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
Eye Clinic Sulzbach, Knappschaftshopsital Sulzbach/Saar, Sulzbach-Saar,
Centre for Ophthalmology, University Eye Hospital Tübingen, Tübingen,
Ophthalmologica. 2018;240(4):236-243. doi: 10.1159/000488504. Epub 2018 Jul 12.
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.
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.
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.
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.
与视网膜直接接触的医疗器械的视网膜毒性/生物相容性是临床医生和科学家关注的重要课题。由于这些影响并不常见，许多临床医生也相对缺乏相关信息。过去多次告诫我们，受影响患者出现严重视力丧失存在重大安全问题。在本综述中，我们希望对用于眼后部的医疗产品进行分类，描述近期的毒性实例，批判性地反思现有法规，并提出在不阻碍创新的情况下可采取的改进措施以确保患者安全。
对近期相关论文进行批判性综述，并结合作者在该问题上的个人经验。描述用于眼后部的医疗器械及近期的毒性实例，批判性地反思现有法规，并提出可确保患者安全且不阻碍创新的改进措施。
有明确证据表明任何类别眼内手术后均存在毒性。一些细胞毒性间接检测方法未能检测到这种毒性。一些ISO规则似乎并不合适。上市后安全性缺失。关于此问题的数据很少。
医疗器械的生产、纯化及毒性作用评估缺乏明确规定，这意味着产品可能因安全性不足而无法获得CE标志。
