News Digest 29.07.2024 — 31.07.2024
Regulators
The Ministry of Labor will approve indications and contraindications for issuing technical means to the disabled
The Ministry of Labor plans to approve a list of medical and social indications and contraindications for providing disabled people with technical rehabilitation means (TRM) — the draft order is posted on the regulation.gov.ru portal. For the first time, the agency intends to prescribe not only indications, but also contraindications for “prescribing” a certain TRM. These include an active wheelchair or an electric one, upper and lower limb prostheses with microprocessor control, an electronic handheld video magnifier, a Braille display, screen access software for the disabled, etc.
For example, an electric wheelchair can be issued to a patient with “persistent severe impairments of the functions of the upper limbs due to diseases, deformations, developmental anomalies and paresis of the upper limbs” (specific indicators are prescribed, down to the degree of amplitude of active movements in the shoulder and elbow joints). An absolute contraindication to the appointment of this type of TSR will be the presence of epileptic seizures with impaired consciousness, severe or significantly severe visual impairment, impaired statics and movement coordination, as well as "mental impairments leading to a significant decrease or absence of critical assessment of one's condition and situation." In 2022, a pilot project for the rehabilitation and habilitation of disabled people through an electronic certificate system was launched in several regions of Russia (we are talking about an experiment taking place in the Sverdlovsk, Tyumen and Ryazan regions). Initially, it was supposed to be completed at the end of 2024, but later it was extended until the end of 2026. The list includes diseases, consequences of injuries or defects leading to health problems with the second or higher degrees of severity of persistent dysfunctions of the body (the order is available on "MV"). The cost of an electronic certificate for purchasing a comprehensive rehabilitation program is 102.9 thousand rubles, but, depending on the chosen form of service provision, cannot exceed 79.8 thousand rubles in semi-stationary conditions, 96.6 thousand rubles in stationary conditions and 102.9 thousand rubles in stationary conditions.
Earlier, it also became known that a separate platform (in the form of a phone application) will appear in Russia for interaction between disabled people with medical and social expertise specialists and employees of enterprises where TSR are manufactured.
Market news
Moscow uncovers cartel agreement in medical products market worth 642 million rubles
The Federal Antimonopoly Service Administration for Moscow reported a cartel agreement in the medical products market worth more than 642 million rubles.
The customers of the products were federal scientific medical centers, healthcare institutions of the city of Moscow, Moscow and Samara regions. The following were recognized as violators of antimonopoly legislation: OOO TK Agatmed, OOO Lifemedika, OOO Medicine-Plus, OOO Asmed and OOO Medicine and Trade. The Antimonopoly Service found signs of violations in 253 purchases by these companies. The materials of the antitrust case have already been transferred to law enforcement agencies to decide on initiating a criminal case. Violators face turnover fines under administrative articles.
Other
In the US, a patient was implanted with a titanium artificial heart for the first time
The Texas Heart Institute at the Texas Medical Center in Houston reported the successful implantation of a completely artificial heart in a patient with end-stage heart failure for the first time in the world. The operation was carried out during a preliminary study of the possibility of using the BiVACOR system called Total Artificial Heart (TAH). The experiment was approved by the US Food and Drug Administration (FDA). The operation, during which the patient's organ was replaced with a 650-gram device, was performed on July 9 and lasted 4.5 hours. The developers of the artificial heart say that the purpose of the first clinical trial of the medical device is to evaluate the safety and effectiveness of the device. Such an artificial organ is planned to be implanted in patients with severe biventricular heart failure (HF) or single-ventricular HF. After doctors can verify the stability of the study participant, similar operations will be performed on four more patients.
During the first trials of the artificial heart, doctors will use the device as a temporary measure to support the lives of patients until a donor organ appears.
TAH, as specified by BiVACOR, is a biventricular rotary blood pump made of titanium with one moving part - a rotor with magnetic levitation, a method pump blood and replace both ventricles of the heart. The moving part of the device does not come into contact with its other parts, which helps to minimize wear of the implant. It is noteworthy that when this medical device is implanted, the recipient has no pulse. The developers of the device emphasize that existing implants offer a replacement for only the left side of the heart, while TAH is capable of replacing the entire organ.
BiVACOR founder and chief technical officer Daniel Timms clarified that the cost of the artificial heart is $ 100 thousand, and the company plans to sell TAH for $ 200 thousand.
In March 2024, the world's first transplant of a kidney from a genetically modified pig to a living person took place. The recipient was 62-year-old Rick Slayman, who was diagnosed with terminal kidney disease. In early April, the patient was discharged from Massachusetts General Hospital, whose transplant surgeons performed the operation, to continue treatment at home, but in May, the clinic reported Slayman's death.
Samara scientists are developing an innovative vascular prosthesis for reconstructive surgeries on the heart and aorta
An innovative biological vascular prosthesis is being developed at the Samara State Medical University of the Ministry of Health of the Russian Federation. The development will allow reconstructive surgeries on the heart and large main vessels to be performed in a severe group of patients for whom it is impossible to use standard techniques adopted in cardiovascular surgery. Such patients include, for example, pregnant women who are contraindicated in anticoagulant therapy in the postoperative period, or patients with an infected synthetic prosthesis after primary surgery.
Source: https://samsmu.ru/news/2024/3007/
Specialists from the Pirogov Russian National Research Medical University of the Ministry of Health of the Russian Federation presented the wireless mobile rehabilitation exoskeleton complex "Exokist-M" at the Healthy Society forum
In 2018, the University developed the rehabilitation complex "Exokist-2", which received a registration certificate and is distributed in clinics, neurological and rehabilitation centers as a means of rehabilitation of post-stroke and post-traumatic patients, as well as children with cerebral palsy.
Further development of the complex was the work on the manufacture, design and construction of its mobile version, presented at the forum, which was called "Exokist-M". The mobile version of the complex is completely wireless and also has improved adjustment options for attaching the patient's hand. All these innovations together significantly reduce the labor intensity of the procedure and provide much greater convenience for the patient.
Source: https://t.me/daily_2med/4862
A needle for safe entry into the abdominal cavity has been developed at the First Moscow State Medical University named after I.M. Sechenov
The Nette-MG needle for safe access to the abdominal cavity before laparoscopic surgery is undergoing preclinical testing on laboratory animals; scientists at the First Moscow State Medical University named after I.M. Sechenov are currently preparing a publication based on the results of the experiment in a scientific journal. The registration date of the medical device is scheduled for 2025.
"Unlike the traditional Veresh needle, which is used for this purpose by surgeons, the "dive" design allows the surgeon to accurately determine the moment of needle penetration into the abdominal cavity. This means that the risk of damage to internal organs during the manipulation is minimized," the press release of the medical university notes.
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