News Digest 07.08.2024 — 09.08.2024

Regulators

Putin reappoints deputy heads of the FMBA

The presidential decree of August 8 approved an updated list of deputy heads of the Federal Medical and Biological Agency (FMBA). Andrei Dydykin, who joined the agency in 2021 from the Ministry of Industry and Trade, disappeared from the previous composition.

The current post was retained by the former head of the Federal Compulsory Medical Insurance Fund Natalia Stadchenko, responsible for financial and property issues, first deputy Tatyana Yakovleva, overseeing the investment and contract activities department Natalia Mikhailova and responsible for scientific research and the work of the territorial departments of the FMBA Igor Borisevich.

Nikolai Solntsev was appointed to the post of state secretary - deputy head of the agency created in July. Previously, he headed the Department of Legal Support and Property Relations of the FMBA.

In June of this year, the management of the FMBA's activities was transferred to the president, MV reported. Previously, the agency was subordinate to the government. The post of head remained with Veronika Skvortsova. In accordance with the regulations on the work, the head of the FMBA can have seven deputies, including one first deputy and one state secretary - deputy head, as well as up to 15 departments for the main areas of activity.

Source: https://medvestnik.ru/content/news/Putin-perenaznachil-zamestitelei-glavy-FMBA.html


Market news

The government will allocate 250 million rubles for the purchase of a tomograph for the Rogachev Oncology Center

The government allocated 250 million rubles for the purchase of a single-photon emission computed tomograph (SPECT) for the Dmitry Rogachev National Medical Research Center for Pediatric Hematology, Oncology and Immunology. The president gave this order following a meeting with members of the cabinet on November 8, 2023.

According to the order, money from the government reserve fund should be allocated in 2024. The Ministry of Health must report on the purchase by March 1, 2025.

The equipment manufacturer and the tomograph parameters are not specified. According to the government procurement website, Russian medical institutions mainly purchased Symbia SPECT from the American Siemens. The domestic two-detector single-photon emission tomograph is manufactured by JSC Research and Production Company Electron.

At the end of July, Deputy Prime Minister Tatyana Golikova warned the NMIC against "fragmentary" purchase of medical equipment. She clarified that the government plans to more strictly control the spending of funds for the modernization of federal medical centers: they will be required to have comprehensive development programs, MV reported.

Source: https://medvestnik.ru/content/news/Pravitelstvo-vydelit-250-mln-rublei-na-zakupku-tomografa-dlya-onkocentra-imeni-Rogacheva.html

The People's Front pointed out problems in providing children with diabetes with glucometers

The People's Front identified problems in providing diabetics with glucose monitoring devices, the need for which has to be proven through the chief endocrinologist or the regional hospital. There are difficulties with patient routing, it became clear at a meeting of the organization's experts with the participation of representatives of the Ministry of Health and the National Medical Chamber (NMP) on August 7.

Data on problems in providing glucometers were obtained on the basis of selective interviews with patients and a survey of about 5 thousand respondents from all regions of the country, organized jointly with the All-Russian Organization of Parents of Disabled Children in June - July 2024.

"Due to the lack of a general federal procedure for the provision of continuous glucose monitoring systems (CGMS), additional requirements for patients are being introduced within the framework of the federal project in some regions, for example, to hand in used sensors to receive new ones or to provide proof of sensor use," the NF report says.

There were cases of refusals to provide glucose monitoring systems to children with type 1 diabetes and consumables due to auctions for their purchase not being held in a timely manner. For example, children with temporary registration received such refusals.

"Almost 50% of those who applied for medicines were refused registration for deferred prescription servicing, since the relevant requirements of the Ministry of Health ceased to be in effect in 2022. These issues require attention and development," emphasized Sergei Sokolov, Deputy Head of the Executive Committee of the People's Front.

In March, the government planned to allocate an additional 30 million rubles to the regions for the purchase of continuous glucose monitoring systems for children with diabetes. The situation with the availability of CGMS devices for patients with diabetes remains tense in Russia. The issue was raised at a meeting between the head of state and members of the government in September last year, MV reported. Disruptions in the supply of CGM systems for children arose after the US authorities added components for them, manufactured by Medtronic, to the list of dual-use products. According to the head of the Ministry of Health, Mikhail Murashko, four such devices for children with type 1 diabetes have been registered in Russia, two of which are manufactured in friendly countries. Another two CGM systems were developed Russian manufacturers are engaged, clinical trials of medical devices are planned for the first quarter of 2024. Then President Vladimir Putin instructed the minister to develop proposals to improve the situation within a week.

