Clinical Guidelines For The Use Of 3D-printed Products Will Appear In The Russian Federation

2023 Author: Abraham Higgins | [email protected]. Last modified: 2023-11-27 23:16

Clinical guidelines for the use of 3D-printed products will appear in the Russian Federation

To develop them, the Association of Specialists in 3D Printing in Medicine has created a special working group. Today, traumatology-orthopedics ranks second in the world in terms of the volume of use of personalized 3D-printed medical devices after dentistry. Currently, about 900 patients are under observation, in the treatment of which additive technologies were used.

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Today, traumatology and orthopedics ranks second in the world in terms of the volume of use of personalized medical devices made by 3D printing after dentistry. Currently, there are about 900 patients under observation, in the treatment of which additive technologies have been used over the past 3 years.

To develop clinical guidelines, the Association of 3D Printing in Medicine has created a special working group. This was announced at the Eurasian Orthopedic Forum-2019 in Moscow by the Chairman of the Board of the Association, Rector of the Volga Research Medical University Nikolai Karjakin. According to him, in Russian medicine, the process of using 3D printing is not regulated. As in many other countries, the issue of using additive technologies is left to the level of healthcare institutions that manufacture such products themselves. And the law only stipulates the use of materials that have registration certificates. Therefore, professionals must fill the existing legal vacuum, said Karjakin.

According to Healthcare 3D Printing Market Analysis, 480,901 custom implants were 3D printed in 2018. In Russia, according to the results of the analysis of the protocols of clinical approbation, for the period from 2016 to 2018, 877 patients received treatment using additive 3D printing technologies in federal healthcare institutions, of which 611 patients underwent surgery using individual implants made on 3D printer. The corresponding figures for 2018 are 354 and 279 patients.

“Our experience shows that the use of additive technologies is shown, first of all, for purulent diseases of the bones and joints, when the patient comes, as a rule, after 2-3 endoprosthetics operations with a large deficit of bone tissue. And, of course, orthopedic oncology for large lesions,”Nikolai Karjakin explained. - Additive technologies significantly reduce the cost of treatment in the case of oncological primary or secondary tumors and other severe pathologies, but we must understand that 3D printing is not a financially substitute method. It has very narrow indications and cannot be used to save money when there is no money for standard implants, as some doctors think."

In addition, although about 900 patients are now under observation in Russia, in the treatment of whom additive technologies have been used over the past 3 years, there are no published observations with an annual retrospective analysis. “We believe that it is necessary to introduce a unified registry of patients who receive individual implants made using additive technologies. It is important for us to understand what is happening, especially given that at present Roszdravnadzor is giving control over the quality of treatment of such patients to our level,”Karjakin stressed.