TEN.MedPrint, a contract manufacturer of medical items using 3D printing (belongs to the TechnoSpark Group of Companies), is going to take part in the development of usage standards for individual additive items in medicine within the framework of a working group created by the Association of Experts in Medical 3D Printing in the summer 2019.
In 2018, over 480,000 individual implants were 3D-printed worldwide according to the Healthcare 3D Printing Market Analysis. In Russia, too, the number of operations involving individual implants is on the rise: in 2018, individual 3D-printed implants were provided to 279 federal hospital patients, double the number registered in 2017.
There are no systematic usage regulations concerning 3D-printed individual items in Russian medicine, which forces every healthcare institution to develop their own standards of operations and rehab practices that involve additive implants. The Association of Experts in Medical 3D Printing created a working group, which among others includes TEN.MedPrint, a contract manufacturer, to regulate the usage of 3D-printed items and develop unified clinical guidelines.
‘Throughout all stages our activities are controlled by the quality management system intended for production of medical items in regard to preparing a model for printing, setting the equipment for production, and post-processing, and we also have to pass through a regular certification procedure. The unified standard will simplify the application of latest technologies for the entire process chain— doctors, engineers, manufacturers—and it will make it more reliable for patients as well. This has been the way it evolved in the countries that are the leaders in the application of additive implants—countries of Western Europe and the USA,” Director of TEN.MedPrint Alexander Narchuk comments.
The Association of Manufacturers proposes adopting a unified register of patients with individual additive implants, developing a standard for operational procedures, production of 3D-printed individual items for medical use, and clinical guidelines for their application.
3D printing is used in the production of individual endoprotheses of hip joints, cranial implants to restore the skull contour after traumas and resections (most commonly in cancer treatment), and intervertebral fusion cages. Individual implants are made to precise measurements of a given patient using biologically compatible safe materials. Individual additive implants significantly improve the patient’s quality of life, and in the case of osseous lesions it is the only attainable way to restore their welfare.
TEN.MedPrint (part of the TEN Group within the TechnoSpark Group of Companies) is a contract manufacturer of individual and serial medical 3D-printed items. The production is certified in compliance with the latest international standard of GOST ISO13485-2017, Medical devices, Quality Management Systems, Requirements for regulatory purposes.