News Digest 05.04.2024 — 08.04.2024
Regulators
The rules for labeling medical devices with a limited service life have been changed
The government has changed the rules for labeling medical devices (MD) - Resolution No. 392 of 03/29/2024 (available on “MD”). The document came into force on April 5.
Remains of medical products with a limited service life can be sold without labeling until August 31, 2024. The requirement does not apply to medical organizations that can store, transport and donate already purchased medical products without labeling.
Changes were made to Resolution No. 894 dated May 31, 2023.
Mandatory labeling for medical products, antiseptics, dietary supplements and wheelchairs was introduced in June 2023; it must be applied from October 1, 2023. In March 2024, the Ministry of Industry and Trade proposed conducting an experiment on labeling condoms, syringes, masks, fillers, ventilators and infusion systems. The experiment will run for a year from September 1.
Market news
A plant for the production of glucometers was built in Moscow
The Elta company has completed the construction of a plant for the production of medical equipment and consumables in the Technopolis Moscow special economic zone, the press service of the capital’s Complex of Economic Policy and Property and Land Relations told MV. It is planned that the new production will provide the country’s market with “smart” glucometers, as well as the first Russian devices for continuous glucose monitoring (CGM).
In addition, the company plans to launch the production of the first Russian oncotesters, as well as portable devices for determining the prothrombin index and cholesterol levels in the blood, and laboratory DNA analyzers.
The area of the Elta company's plant at the Alabushevo site exceeds 11.3 thousand m2. Investments in the project exceeded 2.2 billion rubles. The start of production is scheduled for the end of 2024.
As the general director of the company, Yuri Glukhov, said, in 2023 the Elta company was included in the register of startups and technology companies in Moscow and backbone organizations of the Russian economy.
The situation with the availability of LMWH devices for patients with diabetes remains tense in Russia. The problem was raised at a meeting of the head of state with members of the government on September 27, MV reported. Disruptions in the supply of LMWH systems for children arose after the US authorities included components for them produced by Medtronic into 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 are registered in Russia, two of them are produced in friendly countries. Two more LMWH systems are being developed by Russian manufacturers; clinical trials of medical devices are planned for the first quarter of 2024. President Vladimir Putin instructed the minister to develop proposals to improve the situation within a week.
Patients complained that regions were purchasing Chinese LMWH systems. Thus, in Novosibirsk, the prosecutor’s office even began an investigation after it became known that for diabetic children in the region they purchased systems that left bruises and that could stop working if they got wet.
Source: https://medvestnik.ru/content/news/V-Moskve-postroili-zavod-po-proizvodstvu-glukometrov.html
Federal medical centers will receive another 1.6 billion rubles for rehabilitation equipment
The government will allocate almost 1.6 billion rubles to equip federal medical centers with modern rehabilitation equipment in 2024. According to the order, funds will be allocated from the budget.
Funding is allocated within the framework of the federal project “Optimal medical rehabilitation for restoring health.” The money will be received by the Ministry of Health (685.8 million rubles), the Ministry of Education and Science (368.3 million rubles), the Ministry of Defense (158.8 million rubles), the Ministry of Labor (18 million rubles), the Ministry of Emergency Situations (18 million rubles) and the FMBA of Russia (RUB 339.6 million). In total, it is planned to upgrade or re-equip medical rehabilitation departments in 49 organizations in different regions of the country. For their needs, it is necessary to supply more than 600 units of various equipment, including specialized equipment.
J&J will buy a manufacturer of devices for the treatment of heart disease
Johnson & Johnson (J&J) announced the purchase of Shockwave Medical for $13.1 billion. This became known from a press release from the manufacturer.
The transaction will strengthen J&J's position in interventional cardiology, one of the fastest growing areas of the global medical device market in the world. The pharmaceutical giant will expand its portfolio with a lithotripter for the treatment of coronary heart disease and peripheral artery disease.
Intravascular lithotripsy (IVL) is a procedure used to treat heart conditions in which a coronary artery becomes blocked because calcium or stones are deposited in the artery, obstructing normal blood flow. During therapy, a lithotripter device is used, which creates shock waves that destroy stones in the heart vessels.
The acquisition is expected to be completed by mid-2024. The Shockwave acquisition follows a series of transactions that have seen J&J add companies including Abiomed, a leader in cardiovascular medical technology; Laminar, an innovator of equipment for left atrial appendage removal in patients with non-valvular atrial fibrillation; Biosense Webster, a developer of electrophysiological instruments.
