The regulatory challenges in the biological evaluation of nanotechnology-based medical devices under a risk management perspective: a scoping review
Creators: name: MOREIRA, CAMILA
Publisher: name: Open Science Framework
Year: 2022
Subjects: subject: Nanomedicine
subject: Medicine and Health Sciences
subject: Nanotechnology
subject: FOS: Nanotechnology

description: 1. Background: As nanotechnology is an enabling technology with potential to be applied in a wide variety of fields, it has aroused interest, hopes, but also concerns in the heath field due to both its potential to solve unresolved medical issues, and the risks related to their biological safety and the countless uncertainties related to its behavior at the biological interface and its consequences in long term. In this sense, the emergence of nanotoxicology, as a fundamental science to understand the nanosafety in nanomedicine context, associated with the growing development of nanotechnology-based medical devices have highlighted the importance of mapping the available knowlegde in these fields to better structure and address the regulatory approach applied to this new category of medical devices. Being the literature about those topics disperse and diverse, the adoption of a broad and somewhat systematic review to provide an overview of existing evidence (regardless of its quality), such that provided by Scoping Reviews, was considered as the most appropriated strategy to guide the objectives proposed for this project. 2. Objective: The purpose of this scoping review is to map and assess the available literature regarding biological evaluation of nanotechnology based medical devices under a risk management perspective, in order to support the proposal of a general regulatory guidance for this product category in Brazil, taking into account the challenges imposed by specificities of this enabling technology in the health field and the existing knowledge gaps. 3. Questions: 3.1. Main Question: - How does the biological evaluation of nanotechnology-based medical devices differ from regular evaluation performed for medical devices in general? 3.2. Secondary Questions: - Which are the challenges involved in biological evaluation of nanotechnology-based medical devices? - How they have been addressed? - How the biological evaluation of nanotechnology-based medical devices has advanced to overcome inherent challenges and difficulties in this context? 4. Elegibility Criteria: The inclusion and exclusion criteria proposed for this scoping review are not strict due to the purpose and nature of the project. -Inclusion criteria: unrestricted publications related to nanotechnology-based medical devices with focus on "general health care materials", regulation, biological safety evaluation and/or biological risk management applied to nanotechnology-based medical devices. Furthermore, general publications related to these topics (even if not especifically related to medical devices) will also be considered for their potential to subsidize a knowledge still under construction in this field. - Exclusion criteria: publications related to equipments and in vitro diagnostic products, as thoses medical devices categories are out of the scope of this project, as well as those borderline nanomedicines, whose classification is not well established yet. Additionally, publications in languages other than Portuguese, English or Spanish will be disregarded. It should be noted that prior to this scoping review protocol registry, preliminary researches were conducted to identify possible scoping reviews related to this study topic. These were carried out on December 6th, 2020 by the PubMed and Cochrane Library databases, using the terms ((((("nanotechnology 138669"[All Fields]) ) ) AND ("medical devices"[All Fields])) AND ("regulation"[All Fields])) AND ("scoping review"[All Fields]); and ((((nanotechnology) AND (medical devices)) AND (regulation)) AND (safety management)) AND (scoping review), respectively. No results were found. 5. Search Strategy: Regarding the search strategy, in order to be comprehensive in identifying the available literature on the topic, it will be implemented in at least two database of general scope, such as PubMed, Cochrane Lybrary, Embase, Scopus - to be defined. Considering the extention of possible applicable terms, the appropriate search strategy will just be defined after a reasonable evaluation of its feasibility as a unique block of terms or searching groups (by macrothems related to regulation, biological evaluation and risk management of nanotechnology-based medical devices). 6. Extraction of the Results: The data extraction will be processsed after publication selection process (based on established inclusion and exclusion criteria). 7. Presenting Results: A flowchart will detail the review decision process, indicating the results from the search, removal of duplicate citations, study selection, full retrieval and potential additions. The narrative summary of findings will be structured and presented as a charting table to record the key information of selected sources, such as authorship, year of publication, publication title, journal/impact factor, relevant findings to the review questions. This content can be reviewed and refined during the data evaluation, if necessary. 8. Discussion, Conclusion and Future Implications: The results will be discussed in the context of current literature, being the conclusions presented accordingly to review questions. As for implications, some recommendations may be done for future researches based on the knowledge gaps identified and prospects for advancement in the area.