News Digest 21.02.2025 — 28.02.2025
Regulators
Mandatory labeling of rehabilitation products was postponed until September
The Government has approved amendments to the Rules for Labeling certain Types of Technical Rehabilitation Equipment with identification tools. The corresponding resolution No. 221 dated 02/25/2025 was published on the portal of legal acts.
Amendments are being made to Government Decree No. 744 dated 05/31/2024. Participants in the turnover of certain types of rehabilitation equipment that have unsold goods in Russia as of October 1, 2024 (they must be manufactured in Russia or put into circulation in the country before September 30, 2024) can label these goods with identification tools until February 28, 2025 (inclusive). We are talking about products that have not been labeled before. The deadline for labeling such goods with identification tools has now been extended until August 31.
Rospotrebnadzor has developed a procedure for accounting for medical waste
Rospotrebnadzor has developed a procedure for accounting for medical waste, including the composition of information to be transmitted to the federal executive authority responsible for sanitary and epidemiological control, and the procedure for information interaction when transmitting such information. The draft resolution is being publicly discussed until February 28.
As follows from the general provisions of the document, medical waste includes all types of waste, including anatomical, pathological, anatomical, biochemical, microbiological and physiological, which are formed in the process of medical and pharmaceutical activities, as well as activities for the production of medicines and medical products, activities in the field of the use of pathogens of infectious diseases and genetic engineeringmodified organisms in medical devices, as well as in the production and storage of biomedical cellular products.
The criteria for dividing medical waste into classes according to the degree of epidemiological, toxicological, radiation hazard, as well as negative impact on the environment are determined by the government. Medical waste is handled in accordance with the legislation in the field of sanitary and epidemiological welfare of the population.
The procedure stipulates that medical waste is recorded by:
- organizations that produce them;
- organizations that decontaminate waste;
- organizations that transport and dispose of waste.
The volume and mass of waste at different stages are taken into account:
- class A: education, storage, burial, incineration, sorting, recycling;
- class B: education, storage, disinfection, burial, sorting, recycling;
- class V: education, storage, disinfection, burial, sorting, recycling;
- class G: education, storage, burial, incineration;
- class D: education, storage, burial.
The information that is being transmitted must include:
- waste hazard class;
- mass of waste at the beginning of the year;
- the mass of waste generated during the reporting period;
- the mass of waste received from other organizations (for those involved in disinfection);
- mass of neutralized waste;
- the mass of waste transferred for burial or disinfection;
- the remaining waste at the end of the reporting period.
The document also establishes rules governing the transfer of information about medical waste to the sanitary and epidemiological control authorities. The information is transmitted in the form of Federal Statistical Observation No. 2-Medical waste ("Information on medical waste management"). The form must be filled out by a legal entity or sole proprietor. Then it is signed by the head of the organization, stamped and sent to the sanitary control authorities by February 1 of the year following the reporting period.
If approved, the document will enter into force on the day of its official publication.
Source: https://pharmvestnik.ru/content/news/Rospotrebnadzor-razrabotal-poryadok-ucheta-medothodov.html
Market news
South Korea to lift sanctions on supplies of medical equipment to Russia
The Ministry of Industry, Trade and Resources of South Korea announced the lifting of sanctions restrictions on the supply of medical equipment to Russia from February 28. We are talking about freeing exporters from the need to obtain individual permits.
Such measures will make it possible to supply medical equipment to Russia, which "is of a humanitarian nature and the likelihood of its use as weapons is relatively low." The Ministry cites X-ray machines and radiation imaging equipment as examples.
Roszdravnadzor has registered a defibrillator with voice and visual prompts
Roszdravnadzor has registered the AND-25 defibrillator, developed by Rostec's Ural Optical and Mechanical Plant named after E.S. Yalamov (UOMZ). The device is equipped with voice and visual prompt functions, which allows it to be used not only by medical workers, but also by citizens who have completed a specialized course in basic cardiopulmonary resuscitation, the press service of the state corporation told MV on February 27.
