Medical devices and the pendulum’s law

Pastor, José Carlos

doi:10.1016/j.oftale.2021.07.001

Cited by 1 publication

(1 citation statement)

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“…The regulation of medical devices across the world is very varied, ranging from comprehensive to none [ 11 ]. However, the increasing numbers of reports in recent years published for adverse events due to some PFCL batches and other medical devices (intraocular lenses and vital dies used for visualization of epiretinal membranes and inner limiting membrane (ILM) peeling) [ 4 , 12 ] in different countries confirm that one or several of the recommendations and standards have failed. Consequently, it becomes essential worldwide to focus on quality standards and recommendations to ensure that only high-quality, pure, and safe PFCL medical devices are released in the market.…”

Section: Introductionmentioning

confidence: 99%

Acute intraocular toxicity caused by perfluorocarbon liquids: safety control systems of medical devices

Srivastava

Kalaiselvan

Andrés-Iglesias

et al. 2022

Graefes Arch Clin Exp Ophthalmol

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Background Acute retinal toxicity has been demonstrated to be associated with the intraoperative use of perfluorocarbon liquids (PFCLs), especially perfluorooctane (PFO). Recently, several cases of PFO-associated blindness have been reported in Spain, Holland, France, Italy, the Middle East, and South America. Methods As a result, a new ISO guideline ( ISO 16672:2020) was drafted, discussed, approved, and released in 2019. This recent ISO16672:2020 guideline recommends performing direct cytotoxicity tests as an option along with chemical analysis to measure PFCL quality (purity and safety). Results In this review paper, it has been emphasized why an appropriate biological test, specifically direct exposure of PFCL to live cells, for measuring cytotoxicity must be performed with each PFCL batch along with chemical analysis. Conclusions The paper intends to compile all available information to discuss possible approaches for avoiding adverse clinical cases in future.

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Section: Introductionmentioning

confidence: 99%