Source: https://medvestnik.ru/content/news/Narodnyi-front-ukazal-na-problemy-v-obespechenii-detei-s-diabetom-glukometrami.html

Rosatom will acquire the rights to develop biodegradable implants for 253 million rubles

The Rusatom RDS division (a high-tech integrator of civilian products), subordinate to the Rosatom state corporation, will acquire the rights to develop biodegradable fasteners for implants created in partnership with the Kurchatov Institute National Research Center for Science and Technology for 253 million rubles. The total project bill, taking into account development costs, is estimated at 468 million rubles.

We are talking about screws, a plate and a rod created from innovative copolymers of lactide and calcium phosphate fillers, which allow patients with implants to undergo MRI, improve survival and reduce side effects, including cysts and inflammation, without causing bone tissue degradation.

The Science and Innovations Division of Rosatom State Corporation announced R&D for the development of copolymers and the production of a pilot version of a screw, plate and rod in October 2023. At that time, it was assumed that medical devices could find their application in traumatology, orthopedics and maxillofacial surgery. The initial maximum contract price was 215 million rubles.

The winner of the competition had to evaluate raw materials for the production of implants on the market of Russia and friendly countries, develop laboratory regulations for their production, and conduct technical and medical-biological tests of prototypes of medical devices. In August 2024, the Rusatom RDS division placed a purchase order for the alienation of exclusive rights to the development in full from the contractor, the Kurchatov Institute Research Center. The purchase amount was 253 million rubles.

Rusatom RDS is an industry integrator of the Rosatom State Corporation in the field of production of equipment and electronics.

The Kurchatov Institute Research Center is one of the key executors of the nuclear medicine roadmap; the institution is one of the operators of the synchrotron network development program. In June 2022, it became known that the Kurchatov Institute will receive 12.4 billion rubles to create a megascience-class scientific facility based at the Far Eastern Federal University by 2026. In addition, the institute will receive 8.8 billion rubles from 2024 to 2027 to create and develop scientific laboratories, as well as world-class genomic research centers during the implementation of the program for the development of genetic technologies for 2019-2030.

Source: https://vademec.ru/news/2024/08/09/rosatom-priobretet-za-253-mln-rubley-prava-na-razrabotku-biorazlagaemykh-krepezhey-dlya-implantov/

Mikhail Mishustin gave instructions following a working trip to the Far Eastern and Siberian Federal Districts

The tasks of improving the quality of life and developing the economy of the Far Eastern and Siberian regions were reflected in the list of instructions of Prime Minister Mikhail Mishustin following a working trip to the Far Eastern and Siberian Federal Districts, which took place on July 21-25, 2024.

During his working visit to the Magadan Region, Khabarovsk Krai, Novosibirsk Region and the Altai Republic, Mikhail Mishustin met with senior officials, visited educational and healthcare facilities and enterprises that make a significant contribution to the regional economy and the solution of the task set by the President to achieve technological sovereignty.

In the Magadan Region, the head of the Cabinet visited the Mayak Park, the improvement of which is being carried out with the support of the Government, got acquainted with the results of clearing Nagaevskaya Bay from sunken ships and plans for the reconstruction of the Magadan Sea Fishing Port. The Chairman of the Government gave instructions to develop and implement a list of steps to develop the logistics center of the Magadan port, determine the deadlines and those responsible. The corresponding instructions were given to the Ministry of Transport, the Ministry of Agriculture, the Ministry of Economic Development, the Ministry for the Development of the Russian Far East, Rosrezerv and the Government of the Magadan Region.

The Ministry for the Development of the Russian Far East and the Government of the Magadan Region have been tasked with ensuring the implementation of measures to improve courtyards in the Magadan Region, to reconstruct the building to create a center for advanced professional training. A large block of instructions concerns the modernization of socially significant facilities. The Ministry of Health, together with the government of Khabarovsk Krai, must prepare a list of medical equipment for the additional equipment of the A.K. Piotrovich Children's Regional Clinical Hospital and, together with the Ministry of Finance, ensure the allocation of funds from the Cabinet's reserve fund for these purposes in 2024.

