Retinal Toxicity of Medical Devices Used during Vitreoretinal Surgery: A Critical Overview
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Retinal Toxicity of Medical Devices Used during Vitreoretinal Surgery: A Critical Overview. / Januschowski, Kai; Irigoyen, Cristina; Pastor, J Carlos; Srivastava, Girish K; Romano, Mario R; Heimann, Heinrich; Stalmans, Peter; Van Keer, Karel; Boden, Karl; Szurman, Peter; Spitzer, Martin S.
in: OPHTHALMOLOGICA, Jahrgang 240, Nr. 4, 2018, S. 236-243.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Review › Forschung
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TY - JOUR
T1 - Retinal Toxicity of Medical Devices Used during Vitreoretinal Surgery: A Critical Overview
AU - Januschowski, Kai
AU - Irigoyen, Cristina
AU - Pastor, J Carlos
AU - Srivastava, Girish K
AU - Romano, Mario R
AU - Heimann, Heinrich
AU - Stalmans, Peter
AU - Van Keer, Karel
AU - Boden, Karl
AU - Szurman, Peter
AU - Spitzer, Martin S
N1 - © 2018 S. Karger AG, Basel.
PY - 2018
Y1 - 2018
N2 - Retinal toxicity/biocompatibility of medical devices in direct contact with the retina is an important subject for clinicians and scientists. As these effects are not very frequent, there is also a relative lack of information for many clinicians. The past has taught us multiple times that there is a significant safety problem associated with severe loss of vision in affected patients. In this review, we want to classify medical products that are used in the back of the eye, describe recent examples of toxicity, critically reflect on the regulations that exist and suggest improvements that can be done to ensure patient safety without hindering innovation.METHODS: Critical review of the recent papers and personal experience of the authors in this issue. Medical devices used in the back of the eye and recent examples of toxicity are described, regulations that exist are critically reflected and improvements suggested that can ensure patient safety without hindering innovation.RESULTS: There is clear evidence of toxicity after intraocular surgery in any category. Some cytotoxic indirect methods have failed in detecting this toxicity. Some ISO rules do not seem appropriate. Postmarketing safety is missing. There is little data on this issue.CONCLUSIONS: The absence of a clear regulation of the production, purification and evaluation of the toxic effects of the medical devices supposes the possibility that products are not sufficiently safe to obtain the CE mark.
AB - Retinal toxicity/biocompatibility of medical devices in direct contact with the retina is an important subject for clinicians and scientists. As these effects are not very frequent, there is also a relative lack of information for many clinicians. The past has taught us multiple times that there is a significant safety problem associated with severe loss of vision in affected patients. In this review, we want to classify medical products that are used in the back of the eye, describe recent examples of toxicity, critically reflect on the regulations that exist and suggest improvements that can be done to ensure patient safety without hindering innovation.METHODS: Critical review of the recent papers and personal experience of the authors in this issue. Medical devices used in the back of the eye and recent examples of toxicity are described, regulations that exist are critically reflected and improvements suggested that can ensure patient safety without hindering innovation.RESULTS: There is clear evidence of toxicity after intraocular surgery in any category. Some cytotoxic indirect methods have failed in detecting this toxicity. Some ISO rules do not seem appropriate. Postmarketing safety is missing. There is little data on this issue.CONCLUSIONS: The absence of a clear regulation of the production, purification and evaluation of the toxic effects of the medical devices supposes the possibility that products are not sufficiently safe to obtain the CE mark.
KW - Blindness/etiology
KW - Humans
KW - Intraoperative Complications
KW - Postoperative Complications
KW - Retina/pathology
KW - Risk Factors
KW - Surgical Instruments/adverse effects
KW - Vitreoretinal Surgery/adverse effects
U2 - 10.1159/000488504
DO - 10.1159/000488504
M3 - SCORING: Review article
C2 - 30001544
VL - 240
SP - 236
EP - 243
JO - OPHTHALMOLOGICA
JF - OPHTHALMOLOGICA
SN - 0030-3755
IS - 4
ER -