A clinic will be built in Troitsk for 3.5 billion rubles
The capital's Department for Competition Policy has announced a tender for the construction of an adult clinic in Troitsk (an urban district within Moscow). The initial maximum contract price is 3.5 billion rubles.
According to the Unified Information System, the customer set the deadline for completing the work at 610 calendar days.
The total area of the land plot for construction is 3.04 thousand square meters. m, the area of the clinic itself is 2.9 thousand square meters. m. It is planned that the medical facility will consist of 3-4 floors and one underground floor. The clinic will be able to accommodate 750 people per shift. In addition to the construction of the building itself, it is planned to develop parking lots for 74 parking spaces, including 10 for people with limited mobility.
In February 2024, the Moscow Department of Competition Policy announced a competition for the construction of a clinic in the village of Pervomaiskoye. The initial maximum contract price was 3.7 billion rubles. LLC GC "Construction Management-555" was chosen as the contractor. The facility will be designed for 750 visits per shift.
Also in March 2024, Moscow authorities announced four tenders for major repairs and retrofitting of four facilities of the obstetrics and gynecology service of the capital’s Department of Health – three women’s health centers and the maternity hospital of City Clinical Hospital No. 15. Also, the buildings of the State Clinical Hospital named after. V.V. Veresaev and State Clinical Hospital named after. F.I. Inozemtseva. The total starting price for all tenders was 11.8 billion rubles and separately for women’s health and obstetrics facilities – 5.8 billion rubles
Source: https://vademec.ru/news/2024/04/08/v-troitske-postroyat-polikliniku-za-3-5-mlrd-rubley/
The Samara War Veterans Hospital will receive 89 million rubles from the federal budget to install an MRI
The Government of the Russian Federation allocated 89.566 million rubles from the reserve fund for the Samara Regional Clinical Hospital for War Veterans named after. O. G. Yakovleva. The funds will be used to prepare the clinic premises for the installation of a magnetic resonance imaging (MRI) scanner, as well as to purchase the device itself and put it into operation.
The government order stipulates that the funds will first be received by the Russian Ministry of Health and then transferred in the form of a subsidy to the regional budget. The department must also monitor the intended use of the tranche and submit a report to the Government of the Russian Federation by February 1, 2025.
Of the total amount, 6.366 million rubles will be spent on major renovations of the premises of the medical institution for the installation of MRI. Another 83.2 million rubles are intended for the purchase of MRI and its commissioning in 2024.
In March 2024, the Russian Government allocated 182.5 million rubles for the retrofitting of two medical institutions in the Belgorod region. With this money, the region will be able to purchase the missing equipment for the Belgorod Regional Clinical Hospital of St. Joasaph and the Belgorod city clinic.
According to the program for modernizing primary healthcare, as Prime Minister Mikhail Mishustin said in a report on the work of the government in the State Duma on April 3, 2024, “147 thousand units of medical equipment, about 5 thousand ambulances and three times as many vehicles for transporting doctors and paramedics were purchased.” .
The Moscow region will purchase medical equipment worth 1 billion rubles to re-equip maternity hospitals
The authorities of the Moscow region plan to purchase more than 700 ultrasound and ventilator machines in 2024 for the needs of perinatal centers and maternity hospitals in the region. The total purchase bill will be more than 1 billion rubles.
The equipment is planned to be supplied to 12 medical organizations, including city hospitals in Khimki and Klin, perinatal centers in Kolomna and Vidnoye, as well as other clinics.
Another 192 pieces of equipment, including mammographs with a biopsy attachment, ultrasound machines, endoscopic stands and laboratory equipment, are planned for purchase to equip the oncology departments of hospitals in the region. The amount of funds that will be allocated for the purchase of equipment is not disclosed.
In addition to equipping specialized departments, there is a program in the Moscow region to replace “heavy” medical equipment. Purchases are carried out under the program for upgrading analog equipment to digital equipment.
In 2024, the regional authorities plan to purchase 137 pieces of heavy medical equipment for a total amount of 4.6 billion rubles. The range of medical equipment includes X-ray machines, mammographs, fluorographs, computed tomography machines, MRI and angiographs.
The first 16 tenders for the supply of X-ray machines, computer and magnetic resonance imaging scanners, fluorographs, angiographs and mammographs totaling 2.935 billion rubles were announced in February-March 2024.
