News Digest 27.03.2024 — 29.03.2024
Regulators
03/27/2024 The Commission of the Scientific Expert Council approved the minutes of the meeting of Commission No. 9
AGENDA:
1. On the issue of assessing the compliance of medical devices for in vitro diagnostics with the requirements of GOST R ISO 23640-2015 “Assessment of the stability of reagents for in vitro diagnostics” and GOST R ISO 17511-2022 in terms of establishing metrological traceability of values assigned to calibrators, accuracy control materials and samples human biological material. Speaker: Momynaliev K.T., Tarasenko O.A., Nikiforova L.Yu.
2. Discussion of the received proposals from FLM, APSKLD, IMEDA IC Vympel “Justification for the impossibility of confirming the measurement uncertainty of the value assigned to the calibrator within the framework of technical tests for the purpose of state registration of MI IVD”, “On accelerated assessment of stability” and “National and interstate standards in the field of medical devices for in vitro diagnostics”, positions of the Elektrontest Institute of Sciences, the Research Center LLC MIITs MI, the Research Center Central Control and Control Center Biolife.
DECIDED:
1. In order to confirm compliance by manufacturers of medical devices with the requirements of the GOST R ISO 23640-2015 standard in terms of assessing the stability of medical devices for in vitro diagnostics and GOST R ISO 17511-2022 in terms of establishing metrological traceability of values assigned to calibrators, accuracy control materials and biological samples human material, NES participants decided:
1. Testing laboratories review the stability reports provided during technical testing to ensure that the information is complete and the results of the manufacturer’s reports are comparable with the requirements of the GOST R ISO 23640-2015 standard. Testing laboratories conduct assessments for compliance with GOST R ISO 23640-2015 if available in the field of accreditation.
2. Testing laboratories review provided reports on metrological traceability of values assigned to calibrators, accuracy control materials and samples of human biological material (as applicable) in the process of technical testing for completeness of information and comparability of results from the manufacturer, the requirements of the IAM standard GOST R ISO 17511- 2022.
3. Testing laboratories carry out an assessment under paragraph 2 of the Protocol outside the scope of accreditation” by entering the necessary information into the Technical Test Results Assessment Report for assessing reports on metrological traceability of values assigned to calibrators, accuracy control materials and samples of human biological material (as applicable).
4. Develop checklists for assessing metrological traceability reports of values assigned to calibrators, accuracy control materials and human biological samples by technical organizations and experts. Completion period: 2 months.
Source: https://www.vniiimt.ru/nes/
Market news
In the Altai Territory they plan to build a clinic for 1 billion rubles
Deputy Minister of Health of the Altai Territory Vitaly Lazarev said that a consultative and diagnostic clinic for 650 visits per shift will appear in the city of Kamen-on-Obi. The cost of constructing the facility was estimated at 1 billion rubles.
The construction of the clinic will be carried out under the primary healthcare modernization program. The area of the three-story building will be 6 thousand square meters. m. The medical facility will be located on the territory of the hospital campus between the infectious diseases and administrative buildings.
The medical organization will include three operating divisions of the Kamensk Interdistrict Hospital - adult, children's and dental clinics. Currently they are housed in dilapidated or adapted buildings. The clinic will operate on a district basis - residents of the entire Kamensky medical-geographical district, which includes Kamen-on-Obi, Kamensky, Krutikhinsky, Pankrushikhinsky, Bayevsky and Tyumentsevsky districts, will be able to receive medical care.
The state contract for the construction of a clinic was concluded by the single customer for capital construction in the Altai Territory with Self LLC. Construction is planned to be completed by the end of 2025.
According to SPARK-Interfax, Self LLC was registered in 1996 in the Altai Territory, the main activity is the construction of residential and non-residential buildings. The manager and beneficiary is Nodar Shonia - he owns 100%. The company's revenue in 2022 amounted to 1.4 billion rubles, net profit - 21 million rubles.
The single customer for capital construction in the Altai Territory is the company’s largest partner. Thus, in 2020, a contract for 1.2 billion rubles was signed for the construction of a clinic in Barnaul, and in July 2022, the company received a contract for the construction of a surgical building for 165 beds in the Altai Regional Clinical Center for Maternal and Child Health. The cost was 2.77 billion rubles. At the end of October 2022, the contractor also began reconstruction of the building of the Regional Tuberculosis Hospital No. 1. The cost of the work is 1.9 billion rubles.
In July 2023, the Governor of the Altai Territory, Viktor Tomenko, during a meeting with the Minister of Health of the Russian Federation, Mikhail Murashko, announced that they plan to build a building with an operating unit and an intensive care unit on the territory of the emergency hospital. Preliminary construction and equipment of the facility will require about 3 billion rubles. In this regard, Tomenko asked for federal support.
A new and modern clinic has opened in the village of Kurskaya, Stavropol Territory
The Federal Service for Surveillance in Healthcare constantly monitors the implementation of the National Healthcare Project in all regions of the country. According to the Territorial Authority of Roszdravnadzor for the Stavropol Territory, thanks to the national project “Healthcare” a new clinic has opened in the village of Kurskaya.
The new clinic is designed for 350 visits per shift. This is a unique institution, equipped with the latest equipment and built with the latest technology. There is a digital X-ray machine, a latest-generation digital video indoscope, a mammograph with a biopsy module and two ultrasound machines, one of which is of expert class.
