Development Of Medical Equipment Research Articles

Hardware and software co-design for detecting hypertension from photoplethysmogram

Hypertension is one of the leading causes of cardiovascular disease morbidity in the world. If remains untreated, it may cause severe damage like heart attack or even death. Early detection is required to prevent the development of other cardiac abnormalities. Photoplethysmogram (PPG) is a bio signal that can be obtained optically by a sensor. It is studied to monitor the change of volume of blood and detect heart conditions. Previous studies have already applied PPG to detect hypertension at the software level. In this article, along with software-based detection, we have implemented a digital hardware-based system for detecting hypertension from signals recorded using PPG sensor. Xilinx ZedBoard Zynq-7000 field programmable gate array (FPGA) board is utilized for designing the embedded system. The hypertension detection accuracy is 98.02% at the software level while for the digital system, it is 96.05% consuming 0.374 W power. The study can be analyzed for other cardiac disease detection and medical equipment development.

Blood culture contamination in a tertiary care hospital: a retrospective three-year study

BackgroundBloodstream infections (BSI) are a leading cause of morbidity and mortality in hospitalized patients worldwide. A blood culture is the primary tool for determining whether a patient has BSI and requires antimicrobial therapy, but it can result in an inappropriate outcome if the isolated microorganisms are deemed contaminants from the skin. Despite the development of medical equipment and technology, there is still a percentage of blood culture contamination. The aims of this study were to detect the blood culture contamination (BCC) rate in a tertiary care hospital in Palestine and to identify the departments with the highest rates along with the microorganisms isolated from the contaminated blood samples.MethodBlood cultures that were taken at An-Najah National University Hospital between January 2019 and December 2021 were evaluated retrospectively. Positive blood cultures were classified as either true positives or false positives based on laboratory results and clinical pictures. Statistical analysis was performed using the Statistical Package for Social Sciences (SPSS) version 21. A p-value of less than 0.05 was considered statistically significant for all analyses.ResultsOut of 10,930 blood cultures performed in the microbiology laboratory from 2019 to 2021, 1479 (13.6%) were identified as positive blood cultures that showed microbial growth. Of these, 453 were blood culture contaminations, representing 4.17% of total blood cultures and 30.63% of the positive blood culture samples. The highest rate of contamination was in the hemodialysis unit (26.49%), followed by the emergency department (15.89%). Staphylococcus epidermidis was the most prevalent (49.2%), followed by Staphylococcus hominis (20.8%) and Staphylococcus haemolyticus (13.2%). The highest annual contamination rate was observed in 2019 (4.78%) followed by 2020 (3.95%) and the lowest was in 2021 (3.79%). The rate of BCC was decreasing, although it did not reach statistically significant levels (P value = 0.085).ConclusionThe rate of BCC is higher than recommended. The rates of BCC are different in different wards and over time. Continuous monitoring and performance improvement projects are needed to minimize blood culture contamination and unnecessary antibiotic use.

Comprehension of fundamental knowledge about pediatric endoscopic surgery: a cross-sectional study in Japan.

Pediatric endoscopic surgery has become an alternative to conventional techniques with the development of medical equipment. However, there is no formal, standardized curriculum for pediatric endoscopic surgery, and its requirement remains elusive. The purpose of this study is to determine the baseline knowledge of pediatric surgeons that is considered essential for pediatric laparoscopic and thoracoscopic surgery. Sixteen web-based multiple-choice questions based on the fundamental cognitive knowledge of pediatric endoscopic surgery were administered. The questions were created based on the fields covered by the Fundamentals of Laparoscopic Surgery ™ (FLS) certification examination blueprints and eight specific diseases of pediatric surgery. Pediatric surgeons and pediatric surgical trainees participated in this study voluntarily. A total of 122 surgeons participated through the Japanese Society of Pediatric Surgeons. The response rate was 95% (122/128). The total mean examination score of all participants was 79.4% (77.3-81.4%). There were no significant differences in total scores between the board-certified pediatric surgeons without an endoscopic surgical skill qualification and the non-board-certified pediatric surgeons (80.4% vs. 77.1%, p = 0.12). The endoscopic surgical skill-qualified surgeons had significantly higher percentages of correct responses in specific subjects than board-certified pediatric surgeons and surgeons without pediatric board certification (94.3% vs. 82.9%, p = 0.02; 94.3% vs. 77.5%, p = 0.0002). The FLS original subjects' scores were not significantly different among them. The mean score of surgeons who had experienced more than 200 cases of endoscopic surgery, including adult cases, was 83.2% (80.4-85.9%). A knowledge gap exists between surgeons, board-certified pediatric surgeons, and endoscopic surgical skill-qualified surgeons in Japan. In the field of pediatric surgery, an effective formal curriculum, such as FLS, is required to help address this vast knowledge gap for the safe conduct of endoscopic surgeries.