The world's most powerful MRI machine was unveiled in France
The French Commission for Alternative and Atomic Energy (CEA) presented the most powerful MRI machine Iseult MRI. Its magnetic field power is 11.7 tesla, which makes it possible to obtain images of the brain in a 0.2 mm plane and a slice thickness of 1 mm. In addition, using the device, you can more accurately see the distribution of lithium, glucose and glutamate in the brain. It will take 4 minutes to get the finished photo.
The technology will help in the diagnosis and treatment of neurodegenerative diseases, such as Alzheimer's and Parkinson's diseases, experts report. The development will also make it possible to find out how the brain encodes mental representations and clarify which neural signals are associated with the state of consciousness.
Other
The Ministry of Health proposed adding an isothermal blanket to the car first aid kit
The Ministry of Health of the Russian Federation has prepared a draft order on the provision of a car first aid kit for providing first aid to victims of road accidents. Among other things, the department proposes to add a rescue isothermal blanket and surgical scissors to the kit. As planned, the approval of the new composition of the first aid kit will “most adequately meet the task of providing first aid” and will increase its effectiveness.
The draft list also includes a CPR mouthpiece/covering, reusable and disposable elastic bandages. The isothermal blanket must be at least 160x210 cm.
“The approval of a new composition of the first aid kit, which most adequately meets the task of providing first aid to vehicle drivers injured in road accidents, will increase the efficiency of first aid and, accordingly, reduce mortality, disability and the timing of temporary disability from injuries in road accidents.” , says the explanatory note to the draft order.
The Ministry of Health noted that injuries resulting from road accidents are among the most severe types of injuries and rank first among the causes of death from mechanical injuries. Often it is the early provision of first aid to the victim that allows him to save his life and reduce the time of treatment. Therefore, in order to achieve the greatest effect, first aid to victims must begin to be provided even before the ambulance crews arrive.
When developing the kit, the explanatory note notes, the practice of using a first aid kit was taken into account, and therefore the list of medical products included in its composition was adjusted.
If the document is adopted, it will come into force on September 1, 2024 and will be valid until September 1, 2030. Drivers will be able to use first aid kits produced before this time until December 31, 2025.
The development program for synchrotron and neutron research has been extended until 2030
The Government of the Russian Federation has expanded and extended until 2030 the federal scientific and technical program for the development of synchrotron and neutron research, with the help of which a network of “megascience” class facilities is being formed. They plan to allocate about 450 billion rubles for the implementation of the program. The funds will be used for the creation, modernization and operation of “megascience” installations and nuclear medicine complexes.
Funding will also be used for state support of research projects in scientific fields and training of personnel for science. In connection with the extension of the program, a decision was made on a new, third stage of implementation, which will take place from 2028 to 2032. It is planned to expand the network of infrastructure for conducting neutron research and create a new one, which is expected to surpass the technical characteristics of existing and projected international sources of synchrotron radiation.
During this period, they can also conduct technical and clinical tests and registration of new medical products, develop new technologies in the areas of program implementation.
Wearing Stellest spectacle lenses slowed the progression of myopia in children
Scientists from the National Medical Research Center for Eye Diseases named after. Helmholtz during the scientific and practical conference “Current issues in pediatric ophthalmology” spoke about the results of a two-year study of the use of Stellest spectacle lenses in children with progressive myopia.
Analysis of the data obtained confirmed that wearing Stellest spectacle lenses stabilizes the dynamics of refraction and eye growth with progressive myopia in children.
The frequency of a decrease in the annual gradient of progression increased as the follow-up period increased in both groups, but in the Stellest group, a decrease in the annual gradient of myopia progression was observed much more often: in 78.6% of cases after six months and in 93.5% of cases after two years of follow-up. In the group of monofocal glasses, a decrease in the annual progression gradient after two years of follow-up was detected only in 61.1% of participants.
A new method for correcting laryngeal defects after mechanical ventilation and operations has been patented in Tomsk
A transplant in the form of an arcuate plate made of porous-permeable titanium nickelide and an implant made of metal knitwear was developed and patented by scientists from TSU and Siberian State Medical University. The new implant will be used to correct laryngeal defects that arise as a result of long periods of time on mechanical ventilation (ALV), complex operations or injuries. As the scientists noted, a metal knitted implant can significantly simplify and speed up the surgeon’s work due to its ability to “stick” to tissue, which reduces the risk of its displacement and further complications.
After using the transplant, Tomsk surgeons came to the conclusion that the new approach to treating defects was less traumatic for the patient and also shortened the recovery time. Previously, for the same operation, meshes and arched implants that were less biocompatible were used, which were not resistant to infection.
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