Risk Management Framework for Nano-Biomaterials Used in Medical Devices and Advanced Therapy Medicinal Products - Ineris - Institut national de l'environnement industriel et des risques Access content directly
Journal Articles Materials Year : 2020

Risk Management Framework for Nano-Biomaterials Used in Medical Devices and Advanced Therapy Medicinal Products

Carlos Fito
  • Function : Author
Lisa Pizzol
  • Function : Author
Burkhard Stahlmecke
  • Function : Author
Alex Zabeo
  • Function : Author
Lang Tran
  • Function : Author

Abstract

The convergence of nanotechnology and biotechnology has led to substantial advancements in nano-biomaterials (NBMs) used in medical devices (MD) and advanced therapy medicinal products (ATMP). However, there are concerns that applications of NBMs for medical diagnostics, therapeutics and regenerative medicine could also pose health and/or environmental risks since the current understanding of their safety is incomplete. A scientific strategy is therefore needed to assess all risks emerging along the life cycles of these products. To address this need, an overarching risk management framework (RMF) for NBMs used in MD and ATMP is presented in this paper, as a result of a collaborative effort of a team of experts within the EU Project BIORIMA and with relevant inputs from external stakeholders. The framework, in line with current regulatory requirements, is designed according to state-of-the-art approaches to risk assessment and management of both nanomaterials and biomaterials. The collection/generation of data for NBMs safety assessment is based on innovative integrated approaches to testing and assessment (IATA). The framework can support stakeholders (e.g., manufacturers, regulators, consultants) in systematically assessing not only patient safety but also occupational (including healthcare workers) and environmental risks along the life cycle of MD and ATMP. The outputs of the framework enable the user to identify suitable safe(r)-by-design alternatives and/or risk management measures and to compare the risks of NBMs to their (clinical) benefits, based on efficacy, quality and cost criteria, in order to inform robust risk management decision-making.
Fichier principal
Vignette du fichier
2020-124.pdf (1.87 Mo) Télécharger le fichier
Origin Publication funded by an institution

Dates and versions

ineris-03318334 , version 1 (09-08-2021)

Identifiers

Cite

Elisa Giubilato, Virginia Cazzagon, Monica Amorim, Magda Blosi, Jacques Bouillard, et al.. Risk Management Framework for Nano-Biomaterials Used in Medical Devices and Advanced Therapy Medicinal Products. Materials, 2020, 13 (20), pp.4532. ⟨10.3390/ma13204532⟩. ⟨ineris-03318334⟩

Collections

INERIS
62 View
100 Download

Altmetric

Share

Gmail Mastodon Facebook X LinkedIn More