Calibrating and Graduating of Multi-Sensor Gas Analyzer

Introduction. The article is devoted to the calibration and graduation of the multi-sensor gas analyzer developed at the V.M. Glushkov Institute of Cybernetics of National Academy of Sciences of Ukraine. The modern trend in the development of medical equipment, in particular, containing built-in measuring devices, consists in its miniaturization, intellectualization, the use of information technologies, and the introduction of wireless and network means of data transmission. The purpose of the article is to design, create electronics and software for recording the concentration of three gases (oxygen, carbon dioxide and carbon monoxide), test and calibrate the device. Results. Three prototypes of sensor modules for oxygen, carbon dioxide and carbon monoxide have been created. The structure, scheme of connection of sensor modules, and the principle of operation of the gas analyzer was described. Testing and optimization of these prototypes were performed. Auxiliary pneumatic equipment for checking the performance of devices, their calibration and graduation was manufactured. Measurement technique was developed and test measurements of the specified gases were performed. The calibration technique was developed and the device was calibrated using two test gas samples such as ethanol vapor and air-gas mixture of carbon dioxide. In addition, a special software has been developed, which allow observe a registered input signal from sensor modules and store it to the file. Conclusions. As a result of the work, prototype of the device was created, its testing, calibration and graduation were carried out at the State Enterprise "Ukrmetrteststandart", 4 certificates of metrological attestation were obtained. The gas analyzer can be used for screening of healthy persons based on study of exhalation to predict the risk of diseases. Keywords: multi-sensor gas analyzer, oxygen, carbon dioxide, carbon monoxide, calibration, graduation.

Improving the accuracy of estimates of the pulse sequence period using the methodology of complete sufficient statistics

This paper is devoted to the synthesis of new signal processing algorithms based on the methodology of complete sufficient statistics and the possibility of using the Lehmann–Scheffe theorem. Using the example of a sequence of quasi-rectangular pulses, an approach to estimating their period was illustrated, taking into account the duty-off factor and the pulse squareness coefficient. A mathematical model was developed, on the basis of which, estimates of the potential accuracy of the methods were carried out. It is established that for the sample size value (n > 8), the relative root-mean-square error of estimating the repetition period using the methodology of complete sufficient statistics is lower than that of the traditional estimate. In addition to theoretical calculations, simulation results confirming the achieved effect are presented. The results obtained have a wide range of applicability and can be used in the design of control and measuring equipment in the oil and gas industry, in the development of medical equipment, in the field of telecommunications, in the design of pulse-Doppler radars, etc.

Pulse Signal Analysis Based on Deep Learning Network.

