News Digest 16.05.2025 — 23.05.2025
Regulators
The composition of the first aid kit for the prevention of parenteral infections in medical workers has been updated
The Russian Ministry of Health has approved an updated version of the requirements for the complete set of medical devices and drugs for providing first aid to medical workers who, in the workplace, in "emergency situations" risk contracting parenteral infections when performing medical procedures on patients. To prevent such cases, the regulator added chlorhexidine, which is a disinfectant, as well as a non-woven napkin to the list.
The order will come into force on September 1, 2025 and will be valid until the same date in 2031, and a similar document from 2018 will lose its force. In addition to chlorhexidine, the first aid kit will still contain iodine and ethanol. It is also envisaged to have a sterile medical gauze bandage, a bactericidal adhesive plaster measuring at least 1.9 x 7.2 cm, and two types of napkins - non-woven and medical sterile.
Medical products and drugs used to complete the first aid kit may be used until the expiration date, but no later than September 1, 2027. The explanatory note to the draft order, which the department submitted in January 2025, noted that when preparing the composition of the kit, the experience of developing, implementing and subsequently using various first aid kits and kits, current legislation in the field of first aid, as well as current approaches to providing such assistance were taken into account. "To prevent parenteral infections, it is necessary to immediately provide first aid to persons providing medical care in emergency situations (cuts and injections with instruments contaminated with blood and other biological fluids, including from HIV-infected patients, patients with hepatitis B, C, as well as blood and other biological fluids getting on the mucous membranes of the oropharynx, nose and eyes)," the explanatory note noted.
In the event of an emergency, the clinic administration must immediately organize a set of measures to provide first aid to the injured health worker, the order says.
In early December 2024, the Ministry of Health also approved the requirements for the first aid kit for the use of medical devices by officials of the Federal Penitentiary Service. The updated rules will be effective from September 1, 2025. According to the regulations, the first aid kit must contain, among other things, two devices for artificial respiration, one tourniquet to stop arterial bleeding, plasters and medical masks.
Health centers will be equipped with equipment for the prevention of chronic diseases
The Ministry of Health of the Russian Federation has developed a draft order for additional equipment of health centers for adults in clinics or on the basis of medical prevention offices in central and district hospitals, including in remote settlements. The list of equipment for identifying and correcting risk factors for the development of chronic non-communicable diseases includes devices for measuring blood pressure and glucose levels, analyzers, ophthalmological tonometers and other products.
According to the explanatory note to the draft, the changes were developed to implement one of the points of the protocol of the meeting of the relevant committee for the national project "Long and Active Life" - additional equipment of health centers is necessary to improve the provision of medical care to adult citizens by preventing behavioral risk factors for the development of chronic non-communicable diseases.
The draft document contains a list of 15 blocks with the names of products that such offices and centers should be additionally equipped with. The necessary equipment includes blood pressure measuring devices (portable, stationary, automatic, mechanical, electronic, etc.), glucose monitoring systems, glucometers, tonometers, analyzers, scales, examination tables, an electrocardiograph and other equipment.
Public discussion of the initiative will last until June 2, 2025.
The Ministry of Labor has expanded the list of technical rehabilitation equipment for providing certain groups of disabled people
The Ministry of Labor of the Russian Federation has changed a number of departmental orders on issues of providing disabled people with technical rehabilitation equipment (TSR). Thus, the regulator has added new items to the List of medical and social indications/contraindications for providing disabled people with TSR - the list of TSR includes urological pads for men and women with a total moisture absorption of at least 450 and 750 grams.
Market news
Moscow will become a center for accelerated testing of AI in medicine
A decree of the Government of the Russian Federation has entered into force in Russia, which allows for simplified testing of AI services in medicine. Moscow
Market news is ready to become one of the first regions to implement these innovations. Based on the capital's Center for Diagnostics and Telemedicine, algorithms for radiation diagnostics will be able to undergo testing in the green corridor mode. This will speed up the introduction of reliable technologies into clinical practice throughout the country. This was reported by the chief freelance specialist in radiation and instrumental diagnostics of Moscow, Yuri Vasiliev.
Services for analyzing CT, MRI, mammography, fluorography and X-ray images automatically highlight areas in the images that require attention and help radiologists quickly find possible signs of diseases. A special verification mode will speed up the implementation of reliable AI services, which means that doctors will be able to gain earlier access to technologies that improve the accuracy and speed of diagnosis. The purpose of such tests is to confirm the safety and effectiveness of new digital solutions before they begin to be used in medical organizations throughout the country.
Source: https://www.mos.ru/news/item/154148073/
FDA approves first blood test used to diagnose Alzheimer's disease
The US Food and Drug Administration (FDA) has approved for sale the first in vitro device that helps diagnose Alzheimer's disease through a blood test. Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, developed by Japanese Fujirebio Diagnostics, is designed for the early detection of amyloid plaques in patients over 55 years of age.
A hallmark of Alzheimer's disease is the presence of amyloid plaques. They can be detected by PET brain scanning or by studying cerebrospinal fluid samples. Diagnosis in this way is expensive and labor-intensive. The Lumipulse test only requires blood sampling, making it less invasive and more accessible to patients.
Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio measures two proteins, pTau217 and ß-Amyloid 1-42, found in blood plasma. The device then measures the numerical ratio of the two proteins, which correlates with the presence or absence of amyloid plaques in a patient’s brain, reducing the need for PET scanning.
The FDA evaluated data from a multicenter clinical trial of 499 individual plasma samples from adults with cognitive impairment in making its decision. The samples were tested with Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio and compared with amyloid PET scanning. The clinical trial showed that 91.7% of participants with positive Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio results had amyloid plaques, which was confirmed by PET scanning. At the same time, 97.3% of people with negative PET scanning results did not have plaques.
Other
Rostec launches mass production of a scanner for diagnosing oncological diseases
The company Vansel (OneCell) has launched mass production of the first domestic scanner of micropreparations OneCell Scan 3.0, which helps in diagnosing oncological diseases. This year, it is planned to release about 25 devices. In February 2025, a Rostec structure acquired a 25% blocking stake in OneCell.
The OneCell Scan 3.0 scanner is designed to digitize histological and cytological micropreparations in medical laboratories. It can be used to determine the structure and number of affected cells, as well as to recognize pathological tissue regardless of its size. The developer calls the main task the transformation of analog glasses into digital twins and monitoring their quality - this work is carried out by artificial intelligence.
The device can operate without interruption and simultaneously scan 288 glasses with material. The average scanning time is about 2-3 minutes. The total magnification of the optical system of the device is 63 times. Immediately after digitizing the image, the device automatically sorts the samples and then transfers them to the database on the computer. The developer assured that the scanner is compatible with state digital healthcare platforms. Rostec noted that the device “complies with international standards in the field of digital pathomorphology and exceeds imported analogues in its characteristics.” The cost of the device is 10-15% lower.
The scanner has been tested in several leading federal research and clinical centers, including the Sechenov Moscow State Medical University and the Russian Scientific Center of Surgery named after Academician B.V. Petrovsky.
Source: https://t.me/vademecum_live/17935
New registered medical devices
We publish a list of new medical devices registered from 05.16.2025 to 05.23.2025
Link to the list: [see table in the attachment]
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