Reducing FDA regulations for medical devices: cutting red tape or putting patients’ lives at risk?

Janetos, Timothy M.; Xu, Renxiao; Walter, Jessica; Xu, Shuai

doi:10.1080/17434440.2018.1539666

Cited by 3 publications

(4 citation statements)

References 16 publications

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“…Compared to the process for most Class I devices, which are exempt from Premarket Notification 510(k), and Class II devices, which require Premarket Notification 510(k), the PMA is more complicated and involves clinical data (34,35,37). Based on nonrandomized, single-arm prospective clinical studies, the FDA conditionally granted Essure approval as a Class III medical device in November 2002 via an expedited review within the PMA process, which requires mandatory post-approval studies of five-year follow-up of participants in phase II and pivotal trials, as well as success rate for bilateral placement (34,38,39). From 2000 to 2015, 18 obstetrics and gynecology devices were introduced to the U.S. market through PMA (40).…”

Section: Discussionmentioning

confidence: 99%

Safety reporting of Essure medical device: a qualitative and quantitative assessment on the FDA manufacturer and user facility device experience database in 2018

Zou

Davis

Wigle

et al. 2023

Front. Reprod. Health

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BackgroundThere have been numerous cases of adverse events since the introduction of Essure medical devices for sterilization in 2002. This study analyzed the safety event reports of the Essure reported in the Manufacturer and User Facility Device Experience (MAUDE).MethodsA retrospective analysis examined the MAUDE reports between Jan-1, 2018, and Oct-31, 2018 and focused on safety reports related to the Essure device. Safety reports were categorized and analyzed by their event type, device problem, patients’ symptoms and the level of harm. Of this study cohort, 10% of samples were randomly selected for quantitative analyses. Thematic analysis was conducted for reports included death cases.ResultsA total of 4,994 eligible reports were analyzed. There were ten reports associated with individuals’ deaths, and the main themes of safety reports from qualitative analysis were pains, bleeding, surgery, migraine, and infection. Quantitative analysis of 500 randomly selected samples showed that 98% of adverse event reports were associated with different injuries such as surgery, pain, bleeding, hysterectomy, and menorrhagia. Additionally, more than 90% of reports were submitted by the manufacturer.ConclusionThese findings indicated several safety issues of Essure. More meaningful pre- and post-marketing surveillance and regulation are warranted in the medical device market to ensure safety and effectiveness, including investigating complaints, promptly sharing relevant information with regulators and users, and implementing corrective actions

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Section: Discussionmentioning

confidence: 99%

Safety reporting of Essure medical device: a qualitative and quantitative assessment on the FDA manufacturer and user facility device experience database in 2018

Zou

Davis

Wigle

et al. 2023

Front. Reprod. Health

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“…The medical device regulatory approval process is a potential threat to public health when it concerns high-risk devices for patients (Van Norman, 2016; Janetos et al , 2018). The pre-approval process is still taking more time (Di Prima et al , 2016; Kitchens, 2016; Giese et al , 2021).…”

Section: Literature Reviewmentioning

confidence: 99%

3D-printed medical models supply chain: barriers modeling and analysis

Verma

Kamble

Ganapathy

2022

RPJ

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Purpose This study aims to identify 3D-printed medical model (3DPMM) supply chain barriers that affect the supply chain of 3DPMM in the Indian context and investigate the interdependencies between the barriers to establish hierarchical relations between them to improve the supply chain. Design/methodology/approach The methodology used interpretive structural modeling (ISM) and a decision-making trial and evaluation laboratory (DEMATEL) to identify the hierarchical and contextual relations among the barriers to the 3DPMM supply chain. Findings A total of 15 3DPMM supply chain barriers were identified in this study. The analysis identified limited materials options, slow production speed, manual post-processing, high-skilled data analyst, design and customization expert and simulation accuracy as the significant driving barriers for the medical models supply chain for hospitals. In addition, the authors identified linkage and dependent barriers. The present study findings would help to improve the 3DPMM supply chain. Research limitations/implications There were no experts from other nations, so this study might have missed a few 3DPMM supply chain barriers that would have been significant from another nation’s perspective. Practical implications ISM would help practitioners minimize 3DPMM supply chain barriers, while DEMATEL allows practitioners to emphasize the causal effects of 3DPMM supply chain barriers. Originality/value This study minimizes the 3DPMM supply chain barriers for medical applications through a hybrid ISM and DEMATEL methodology that has not been investigated in the literature.

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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%

“…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%

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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Reducing FDA regulations for medical devices: cutting red tape or putting patients’ lives at risk?

Cited by 3 publications

References 16 publications

Safety reporting of Essure medical device: a qualitative and quantitative assessment on the FDA manufacturer and user facility device experience database in 2018

Safety reporting of Essure medical device: a qualitative and quantitative assessment on the FDA manufacturer and user facility device experience database in 2018

3D-printed medical models supply chain: barriers modeling and analysis

Impact of Design on Medical Device Safety

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