Pulse signal is one of the most important physiological features of human body, which is caused by the cyclical contraction and diastole. It has great research value and broad application prospect in the detection of physiological parameters, the development of medical equipment, and the study of cardiovascular diseases and pulse diagnosis objective. In recent years, with the development of the sensor, measuring and saving of pulse signal has become very convenient. Now the pulse signal feature analysis is a hotspot and difficulty in the signal processing field. Therefore, to realize pulse signal automatic analysis and recognition is vital significance in the aspects of the noninvasive diagnosis and remote monitoring, etc. In this article, we combined the pulse signal feature extraction in time and frequency domain and convolution neural network to analyze the pulse signal. Firstly, a theory of wavelet transform and the ensemble empirical mode decomposition (EEMD) which is gradually developed in recent years have been used to remove the noises in the pulse signal. Moreover, a method of feature point detection based on differential threshold method is proposed which realized the accurate positioning and extraction time-domain values. Finally, a deep learning method based on one-dimensional CNN has been utilized to make the classification of multiple pulse signals in the article. In conclusion, a deep learning method is proposed for the pulse signal classification combined with the feature extraction in time and frequency domain in this article.

Planning and Budgeting of Medical Devices Among Ethiopian Public Hospitals.

BackgroundPlanning and budgeting of medical devices allow a healthcare institution to properly use funds, acquire quality and efficient medical devices, and improve healthcare service delivery. The lack of proper policy in the procurement and management of medical devices causes inappropriate usage of funds and impedes the quality of a product. This study aimed to identify the current practices and gaps in the planning and budgeting of medical devices in Ethiopian public hospitals. In this study, an assessment was conducted in all regional public hospitals to assess the current status of medical device management, identify the gaps, and provide suggestions for areas of improvement.MethodsA descriptive cross-sectional design was used for the study assessment where a structured data collection tool was utilized to collect data. A multi-stage stratified random sampling proportionate to size technique was employed for the sampling of public hospitals in all regions of Ethiopia. The collected data was analyzed using SPSS version 26 software.ResultsThe availability of medical equipment development plans, budgeting, and spare parts procurement plans were found to be below 50% in public hospitals. It was also noted that 40.3% of hospitals do not prepare medical device technical specifications during procurement orders. Moreover, the engagement of biomedical engineers/technicians in the planning and procurement of medical devices was found to be below 50%.ConclusionThis assessment showed that there is a need for improvement in the development of procurement plans and preparation of technical specifications for medical devices in Ethiopian public hospitals. Developing policies and strategies for the proper use of funds in the procurement of medical devices, involving biomedical engineering professionals in the planning, procurement and use of medical devices could help to improve the quality, optimized utilization and efficiency of medical devices and ultimately enhance healthcare service delivery.

Physiologic-range flow and pressure sensor for respiratory systems

A low-cost but reliable flow and pressure sensor is an impediment to development of medical equipment, and studies of human respiratory function, which is characterised by relatively low pressures and flows. A Venturi tube (D1=15mm,D2=10mm) connected to a differential pressure sensor (SDP816-125 Pa) allows accurate measurement of flow between 5-75L·min-1, with Pearson Correlation over 4 min at 50Hz⩾0.97, and distance correlation ⩾0.96. The pressure measurement was similarly accurate using a MPVZ4006GW7U. Both sensors provide an analogue output from a 5.0V supply, aiding compatibility and customisation. Each populated PCB costs approximately $50USD, and each Venturi sensor costs approximately $1USD. Multiple configurations exist, allowing flow rates up to 250L·min-1, increased resolution for specific ranges, and different physical characteristics.

Design of Automation for Infusion Monitoring Using a Weight Sensor (Load Cell) Based on AT-MEGA 328 Microcontroller

