News Digest 31.01.2024 — 02.02.2024
Regulators
The State Duma wants to speed up the introduction of Russian medical products to the market
The current uniform requirements for registration of medical devices slow down the implementation of innovations and overload accreditation bodies. This was stated at a meeting of the expert council under the State Duma Committee on Industry and Trade, writes Parlamentskaya Gazeta.
The meeting participants agreed to send an appeal to the Ministry of Health and the Ministry of Industry and Trade with a request to introduce differentiated requirements for the registration of medical devices of different classes of potential risk and thereby speed up the process of introducing innovative solutions. In particular, it is proposed to establish clear requirements for changes made to the registration dossier. This will speed up the process of introducing innovative solutions and reduce the burden on accreditation bodies. The text of the relevant resolution is at the disposal of the publication.
Chairman of the State Duma Committee on Industry and Trade Vladimir Gutenev said that today it is necessary to quickly acquire technological sovereignty as part of the development of key industries for the country. He recalled that earlier the government approved a list of the first ten megaprojects with an investment volume of at least 10 billion rubles. everyone in critical industries.
Mandatory labeling of technical rehabilitation equipment may be introduced from September 1
The Ministry of Industry and Trade intends to introduce mandatory labeling of technical means of rehabilitation (TSR) from September 1, 2024. The corresponding draft resolution is posted on the portal regulation.gov.ru.
Products covered by the label include support and tactile canes, crutches, supports, handrails, parts and accessories of prostheses, functional units and orthoses, anti-decubitus mattresses and pillows, special means for impaired excretory functions (urine and colostomy bags), as well as chairs -chairs with sanitary equipment. In total, the list contains more than 400 product codes or product categories.
Participants will submit to the information monitoring system information about the withdrawal of certain types of TSR from circulation from March 1, 2025.
At the end of June 2023, the Ministry of Industry and Trade proposed conducting an experiment on labeling certain types of technical rehabilitation equipment. It was then proposed to include in the list functional units of prostheses, special means for disorders of excretory functions and a number of other products. The pilot began on October 15, 2023, and will run until August 31, 2024.
Outdated equipment will be removed from the standards for equipping medical institutions
The Ministry of Health agreed to exclude obsolete types of equipment from the standards for equipping medical offices. This is stated in the response received by the office of Business Ombudsman Boris Titov signed by Deputy Minister of Health Evgeny Kamkin.
“In certain areas, such as magnetic resonance imaging, neurology, pediatric urology-andrology, obstetrics and gynecology, dentistry, neurology, ophthalmology, etc., the products specified in the standards are either obsolete and not produced, or are not medical and, accordingly, are not subject to registration in the state register,” Titov reported.
According to him, discrepancies between the standards and the actual content of the State Register of Medical Devices create problems in the work of medical organizations. For example, the equipment standard for a neurologist’s office and a clinical diagnostic office, approved by Order of the Ministry of Health of Russia No. 926n dated November 15, 2012, mentions “a set of odorous substances for studying the functions of the olfactory analyzer,” but it is not in the state register of medical devices. Private organizations specializing in neuroscience have experienced problems because of this.
Other “problematic” medical products include a radiofrequency coil for magnetic resonance imaging, an orchidometer for pediatric urology and andrology, analytical mechanical scales for dentistry, etc. The Ministry of Health, together with Roszdravnadzor and freelance industry specialists, is exploring the issue of their exclusion from the standards.
The Ministry of Health stated that the plan for the supply of medical equipment to primary care medical institutions was exceeded by 40% in 2022. At the same time, the overall planned budget has not changed, MV wrote. Earlier, Prime Minister Mikhail Mishustin called for localizing the production of medical equipment and spare parts for it. Domestic production will be supported by subsidies.
Market news
The Novosibirsk prosecutor's office will check the Ministry of Health's purchase of Chinese systems for diabetic children
The prosecutor's office of the Novosibirsk region organized an inspection based on information in the media about violations in the purchase of medical products for children suffering from type 1 diabetes, the department's press service reported. It is planned to evaluate the quality of continuous glucose monitoring (CGM) systems.
The audit was organized after the local publication of the NHS published information about the centralized purchase by the Ministry of Health of the region of Dr. CGM systems. Brinner RGSM-II from the Chinese company MeiQi Medical Instruments. The Novosibirsk public organization for supporting people with diabetes “Dialife” said that the system consists of three carbon needles that will be located in the human body. The instructions also state that the correctness of the readings may be impaired due to the person's sweat. The manufacturer suggests solving this problem by “drying the device with a hairdryer.” The documents also mention possible bleeding as a side effect.
“Taken together, the documents make it clear that the child will not be able to use this device independently; in addition, it is simply dangerous. That is, the risks of its use are much higher than the benefits it can bring,” the NGO explained.
Putin reported problems with servicing imported medical equipment due to sanctions
Some exporters refuse to service medical equipment supplied to Russia, Russian President Vladimir Putin said at a meeting with his proxies. He did not specify which specific states he was talking about.
