News Digest 14.08.2024 — 16.08.2024

Regulators

The regulator clarified the procedure for providing disabled people with technical rehabilitation equipment

The Ministry of Labor of Russia approved amendments to some legal acts on issues of providing disabled people with technical rehabilitation equipment (TRE). For example, now, when selecting support for crawling, sitting, lying and standing for disabled children, not only the child's height and weight will be taken into account, but also the distance from the foot to the chest, from the foot to the knee and from the foot to the perineum.

In addition, when selecting walkers, wheelchairs for children and adults with cerebral palsy or if additional body support is needed, the activity level according to GMFCS (cerebral palsy assessment scale) will be taken into account. When prescribing special clothing, the manufacturing feature will be determined - for typical figures, custom-made or for complex combined pathology requiring particularly complex manufacturing methods.

The department also supplemented the list of TRE with 161 items. For example, for children - folding/non-folding/large-sized walking walkers, on wheels/without wheels, with underarm support, with additional fixation, rollator walkers. For children and adults - a wheelchair with a hard seat and backrest, with a folding backrest, with adjustable footrest angle, with additional fixation, with an electric drive, for people with a lot of weight and other types.

In July 2024, the Ministry of Labor submitted for public discussion a draft order approving a list of medical and social indications and contraindications for providing disabled people with TSR. The agency intended to prescribe for the first time social indications that will be determined during a medical and social examination (MSE) in order to increase the activity and participation of a disabled person, as well as the effectiveness of restoring the ability to self-service and work. At the moment, the project is at the stage of completing an independent anti-corruption examination. In July 2024, the department also developed a draft resolution of the Government of the Russian Federation on changing the rules for providing disabled people with TSR. According to the adjustments, a disabled person or their legal representative will be able to submit an application for replacement of the TSR 60 calendar days before the expiration of the established terms of use of the TSR. At the moment, this is only possible after the expiration of the term of use of the product. The innovation was developed to continuously provide those in need of TSR.

Source: https://vademec.ru/news/2024/08/15/regulyator-utochnil-poryadok-obespecheniya-invalidov-tekhnicheskimi-sredstvami-reabilitatsii/


Market news

The CV "Protek" reported on fifteen million units of products marked since the beginning of the year

The list of regular customers using marking services includes seventeen manufacturing and distribution companies - Russian legal entities specializing in import deliveries within the EAEU, the company said.

The first labeling line, designed for the side application of stickers on packaging, was launched at the Transservice-2 terminal site of the logistics park in June 2023. The second and third lines (side and top application) were launched in April 2024 within the Transservice-3 terminal circuit.

The capacity of each line in operation is from 12,000 to 22,000 packages per shift (12 hours), depending on the characteristics of the product, including box and pallet aggregation, CV Protek clarified.

The company also reported that by the end of 2024, it is planned to launch a fourth line at the Transservice-2 terminal site, designed for labeling medicines and dietary supplements. "Marking has become an integral part of the Russian economy — the presence of identification codes that allow monitoring the movement of goods from the manufacturer to the end consumer in order to exclude counterfeit and falsified goods from circulation has become mandatory for tobacco and fur products, footwear, drinking water and a number of other product categories, including medicines and dietary supplements," said Dmitry Pogrebinsky, CEO of CV Protek. "The list is being expanded with medical products. Marking services are a logical and timely step in the development of the logistics service of CV Protek. The customs warehouse infrastructure designed to ensure the supply of imported goods to the Russian Federation and their marking before entering into circulation is gaining capacity. 4 thousand square meters of space have been allocated for it. In addition to automatic marking lines, 50 additional workstations have been organized for manual marking and aggregation, which are equipped with everything necessary for identifying goods by barcodes, automatic printing of stickers and entering information into the warehouse accounting and aggregation system. We are considering the prospects for launching the labeling of medical equipment and medical products."

Source: https://pharmvestnik.ru/content/news/V-CV-Protek-rasskazali-o-pyatnadcati-millionah-edinic-promarkirovannoi-s-nachala-goda-produkcii.html

A polyclinic will be built in St. Petersburg for 4.2 billion rubles

The Committee for State Orders of St. Petersburg has announced a tender for the construction of an outpatient clinic in the Moskovsky district of the city. The starting price and the contract is 4.2 billion rubles. The money will be allocated from the budget of St. Petersburg.

