International Medical Standards Research Articles

Advanced Design and Implementation of a 2-Channel, Multi-Functional Therapeutic Electrical Stimulator

This research introduces the design, implementation, and rigorous evaluation of a novel 2-channel, multi-functional therapeutic electrical stimulator, meticulously engineered to meet the stringent demands of contemporary clinical applications. The device integrates a high-speed R-2R ladder DAC and a sophisticated pulse generator unit, capable of producing twelve essential current waveforms with fully adjustable parameters, including pulse amplitude, pulse duration, and pulse repetitive frequency. The proposed driving stage unit ensures precise voltage-to-current conversion, delivering stable and accurate output currents even under varying load conditions, which effectively simulate the diverse impedance characteristics of human tissue. Extensive testing confirmed the compliance with international medical standards, notably IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-10. The experimental results underscore the device’s consistent operation within prescribed safety and performance thresholds, with all deviations in pulse parameters remaining well below the permissible limits. Furthermore, the proposed electrical stimulator demonstrated exceptional stability across variable load conditions, as evidenced by minimal amplitude errors and high correlation between waveform characteristics. These findings highlight the proposed device’s robustness and its potential as a versatile tool for a wide range of therapeutic applications, including pain management, muscle stimulation, and nerve rehabilitation, thus marking a significant advancement in the field of therapeutic electrical stimulation.

Medical code of ethics as an instrument of power and autonomy of the professional community

The article focuses on the activity of a doctor, considered from the standpoint of professional ethics. The practice of forming and controlling the implementation of the ethos of a doctor is shown as an instrument of power and autonomy of the professional community in the work space. The main sources of the study were texts codifying the ethics of the profession and implementing international medical standards in Russian context.

Implementation and Validation of a Novel Noninvasive blood Pressure Measurement Algorithm Based on Oscillometric Method with Obtaining International Hypertension Standards.

Background:One of the most prevalent methods in noninvasive blood pressure (BP) measurement with cuff is oscillometric, which has two different types of deflation, including linear and step deflation. With this approach, in addition to designing a novel algorithm by the step deflation method, a sample of its module was constructed and validated during clinical tests in different hospitals.Method:In this study, by controlling the valve, the pressure would be deflated through optimized steps. By real-time processing on the obtained signal from the pressure sensor, pulses in each step would be extracted. After that, in offline mode, mean arterial pressure is estimated based on curve fitting.Result:A BP simulator, various modules, and an auditory method were used to validate the algorithm and its results. During clinical tests, 80 people (men and women), 11 dialysis patients, and 69 non-dialysis (healthy or with other diseases) in the age range of 17–85 years participated.Conclusion:The obtained results compared with the BP simulator are in the standard range according to the international medical standards of the British Hypertension Society (BHS) and the US Association for the Advancement of Medical Instrumentation (AAMI), which are the global standard of comparison in this field.

Highly Sensitive Surface Plasmon Resonance Sensor Modified With 2D Ti₂C MXene for Solution Detection

Two-dimensional (2D) Ti2C MXene has great prospects in many fields of biotechnology and biosensing owning to their highly active 2D surfaces, in this work, we demonstrate a high sensitivity surface plasmon resonance (SPR) sensor modified by the 2D Ti2C nanosheets overlayer. Our experimental results show that the performances of the SPR sensor are closely related to the thickness of 2D Ti2C nanosheets, and the proposed design gives the wavelength sensitivity of 3579.6 nm/RIU, which are 79% higher than the SPR sensor without Ti2C overlayer. In addition, the Ti2C covered SPR sensor is capable of detecting low concentrations of heavy metal ions, our results show that the maximum concentrate sensitivities are 3.788 nm/ $\mu \text{g}$ /L, 5.308 nm/ $\mu \text{g}$ /L and 3.233 nm/ $\mu \text{g}$ /L for Pb2+, Cr2+ and Hg2+ ions, and the corresponding detection limits are 79.2 ng/L, 56.5 ng/L and 92.8 ng/L, which are lower than the international medical standards. Our results pave the way to realize high sensitivity biosensor and environmental pollution detection.

The current state of fish market in Ukraine

The fishing industry is an important component of the economy of Ukraine at the present stage of development. The development and implementation of the innovative technologies in fish farming and fish processing require mandatory and ongoing analysis of a fish market infrastructure. The demand for food protein, which is characterized by a balanced amino acid content is provided by fish and seafood at 20–30 %. The aim of this work was to understand a current state of a fish products market in Ukraine, its pricing and consumption. Based on the specialized literature the evaluation of a current state of fish and fish products consumption in Ukraine and own studies of the price category of fish products in Ukraine in recent years were conducted. We studied fish and fish products consumption per year per capita in Ukraine over the last 20 years, assortment of fish in Ukraine, the import of fish and fishery products by species, the product prices in UAH per kg both in previous years and today. According to international medical standards the annual consumption of fish and seafood should be 20 kg per person. At the same time in Ukraine according to the State Statistics Committee on the 01.01.2019 14.5 kg of fish and seafood came out per capita. In 2018–2019 herring traditionally remained a leader of consumption in Ukraine. Ukraine also imported such species of fish: mackerel, hake, herring, salmon, pilchards, pollack, capelin, sardines, notating. In addition pangasius, shrimp, blue whiting, mussels, squid, saury, Jack mackerel, sea bass, tuna, flounder, anchovies, smelt, cod, salmon and other species of fish, caviar and seafood are imported in Ukraine. The investigated assortment of fish in Ukraine is represented both domestic and imported products. The domestic production are: carp, pike, capelin, herring, mackerel, sprat, the imported products are: flounder, perch, pangasius, salmon, butter, hake, Pollock, capelin, nototenia, herring, mackerel, cod, tuna, tilapia (sole), sea trout, whiting and so forth. It is established that the condition of a fish market in Ukraine is affected by an unstable economic and political situation in the country, low solvency of the population, corruption and the high payables of the enterprises. In Ukraine a tendency towards a decrease in the volume of fish and fish products consumption by the population of Ukraine is observed annually, which is a consequence of the decline in fish catch and fish production, depreciation of fixed assets and a lack of financial support to the fishing industry.