The Ministry for the Development of the Russian Far East and the government of Khabarovsk Krai must ensure the implementation of measures to repair, equip and improve social facilities, including kindergartens, an arboretum and public areas.

In order to complete the reconstruction of the embankment in the Central District of Kha Barovsk The Ministry of Construction, the Ministry of Economic Development and the Ministry of Finance, together with the government of Khabarovsk Krai, have been instructed to submit proposals for the redistribution of federal budget funds for these purposes; the Ministry of Construction, the Ministry of Finance and the Ministry for the Development of the Russian Far East have been instructed to prepare proposals for possible sources of financing for the improvement of the dam in the Southern District of Khabarovsk.

Another block of instructions is devoted to issues of transport infrastructure development. The Ministry of Transport and the Ministry of Finance will present proposals for financing the construction of the first stage of the eastern bypass of Novosibirsk for its commissioning in 2025 and for the timing of the next stages of construction of this bypass.

The Ministry of Transport has been instructed to ensure the reconstruction of a section of the R-256 Chuysky Tract highway with bypasses of the settlements of Souzga and Manzherok in the Altai Republic and to submit proposals for the further development of this road.

A separate instruction in this block concerns the development of the airport in Gorno-Altaisk. Mikhail Mishustin personally familiarized himself with the reconstruction project and, following the results of the trip, instructed the Ministry of Transport, the Ministry of Finance, the Ministry of Economic Development, the Federal Antimonopoly Service and the Federal Air Transport Agency to complete work on concluding a concession agreement for the reconstruction of the airport's airfield infrastructure.

The list of instructions also paid attention to issues of developing international cooperation in the field of education and sports. The Ministry of Transport, the Ministry of Economic Development, the Ministry of Education and Science, the Ministry of Culture and the Russian Railways must ensure the implementation of measures aimed at increasing international academic exchange at the Far Eastern State Transport University.

The Ministry of Sports, the Ministry of Foreign Affairs and the Ministry of Finance were instructed to submit proposals for holding an international sports event in Khabarovsk with the participation of member states of the Shanghai Cooperation Organization.

Source: http://government.ru/news/52337/


Other

An unconventional treatment method allowed Khabarovsk cardiac surgeons to cure heart disease and preserve the reproductive function of a young patient

A 29-year-old girl from the Khabarovsk Territory sought help from the Khabarovsk Federal Center for Cardiovascular Surgery of the Russian Ministry of Health with complaints of shortness of breath with minor physical exertion and chest pain.

Earlier in 2018, the girl had already had heart valves replaced with biological prostheses. However, the service life for young patients is shorter due to a more pronounced immune response, and doctors revealed dysfunction of both prostheses during examination.

When using bioprostheses, young women do not need to take blood thinners compared to mechanical prostheses. And their use is a contraindication for pregnancy.

The center's specialists faced a difficult task: to correct the valve pathology with the help of durable prostheses, as well as preserve the patient's reproductive function.

The use of new biological prostheses would have forced the patient to undergo surgery again for several years;

Mechanical prostheses with a long service life would have excluded the possibility of having children in the future.

A multidisciplinary team of cardiac specialists at a consultation decided to implant two prostheses, the flaps of which are made of the thinnest synthetic material - polytetrafluoroethylene. The valves are designed and manufactured in Russia, and the service life of their flaps is more than 10 years.

The required valve size was selected after 3D modeling of the heart using CT.

The five-hour operation took place in several stages:

  1. The heart was isolated from adhesions;
  2. The artificial blood circulation machine was connected;
  3. In conditions of cardioplegic cardiac arrest, the MedLabKT prosthesis No. 25 was installed in the mitral valve position
  4. The EvRos-MI prosthesis No. 23 was implanted in the tricuspid valve position.

Echocardiography showed satisfactory operation of the new prostheses, the postoperative period passed without complications. The girl has already been discharged for outpatient treatment and observation without the need to take blood thinners, and with the ability to have children.

Source: https://minzdrav.gov.ru/regional_news/21630-nestandartnyy-metod-lecheniya-pozvolil-habarovskim-kardiohirurgam-vylechit-patologiyu-serdtsa-i-sohranit-reproduktivnuyu-funktsiyu-molodoy-patsientki


Newly registered medical products

We publish a list of new medical products registered from 09.02.2024 to 08.09.2024

Link to the list: [see table in the attachment]

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