A multi-story building (3, 4, 6 floors) of a U-shape is designed to serve children and adults. According to preliminary data, 585 employees will work in the institution.

To serve the adult population with 600 visits per shift, there are doctors' offices, as well as several departments - three therapeutic, surgical, dental, traumatology and obstetrics and gynecology. In addition, the contractor undertakes to build a day care department for 20 people and an occupational pathology department.

The children's department with a capacity of 300 visits per shift includes pediatric and consultative and diagnostic departments, as well as a medical and social assistance office, a prevention department, an organization of medical care for minors in educational institutions and an ambulance department for six mobile teams. In addition, the building will be adjacent to an underground parking lot for 54 cars.

Separately, it is planned to build a general clinical laboratory and a medical waste management area. The territory will house a children's playground with play equipment, as well as a parking lot for bicycles, scooters, strollers and sleds.

In 2023, the Capital Construction and Reconstruction Fund of St. Petersburg placed tenders for the construction of medical institutions in St. Petersburg and Sestroretsk. The total cost of four contracts reaches 30 billion rubles. Winners were determined for all four lots. The contract for the construction of a children's center for surgery of congenital malformations and rehabilitation treatment with 250 beds and a high-tech medical building of Hospital No. 15 was concluded with the company "BaltInvestStroy".

The tender for the construction of an adult polyclinic on the territory bounded by Marshal Blucher Avenue, Laboratorny Avenue and Bestuzhevskaya Street was won by the S-Industry company. The winner of the competition for the construction of a multidisciplinary treatment and diagnostic building of City Hospital No. 40 in the Kurortny District was the Lentekhstroy company.

Source: https://vademec.ru/news/2024/08/15/v-sankt-peterburge-vozvedut-polikliniku-za-4-2-mlrd-rubley/


Other

Scientists from the Bashkir State Medical University of the Ministry of Health of the Russian Federation have developed a method for the early diagnosis of diseases of the musculoskeletal system and associated pathology

Specialists from the Bashkir State Medical University of the Ministry of Health of the Russian Federation are developing predictive and personalized medicine.

One of the projects is “Comprehensive analysis of the musculoskeletal system in young people with various types of connective tissue dysplasia.”

Connective tissue is the most common tissue in the human body, and its disorders provoke the development of musculoskeletal diseases, including osteoarthritis with joint pain and osteoporosis with fractures.

— Such diseases are often detected at later stages, when they are much more difficult to treat. Therefore, early diagnostics within the concept of preventive and personalized medicine is relevant today, — noted Karina Akhiyarova, a graduate student and author of the project.

Today, studying the development of diseases is impossible without genetic research.

As part of a scientific study, scientists from the Bashkir State Medical University of the Ministry of Health of the Russian Federation are studying genes that encode the structure and metabolism of bone and cartilage tissue.

A new approach to disease prevention will allow creating an individual prognosis for each person.

Another important step in the methodology is X-ray densitometry — a study of bone density.

The densitometry device at the university clinic determines bone pathology with high accuracy and allows you to assess body composition using the Total body program.

- Thanks to the analysis of body composition, we learn how much fat tissue and muscle mass a person has, how they are distributed. Today, body composition is a very important parameter for assessing overall health, the risk of developing not only musculoskeletal pathology, but also cardiovascular pathology, diabetes, emphasized Karina Akhiyarova.

Two patents have already been received and articles have been published in highly rated scientific journals.

The combination of the results of these two types of research (X-ray densitometry and genetic) allows you to determine the factors that affect bone density, and therefore prevent early bone loss and unwanted fractures in the future.

Source: https://minzdrav.gov.ru/special/regional_news/21628-uchenye-bashkirskogo-gmu-minzdrava-rossii-razrabotali-metodiku-ranney-diagnostiki-zabolevaniy-oporno-dvigatelnogo-apparata-i-soputstvuyuschey-patologii


Newly registered medical products

We publish a list of new medical products registered from 08.09.2024 to 08.16.2024

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

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