Medical device regulation: the need for clinical vigilance and oversight

Charlesworth, M.; Zundert, André van

doi:10.1111/anae.14603

Cited by 5 publications

(12 citation statements)

References 17 publications

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“…In their 2019 commentary on medical device regulation, Charlesworth and van Zundert argued that while medical device manufacturers may posit that it is too costly, time-consuming, and impractical to generate evidence on devices from large studies, primary research is undeniably critical to ensuring that large-scale implementation will be beneficial. 22 Relatedly, a major finding from this review is that further research on portable ultrasound devices-in particular their accuracy and acceptability when used in antenatal care contexts-are needed to guide decision-making around selection and procurement of ultrasound models. Since 2016, WHO has recommended that all women should have an ultrasound prior to 24 weeks' gestation; however, the coverage of ultrasound use remains limited in many countries.…”

Section: Discussionmentioning

confidence: 99%

Portable ultrasound technologies for estimating gestational age in pregnant women: a scoping review and analysis of commercially available models

et al. 2022

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ObjectivesTo identify all available studies assessing the use of portable ultrasound devices for pregnant women, with the specific aim of finding evidence for devices used to determine gestational age and their validity when compared with conventional ultrasound machines. We also wanted to determine what portable ultrasound models are commercially available for obstetric use.DesignSystematic scoping review.Primary and secondary outcome measuresExtracted variables included study design, population, method of ultrasound measurement, devices used and whether studies formally validated accuracy against conventional ultrasound.ResultsWe searched four databases—Medline, Embase, CINAHL and Maternal and Infant Care. In total 56 studies from 34 countries were identified; most were observational studies. Across all studies, 27 different portable ultrasound models (from 17 manufacturers) were evaluated. Twenty-one studies assessed use of portable ultrasound for evaluating fetal characteristics or estimating gestational age, and 10 of these were formal validation studies. In total, six portable devices have been validated for gestational age estimation against a conventional ultrasound comparator. The web searches identified 102 portable devices (21 manufacturers). These were a mix of handheld devices that connected to a phone or computer, or laptop-style portable ultrasound devices. Prices ranged from US$1190 to US$30 000 and weight ranged from 0.9 kg to 13.0 kg.ConclusionWhile the number of commercially available portable ultrasound devices continues to grow, there remains a lack of peer-reviewed, quality evidence demonstrating their accuracy and validity when compared with conventional ultrasound machines. This review identified some models that may be useful in gestational age estimation in low-resource settings, but more research is required to help implement the technology at scale.Trial registration numberRegistered via Open Science Framework (DOI: 10.17605/OSF.IO/U8KXP).

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Section: Discussionmentioning

confidence: 99%

Portable ultrasound technologies for estimating gestational age in pregnant women: a scoping review and analysis of commercially available models

et al. 2022

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“…MD manufacturers must ensure traceability of all customer complaints they receive and establish documentation of procedures to analyze and evaluate these complaints which make it possible to notify vigilance procedures if need be [33]. Health professionals, for their part, should be aware of the importance of reporting an AR, particularly with the emergence of new situations, and this by institutionally encouraging formal education on patient safety and MD regulation [34]. Also, interested parties , who are entrusted with MD use, be they patients or consumers in this system, should assigned a role and involved in the conservation of the quality of their health.…”

Section: Regulations and Proceduresmentioning

confidence: 99%

Development and implementation of a system for medical devices monitoring in Morocco

et al. 2021

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Given the importance of medical devices in improving health, a system of monitoring their use is necessary to ensure an acceptable benefit/risk ratio. The present study focuses on the post-marketing monitoring system, of which the aimis to develop, a national strategy for the establishment of a multidimensional vigilance system to monitor medical devices in Morocco. Methods : The study is based on a systemic review selected by the PRISMA method for the period between [2011-2021] and on the Scopus, Pubmed, Science direct and Web of science databases. Results: A preliminary analysis of the data identified some challenges such as under-reporting and lack of standardization of adverse reaction coding, standard nomenclature problem for international trade, lack of clarity of requirements for manufacturers, and insufficient regulation and significant incentives for the use of unique device identifiers. Recommendations for a more effective national system are put for ward which address the regulation and computerization of the system for the development of medical devices monitoring mechanisms.

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“…Harmonization of National and International Regulations could serve as a safety net that would ensure patients and users throughout the world have access to the same level of design and safety controls. This might be able to prevent situations such as the PIP breast implants scandal or the DePuy MoM hip replacement recalls [9,34,38].…”

Section: Overview Of Design-related Regulationsmentioning

confidence: 99%

“…During this stage, MD design control is performed as part of the QMS requirements [ 35 , 37 , 53 , 55 ]. In practice, an MD’s design aims to define the necessary specifications and exclude all potential hazards related to the intended use through the risk assessment process and conformity with national and international safety requirements [ 31 , 33 , 35 , 36 , 38 ]. Safe and effective MD design therefore begins as early as the product definition phase, even before product requirements and architecture have been specified [ 83 ].…”

Section: Overview Of Design-related Regulationsmentioning

confidence: 99%

“…The modern physician must have a proficient technical dexterity, spatial awareness, and the ability to rapidly integrate information deriving from multiple user-interfaces into his decisions [28,29]. To cut this Gordian knot, Authorities are struggling to set up a harmonized regulatory framework that will, as much as possible, allow a timely, integrated identification and communication of potential hazards, risks and adverse events, eventually resulting in MD-related risk mitigation [30][31][32][33][34][35][36][37][38][39][40][41].…”

Section: Introductionmentioning

confidence: 99%

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Impact of Design on Medical Device Safety

Miclăuş

Valla

Koukoura

et al. 2019

Ther Innov Regul Sci

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The growing number of emerging medical technologies and sophistication of modern medical devices (MDs) that improve both survival and quality of life indexes are often challenged by alarming cases of vigilance data cover-up and lack of sufficient pre-and post-authorization controls. Combining Quality with Risk Management processes and implementing them as early as possible in the design of MDs has proven to be an effective strategy to minimize residual risk. This article aims to discuss how the design of MDs interacts with their safety profile and how this dipole of intended performance and safety may be supported by Human Factors Engineering (HFE) throughout the Total Product Life-Cycle (TPLC) of an MD in order to capitalize on medical technologies without exposing users and patients to unnecessary risks.

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Medical device regulation: the need for clinical vigilance and oversight

Cited by 5 publications

References 17 publications

Portable ultrasound technologies for estimating gestational age in pregnant women: a scoping review and analysis of commercially available models

Portable ultrasound technologies for estimating gestational age in pregnant women: a scoping review and analysis of commercially available models

Development and implementation of a system for medical devices monitoring in Morocco

Impact of Design on Medical Device Safety

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