News Digest 22.08.2023-24.08.2023
Regulators
The Ministry of Health approved new risk indicators to control the maintenance of medical devices
The Ministry of Health approved new risk indicators for monitoring the maintenance of medical devices. Such order No. 368n dated July 17, 2023 was published on the legal information portal. The previous order of the department No. 503n dated May 24, 2021 has lost its force.
According to the approved document, three new risk indicators will appear.
- Roszdravnadzor will be able to initiate inspections of licensees for the maintenance of medical equipment if, within a year, it receives an application for issuing or reissuing a license, which will indicate the data of the repair and measuring equipment (name, brand, modification, factory (serial) number, manufacturer), earlier declared for the past year by another applicant (licensee). The exception includes cases when maintenance is planned to be carried out for the own needs of an organization or individual entrepreneur, as well as for the maintenance of medical devices with a low degree of potential risk of their use.
- Similar inspection risks will arise when two different market players use the same premises, which will be declared within one year when submitting documents for licensing.
- The licensee has an employee who performs maintenance of medical devices, who also concluded an employment contract with another licensee located in another subject of Russia during the calendar year. At the same time, the region should not have common administrative boundaries with the subject in which the specified licensee operates.
The government approved the purchase of Russian medical devices with a trademark for specific patients
The Government of the Russian Federation approved the procedure proposed by the Ministry of Health for the formation of a list of medical devices and specialized medical nutrition, the purchase of which is allowed to indicate a trademark if they are purchased for the needs of a particular patient.
The basis is individual intolerance or vital indications, the decision must be fixed by the medical commission. To be included in the list, medical devices and nutrition must have a conclusion from the relevant chief freelance specialist of the Ministry of Health.
Market news
Novikombank will issue 5 billion rubles to KRET
The Radioelectronic Technologies Concern (KRET, part of the Rostec State Corporation) will build a “laboratory for strengthening technological sovereignty” and a production and training center in Ramenskoye. The KRET portfolio also includes medical equipment, including ventilators. In this category, the company is one of the largest domestic manufacturers.
At the end of June, the Ministry of Industry and Trade proposed a ban on the purchase of foreign-made ventilators by state hospitals.
Some medical devices will be purchased by trade names. The main freelance specialists of the constituent entities of the Russian Federation will be able to influence this
The Government of the Russian Federation has approved a simplified scheme for the procurement of medical devices and medical nutrition for patients with serious illnesses. Hospitals and clinics will be able to purchase certain goods under specific trade names - without the obligation to take into account possible equivalents, as is required in the general procedure for public procurement.
We are talking about the purchase of products and products that are needed by specific patients for medical reasons. For example, with individual intolerance to certain components or for health reasons.
An application for the inclusion of a medical device or specialized products in the list can be sent to the Ministry of Health by regional health authorities, their main freelance specialists, as well as medical organizations that provide assistance to a particular patient.
Source: http://government.ru/news/49329/
Other
A neural network has been created at the Higher School of Economics to control a prosthetic hand
In the future, the model will help people with disabilities to quickly master the capabilities of prostheses and manage them more efficiently.
Existing hand prostheses are far from ideal. As a rule, they allow patients to control the movement of the entire hand as a whole, but not individual fingers, despite the technical possibility.
This is due to the fact that many modern bioelectric (bionic) hand prostheses have rather primitive control systems based on the use of only two large muscles of the forearm. The device reads how these muscles tense and relax and converts the signals into commands to move the prosthesis. Disabled people master such a control system in much the same way as if they were learning to program.
Source: https://nauka.tass.ru/nauka/18473481
Sechenov University is developing a tool for performing operations on the thyroid gland
The new device was called "tuneller". Its main purpose is to create a tunnel in the tissues through which surgeons can insert the endoscope. This will reduce the impact on the vessels, minimize possible tissue damage and bleeding, and reduce the length of stay of patients in the hospital.
The author of the project is a fifth-year student of the Institute of Clinical Medicine named after Sklifosovsky Ivan Lychagin. He received 500 thousand rubles in the form of a grant from the Innovation Promotion Fund under the UMNIK program to support talented youth. Together with him, Maxim Saliba, Associate Professor of the Faculty Surgery Department of the Institute, is working on the project.
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