PMID- 33066064
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231112
IS  - 1996-1944 (Print)
IS  - 1996-1944 (Electronic)
IS  - 1996-1944 (Linking)
VI  - 13
IP  - 20
DP  - 2020 Oct 13
TI  - Risk Management Framework for Nano-Biomaterials Used in Medical Devices and 
      Advanced Therapy Medicinal Products.
LID - 10.3390/ma13204532 [doi]
LID - 4532
AB  - 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.
FAU - Giubilato, Elisa
AU  - Giubilato E
AUID- ORCID: 0000-0001-6335-0735
AD  - Department of Environmental Sciences, Informatics and Statistics, University Ca' 
      Foscari of Venice, Via Torino 155, 30172 Venice, Italy.
FAU - Cazzagon, Virginia
AU  - Cazzagon V
AUID- ORCID: 0000-0003-2565-1654
AD  - Department of Environmental Sciences, Informatics and Statistics, University Ca' 
      Foscari of Venice, Via Torino 155, 30172 Venice, Italy.
FAU - Amorim, Monica J B
AU  - Amorim MJB
AUID- ORCID: 0000-0001-8137-3295
AD  - Department of Biology and CESAM, University of Aveiro, 3810-193 Aveiro, Portugal.
FAU - Blosi, Magda
AU  - Blosi M
AD  - Institute of Science and Technology for Ceramics, National Research Council of 
      Italy (CNR-ISTEC), Via Granarolo 64, 48018 Faenza, Italy.
FAU - Bouillard, Jacques
AU  - Bouillard J
AD  - Institut National de l'Environnement industriel et des Risques, Parc 
      Technologique ALATA, 60550 Verneuil-en-Halatte, France.
FAU - Bouwmeester, Hans
AU  - Bouwmeester H
AUID- ORCID: 0000-0001-9318-4272
AD  - Division of Toxicology, Wageningen University, 6708 WE Wageningen, The 
      Netherlands.
FAU - Costa, Anna Luisa
AU  - Costa AL
AUID- ORCID: 0000-0003-1407-6498
AD  - Institute of Science and Technology for Ceramics, National Research Council of 
      Italy (CNR-ISTEC), Via Granarolo 64, 48018 Faenza, Italy.
FAU - Fadeel, Bengt
AU  - Fadeel B
AD  - Division of Molecular Toxicology, Institute of Environmental Medicine, Karolinska 
      Institutet, 171 77 Stockholm, Sweden.
FAU - Fernandes, Teresa F
AU  - Fernandes TF
AD  - Institute of Life and Earth Sciences, School of Energy, Geoscience, 
      Infrastructure and Society, Heriot-Watt University, Edinburgh EH14 4AS, UK.
FAU - Fito, Carlos
AU  - Fito C
AD  - Instituto Tecnologico del Embalaje, Transporte y Logistica, 46980 
      Paterna-Valencia, Spain.
FAU - Hauser, Marina
AU  - Hauser M
AD  - Empa, Swiss Federal Laboratories for Materials Science and Technology, 
      Lerchenfeldstrasse 5, 9014 St. Gallen, Switzerland.
FAU - Marcomini, Antonio
AU  - Marcomini A
AD  - Department of Environmental Sciences, Informatics and Statistics, University Ca' 
      Foscari of Venice, Via Torino 155, 30172 Venice, Italy.
FAU - Nowack, Bernd
AU  - Nowack B
AUID- ORCID: 0000-0002-5676-112X
AD  - Empa, Swiss Federal Laboratories for Materials Science and Technology, 
      Lerchenfeldstrasse 5, 9014 St. Gallen, Switzerland.
FAU - Pizzol, Lisa
AU  - Pizzol L
AUID- ORCID: 0000-0001-9434-9104
AD  - GreenDecision Srl, Via delle Industrie, 21/8, 30175 Venice, Italy.
FAU - Powell, Leagh
AU  - Powell L
AD  - Institute of Biological Chemistry, Biophysics and Bioengineering, School of 
      Engineering and Physical Sciences, Heriot-Watt University, Edinburgh EH14 4AS, 
      UK.