Electronic implementation of a PWM electrical nerve stimulation system for medical treatment of acute and chronic pains

In this paper we will implement a transcutaneous electrical nerve stimulation (TENS) designed for medical applications in order to reduce acute and chronic pains. This procedure uses electrical currents pulses applied on the skin area via electrodes. Two kinds of stimulation are adopted: the peripheral nerve stimulation (PNS) and the spinal cord stimulation (SCS). In either, a small pulse generator sends electrical pulses to the nerves (in PNS stimulation) or to the spinal cord (SCS stimulation). Previous studies on TENS technique showed that the obtained results are not very satisfactory and depend on the patient’s state, condition, age, and stimulation parameters. In order to optimize the conditions and parameters stimulation during treatments, we present in this paper a new strategy called pulse width modulation stimulation (PWM-TENS) based on a parametric computing of frequency, current intensity, pulse duration of stimuli. To implement our approach, we used an embedded platform under Arduino-Uno with five several programs depending on the pain category and according to international medical standards and specifications. The first tests on 15 volunteer patients showed satisfaction ratio (EVA) after 5–12 days and a pain reduction between 80 and 20 after 1 month of stimulation. This result is important because it prolongs the analgesic effect and reduces therapeutic rehabilitation period. The medical aspect of the subject is to have a medical tool that allows objective evaluations for short and medium periods of pain treatments with dynamic evaluation metrics.

Differences and international standardization between acupuncture as therapy and as specialty

The purpose of this study is to explore the differences of definition and clinical roles as well as international standardization between acupuncture as therapy and as specialty, which can provide reference evidence for specialization and internationalization of acupuncture. Owing to the clinical efficacy and safety, the credibility and controversy both exist in acupuncture; moreover, there is a lack of fair definition and international precedent regarding acupuncture specialty. Therefore, it is particularly essential to objectively compare the differences of definitions and clinical roles as well as criteria of international standardization for acupuncture as therapy and as specialty. It is believed acupuncture standardization can draw lessons from the international medical standards, evidence-based medicine and acupuncture theory from the following three major projects:acupuncture safety and contraindications; acupuncture indications and treatment guidelines; acupuncture indication classified into 3 levels of evidence-based acupuncture disease spectrum, as objective evidence of indication of acupuncture specialty.

Little soldiers in their cardboard cells

As medical professionals with long-standing experience in sports physiology and sports medicine in both the academic and sports world, we would like to comment on the recent manuscript by Heuberger et al. 1 regarding the lack of evidence for the efficacy and the negative risk–benefit of erythropoietin (EPO) use in cycling. Indeed, it has been a moving sports summer, with the confession by dozens of professional cyclists of the use of, among other substances, erythropoietin, with the public confession of seven times Tour de France winner Lance Armstrong as the anticlimax. Erythropoietin use was like taking cups of coffee in the cycling world according to the following quotation: ‘Hey Dude, you got any Poe I can borrow? Lance pointed casually to the fridge. I opened it and there, on the door, next to a carton of milk, was a carton of EPO, each stoppered vial standing upright, little soldiers in their cardboard cells.’ 2.

Reproductive health information and abortion services: Standards developed by the European Court of Human Rights

In 3 recent judgments, the European Court of Human Rights addressed the issue of access to abortion and related reproductive health services. In 2 of the judgments, the Court declared that the state violated women’s rights by obstructing access to legal health services, including abortion. In so doing, it referred to the state’s failure to implement domestic norms on prenatal testing and conscientious objection, and recognized the relevance of international medical guidelines. This illustrates that domestic and international medical standards can serve as critical guidance to human rights courts. In the third case, the Court showed its unwillingness to declare access to abortion a human right per se, which is troubling from the perspective of women’s right to health and dignity. The present article outlines the relevance of these cases for the reproductive health profession and argues that medical professional societies can influence human rights courts by developing and enforcing medical standards, not only for the benefit of abortion rights domestically but also for the advancement of women’s human rights worldwide.

Method and device for bio-impedance measurement with hard-tissue applications

Bio-impedance measurements can be used to detect and monitor several properties of living hard-tissues, some of which include bone mineral density, bone fracture healing or dental caries detection. In this paper a simple method and hardware architecture for hard tissue bio-impedance measurement is proposed. The key design aspects of such architecture are discussed and a commercial handheld ac impedance device is presented that is fully certified to international medical standards. It includes a 4-channel multiplexer and is capable of measuring impedances from 10 kΩ to 10 MΩ across a frequency range of 100 Hz to 100 kHz with a maximum error of 5%. The device incorporates several user interface methods and a Bluetooth link for bi-directional wireless data transfer. Low-power design techniques have been implemented, ensuring the device exceeds 8 h of continuous use. Finally, bench test results using dummy cells consisting of parallel connected resistors and capacitors, from 10 kΩ to 10 MΩ and from 20 pF to 100 pF, are discussed.