The development of medical equipment with advanced technology can provide convenience in providing services to the community. One of the equipment that is in the hospital and most often used is an IV. In its use, manual infusion is used to determine the volume of the infusion and must be monitored every hour or even minute by the nurse. This is considered quite difficult, especially in the era of the Covid-19 pandemic where minimal interaction is required from 2 individuals. This is done by utilizing sensor technology to monitor the patient's condition so that the frequency of the nurses checking the condition of the infusion is getting less. Therefore, in this research, manufactured of an infusion monitoring system using aweight sensor (Load Cell) based on the ATMEGA 328 microcontroller was carried out. The sensor of this monitoring system uses a Load Cell Weight Sensor with the HX711 module which is integrated into the ARDUINO UNO MCU. The output of the system is displayed on a 16 x 2 mm LCD as well as a Macro Excel which will display the percentage value of intravenous fluids in the PC and real-time automatic data logging into the macro excel. The infusion used uses Nacl fluid infusion. The test results of the system as a whole show that the data for measuring levels (%) of intravenous fluids can be sent and displayed on the LCD and PC. The incoming data is converted into a table at certain time intervals according to the user's choice into the operator. The experiment was carried out 10 times by looking at changes in the contents of the infusion fluid over time in 11 stages where the LED lights up when the weight of the infusion reaches 40 - 46 grams. Then, the buzzer and LED have turned on when the weight of the infusion is less than 5 grams. From the experiment, it can be concluded the 10% setpoint alarm works well, i.e. when the infusion load is less than the 1% set point, the buzzer and LED will light up until the intravenous fluid is replaced with a new one.

Designing a Planar Fluxgate Using the PCB Technology

The development of novel methods, scientific devices and means for measuring magnetic fields generated by ultra-low current is among promising directions in the development of medical equipment and instruments for geodetic surveys and space exploration. The present work is to develop a small sensor capable of detecting weak magnetic fields, which sources are biocurrents, radiation of far space objects and slight fluctuations of the geomagnetic field. Scientists estimate the strength of such magnetic fields as deciles of nanotesla. The key requirements for the sensors of ultra-low magnetic field are: resolution, noise level in the measurement channel, temperature stability, linearity and repeatability of the characteristics from one produced item to another. The aforementioned characteristics can be achieved by using planar technologies and microelectromechanical systems (MEMS) in such advanced sensors.The work describes a complete R&D cycle, from creating the computer model of the sensor under study to manufacturing of a working prototype. To assess the effect of the geometry and material properties, the Jiles–Atherton model is implemented which, unlike the majority of the models used, allows considering the non-linearity of the core, its hysteresis properties and influence of residual magnetization.The dimensions of the developed sensor are 40×20×5 mm, while the technology allows its further diminishment. The sensor has demonstrated the linearity of its properties in the range of magnetic field strength from 0.1 nT to 50 µT for a rms current of excitation of 1.25 mA at a frequency of 30 kHz. The average sensitivity for the second harmonic is 54 µV/nT.

CT Image Examination Based on Virtual Reality Analysis in Clinical Diagnosis of Gastrointestinal Stromal Tumors.

With the advancement and development of medical equipment, CT images have become a common lung examination tool. This article mainly studies the application of CT imaging examination based on virtual reality analysis in the clinical diagnosis of gastrointestinal stromal tumors. Before extracting suspected lymph nodes from a CT image of the stomach, the CT image sequence is preprocessed first, which can reduce the cumbersomeness of subsequent extraction of suspected lymph nodes and speed up the subsequent processing. According to medical knowledge, CT images of the stomach show that lymph nodes mainly exist in the adipose tissue around the gastric wall, but there are no lymph nodes in the subcutaneous fat outside the chest. The most basic gray value in the image and the neighborhood average difference feature related to gray level are used as the primary features of visual attention detection. When extracting the neighborhood average difference feature, we use a 3∗3 sliding window method to traverse each point of the pixel matrix in the image, thereby calculating the feature value of each pixel in the image. After the feature extraction is completed, it is necessary to calibrate the data and make a training data set. The SP immunohistochemical staining method was used. The specimens were fixed with 10% formaldehyde, routinely embedded in paraffin, sectioned, and stained with HE. The tumor tissue was determined by immunohistochemistry, and the reagents were products of Maixin Company. All patients were followed up by regular outpatient review, letters, and visits or phone calls. The data showed that immunohistochemical tumor cells showed positive staining for CD117 (14/15, 93.3%) and CD34 (10/15, 66.7%). The results show that the application of virtual reality technology to CT imaging examination can significantly improve the diagnostic accuracy of gastrointestinal stromal tumors.