“Some of our so-called partners, despite the fact that this is a purely humanitarian sphere - healthcare, refuse to service and carry out routine maintenance,” TASS quotes Putin as saying: “Heavy equipment that we purchased 100% abroad in previous years. In this regard, he said, technological sovereignty in the field of healthcare is the most important task.
Over 70% of Russian medical institutions encounter difficulties in servicing medical equipment, MV reported. After the introduction of sanctions, it was necessary to reconfigure supply chains, which increased the delivery time for equipment and consumables. More than 75% of respondents reported difficulties in obtaining equipment and spare parts.
At least five contracts for the supply of Truebeam linear accelerators for radiation therapy equipment from the American company Varian to Russian cancer clinics for a total amount of 1.39 billion rubles. were delayed for more than a year due to sanctions.
New biomimetic materials tested for effective wound healing
A team of scientists from the Russian Economic University named after G.V. Plekhanov (Republic of Economics named after G.V. Plekhanov) and the Institute of Biochemical Physics named after. N.M. Emanuel Institute of the Russian Academy of Sciences (IBCP RAS) has completed a series of tests on laboratory animals of new wound-healing materials. The study was published in the International Journal of Biological Macromolecules.
Wound healing is a complex process that includes stages such as coagulation (up to 1 day), inflammation (from 1 to 3.5 days), cell proliferation and epithelialization (from 1.5 to 13 days) and wound remodeling (from 5 days until the end of recovery). These time frames are typical for ideal wound healing conditions, and can be extended by external factors, with bacterial infection being the main threat to rapid healing. The urgent task is to reduce the healing time in the early stages of coagulation and inflammation, as well as to provide reliable protection against wound infection.
A team of scientists from REU named after. G.V. Plekhanov and the Institute of Biochemistry and Physics of the Russian Academy of Sciences managed to develop materials that can effectively solve these problems, accelerating wound healing in the first stages. Results from studies on laboratory animals showed that the new materials accelerated wound closure by 35% already on the 3rd day. It is important that the developed wound-healing materials provide wound protection from bacterial infections for more than 10 days, and are also carriers of additional growth factors - protein molecules that allow for scarless wound healing.
Other
In Russia, AI helped increase the share of successful doctor appointments by 196% per year
Deputy Minister of Health of the Russian Federation Pavel Pugachev said that thanks to the introduction of artificial intelligence (AI), the share of successful appointments with a doctor through the State Services portal increased by 196% over the year. He also added that AI relieves local therapists by calling patients and reminding them about visits to the doctor, and helps specialists fill out medical records (translates a voice message into a text message).
The federal project “Incident No. 38” to solve problems that arise when registering patients through the Unified Portal of State Services was launched in September 2022. Methodological recommendations for organizing an appointment with a doctor were developed by experts from the Central Research Institute of Organization and Informatization of Healthcare
Source: https://tass.ru/obschestvo/19883295
In China, following Elon Musk, they successfully tested a brain implant on a person
A team of specialists from Beijing Tsinghua University reported their first successful human test of the Neural Electronic Opportunity neural interface. According to the university, with the help of the implant, the paralyzed patient was able to perform some movements with his hands. The devices are expected to help patients with spinal cord injuries, epilepsy and amyotrophic lateral sclerosis.
The “minimally invasive” implant (according to the developers, the chip is not embedded in the brain tissue and is therefore less “aggressive” than the chip from Elon Musk’s Neuralink company) is the size of two coins. The device is installed in a person's skull, and its electrodes are placed in the epidural space between the brain and skull. The electrodes pick up nerve signals and send them wirelessly to an external receiver attached to the scalp. The signals can then be decoded using a telephone or computer.
Tsinghua University said that with further rehabilitation and development of the algorithm, the patient “will be able to restore numerous movements and functions of the hands.” The university believes that the device will also allow the integration of computer and human intelligence. This will help expand the brain's processing capabilities.
On January 28, 2024, Elon Musk’s neurotechnology company Neuralink also implanted a computer chip into the human brain. According to Musk, the operation was successful. There is no information about the patient having any diseases. Previously, the company was looking for people with quadriplegia due to cervical spinal cord injury or patients with amyotrophic lateral sclerosis.
In the US, 561 deaths were identified due to ventilators from Philips
The US Food and Drug Administration (FDA) has reported 561 deaths associated with Philips BiPAP and CPAP ventilators. From April 2021 to September 30, 2023, the FDA received more than 116 thousand of these devices for inspection.
The deaths are believed to be related to the breakdown of PE-PUR foam or suspected breakdown of the foam inside the devices. In addition, the department's report reports other consequences of procedures on these ventilators: the occurrence of cancer, pneumonia, asthma, infections, headaches, cough, shortness of breath, dizziness and chest pain in patients.
The devices received were accompanied by mandatory Philips reports and voluntary reviews from healthcare professionals, consumers and patients.
New registered medical devices
We publish a list of new medical devices registered from 01/26/2024 to 02/02/2024
Link to the list: [see. table in attachment]
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