News Digest 25.12.2023 — 27.12.2023
Regulators
The government has extended the ban on the export of medical products until the end of 2025
The temporary ban on the export of certain goods and equipment from Russia is extended for another two years – until the end of 2025. The resolution was published on the government website.
The export restriction applies, among other things, to medical equipment. Its export is prohibited to all foreign countries, with the exception of member states of the Eurasian Economic Union.
In March 2022, the government determined a list of goods and equipment prohibited from being exported from Russia until the end of 2022. The list contains more than 200 items.
In July, First Deputy Minister of Industry and Trade Vasily Osmakov said that the department plans to allow the export of medical equipment for repairs. However, in November the ban was extended until 2024.
The ban on the export of medical products hit certain categories of citizens, for example, people with disabilities: they lost the opportunity to receive manufacturer-guaranteed repairs for foreign-made prostheses (since repairs are carried out only at the place of production). The procedure for issuing permits for the export of medical goods from the country was approved by Roszdravnadzor. As practice has shown, obtaining this permit is very difficult and its presence does not guarantee the absence of problems with customs, MV wrote.
In 2023, the Ministry of Economic Development initiated changes to the list of medical products prohibited for export. Excluded from the regulation were, for example, sleeves for patients with lymphovenous insufficiency of the upper extremities, disposable gowns for surgical operations, burs, discs, handpieces and brushes for use in drills, instruments and equipment for measuring blood pressure.
In addition, the export ban was lifted from such items as artificial teeth and hearing aids.
1.6 billion rubles will be allocated to provide disabled people with rehabilitation facilities
The Government of the Russian Federation has allocated an additional 1.6 billion rubles from the reserve fund to provide disabled people with technical means of rehabilitation (TSR). The funds will be allocated by the end of 2023.
The decision on additional financing was made during a government meeting on December 22. In total, in 2023, the budget provides more than 57 billion rubles for the provision of disabled people in the TSR. According to the government, the additional funds allocated will make it possible to provide the citizens of the TSR in full.
Additional financing is provided for the purchase of hearing aids, wheelchairs, speech synthesizers, prostheses, orthoses and other products that the state provides for disabled people.
In October 2023, the Ministry of Labor of the Russian Federation approved the Procedure for paying compensation for self-acquired TSR by a disabled person. The funds will be paid based on the cost of the purchased products, taking into account payment for banking services or postal services for the transfer and forwarding of funds, but not more than the size of the weighted average price of a homogeneous TSR. The authorized body will be able to determine the parameters of reimbursable funds on the basis of an individual rehabilitation or habilitation program for a disabled person (IPRA).
The amount of compensation for the funds spent on the purchase or repair of TSR is going to be determined by comparing the characteristics specified in the IPRA. If there are no such characteristics, the amount will be calculated when comparing the name of the product and the type of technical means of rehabilitation.
In November 2023, the government also decided to update the list of TSR provided to a disabled person, including high-functional prostheses with microprocessor control. Previously, the list contained the general position "prostheses and orthoses" without detailing. Now the list is divided into two components – prostheses and orthoses, as well as high-functional prostheses with microprocessor control.
Market news
The unique Russian videolaryngoscope is ready for mass production
Specialists of the Russian Scientific Center of Surgery (RNCC) named after Petrovsky developed the first domestic video monitoring telescope for import substitution of foreign devices. An agreement has been reached on its serial release, Izvestia reports.
A videolaryngoscope is a medical device for internal examination of the trachea, installation (intubation) of an endotracheal tube for artificial lung ventilation. It is necessary for operations under general anesthesia. Such equipment is used in the departments of anesthesiology and intensive care and by emergency physicians. The videolaryngoscope is also necessary for the examination of patients with various conditions: sore throat, increased swallowing, difficulty swallowing or breathing, sensation of a foreign body, changes in the contours of the neck, during emergency care.
Source: https://pharmmedprom.ru/news/rossiiskii-videolaringoskop-gotov-k-seriinomu-proizvodstvu/
In Moscow, 15% of the services And for decoding medical images have been sent for revision
To identify errors in the work of artificial intelligence (AI) being implemented in the capital's healthcare, specialists conducted more than 200 tests and 500 monitoring in 2023. As a result, 15% of the services that were used to decrypt medical images were sent for revision, said Anastasia Rakova, Deputy Mayor of Moscow for Social Development.
According to her, great attention is paid to the safe operation of services that are allowed to work with patient data. Strict selection and subsequent control of all solutions based on And is carried out: testing at the entrance, when changing versions of the service, when changes to the requirements of its operation, as well as quality monitoring on the research stream. In case of incorrect operation, the service is sent for revision.
The FDA has recalled the Philips MRI machine due to the high risk of explosion
The FDA has recalled Panorama 1.0T WO, an MRI scanner from Philips, due to spontaneous loss of superconductivity by a magnet in devices of this brand. The regulator's recall was assigned Class I. It includes products that can cause serious harm to health and lead to death.
Other
For the first time in Russia, a domestic sliding endoprosthesis of its own production was installed at SamSMU
For the first time in the country, a sliding individual hip replacement of domestic production was installed in the Clinics of Samara State Medical University. The implant, which provides for the possibility of changing its length without surgery, will be able to replace imported analogues. The work on the creation of an endoprosthesis was carried out by specialists of the Research Institute of Bionics and Personalized Medicine of SamSMU, as well as university Clinics together with partners.
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