News Digest 19.07.2024 — 22.07.2024
Regulators
The Ministry of Health has changed the standard for equipping field hospitals
The Ministry of Health of the Russian Federation has issued an order containing changes to the Procedure for organizing and providing assistance in emergency situations by the All-Russian Disaster Medicine Service. The new document adjusts the standards for equipping field multidisciplinary hospitals (FMH) with medical devices in terms of basic equipment, other equipment, and motor vehicles. In addition, the department has rewritten the FMH's rights to involve emergency rescue services and expand its own staff.
Thus, 10 new names were added to the group of sterilization devices, including: dry-heat sterilizer, chemical liquid sterilizer, sterilizer-boiler, ethylene oxide sterilizer, plasma sterilizer, and others. The list of devices suitable for equipping for heating blood and infusion solutions and defrosting blood or tissue was also expanded by three items. The list includes a radiant blood/fluid heater, a high-flow convection blood/infusion solution heater, and a blood/tissue defrosting device. The Ministry of Health has added two new types of medical devices to the group of neonatal intensive care incubators, three items to the list of washer-disinfectors, one item to the group of neonatal resuscitation tables for newborns, and three items to the list of instrument tables. The Ministry of Health's order also requires the PMG to have at least one difficult intubation kit, one device for aerosol surface disinfection, at least two medical sinks, two patient body heating systems, one heat sealing machine, two variable-volume container bodies, 20 impact-resistant cases, three container trucks on chassis, and three trailers for them. At the same time, spirographs were excluded from the PMG equipment standard, and the minimum number of negative pressure wound treatment systems was reduced threefold - from 30 to 10 units of medical equipment.
PMGs are structural divisions of the N.I. Pirogov National Medical and Surgical Center. Such hospitals participate in the elimination of the consequences of emergencies in the territory of the Russian Federation and other countries.
In the rules, the Ministry of Health prescribed the possibility of involving emergency rescue services of medical and other organizations certified for the right to conduct emergency rescue operations and licensed to carry out medical activities to provide medical care and carry out work to eliminate the medical consequences in emergency zones. Previously, PMGs could interact with emergency rescue teams to provide medical care to victims and evacuate them.
The changes also affected the PMG's ability to expand its staff: hospitals were granted the right not only to organize additional structural divisions, but also to change the staffing level. The Ministry of Health also clarified the list of places where the PMG can organize its work. This list includes mobile medical complexes, transportable container-type structures, any types and objects of transport and real estate, as well as non-capital buildings and structures.
The draft of the adopted amendments was published for public discussion in May 2024.
In May 2024, the Ministry of Health presented a draft of an updated list of federal government agencies that carry out medical evacuation. The previous similar list was adopted in May 2012. In the draft of the new list, the number of institutions authorized to carry out evacuation has been reduced from 140 to 114.
Source: https://vademec.ru/news/2024/07/19/minzdrav-izmenil-standart-osnashcheniya-polevykh-gospitaley/
Market news
Medical device manufacturer SmithHealthcare excluded from Saint Petersburg SEZ
The Arbitration Court of Saint Petersburg and the Leningrad Region granted the claim of the city committee for industrial policy, innovation and trade to deprive the medical device manufacturer and distributor SmithHealthcare (JSC SmithHealthcare) of its resident status in the Saint Petersburg special economic zone (SEZ). In 2021, the company received permission to build a facility for the production of hemodialysis filters in the SEZ for 2.2 billion rubles, but the project was not implemented, which violates the terms of the agreement on technical implementation activities at the SEZ site. The Committee filed a lawsuit demanding the termination of the agreement between the parties on the implementation of technical implementation activities, which means depriving the company of its resident status. SmithHealthcare must pay a state fee and a fine of 5 million rubles to the regional budget - the amount of the penalty "for a material breach of the terms of the agreement" is the maximum.
The company did not officially comment on the situation.
In December 2017, SmithHealthcare JSC submitted an application for the construction of a plant in the Saint Petersburg SEZ at the Novoorlovskaya site. It was planned that the enterprise would start operating in 2020, and the volume of investment in the project was estimated at 915.4 million rubles.
In December 2019, it became known that investments in the creation of production of medical devices for dialysis would be increased more than twofold - to 2.21 billion rubles. The production capacity at the first stage is estimated1 million medical devices per year with a gradual increase as it develops over nine years.
According to the city committee, the permit for the construction of the plant expired in November 2022. The authorities of St. Petersburg tried to update the agreement with the company, but the investor never started implementing the project. There is no information on why the construction of the production facility did not begin.
During the consideration of the case, SmithHealthcare filed a counterclaim against the regional government. The company wanted to conclude another additional agreement and extend the contract for five years. But the arbitration court returned the claim, considering that it was not related to the requirements of the industrial policy committee.
Smith Healthcare has been operating since 2008 and is a distributor of medical devices from leading global manufacturers, including Philips, Abbott, Drager, Jonson & Jonson. According to SPARK-Interfax, SmithHealthcare JSC was registered in St. Petersburg in 2017. The company's main activity is the production of medical instruments and equipment. There is no information about the beneficiaries. In 2017, it was reported that the legal entity at that time belonged to four Russian citizens: CEO Nikolai Kuznetsov, Elena Chelnokova and Alexander Ilyin had a 32% stake in the company. There is no information about revenue for 2023, the loss amounted to 12.9 million rubles.
