The problem of normative legal regulation of orthopedic footwear circulation

Authors:

Yulia B. Golubeva, Head of the Department of orthopedic footwear and special clothing for the disabled of Institute of Prosthetics and Orthotics of the Federal Scientific Center of Rehabilitation of the Disabled named after G.A. Albrecht, 50 Bestuzhevskaya Street, 195067 Saint-Petersburg, Russian Federation. Е-mail: 812golub@mail.ru

Irina K. Gorelova, senior researcher of the Department of orthopedic shoes and special clothing for the disabled of Institute of Prosthetics and Orthotics of the Federal Scientific Center of Rehabilitation of the Disabled named after G.A. Albrecht, 50 Bestuzhevskaya Street, 195067 Saint-Petersburg, Russian Federation. Е-mail: 812gorelova@mail.ru

Valentina V. Galaudina, Head of Standardization and Metrology Department (Center for Expert Evaluation of Prosthetic and Orthopedic Products) of the Federal Scientific Center of Rehabilitation of the Disabled named after G.A. Albrecht, 50 Bestuzhevskaya Street, 195067 Saint-Petersburg, Russian Federation. Е-mail: 812galaudina@mail.ru

Jamil R. Giniyatullov, candidate. Econ. Sciences, Deputy head Of the technical Department for orthopedics of the “Moscow prosthetic and orthopedic enterprise” Federal state unitary enterprise, Ministry of labor of the Russian Federation, 17A Korovinskoe shosse, Moscow, 125412, Russian Federation. Е-mail:info@mprop.ru

Annotation:

Introduction. Inconsistency and misinterpretation of basic concepts, terminology, and classification principles in regulatory legal documents leads to incorrect identification of orthopedic shoes and, as a result, uncontrolled circulation of products on the market, serious errors in the preparation of technical specifications for the state contract, and consumer complaints about quality.

Aim. The aim is to analyze the main regulatory legal documents in the field of regulating the circulation of orthopedic shoes, to determine the completeness and unambiguity of classification features and characteristics of orthopedic shoes in existing regulatory documents and to make suggestions for their updating.

Materials and methods. We have studied and analyzed the current regulatory legal documents of the federal level regulating the circulation of orthopedic shoes, national standards, and all-Russian classifiers. Analytical, complex and system methods are used in the performance of the work.

Results and discussion. The analysis of the classification of the technical means of rehabilitation showed that the description of the types of technical means of rehabilitation does not contain information about the technical characteristics and methods of manufacturing a specific product (serial or custom-made with individual manufacturing parameters). In the All-Russian Product Classifier 034 (All-Russia Classifier of Products in Accordance with Types of Economic Activity – OKPD 2) there is no such classification feature as “materials”, which was in the previous product classifier All-Russian Product Classifier 005, and materials make up 70 % of the cost of shoes, so manufacturers using cheaper materials have a competitive advantage. The term «prosthetics and orthotics» is not interpreted as a service, but as a «direction of rehabilitation» in Federal Law 181-FZ or as a «rehabilitation event» in the Federal List of Rehabilitation Measures, Technical Means of Rehabilitation and Services Provided to a Disabled Person, the code of which is not specified in the documents defining the pricing policy. The revealed imperfection of regulatory documents forces manufacturers to assign incorrect codes for prosthetics and orthotics to All-Russian Product Classifier 034 (OKPD 2) when performing various procedures related to the production and handling of technical means of rehabilitation. The lack of a uniform and unambiguous approach to the identification of orthopedic shoes in various regulatory documents and the absence of a service to be financed in them leads to inefficient use of budget funds in public procurement, to violation of consumer rights in terms of providing reliable information, and to an increase in the risk of harm from improper use of a medical device (orthopedic shoes).

Conclusion. The current regulatory documents do not take into account the quantitative and qualitative characteristics of orthopedic shoes, but apply different levels of classification of orthopedic shoes, do not identify common classification features for describing products, and use different terminology. Discrepancies, the inconsistency and even contradictory in the data provided in regulatory legal documents (terms, concepts, coding, classification characteristics) introduces misunderstandings in terms of ensuring the correct identification of orthopedic shoes and shows the need to update the information set out in regulatory documents.

List of cited literature:

1. Svintsov AA, Golubeva YB, Galaudina VV. Standartizaciya i tekhnicheskoe regulirovanie v reabilitacii [Standardization and technical regulation in rehabilitation / V knige: Reabilitaciya invalidov nacional’noe rukovodstvo. Ser. «Nacional’nye rukovodstva\» pod redakciej GN Ponomarenko]. In the book: Rehabilitation of disabled people national guidelines. Ser. «National guidelines» edited by GN Ponomarenko. Moscow, 2018:145-53 (In Russian).

2. Ponomarenko GN, Shcherbina KK, Golubeva YB, Galaudina VV O kachestve protezno-ortopedicheskih izdelij // Standarty i kachestvo. [About the quality of prosthetic and orthopedic products]. Standards and quality. 2020;2:94-9. (In Russian).