk mitigation, including retesting in 69 and 75 cases, respectively. Requests to pass FSN to persons needing awareness were found in 108 and 87 cases, and contact data were provided in 127 and 131 cases, respectively. We conclude that most FSN fulfilled the MEDDEV criteria. However, type and content of FSN should be improved to ensure a better mitigation of risks due to product failure.

Determining the utility and durability of medical equipment donated to a rural clinic in a low-income country.

BACKGROUND: Health centers in low-income countries often depend on donations to provide appropriate diagnostic equipment. However, donations are sometimes made without an understanding of the recipient's needs, practical constraints or sustainability of supplies. METHODS: We donated a set of physical diagnostic equipment, non-invasive instrument tests and laboratory supplies to a rural health center in the Democratic Republic of Congo. We collected information on the usage and durability of equipment and supplies for each patient encounter over a 1-year period. RESULTS: We recorded 913 patient encounters. The most commonly used physical diagnostic equipment were the stethoscope (98.9%; 903/913), thermometer (81.7%; 746/913), adult scale (81.4%; 744/913), stop watch (62.6%; 572/913), adult sphygmomanometer (55.8%; 510/913), infant scale (24.9%; 228/913), measuring tape (24.3%; 222/913) and fetoscope (23.8%; 218/913). The most commonly used laboratory tests were the blood smear for malaria (53.7%; 491/913), hematocrit (23.5%; 215/913), urinalysis (20.1%; 184/913) and sputum stain for TB (13.3%; 122/913). With the exception of a penlight and solar lantern, all equipment remained functional. CONCLUSIONS: This study adds valuable information about the utility and durability of equipment supplied to a health center in the Democratic Republic of Congo. Our results might aid in determining the appropriateness of donated medical equipment in similar settings. The selection of donated goods should be made with knowledge of the context in which it will be used, and utilization should be monitored.

Analysis of licensed South African diagnostic imaging equipment.

INTRODUCTION OBJECTIVE: To conduct an analysis of all registered South Africa (SA) diagnostic radiology equipment, assess the number of equipment units per capita by imaging modality, and compare SA figures with published international data, in preparation for the introduction of national health insurance (NHI) in SA. METHODS: The SA Radiation Control Board's database of registered diagnostic radiology equipment was analysed by modality, province and healthcare sector. Access to services was reflected as number of units/million population, and compared with published international data. RESULTS: General X-ray units are the most equitably distributed and accessible resource (34.8/million). For fluoroscopy (6.6/million), mammography (4.96/million), computed tomography (5.0/million) and magnetic resonance imaging (2.9/million), there are at least 10-fold discrepancies between the least and best resourced provinces. Although SA's overall imaging capacity is well above that of other countries in sub-Saharan Africa, it is lower than that of all Organisation for Economic Co-operation and Development (OECD). While SA's radiological resources most closely approximate those of the United Kingdom, they are substantially lower than the UK. CONCLUSION: SA access to radiological services is lower than that of any OECD country. For the NHI to achieve equitable access to diagnostic imaging for all citizens, SA will need a more homogeneous distribution of specialised radiological resources and customized imaging guidelines.

[The shortcomings of technical regulation in sphere of circulation of medical devices for diagnostic in vitro in the Russian Federation: the state of affairs and proposed solutions].

The article presents analysis of international and national trends in area of development of normative legal documents in sphere of circulation of medical devices for diagnostic in vitro. The comparative analysis was made concerning certain principles of formation of nomenclature of medical devices for diagnostic in vitro in the international practice and in the Russian Federation. The necessity of reformation of national normative legal base in this issue is demonstrated.

The clinical impact of different coagulometers on patient outcomes.

