Review of the regulatory framework regarding the use of multifocal IOLs for cataract surgery.

Abstract

Considering the increasing requirements for the quality of postoperative vision, the number of requests from patients for the implantation of a multifocal IOL is increasing, which makes it relevant to analyze the existing regulatory framework for the possibility and obligation to use this medical device in the provision of specialized medical care – surgical treatment of cataract within the framework of the state guarantees program. An analysis of the current regulatory framework showed that the existing regulatory framework allows the use of multifocal IOLs in the provision of medical services under the state guarantees program, however, it does not give the patient the right to choose, and makes considering the patient’s desire to implant this particular type of medical device is not mandatory when planning surgery. Considering the requirements of mandatory informed voluntary consent when receiving a medical service, the patient must be informed about the implantation or refusal to implant this type of medical device when providing him with specialized medical care. Most of the analyzed medical devices – IOLs with multifocal properties – are registered in the Russian Federation as “Intraocular lens for the posterior chamber of the eye, pseudophakic”, and not “Intraocular lens for the posterior chamber of the eye, pseudophakic, with increased depth of focus”. There is both a clinical need for changes (Clinical guidelines), and an organizational need to identify a group of operations, including with the application of additional coefficients to the tariff as part of the payment for medical services included in the program of state guarantees.