Article type
Abstract
Background
Regulation and postmarket surveillance of medical devices have been criticized for being too lenient as compared to drug regulation. Also, the reason for choosing between two similar medical devices for implementation remains to be fully elucidated.
Objective
Our aim was to systematically identify, characterize and map empirical studies on medical device regulation, postmarket surveillance and implementation. Furthermore, we aimed to describe the recurring patterns and trends in the studies. We were interested in studies that examined medical devices approved by the U.S. Food and Drug administration (FDA) and European Union (EU), and studies that revealed important factors for the decision-making process regarding medical device implementation.
Methods
The mapping review was conducted using methodology described in the JBI guidelines for scoping reviews and reporting was done in accordance with PRISMA-ScR guidelines. The study was preregistered, and the protocol was uploaded and is publicly available (https://osf.io/mx36f). The search was conducted in MEDLINE and Embase through Ovid on 31st of July 2023. We included primary studies with empirical data and excluded any secondary studies such as editorials, opinion papers or systematic reviews using bibliographic databases as the primary data source. Graphs were produced in R version 4.3.2, package ggplot2.
Results
We screened 3708 title/abstracts, after which 341 records were assessed in full-text for inclusion, yielding 118 studies considered eligible and included in the review. Out of these, 61 studies (50.4%) examined approval, 31 studies (25.6%) examined postmarket surveillance, 15 studies (12.4%) implementation and 11 studies (9.1%) both approval and postmarket surveillance. The studies were published between 2003-2023 and consisted of 64 cross-sectional studies (54.2%), 30 cohort studies (25.4%), 20 qualitative studies (17.0%) and four mixed-methods studies (3.4%). As data source, 82 studies (69.5%) used FDA, 21 studies (17.8%) semi-structured interviews and 15 studies (12.7%) used other data sources. Few studies investigated regulatory approval within EU, because of limited access to data, and 13 studies (11.0%) adhered to a reporting guideline. We identified 10 recurring themes from the studies.
Conclusions
Studies on medical devices are predominantly conducted using FDA device databases, limited access to publicly available data has hindered research within the EU.
Regulation and postmarket surveillance of medical devices have been criticized for being too lenient as compared to drug regulation. Also, the reason for choosing between two similar medical devices for implementation remains to be fully elucidated.
Objective
Our aim was to systematically identify, characterize and map empirical studies on medical device regulation, postmarket surveillance and implementation. Furthermore, we aimed to describe the recurring patterns and trends in the studies. We were interested in studies that examined medical devices approved by the U.S. Food and Drug administration (FDA) and European Union (EU), and studies that revealed important factors for the decision-making process regarding medical device implementation.
Methods
The mapping review was conducted using methodology described in the JBI guidelines for scoping reviews and reporting was done in accordance with PRISMA-ScR guidelines. The study was preregistered, and the protocol was uploaded and is publicly available (https://osf.io/mx36f). The search was conducted in MEDLINE and Embase through Ovid on 31st of July 2023. We included primary studies with empirical data and excluded any secondary studies such as editorials, opinion papers or systematic reviews using bibliographic databases as the primary data source. Graphs were produced in R version 4.3.2, package ggplot2.
Results
We screened 3708 title/abstracts, after which 341 records were assessed in full-text for inclusion, yielding 118 studies considered eligible and included in the review. Out of these, 61 studies (50.4%) examined approval, 31 studies (25.6%) examined postmarket surveillance, 15 studies (12.4%) implementation and 11 studies (9.1%) both approval and postmarket surveillance. The studies were published between 2003-2023 and consisted of 64 cross-sectional studies (54.2%), 30 cohort studies (25.4%), 20 qualitative studies (17.0%) and four mixed-methods studies (3.4%). As data source, 82 studies (69.5%) used FDA, 21 studies (17.8%) semi-structured interviews and 15 studies (12.7%) used other data sources. Few studies investigated regulatory approval within EU, because of limited access to data, and 13 studies (11.0%) adhered to a reporting guideline. We identified 10 recurring themes from the studies.
Conclusions
Studies on medical devices are predominantly conducted using FDA device databases, limited access to publicly available data has hindered research within the EU.