Retinal Toxicity of Medical Devices Used during Vitreoretinal Surgery: A Critical Overview

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 -