Among the dozens of global manufacturers of medical devices, there is not and there was not a single Russian company. And the entire Russian market of medical devices occupies only 1.3% of the global market, the volume of which, as of the end of 2020, exceeded $ 411 billion. These figures indicate not only the export potential of the Russian medical industry, but also what they use in their work. domestic doctors. After all, medical products are a variety of things that are used in the treatment process: from bandages and gloves to ventilators. In traumatology and orthopedics, these are primarily endoprostheses, nails and plates for osteosynthesis, bone materials, orthoses and rehabilitation means.
Last but not least, the reason for the underdevelopment of the domestic market for medical devices is the unregulated requirements and standards of their production. It is the strict standards, ranging from the composition of the material from which the products are made, and ending with the requirements for the machines on which they are produced, that will provide Russian medical products with a consistently high quality comparable to the world.
“Today in our market there are many medical devices from various manufacturers. For example, plates for osteosynthesis of the same configuration can be made from different alloys and on different equipment. Figuratively speaking, on the same machine and from the same alloy, both a part for an aircraft and an endoprosthesis for a person can be machined. And, since we in Russia do not have separate requirements for materials and equipment for the production of any medical devices, sometimes this can lead to negative consequences for the patient, “said Andrey Generalov, deputy director of the Institute of Medical Materials.
“Our country needs a register of medical materials that will provide uniform requirements for the manufacture of medical devices for any, domestic or foreign, manufacturer. Thereby ensuring constant quality ”, – sums up Generals.
But to begin with, it is necessary to introduce into the legislation the concept of “medical material”, which today, in fact, is not described in it, he noted. The participants of the round table will talk about how to do this and which law should be amended.
In addition, it is necessary to develop or adapt the already existing global quality standards for medical materials and their safety and suitability tests. According to experts, in the standardization of medical devices, our country lags behind European ones by about 5-10 years. Today in Russia there is an approved Perspective Standardization Program in the field of medical devices, which is valid until 2025. It is to it that the standardization of medical materials and their testing will have to be added, if the materials are singled out in a separate category.
Medical biomaterials are of particular interest and even great export potential. In traumatology and orthopedics, these are primarily bone allografts obtained from cadaveric material and processed accordingly. Once this technology of preparation, conservation and use of allografts was introduced at CITO, and today its various modifications are only gaining popularity all over the world.
In order to expand the production of bone allografts and make them of higher quality, it is necessary to change the legislatively established terms in which it is possible to obtain bone material, to regulate the procedures for the selection of sources (donors), sampling, processing, storage, a general decriminalization of the handling of materials of human origin is necessary for the production of medical This issue will also become the subject of discussion of the round table participants.
An important issue in the production of medical devices is also the sterilization of medical devices and the validation of sterilization processes in terms of establishing uniform principles for the safety of sterile medical devices in the country.
The full program of the section can be found on the website of the Eurasian Orthopedic Forum – https://2021.eoforum.ru/
Platinum partner of the EOF-2021 – Johnson & Johnson.
General partners of EOF-2021 – Federal State Unitary Enterprise “CITO”, company Osteomed®️.
General information partner of EOF-2021 – OpinionLeader magazine.
Information partners of EOF-2021 are: MIC “Izvestia”, TV channel “MIR 24”, Doctive LAB project, magazines “Polyclinic”, “Modern Medicine”, SiberianLife, “Healthcare of Russia”, “Science and Life”, “Business of Life”, “Medicine: Targeted Projects”, “Polytrauma / Polytrauma”, newspaper “Medical Bulletin”, TV channel “Pro Business”, publishing house “MEDpress-inform”, publishing house “Russian Doctor”, information and analytical portal Remedium.ru, federal medical portal medsovet.info, medical information agency ” Medforum ”, information and analytical agency 3Dpulse.ru, medical marketing agency“ MediaMedica ”, community“ Doctors of the Russian Federation ”, project YellMed, network of business portals“ GlobalMedia ”, Orthopedic Product News, Hospitals Management, Arab Medi Care, Neurologico Spinale Medico Chirurgico (NSMC), German Medical Journal.
Source: Автономная некоммерческая организация "Редакция журнала «Наука и жизнь»" by www.nkj.ru.
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