INTRODUCTION: Long-term anticoagulation therapy using vitamin K antagonists (VKA) is used in millions of patients worldwide to reduce the risk of thrombotic or thromboembolic events. Control and monitoring of VKA therapy is improved by the regular self-measurement of international normalized ratio (INR) using a home monitoring device. This retrospective analysis of a large cohort of patients in the Netherlands seeks to determine whether the choice of INR monitor could have a clinical impact on patient outcomes. METHODS: The National Thrombosis Service provides medical supervision, training and support to anticoagulant patients eligible for home-monitoring of INR in the Netherlands. Two INR monitors (CoaguChek XS and INRatio2) have been distributed at random to patients since June 2011, and patient self-testing data (INR measurements and other clinical parameters) have been recorded to measure and improve treatment outcomes. The data have been retrospectively analyzed to determine any effect of the choice of monitor. Univariate and multivariate statistical tests are used to assess any differences between groups in terms of efficacy and safety parameters. RESULTS: Data from 4,326 patients were collated, and 156,507 INR values were included in the analysis. Over half the patients (54.3%) were being treated for atrial fibrillation, and 77.6% were prescribed acenocoumarol. There were few differences between the patient populations using the two different monitors. Anticoagulant control overall was good, with high percentage of time (87.9%) in the appropriate INR range and low incidence of excessively high or low INR values (0.085/month). Minor clinical events related to safety were low (0.78 per patient-year) and showed few differences between monitors. Mortality rates were similar [hazard ratio (HR) 1.05, 95% confidence interval (CI) 0.65-1.70]. CONCLUSION: Self-testing data from a large cohort of patients in the Netherlands suggest that there is no clinically relevant effect of the choice of coagulation monitor (CoaguChek XS or INRatio2) on the time in therapeutic range (TTR), minor or fatal outcomes of long-term anticoagulation management.

Managing glaucoma in Lagos State, Nigeria - availability of Human resources and equipment.

AIMS AND OBJECTIVES: There is a paucity of data onthe human resourcesand ophthalmic equipmentavailable for the diagnosis and management of glaucoma in Nigeria. This study is aimed at describing the ophthalmic human resources, as well as available and functioning equipment used in diagnosing and managing glaucoma in Lagos State, Nigeria. MATERIALS AND METHODS: This was a prospective multicentre cross sectional study.Data on human resources and equipmentavailable were collected from all government tertiaryand secondary health institutions in the state. One large-practice private eye hospital in the state was included for comparative purposes. RESULTS: The average number of ophthalmologists per hospital was 1.3 and 4.5 in the secondary and tertiary centres respectively, with overall ophthalmologists to population ratio of 1:400,000, and ophthalmic nurses to population ratio of 1:150,000. There were only 2 full time low vision therapists and 3 equipment technicians. Only the private hospital had a dedicated patient counsellor and an eye unit manager. 64% of ophthalmic equipment in the government sector were functioning compared with 100% in the private centre. Overall, equipment to population ratios were; slit lamp=1:517,000, 78/90D lens=1:1,487,000, tonometer=1:660,000, visual field analyser=1:2,380,000, and pachymeter=1:5,950,000. CONCLUSIONS: Current population ratios for ophthalmologists and ophthalmic nurses in the state meets vision 2020 recommendations, but there are shortages of other key human resources such as equipment technicians, low vision therapists and patient counsellors. In addition, equipment required for the management of glaucoma wereinadequate, not available or not functioning. Findings from this study suggest that there is an urgent need for increased government funding to glaucoma services in Lagos State.

The relationship between the use of the partograph and birth outcomes at Korle-Bu teaching hospital.