The device for providing assistance in case of sudden cardiac arrest automatically analyzes the rhythm of the heart muscle and, having recorded the violations, informs about the need for discharge. For non-professional users, the defibrillator provides clear voice instructions and also shows the sequence of resuscitation measures on the display. In total, the device has 84 voice prompts, including the phrases: "Press the flashing buttons", "Connect the electrodes", "Start cardiopulmonary resuscitation", "Do chest compressions", "Apply the electrodes as shown", "Do not touch the patient", "There is a set of energy".
The AND-25 is designed to equip hospitals and paramedic stations, ambulances, emergency situations and air ambulance services, and medical classrooms in schools and kindergartens. The device can be used in crowded places. It has simple operation, compact size and a fast set of discharge energy.
The development is being prepared for mass production. The volume of the first batch will be determined according to the needs of the customers.
Other
A new method for diagnosing mental disorders has been developed in Russia
A group of employees of the Engineering Physics Institute of Biomedicine of the National Research Nuclear University "MEPhI" has proposed innovative technologies for studying the functional activity of the human brain based on electroencephalography (EEG) data. They can complement the method of functional magnetic resonance imaging, the university's press service told MV.
In the course of the research, it turned out that the classical approach to electroencephalographic examination is not informative enough, since the recorded rhythmic phenomena do not reflect the functional activity of the cortical structures of the brain – rather, they are background characteristics. Events of disappearance (desynchronization) of these rhythms may be more informative, which may signal an increase in the activity of the corresponding area of the brain. That is, in order to understand the processes of active brain activity, researchers' attention should be directed precisely to those parts of the brain where desynchronization and disappearance of brain rhythms are observed.
The research results have been published in Russian and foreign journals, in particular in the Russian Journal of Pediatric Neurology. Since 2022, 19 scientific articles have been published, revealing various aspects of the proposed technologies.
Remote radiation therapy surpassed transarterial chemoembolization in liver cancer
Scientists from the University of Texas Health Science Center compared the efficacy and safety of remote radiation therapy (EBRT) and transarterial chemoembolization (TACE) in patients with early and intermediate-stage hepatocellular carcinoma. The results of the study are published in the journal Cancer.
The analysis showed that, in comparison with transarterial chemoembolization, remote radiation therapy provided better local tumor control. A year later, this figure was 85 versus 35% for TACE, and two years later it was 83 versus 20%. After three years, the local control rate was 62 versus 11%.
EBRT also significantly increased disease progression-free survival. A year later, this figure was 56% versus 32% at TACE. After two years, progression—free survival was 40% and 32%, respectively, and after three years it was 37% versus 7%.
The authors concluded that remote radiation therapy should be considered as a first-line method for patients who require local therapy of hepatocellular carcinoma.
The FDA has approved a neurostimulator for the treatment of Parkinson's disease in real time
The US Food and Drug Administration (FDA) has approved a neurostimulator for the treatment of motor symptoms of Parkinson's disease. This was announced by the press service of Medtronic, the company that created the device.
It took about ten years to develop BrainSense. This is a set of electrodes that are implanted in certain areas of the brain. Similar to the work of pacemakers, the system sends electrical signals, reading changes in the patient's brain activity in real time and adjusting the therapeutic effect accordingly.
The device analyzes the work of areas of the brain associated with Parkinson's disease, such as the pale globe and the subthalamic nucleus, and determines the so–called "on" and "off" phases, i.e. when a particular drug (usually levodopa) actively suppresses symptoms, and when its effect weakens.
When the "shutdown" occurs, the motor and non-motor manifestations of the disease increase. Studies have shown that neurostimulation helps reduce the need for medications, while minimizing the side effects that can occur when electrical impulses are applied to a high concentration of the drug in the blood.
New registered medical devices
We publish a list of new medical devices registered from 02.21.2025 to 02.28.2025
Link to the list: [see table in the attachment]
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