Last Updated on March 20, 2023 by BIOMEDRIC
The article has been adapted from the article entitled “Chemical Characterization and Toxicological Risk Assessment of Medical Devices” in the Journal of IKMIB Chemist (IKMIB Chemist, August 2021, 65, 88-91), written as an expert opinion by Assoc. Prof. Kurtulus Gokduman, the founder of BIOMEDRIC.
Chemical characterization is the determination of the quality and quantity of chemicals extracted from a medical device using analytical chemistry techniques. Toxicological risk assessment is the assessment by a competent toxicologist, considering the worst-case scenario of the toxicological risk during the use of this medical device associated with the exposure levels of the patients to chemicals specified in the chemical characterization test report.
Chemical characterization and toxicological risk assessment of medical devices have gained great importance, especially with the new EU regulation (EU MDR; Regulation (EU) 2017/745). According to previous legislation (EU MDD), based on the category, type of contact, and duration of contact of the relevant medical device, the biocompatibility of medical devices was being proven by following a biological evaluation test matrix, which included in-vitro (tests on cells under laboratory conditions) and in-vivo tests (tests on animals). The new regulation (EU MDR) mainly aims to reduce unnecessary testing and animal use. According to this new approach, in the biocompatibility assessment of medical devices, chemical characterization tests, and a toxicological risk assessment by a competent toxicologist based on these chemical characterization test data should first be performed; only biocompatibility tests that this assessment deems necessary should be carried out.
On the other hand, in addition to the EU MDR, FDA emphasizes the crucial importance of chemical characterization and toxicological risk assessment of medical devices by using the following statement in the FDA 2020 Guidance: “FDA evaluates the safety of medical devices based on duration of exposure and nature of contact. Inherent in the review of medical devices is an understanding of the body’s entire exposure to the medical device, including all chemical entities contained within the device. For devices where the patient-contacting portions may contain potentially toxic chemicals, the evaluation of safety should include both chemical risk (i.e., the level of toxicological concern) and the type and duration of exposure.”.
Thus, due to the tendency of FDA and EU regulations, and its expanding product range, the need for “chemical characterization” and “toxicological risk assessment” methods of the medical device industry will increase rapidly in the coming years.
There are impressive advantages of “chemical characterization” and “toxicological risk assessment” methods, which must first be added to files to be submitted to the competent authorities to prove the biocompatibility of medical devices as mentioned in ISO 10993-1 Flowchart. A comprehensive and justified toxicological risk assessment report on a specific medical device may eliminate the need for some long-term, laborious and costly biocompatibility tests for this device. For example: While carcinogenicity tests can take two years and can be very costly, “chemical characterization” and “toxicological risk assessment” studies can be completed in four to six weeks at much lower costs; based on a comprehensive toxicological risk assessment report prepared by a competent toxicologist based on chemical characterization test data, it can be justified that additional carcinogenicity studies are not needed for the relevant medical device. Even this example alone illustrates that the implementation of these methods can give manufacturers a very valuable advantage, allowing the relevant medical device to reach the market much faster and more cost-effectively. It is worth to reiterate that a comprehensive and justified toxicological risk assessment report prepared in a scientifically strong way can also eliminate the necessity of other biocompatibility tests.
Despite the time and cost advantages, there are aspects of these methods that need to be improved. These methods require special expertise compared to other biocompatibility tests. In this context, it is essential to meet the growing scientific and technical consultancy needs of manufacturers, including “chemical characterization” and “toxicological risk assessment” methods, together with the tendency of FDA (Premarket Approval (PMA), Premarket Notification 510(k), De Novo applications) and EU regulations ((EU) 2017/745 for medical devices and (EU) 2017/746 for in-vitro diagnostic medical devices).
In addition to requiring special expertise, there may be differences between chemical characterization analysis results performed by different laboratories and toxicological risk assessment reports prepared by different toxicologists. Although this raises the question of the reliability of these methods, since they are prepared by considering worst-case scenarios, despite some differences, they do not pose a risk to patient safety. On the other hand, steps are also being taken by the competent authorities to improve these methods; regarding these methods, in addition to the recently announced ISO 10993-18: 2020 guide, the ISO 10993-12: 2021 guide has been published this year and the ISO 10993-17 guide is under revision and is planned to be published in the near future. These developments show that the reliability of these methods will be moved to a much higher level in the future, along with method improvements to these methods made by the competent authorities and to be made in the future
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