FAU - Prina-Mello, Adriele
AU  - Prina-Mello A
AUID- ORCID: 0000-0002-4371-2214
AD  - Trinity Translational Medicine Institute, Trinity College, The University of 
      Dublin, Dublin 8, Ireland.
FAU - Sarimveis, Haralambos
AU  - Sarimveis H
AD  - School of Chemical Engineering, National Technical University of Athens, 15780 
      Athens, Greece.
FAU - Scott-Fordsmand, Janeck James
AU  - Scott-Fordsmand JJ
AD  - Department of Bioscience, Aarhus University, 8600 Silkeborg, Denmark.
FAU - Semenzin, Elena
AU  - Semenzin E
AUID- ORCID: 0000-0001-8032-8687
AD  - Department of Environmental Sciences, Informatics and Statistics, University Ca' 
      Foscari of Venice, Via Torino 155, 30172 Venice, Italy.
FAU - Stahlmecke, Burkhard
AU  - Stahlmecke B
AUID- ORCID: 0000-0001-8035-5589
AD  - Institut fur Energie und Umwelttechnik e.V., 47229 Duisburg, Germany.
FAU - Stone, Vicki
AU  - Stone V
AUID- ORCID: 0000-0001-8346-7471
AD  - Institute of Biological Chemistry, Biophysics and Bioengineering, School of 
      Engineering and Physical Sciences, Heriot-Watt University, Edinburgh EH14 4AS, 
      UK.
FAU - Vignes, Alexis
AU  - Vignes A
AUID- ORCID: 0000-0003-0737-7911
AD  - Institut National de l'Environnement industriel et des Risques, Parc 
      Technologique ALATA, 60550 Verneuil-en-Halatte, France.
FAU - Wilkins, Terry
AU  - Wilkins T
AD  - Nanomanufacturing Institute, School of Chemical and Process Engineering, 
      University of Leeds, Leeds LS2 9JT, UK.
FAU - Zabeo, Alex
AU  - Zabeo A
AD  - GreenDecision Srl, Via delle Industrie, 21/8, 30175 Venice, Italy.
FAU - Tran, Lang
AU  - Tran L
AD  - Institute of Occupational Medicine, Research Avenue North, Riccarton, Edinburgh 
      EH14 4AP, UK.
FAU - Hristozov, Danail
AU  - Hristozov D
AD  - Department of Environmental Sciences, Informatics and Statistics, University Ca' 
      Foscari of Venice, Via Torino 155, 30172 Venice, Italy.
LA  - eng
GR  - 760928/H2020 Industrial Leadership/
GR  - UIDP/50017/2020+UIDB/50017/2020/Fundacao para a Ciencia e a Tecnologia/
PT  - Journal Article
DEP - 20201013
PL  - Switzerland
TA  - Materials (Basel)
JT  - Materials (Basel, Switzerland)
JID - 101555929
PMC - PMC7601697
OTO - NOTNLM
OT  - life cycle
OT  - medical device
OT  - nano-biomaterials
OT  - nanomedicine
OT  - risk management
OT  - safe-by-design
COIS- The authors declare no conflict of interest.
EDAT- 2020/10/18 06:00
MHDA- 2020/10/18 06:01
PMCR- 2020/10/13
CRDT- 2020/10/17 01:02
PHST- 2020/08/21 00:00 [received]
PHST- 2020/09/25 00:00 [revised]
PHST- 2020/09/27 00:00 [accepted]
PHST- 2020/10/17 01:02 [entrez]
PHST- 2020/10/18 06:00 [pubmed]
PHST- 2020/10/18 06:01 [medline]
PHST- 2020/10/13 00:00 [pmc-release]
AID - ma13204532 [pii]
AID - materials-13-04532 [pii]
AID - 10.3390/ma13204532 [doi]
PST - epublish
SO  - Materials (Basel). 2020 Oct 13;13(20):4532. doi: 10.3390/ma13204532.