Now the building of the district clinic will provide medical care to 50 thousand residents of the Kursk District.
Source: https://t.me/roszdravnadzor_official/2383
Other
In Moscow, the capabilities of the AI service for detecting spinal diseases on MRI have been expanded
Moscow doctors will have access to a service using artificial intelligence (AI) to detect protrusions and herniations of intervertebral discs, spinal stenosis on a magnetic resonance imaging (MRI) of the cervical spine. Previously, the neural network determined the signs of these diseases in the lumbosacral region, the press service of the Center for Diagnostics and Telemedicine (CD&T) of the capital’s Department of Health reported on March 28.
The service allows you not only to detect pathology, determine its location and stage of development, but also to assess the level of narrowing of the spinal canal. When analyzing this type of research, the neural network carries out a large number of necessary measurements much faster than a person, said Yuri Vasiliev, director of the Center for Disaster and Testing, chief radiologist of Moscow.
The Center did not specify exactly how much research time is reduced and what percentage of accuracy of this service is. They noted that according to scientific research, the accuracy of AI algorithms is already comparable to the accuracy of a doctor.
According to Vasiliev, CD&T specialists have created an approach to assessing solutions based on AI technologies - a maturity matrix. It allows you not only to evaluate the solutions being implemented and compare them with each other in terms of diagnostic and technical potential, but also to track changes in these parameters over time. “In this way, only proven artificial intelligence services in popular areas become available to radiologists,” he emphasized.
As part of an experiment to introduce computer vision technologies into healthcare, more than 50 AI services are already operating in the capital, which find signs of 37 different diseases. Neural networks integrated into the unified radiological information service EMIAS create a description and mark with color hints areas of possible pathologies in a medical image, and produce measurements that are of clinical value for a radiologist when preparing a diagnostic report.
In February, Moscow authorities decided to open free access to medical services using AI to other entities, MV reported. Doctors throughout Russia will be able to make descriptions of radiation studies using these algorithms.
China has created implantable batteries that can run on the oxygen of living organisms
Specialists from Tianjin University of Technology (China) have developed implantable batteries that can function on the oxygen of the human body. The innovation can be used in pacemakers and neurostimulators, which currently operate from external power sources and require regular battery replacement through surgery. The experiment was carried out on rats. The batteries, made from sodium alloy and nanoporous gold and then encased in a porous polymer film, were implanted under the skin on the backs of rats. After this, the researchers measured the energy output and found that the batteries were able to maintain a stable voltage in the range of 1.3 V and 1.4 V. This power is not enough to power medical devices, but the experiment showed that oxygen inside a living body can be used to generate energy. In addition, it turned out that by-products of chemical reactions generated during battery operation were metabolized by the kidneys and liver without complications.
Source: https://www.cell.com/chem/fulltext/S2451-9294(24)00074-3
Sechenov University has developed a “smart” insole to track the biomechanical parameters of athletes
The software and hardware complex includes an artificial intelligence (AI) algorithm and an insole in which sensors of microelectromechanical systems are built. According to scientists from the Department of Sports Medicine and Medical Rehabilitation of the Institute of Clinical Medicine named after. N.V. Sklifosovsky, using sensors and AI, the program can determine multidirectional shock loads on the musculoskeletal system and internal organs, build a complete picture of locomotor exercises and monitor the dynamics of a person’s condition in real time. Thanks to this, doctors can assess the athlete’s condition, predict the risk of injury, monitor the treatment process, and also make decisions about rehabilitation, resumption of the training process, and admission to competitions.
In order to take measurements, it is enough to insert the insoles into the shoes and undergo several motor tests. The device comes with a tablet with a mobile application, so all results can be immediately saved into an individual digital profile. From there they will go to cloud storage. The athlete’s condition can be analyzed from anywhere in the world.
In the future, they plan to use the development to assess the condition and rehabilitation of patients from the departments of neurology, endocrinology, and traumatology, including after endoprosthetics.
In Japan, artificial intelligence has been developed to determine the causes of back pain from photos
The Japanese IT company NEC Corporation and the Tokyo Medical and Dental University have developed a service based on artificial intelligence (AI) that helps diagnose the causes of back pain using the user’s photographs and a questionnaire. As Japan's population ages, chronic back pain is becoming an acute problem: according to Mobihealthnews, the proportion of the population over 65 in the land of the rising sun is 29.1%. According to a study by the Japanese Ministry of Health, almost every elderly Japanese experiences back pain of varying severity.
So that residents of the Land of the Rising Sun can independently diagnose the causes of back pain, NEC Corporation has developed an AI service to identify the cause of unpleasant symptoms. The program also helps you create a personal exercise plan to relieve pain. The service is based on a technology for evaluating 2D/3D images of the user’s back, taken from different angles.
The media write that in 2024 the service will be tested in organizations caring for the elderly. The main thing is that no one gets hurt as a result of the test: photographing the back from different angles can be a difficult task for people aged 65+.
Source: https://t.me/medicalksu/4914
New registered medical devices
We publish a list of new medical devices registered from 03/22/2024 to 03/29/2024
Link to the list: [see. table in attachment]
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