News Digest 03.06.2024 — 05.06.2024
Regulators
Guidelines for the procedure for conducting an examination of the quality, efficiency and safety of medical devices (in terms of software) for state registration within the national system dated 05/07/2024
Approved by the Federal State Budgetary Institution "National Institute of Quality" of Roszdravnadzor and the Federal State Budgetary Institution "VNIIIMT" of Roszdravnadzor.
Document in the source: https://roszdravnadzor.gov.ru/medproducts/registration/documents/84087
Mandatory labeling of five types of TSR will be introduced in the fall of 2024
The Government of the Russian Federation has introduced mandatory labeling of certain technical rehabilitation devices (TSR). According to the regulations, manufacturers will be required to apply codes to products and transfer data to the system from September 1, 2024, and release labeled TSR onto the market from October 1. Five groups of medical devices will be subject to mandatory labeling.
The marking parameters were approved by Government Resolution No. 744 of May 31, 2024.
The following items are subject to mandatory marking: crutches, supports, support and tactile canes, orthoses and functional units of prostheses, anti-decubitus pillows and mattresses, urine and ostomy bags, and chairs with sanitary equipment.
The circulation of products that have not been marked and were put into circulation before the deadline will be allowed until February 28, 2025. Participants in the circulation system of technical rehabilitation equipment will transmit information on the withdrawal of technical rehabilitation equipment from circulation from March 1, 2025, and data on their turnover on the market - from October 1, 2025.
In October 2023, the Government of the Russian Federation approved an experiment on voluntary marking of technical rehabilitation equipment. The stated purpose of the experiment was to combat the illegal import, production and circulation of technical rehabilitation equipment, including counterfeit ones, as well as to increase the collection of taxes and fiscal payments. The pilot project started on October 15, 2023 and is scheduled to end in August 2024.
Source: https://vademec.ru/news/2024/06/04/obyazatelnuyu-markirovku-pyati-vidov-tsr-vvedut-osenyu-2024-goda/
Market news
Rostec Completes Clinical Trials of New Line of ALV Devices for 630 Million Rubles
KRET Holding (part of Rostec State Corporation) has completed clinical trials of the Mobivent Oxy artificial lung ventilation device. The new line of medical equipment includes five products: the universal Mobivent device, Mobivent Oxy for high-flow oxygen therapy, the mobile Mobivent ARM, Mobivent Neo for newborns, and the expert-class Mobivent Maxi device.
It is expected that after completing the registration and receiving validation for the dossier from Roszdravnadzor, the device will go into serial production.
The state corporation expects to replace foreign ventilators of this class on the Russian market. With regard to ventilators, there is a protectionist rule of “the second is superfluous”, as well as a minimum quota for the purchase of domestic products, and for two types - devices for intensive care for adults and newborns and general-purpose devices for intensive care - government purchases of imported products are completely prohibited.
In October 2021, the plant received 630 million rubles from the federal budget for the development of a new line of ventilators "Mobivent". Source:
Two former deputy heads of the Astrakhan Ministry of Health convicted of fraud with PCR tests
The Leninsky District Court of Astrakhan found the former first deputy and deputy ministers of health of the Astrakhan region guilty of abuse of office in connection with fraud with PCR tests for diagnosing COVID-19. The damage from the actions of the defendants was estimated at 31 million rubles. They were sentenced to 5 and 4 years of imprisonment, respectively, in a general regime penal colony.
The former officials were also deprived of the right to hold certain positions for 2.5 years. The names of the convicted persons are not disclosed. Earlier, the media reported that one of the defendants could presumably be the former First Deputy Minister of Health of the Astrakhan Region, Olga Agafonova.
The court and investigation established that in June 2020, the first deputy head of the department, "acting out of selfish and personal interest" in the interests of a previously familiar to her director of a company engaged in the production of diagnostic drugs, and also in order to "show herself as an effective worker," demanded that he provide charitable assistance to the regional Ministry of Health in the form of a free supply of PCR tests for the diagnosis of COVID-19. In exchange for this, the official guaranteed the unhindered conclusion of contracts for the supply of medical devices at the request of the ministry. "Then in November 2020, the woman, acting as the organizer of the crime, gave an illegal instruction to the Deputy Minister of Health to prepare documents for concluding a state contract with the above-mentioned company for the supply of PCR test systems for diagnosing COVID-19 without holding an auction and in the absence of the need to purchase them," the regional office of the Investigative Committee specified.
In December 2020, the Deputy Minister concluded two state contracts worth 48 million rubles without holding an auction for the supply of reagents for detecting COVID-19 using the PCR method. At the same time, the expiration dates of most of the tests did not meet the requirements and were less than seven months. As a result, in 2022, most of the products were written off "due to excessive purchases." The damage to the regional Ministry of Health amounted to 31 million rubles. Law enforcement officers are not disclosing information about the company involved in the case.
The criminal activity was stopped by Investigative Committee officers together with the Federal Security Service and the Ministry of Internal Affairs of Russia for the Astrakhan Region. The criminal case was opened in July 2023.
Other
Aging Americans Are Using Health Monitoring Apps Actively
According to an April 2024 U.S. News survey of 1,500 Americans aged 55+, more than half of respondents actively use technologies and services aimed at improving their quality of life: mobile apps in the “Health” category, home grocery delivery services, smart home devices, and wearables.
Overall, 93% of Americans surveyed are confident that healthy aging in a familiar, home environment is a goal that every aging boomer should strive for.
Source: https://www.usnews.com/360-reviews/services/senior-tech-aging-in-place-survey
Artificial intelligence blamed for diagnostic errors
It is as fashionable to criticize artificial intelligence (AI) as it is to praise it. Clickbait news headlines with the magic phrase “artificial intelligence” are no longer surprising. I usually ignore provocative news - it distracts and confuses.
But exceptions happen. For example, a news story from a previously unknown media outlet made me really indignant. The headline "Patients complain about incorrect diagnoses of AI in clinics" clearly does not correspond to the content of the news, which gives an example of some patient X, who, allegedly, was given an incorrect diagnosis by a doctor because of AI.
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