Proposal and validation of polyconvex strain-energy function for biological soft tissues.

Mechanical simulations for biological tissues are effective technology for development of medical equipment, because it can be used to evaluate mechanical influences on the tissues. For such simulations, mechanical properties of biological tissues are required. For most biological soft tissues, stress tends to increase monotonically as strain increases. Proposal of a strain-energy function that can guarantee monotonically increasing trend of biological soft tissue stress-strain relationships and applicability confirmation of the proposed function for biological soft tissues. Based on convexity of invariants, a polyconvex strain-energy function that can reproduce monotonically increasing trend was derived. In addition, to confirm its applicability, curve-fitting of the function to stress-strain relationships of several biological soft tissues was performed. A function depending on the first invariant alone was derived. The derived function does not provide such inappropriate negative stress in the tensile region provided by several conventional strain-energy functions. The derived function can reproduce the monotonically increasing trend and is proposed as an appropriate function for biological soft tissues. In addition, as is well-known for functions depending the first invariant alone, uniaxial-compression and equibiaxial-tension of several biological soft tissues can be approximated by curve-fitting to uniaxial-tension alone using the proposed function.

Imagination, Uncertainty and Business Strategies of Russian Companies in the Field of Medical Devices

High-tech innovation is often understood as creating new worlds and trajectories of development and generating uncertainty. On the basis of 15 interviews with the heads of Russian medical technology companies, the paper presents the different types of uncertainties faced by med-tech entrepreneurs. Is the lack of exact knowledge about the results of the development and implementation of new technologies (a classic type of uncertainty in the innovation sector) perceived by entrepreneurs as a difficulty? Or do they deal with uncertainties of another type, for example, related to the political and economic context in the country? What business models are emerging in the industry for regional companies? What is the role of expectations and the imagination in the work of the company director or R & D engineers? How is this related to the specifics of the health industry? As a theoretical basis, the concepts of uncertainty in the innovation sector, as well as uncertainty associated with the rules of the game set by political and economic institutions, are considered. The strategies of innovative entrepreneurs in conditions of uncertainty are investigated using the concept of the imaginary in the version of science and technology studies (STS). This research identifies four business models of hi-tech entrepreneurs in Russia: Small deal supporters, Revolutionaries, Conformists, and Isolationists. In the development of medical equipment, it is important that the main customers of medical devices in Russia are state-owned hospitals. One of the most winning strategies for Russian entrepreneurs is the use of ambiguity, i.e., to secondguess the agenda set by government agencies and use official rhetoric in negotiations with officials. One might have expected that, especially in such a situation, imaginaries might be a vehicle for innovation. However, uncertainty about rules and ambiguity in political priorities results in an imaginary drama-imaginaries in med-tech companies do not exist, and neither does innovation.

3D printing for development of medical equipment amidst coronavirus (COVID-19) pandemic—review and advancements

Background and aimsCoronavirus (COVID-19) has surfaced as a global pandemic and has created an unprecedented global demand for medical equipment. The shortage of onsite workforce, need for social distancing and less time available for sourcing have further made it difficult for the governments and the medical professionals to combat the pandemic. This study’s prime objective is to review the advancements in the area of 3D printing to develop medical equipment and explore the potential of 3D printing in addressing the shortage of medical equipment mainly the personal protective equipment (PPE) amidst COVID-19 pandemic.Methods3D printing or additive manufacturing has emerged as a new manufacturing process with tremendous potential to develop complex products in short time with minimal human interventions. The paper summarises 3D printing’s potential to serve the increasing need for medical equipment, mainly personal protective equipment (PPE) and ventilator equipment in the ongoing global COVID-19 pandemic.ResultsThe minimum human interventions required to carry out production using 3D printing also make the technology an excellent option to deal with the current situation.ConclusionsThe recommendations and opinions presented in the paper shall act as a stimulant to develop components very critical for the pandemic and help save precious lives globally.