OBJECTIVE: maternal mortality represents the single greatest health disparity between high and low income countries. This inequity is especially felt in low income countries in sub Saharan Africa and Southeast Asia where 99% of the global burden of maternal death is borne. A goal of MDG 5 is to reduce maternal mortality and have a skilled attendant at every birth by 2015. A critical skill is ongoing intrapartum monitoring of labour progress and maternal/fetal well-being. The WHO partograph was designed to assess these parameters. DESIGN AND SETTING: a retrospective review of charts (n=1,845) retrieved consecutively over a 2 month period in a tertiary teaching hospital in Ghana was conducted to assess the adequacy of partograph use by skilled birth attendants and the timeliness of action taken if the action line was crossed. WHO guidelines were implemented to assess the adequacy of partograph use and how this affected maternal neonatal outcomes. Further, the timeliness and type of action taken if action line was crossed was assessed. FINDINGS: partographs were adequately completed in accordance with WHO guidelines only 25.6% (472) of the time and some data appeared to be entered retrospectively. Partograph use was associated with less maternal blood loss and neonatal injuries. When the action line was crossed (464), timely action was taken only 48.7% of the time and was associated with less assisted delivery and a fewer low Apgar scores and NICU admissions. CONCLUSION: when adequately used and timely interventions taken, the partograph was an effective tool. Feasibility of partograph use requires more scrutiny; particularly identification of minimum frequency for safe monitoring and key variables as well as a better understanding of why skilled attendants have not consistently 'bought in' to partograph use. Frontline workers need access to ongoing and current education and strategically placed algorhythims.

Saúde: para onde vai a nova classe média / Health: Where is the new middle class

CONASS Debate – Saúde: para onde vai a nova classe média é fruto do seminário. Dividido em capítulos ordenados pela participação dos expositores e dos debatedores durante o evento, o livro traz os textos assinados pelos palestrantes, responsáveis pelo sucesso e riqueza de conteúdo do seminário. No último capítulo, apresentamos a síntese dos debates, feita pela equipe de relatoria do evento

Availability of troponin testing for cardiac patients in New Zealand 2002 to 2011: implications for patient care.

AIMS: For patients presenting with an acute coronary syndrome (ACS), troponin T or I levels are crucial for the diagnosis of myocardial infarction (MI). We investigated troponin tests, analyser types and thresholds used in New Zealand (NZ) from 2002 to 2011. METHODS: We reviewed troponin tests available at hospitals in NZ which admitted ACS patients and those who had troponin testing in 2002 (n=41), 2007 (n=43) and 2011 (n=43). We also contacted community laboratories and manufacturers. RESULTS: In 2010-11 there were nine different troponin analysers in 43 hospitals provided by five companies. Troponin T assays were used in 58% of the hospitals and 42% used troponin I as their first-line method. Quoted cutpoints have become more aligned since 2002 and 2007, but are still different from laboratory cutpoints using point of care methods. CONCLUSIONS: There are differences in troponin tests available across NZ. Test thresholds and units vary, even for the same test, and available diagnostic information cannot always be used to identify a troponin rise and fall. Care is needed when comparing results from different methods and when point of care instruments are used. A coordinated national approach to the development of new biochemical tests, such as troponins, may result in better use of resources and better patient care.

A review of standards and statistics used to describe blood glucose monitor performance.

Glucose performance is reviewed in the context of total error, which includes error from all sources, not just analytical. Many standards require less than 100% of results to be within specific tolerance limits. Analytical error represents the difference between tested glucose and reference method glucose. Medical errors include analytical errors whose magnitude is great enough to likely result in patient harm. The 95% requirements of International Organization for Standardization 15197 and others make little sense, as up to 5% of results can be medically unacceptable. The current American Diabetes Association standard lacks a specification for user error. Error grids can meaningfully specify allowable glucose error. Infrequently, glucose meters do not provide a glucose result; such an occurrence can be devastating when associated with a life-threatening event. Nonreporting failures are ignored by standards. Estimates of analytical error can be classified into the four following categories: imprecision, random patient interferences, protocol-independent bias, and protocol-dependent bias. Methods to estimate total error are parametric, nonparametric, modeling, or direct. The Westgard method underestimates total error by failing to account for random patient interferences. Lawton's method is a more complete model. Bland-Altman, mountain plots, and error grids are direct methods and are easier to use as they do not require modeling. Three types of protocols can be used to estimate glucose errors: method comparison, special studies and risk management, and monitoring performance of meters in the field. Current standards for glucose meter performance are inadequate. The level of performance required in regulatory standards should be based on clinical needs but can only deal with currently achievable performance. Clinical standards state what is needed, whether it can be achieved or not. Rational regulatory decisions about glucose monitors should be based on robust statistical analyses of performance.