Premarket evaluation of medical devices: a cross-sectional analysis of clinical studies submitted to a German ethics committee

Sauerland, Stefan; Fujita-Rohwerder, Naomi; Zens, Yvonne; Molnar, Sandra

doi:10.1136/bmjopen-2018-027041

Cited by 4 publications

(2 citation statements)

References 25 publications

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“…As high-quality evidence is increasingly common for pre-market studies, it is obviously worthwhile to secure these standards through the [Medical Devices Regulation] in Europe and similar regulations in other countries. 46 of society's technological 'fixes' in addressing its problems. However, scientific-technical knowledge and expertise would still be necessary in order to discipline 'lay' knowledges and ensure their integration within the epistemic foundations of decision-making.…”

Section: Using Failure To Address the Systemic Causes Of Harmmentioning

confidence: 99%

Taking Failure Seriously

Flear¹

2021

The Cambridge Handbook of Health Research Regulation

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Failure in health research regulation is nothing new. Indeed, the regulation of clinical trials was developed in response to the Thalidomide scandal, which occurred some fifty years ago. 1 Yet, health research regulation is at the centre of recent failures. 2 Metal-on-metal hip replacements, 3 and, more recently, mesh implants for urinary incontinence and pelvic organ prolapse in womenoften referred to as 'vaginal mesh'have been the subject of intense controversy. 4 Some have even called the latter controversy 'the new Thalidomide'. 5 In these cases, previously licensed medical devices were used to demonstrate the safety of supposedly analogous new medical devices, and obviate the need for health research involving humans. 6 In this chapter, I use health research regulation for medical devices to look at the regulatory framing of harm through the language of technological risk, i.e. relating to safety. My overall argument is that reliance on this narrow discourse of technological risk in the regulatory framing of harm may marginalise stakeholder knowledges of harm to produce a limited knowledge base. The latter may underlie harm, and in turn lead to the construction of failure.I understand failure itself in terms of this framing of harm. 7 Failure is taken to be ontologically and normatively distinct from harm, and as implicating the design and functioning of the system * Many thanks to all those with whom I have discussed the ideas set out in this chapter, especially the editors and

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Section: Using Failure To Address the Systemic Causes Of Harmmentioning

confidence: 99%

Taking Failure Seriously

Flear¹

2021

The Cambridge Handbook of Health Research Regulation

View full text Add to dashboard Cite

show abstract

“…Diese Feststellung steht in keiner Weise im Konflikt mit dem berechtigten Ruf nach hochqualitativen klinischen Studien, auch RCTs, mit Medizinprodukten. Sauerland et al berichten in einer aktuellen Publikation aus 2019 [8] über eine steigende Anzahl von entsprechenden Studien, was sehr zu begrüßen ist. Dennoch kann aus dieser Beobachtung nicht geschlussfolgert werden, dass der RCT-oder ein anderer Studienstandard grundsätzlich für alle Medizinproduktarten möglich oder erstrebenswert wäre.…”

Section: Fazitunclassified