A Meta-Analysis of Comparing Intermittent Epidural Boluses and Continuous Epidural Infusion for Labor Analgesia.

With the development of medical equipment and techniques in labor anesthesia, it is a major issue to investigate the risks and treatment effects among techniques such as continuous epidural infusion (CEI) and intermittent epidural bolus (IEB). However, there is a controversial result regarding two techniques. This study was conducted through meta-analysis of randomized controlled trials (RCTs) for labor analgesia between the CEI and IEB techniques. The pooled results were presented as weighted mean differences (WMDs) together with 95% confidence intervals (CIs) and odds ratios (ORs) together with 95% CIs, respectively. Eleven RCTs were included in this meta-analysis. Four hundred sixty-five parturients accepted CEI, whereas 473 parturients accepted IEB labor analgesia. Elven identified low- risk bias studies were recruited for meta-analysis. The results presented no statistical difference in cesarean delivery rate between IEB and CEI (OR, 0.96; 95% CI, 0.67–1.37) and duration of second stage of labor (WMD, −3.82 min; 95% CI, −8.28 to 0.64). IEB had statistically significant lessened risk of instrumental delivery (OR, 0.59; 95% CI, 0.39–0.90) and for the use in local anesthetic (WMD, −1.71 mg bupivacaine equivalents per hour; 95% CI, −1.88 and −1.55). Accepted IEB had a higher score of maternal satisfaction (WMD, −6.95 mm; 95% CI, −7.77 to −6.13). Based on evidence, IEB showed a greater benefit for slightly reducing the use in local anesthetic, reduced risk of instrumental delivery, and improved maternal satisfaction for the requirement of labor epidural analgesia for healthy women. In the future, more studies need to be conducted to practice the IEB regimen and explore its influence on labor analgesia.

Methods of strategic management in the field of health care

Introduction. The issue of strategic management in the health care field is very acute for Ukraine, as to date, the heads of health care institutions do not use the tools and methods of strategic management to organize activities in such institutions. Thus, all this highlights the need to study the methods of strategic management in the health care field and find out the optimal mechanisms for their implementation. The purpose of the article is to analyze the methods of strategic management in the health care field for the develop-ment of the national industry. Results. In the course of research, the materials of our own researches, and also separate scientific publications of na-tional and foreign authors concerning methods and tools of strategic management are used. Such scientific methods as mor-phological analysis, analysis and synthesis, empirical approach are used. Theoretical analysis of existing methods and tools of strategic management is carried out. Emphasis is placed on the fact that the methods of strategic management in the field of health care are based on the laws and patterns of intra-industry management, which also take into account the scientific and technical level of development in the medical field. The role of a systematic approach in strategic health management is explained. Conclusions. According to the results of the study, it is proved that the unstable situation in the international envi-ronment and the impact of certain global factors, which include the COVID-19 pandemic; competition, significant develop-ment of medical equipment and technologies, determine the historical transformation of traditional management methods in the field of health care. Applying a systematic approach to strategic management of the industry expands the possibilities of planning long-term health care policy and determines a multi-purpose and comprehensive approach to intra-industry or-ganizational and functional segments of the national health sector. Key words: health care, strategic management, methods of strategic management, tools of strategic management, branch of health care.

Hematologist and transplant physicians: How and where to meet for the best of sickle cell disease patients?

Despite huge progress in the fields of newborn screening, encapsulated bacterial infection prophylaxis, immunization, and supportive care in general, people suffering from sickle cell anemia still continue to have a shorter life expectancy and a poorer quality of life due to painful vaso-occlusive events and strokes during childhood, and later, cardiac, pulmonary, and renal injuries, including in Western and high-income countries.From the 2000s, allogeneic stem cell transplantation for severe sickle cell disease from a sibling donor provided the best results—overall as well as disease-free survival—never obtained for any other disease. Nevertheless, this only curative option is proposed to few patient numbers, including in Western countries with high-level medical equipment development, with discrepancies between (i) patients and family, (ii) physicians and care centers dedicated to sickle cell disease, and (iii) hematopoietic stem cell transplant teams.Due to these discrepancies and in order to provide the same quality of discussion and treatment choice for every sickle cell disease patient, we developed a National French multidisciplinary pluri-annual meeting dedicated to sickle cell disease patients and transplantation. We report here our experience of such a meeting.

