The experimental study of the quality and safety of injectable implant medical devices based on hyaluronic acid in accordance with the requirements of the EU regulation.

Abstract

The aim of the article is to present the results of the experimental study of leachables used as primary packaging for medical devices, namely injectable implants based on hyaluronic acid. For the study, a line of injectable implants with identical qualitative composition and differing quantitative hyaluronic acid content was used. When developing the research conditions, the main characteristics of the implant gel were taken into account, and the conditions for using the appropriate medical device were modeled to obtain the most informative results and confirm the safety of the primary packaging selected. The analysis of extracts was carried out using the following methods: GC/MS, HPLC/UV/MS, ICP/MS, and IC. No substances listed as Chemicals of Potential Concern were detected in the extracts obtained, thereby confirming the safety of using the medical device for the patient under the conditions specified by the manufacturer.