News Digest 15.11.2023-17.11.2023
Regulators
The Ministry of Health clarified the procedure for writing off alcohol in medical organizations
The norms for the consumption of ethyl alcohol in laboratories that were in force until now were established by an order of the USSR Ministry of Health dated 1987, and the standards for the consumption of ethanol by healthcare institutions were established by a similar document from 1991. Since then, the regulator has not adopted a single thematic regulation.
According to the estimates of the Ministry of Health of the Russian Federation, in the absence of legislatively approved standards for the write-off of ethyl alcohol, it is advisable to delegate the right to develop standards locally.
In the current legal field, standards for the consumption of material supplies (including ethyl alcohol) can be developed by medical organizations independently, but subject to several conditions. First of all, the regulations must take into account the standards adopted by the founder. You can formulate specialized requirements when approving a state task, as, for example, the Ministry of Health of the Amur Region did in 2018. Also, the standards must correspond to the indicators of resource use in recent years and the requirements for saving material and monetary resources. In addition, the volume of consumption/write-off must be correlated with the volume of material resources spent on similar needs in other organizations that solve comparable problems.
Market news
NPO Medkar brought to the market a mobile complex with a localized tomograph from China
NPO Medkar CJSC, located near Moscow, received a regulatory certificate for a mobile medical complex (MMC) of computed tomography with a localized version of the device under the X-RAYNIKA Mobile brand. As follows from the dossier, the complex allows the use of domestic components or original ones produced by the Chinese Sinovision Technologies. Previously, CT scanners from this manufacturer were not registered in Russia as independent devices, with the exception of the Ventum version localized in Belarus.
Other
Artificial intelligence has made it possible to independently detect the cardiotoxicity of chemotherapy
Artificial intelligence-based software has made it possible to detect cardiomyopathy in women receiving anthracyclines for breast cancer at an early stage using ECG monitoring. Using this technique will allow patients to independently monitor their heart condition.
The study included 989 women without cardiovascular disease who received anthracycline chemotherapy for breast cancer without metastasis. In all participants, the left ventricular ejection fraction remained normal before the start of chemotherapy with anthracycline drugs.
Neuralink is looking for volunteers for brain implant surgery
Neuralink plans to use its brain implant in 11 people by 2024 and more than 22,000 by 2030. This was reported by Bloomberg in a report by one of Elon Musk’s biographers, Ashley Vance.
In a blog post, Neuralink said it is looking for people who have quadriplegia due to spinal cord injury or amyotrophic lateral sclerosis. The company says it ultimately wants to create a device that will create a kind of symbiosis between man and machine, allowing people to send messages or play games using only their thoughts. But first, the company hopes to help people with neurological disorders.
Source: https://www.securitylab.ru/news/543452.php
New registered medical devices
We are publishing a list of new medical devices registered from 11/10/2023 to 11/17/2023
https://cont.asiamc.ru/uploads/blogs/2023-11-17/6557d01080804.pdf
News