A center for the production of prostheses will be built in the Leningrad Region for 286 million rubles
The Construction Department of the Leningrad Region has placed a tender to find a contractor who will design and build a center for the production of medical products intended to provide prosthetic and orthopedic care to the disabled. The initial (maximum) contract price is almost 286 million rubles. The facility will appear in Vsevolozhsk on Shishkanya Street.
The area of the one-story building will be 1 thousand square meters.
The contractor must complete all work by the end of December 2024. The cost of construction of the facility is estimated at 155.7 million rubles, for the purchase and installation of equipment - at 70.4 million rubles. The remaining funds will be used for design and other costs associated with construction.
According to the technical specifications, the center must provide for a number of mandatory facilities - an engineering office, a plaster room (production of a positive stump), a block-lamination room (production of a stump socket) and a metalworking room (assembly of components of the future product). It will also house a ball-grinding room (processing and grinding of prosthetic sockets), a machine room (manufacturing of in-house components of the product), a technician's office, a hall, consultation rooms, a casting room (taking a cast from the stump), five fitting rooms and other auxiliary rooms.
The enterprise will operate in one shift. Up to eight visitors will be able to come there daily, the number of employees should be 18 people.
To equip the offices, the contractor needs to purchase bars for teaching the patient to walk, medical couches with an adjustable headrest, stands for taking casts with an electric drive, a special grinding and ball-grinding angular machine and an infrared orthopedic table.
In December 2023, it became known that Rostec will send a grant to the United Instrument-Making Corporation's TsNITI Tekhnomash to develop a pneumohydraulic prosthetic foot for a human controlled by a processor. The project became one of 13 winners of the Vector program. The total budget of the program is 230 million rubles, of which TsNITI Tekhnomash will receive 45 million rubles. The developers plan that the product will allow patients to walk on rough terrain, as well as quickly and comfortably climb stairs.
1 billion rubles will be invested in the production of medical devices in the Pskov region
The Expert Council of the Moglino Special Economic Zone (SEZ) approved the BetaMed investment project for the construction of a medical device manufacturing plant at a meeting of the Pskov Region Government. The company will invest more than 1 billion rubles in the creation of the enterprise. In January 2024, the project was approved by the SEZ Supervisory Board, at that time the investment in the project was estimated at 665 million rubles, most of which the company planned to allocate from its own funds.
The initiative is scheduled to be implemented in early 2026.
The company plans to organize the production of surgical endoscopic suturing devices, cassettes for them, hemodialysis catheters and other venous catheters. According to BetaMed CEO Alexey Stepanov, the first samples are planned to be presented by the time the project starts. In the first year, the company expects to produce about 160 units of products, as well as create over 80 jobs. In January of this year, it was reported that after the enterprise reaches full capacity, the expected maximum production volume will be 820 thousand unitsmillion per year.
Rector of Pskov State University Natalia Ilyina proposed testing and using the company's products at the sites of universities involved in the training of medical specialists.
According to SPARK-Interfax, BetaMed LLC was registered in the Pskov Region in November 2023, its beneficiary is Alexey Stepanov. The main activity of the legal entity is the production of medical instruments and equipment.
There are 15 residents operating on the territory of the Moglino SEZ, including the Estonian company Elme Messer Rus, which produces medical gases, Screening-M LLC, which produces medical products, and Pskovinbalk LLC, which creates medicines.
In January 2024, after the project was approved by the Supervisory Board of the Moglino SEZ, BetaMed CEO Alexey Stepanov noted that the project would help develop domestic production of a "wide range of medical products." The main sales markets for the products should be medical and preventive institutions and veterinary clinics in Russia and the CIS countries.
Iranian investor plans to establish production of medical equipment in Chuvashia
Head of the Ministry of Economic Development of Chuvashia Dmitry Krasnov reported that Mohammad Golestani, CEO of Asre Sanat Atbeen, arrived in the region to search for partners in the project to localize the production of medical equipment. The region is ready to provide the investor with business preferences and support from the Investment Development Agency.
"If the project is recognized as a priority, we will work on allocating a land plot for lease without bidding. We are also ready to attract financing within the framework of preferential state programs and reserve suitable specialists in the republic's universities. In a word, we will be there at all stages of implementing the investment project," said Denis Vasiliev, head of the republican Investment Development Agency.
Source: http://xn--80adtqegosnyo.xn--p1ai/archives/61141
Other
The Scientific and Practical Center for Diagnostics and Telemedicine Technologies evaluated the "computer vision" services focused on analyzing medical images
The AI decodings were compared with the conclusions of radiologists.
The result was the TOP-3:
No. 1. Celsius 99.4% stable, that is, it works without interruptions, 93.5 units for compliance with the conclusions of doctors.
No. 2. Third opinion 98.8% and 92.2.
No. 3. Abdomen-IRA ("Ayra Labs") 98.1% and 85.9.
The most difficult for AI is to analyze chest X-rays and fluorograms. Services show 90.8-100% stability, but rarely correspond to the conclusion of a real doctor (58.8-75.5 units, although the optimal indicator would be at least 81).
Source: https://t.me/delotom/450
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