Nanomaterials in Medical Devices: Regulations' Review and Future Perspectives

Nanomaterials in Medical Devices: Regulations' Review and Future Perspectives

Karolina Jagiello (QSAR Lab Ltd, Gdansk, Poland & Laboratory of Environmental Chemometrics, Faculty of Chemistry, University of Gdansk, Poland), Anita Sosnowska (QSAR Lab Ltd, Gdansk, Poland & Laboratory of Environmental Chemometrics, Faculty of Chemistry, University of Gdansk, Poland), Alicja Mikolajczyk (Laboratory of Environmental Chemometrics, Faculty of Chemistry, University of Gdansk, Gdansk, Poland) and Tomasz Puzyn (QSAR Lab Ltd, Gdansk, Poland & Laboratory of Environmental Chemometrics, Faculty of Chemistry, University of Gdansk, Poland)
Copyright: © 2017 |Pages: 11
DOI: 10.4018/JNN.2017070101

Abstract

This article gives a brief description of the existing regulations related to biomaterials safety that need to be considered before it is introduced into EU market. According to these regulations, the risk analysis should include two characteristics: probability of occurrence of harm, and severity. Identified user-related harm should be reduced by managing the risk. Additionally, the review presents an overview of engineered biomaterials (EBMs), which in combination with nanoscale components (NPs) have shown promises in Advanced Therapy Medicinal Products (ATMP) and Medical Devices (MD). In this article, recent challenges, objectives and perspectives in risk assessment and risk management of ATMP and MD composed of nanobiomaterials were also highlighted.
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Introduction

Medical Devices (MD) and Advanced Therapy Medicinal Products (ATMP) play a crucial and still growing role in improving human healthcare. The market size related to biomaterials applied in MD and ATMP development, commercialization, manufacturing and distribution was about $330 billion in 2013 and is growing at ~6% per year through 2017 in consequence contributes significantly to the European economy (http://ec.europa.eu/growth/sectors/medical-devices_en)

Due to that biomaterials inevitably come in contact with the patient’s tissue and/or circulatory system their application should be always accompanied with a comprehensive risk assessment and risk management (Hollinger, 2011). Managing and reducing risk is necessary to ensure the safety of the designed devices (Palanichamy, 2002). The risk analysis should include probability of occurrence of harm and severity. According to these two characteristics, there were three risk zones defined: i) risk zone 1 that consists medical devices with generally acceptable risk (low severity and low probability); ii) risk zone 2 – conditionally acceptable risk (medium severity and probability); and iii) risk zone 3 – generally unacceptable risk, Figure1 (Palanichamy, 2002). In consequence, medical devices will be defined as ‘unacceptable’ only in case, if its application provides to catastrophic effects (e.g. to death), and this effect occurs frequently.

Figure 1.

Risk zone defined according to probability and severity (Palanichamy, 2002)

There are existing regulations related to biomaterials safety that need to be considered before their introduction into European (EU) market (EU Communities 1990, 1993, 1998). The three main directives are: directive 90/385/EEC regarding active implantable medical devices (EU Communities 1990); directive 93/42/EEC regarding medical devices (EU Communities 1993) and directive 98/79/EC regarding in vitro diagnostic medical devices (EU Communities 1998). The European Commission also adopted a series of implementation measures and guidelines, of which the most known are the Medical Devices Directive series, also known as MEDDEV (MEDDEV, 1994, 2010). Currently, the ISO 10993-1:2009 (ISO, 2009) is in practice for the safety testing and risk assessment of medical devices including biomaterials. This guideline provides the information on how to perform the biological safety assessment for biomaterials considering the body contact and duration of this contact (ISO, 2009).

The goal of the risk management analysis is to provide tools to minimize user-related hazards that are identified within risk assessment analysis. The risk management process for biological evaluation of medical devices is described in ISO 10993-1:2010 (ISO, 2010), Annex B and follows the wording of ISO 14971:2012 (ISO, 2012) and the guidance document ISO/TR 15499:2016 (ISO/TR, 2016). Further, in ISO 10993-1, Annex B the risk analysis is extended and also comprises risk evaluation and risk control. ISO/TR 15499:2016 provides more detailed advice on carrying out biological risk evaluations within a risk management process than ISO 10993-1.

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