NEW METAL-CONTAINING POLY(URETHANE-SEMICARBAZIDES) ON THE BASIS OF PYRIDINE DERIVATIVES

The growth of science and technology of polyurethanes leads to the development of new materials with more desirable properties. Modification of polyurethane (PU) by incorporating metal and functional groups are used extensively to improve various properties, such as enhanced thermal stability, fire retardancy, flexibility and solubility. In this investigation, a new metal-containing poly(urethane-semicarbazides) bearing a pyridine moiety have been synthesized and characterized by Fourier transform infrared spectroscopy (FTIR), differential thermal analysis (DTA/TG) and tensile strength measurements. The results showed that the incorporation of metal ions into the polymer chain greatly influenced their mechanical and thermal properties. The tensile strength measurements on the PU films showed a marked difference in the elongation and tensile strength for compositions with various metal salts. The nature of the anion of the salt also affects the properties of the polymers, since the anions are able to form complexes with hydrogen atoms of urethane-semicarbazide PU segments. According to the results of DTA, introduction of metal ions leads to the increase of the thermal stability of metal-containing PU, as compared to the original PU. FTIR spectra data confirmed that the metal ions Cu2+, Co2+ are coordinated in the polymer metal chelates with hydrazide and urethane groups. The research results can be used to develop the new materials and methods for the preparation and designing of metal-containing polymers required in various areas, such as development of medical equipment, functional films and other related areas.

A Scalable Multicloud Storage Architecture for Cloud-Supported Medical Internet of Things

Nowadays, cloud-supported Internet of Things (Cloud-IoT) has been broadly deployed in smart medical systems, where the limitations of Internet of Things (IoT)-associated medical devices in terms of data access, storage, scalability, and computing are solved through the use of cloud computing architectures. However, with the rapid development of medical equipment and the increasing number of medical devices, it will be extremely difficult to program or manage such an expanding and massive medical IoT system in traditional single-cloud platforms. In this article, we design and implement a multicloud framework for building OpenStack-based platform for medical IoT, referred to as the tri-storage failure recovery system (Tri-SFRS). To implement Tri-SFRS, we combine several techniques to achieve this reduction in effort, including a multicloud cascading architecture, a low-overhead native testing framework, a medical data storage-backup mechanism, and snapshot-volume cascaded operations for b-ultrasonic data. Tri-SFRS is also able to simultaneously enable resource management specialization. Tri-SFRS has been designed as a native component in the OpenStack platform, and it demonstrates the degree of native OpenStack multicloud platform management by our proposed cascading framework. Comparing with the traditional single-cloud OpenStack platform, Tri-SFRS can reduce the resource-request processing latency from B ultrasonic machines by up to 20%. Our experiments also demonstrate the broad applicability of Tri-SFRS.

Good practices systematization for medical equipment development and certification process: A Brazilian case study

Medical equipment development requires from manufacturers a clear definition of the processes to the core team in order to achieve the user safety. Therefore, considering the lack of a specific product development framework for medical equipment that meets the Brazilian scenario, this work proposes a good practices systematization for medical equipment development. It covers the main Brazilian regulations that impact on development process of these products. Based on the stage-gates process, the systematization proposed divides the development process activities into five phases and nine functional groups. To each functional group is presented the activities expected to be practiced in each phase, tools that could be used, and the regulations that could guide the execution of the activities. The case study method was used to validate the systematization. Three companies of medical devices were presented to the model and their realities of the development process were compared to the proposed systematic. From the results was possible to conclude the potential use of the good practices as a guide for the process development of health equipment. Besides that, the model allows to follow up the regulations that should be used and can be used as training material.