Abstract：
OBJECTIVE: The off-label use in clinical practice of non-approved syringes for intravitreal drug administration has resulted in the detection of silicone oil drops in the vitreous of some patients. This situation derives from the lack of approved syringes for intraocular use in the Spanish market. The aim of this work is to review the use of syringes for intraocular administration, as well as to search for alternatives that meet the legal requirements for these unmet needs.
METHODS: A systematic review was performed following the PRISMA 2020 guidelines by searching PubMed with the descriptors: (silicone) AND (syringes) AND ((intraocular) OR (intravitreal)) and filtering all existing publications from January 2006 to December 2023, including all those articles dealing with silicone oil release in intravitreal injections and analysing the possible consequences.
RESULTS: Sixty-eight results were found, 23 of which were excluded because they did not deal with the subject under study, leaving a total of 45 articles for the systematic review. These were classified according to the conclusions obtained in 4 groups: the adverse reactions produced by silicone; the administration technique; the physicochemical aspects of silicone release; and the characteristics of the medical device. After reviewing the current manufacturers and technical data sheets of commercialised syringes, the existing syringes for this use have been collected, finding 2 that will probably be commercialised in Spain at the beginning of 2024: Zero Residual™ 0.2 ml SiO-free and VitreJect® Ophthalmic.
CONCLUSIONS: From the results obtained, it can be interpreted that the use of syringes and needles with silicone for intravitreal use is a concern for health professionals due to the implications and consequences that may arise in patients, the most important being adverse reactions, so it is necessary to have silicone-free syringes on the market that are specific for intraocular use. Safety and legality in the use of intraocular syringes and needles is essential to guarantee ocular integrity and patient health.
METHODS: A systematic review was performed following the PRISMA 2020 guidelines by searching PubMed with the descriptors: (silicone) AND (syringes) AND ((intraocular) OR (intravitreal)) and filtering all existing publications from January 2006 to December 2023, including all those articles dealing with silicone oil release in intravitreal injections and analysing the possible consequences.
RESULTS: Sixty-eight results were found, 23 of which were excluded because they did not deal with the subject under study, leaving a total of 45 articles for the systematic review. These were classified according to the conclusions obtained in 4 groups: the adverse reactions produced by silicone; the administration technique; the physicochemical aspects of silicone release; and the characteristics of the medical device. After reviewing the current manufacturers and technical data sheets of commercialised syringes, the existing syringes for this use have been collected, finding 2 that will probably be commercialised in Spain at the beginning of 2024: Zero Residual™ 0.2 ml SiO-free and VitreJect® Ophthalmic.
CONCLUSIONS: From the results obtained, it can be interpreted that the use of syringes and needles with silicone for intravitreal use is a concern for health professionals due to the implications and consequences that may arise in patients, the most important being adverse reactions, so it is necessary to have silicone-free syringes on the market that are specific for intraocular use. Safety and legality in the use of intraocular syringes and needles is essential to guarantee ocular integrity and patient health.
摘要：
目的：在临床实践中使用非批准的用于玻璃体腔给药的注射器，导致某些患者的玻璃体中检测到硅油滴。这种情况源于西班牙市场上缺乏批准的眼内使用的注射器。这项工作的目的是回顾使用注射器的眼内给药，以及寻找符合这些未满足需求的法律要求的替代品。
方法：根据PRISMA2020指南，通过搜索PubMed的描述符：（硅胶）和（注射器）和（（眼内）或（玻璃体内））并过滤所有现有出版物从2006年1月至2023年12月，包括所有有关玻璃体内注射中硅油释放的文章，并分析可能的后果。
结果：共发现68个结果，其中23人被排除在外，因为他们没有处理正在研究的主题，共留下45篇文章供系统回顾。根据4组获得的结论将这些分类：有机硅产生的不良反应；给药技术；有机硅释放的物理化学方面；以及医疗器械的特性。在审查了目前商业化注射器的制造商和技术数据表后，已经收集了用于这种用途的现有注射器，发现2可能会在2024年初在西班牙商业化：零残留™0.2ml不含SiO和VitreJect®眼科。
结论：从获得的结果来看，可以解释，由于患者可能产生的影响和后果，使用带有硅胶的注射器和针头进行玻璃体内使用是卫生专业人员关注的问题，最重要的是不良反应，因此，有必要在市场上有专门用于眼内使用的无硅胶注射器。使用眼内注射器和针头的安全性和合法性对于保证眼部完整性和患者健康至关重要。
方法：根据PRISMA2020指南，通过搜索PubMed的描述符：（硅胶）和（注射器）和（（眼内）或（玻璃体内））并过滤所有现有出版物从2006年1月至2023年12月，包括所有有关玻璃体内注射中硅油释放的文章，并分析可能的后果。
结果：共发现68个结果，其中23人被排除在外，因为他们没有处理正在研究的主题，共留下45篇文章供系统回顾。根据4组获得的结论将这些分类：有机硅产生的不良反应；给药技术；有机硅释放的物理化学方面；以及医疗器械的特性。在审查了目前商业化注射器的制造商和技术数据表后，已经收集了用于这种用途的现有注射器，发现2可能会在2024年初在西班牙商业化：零残留™0.2ml不含SiO和VitreJect®眼科。
结论：从获得的结果来看，可以解释，由于患者可能产生的影响和后果，使用带有硅胶的注射器和针头进行玻璃体内使用是卫生专业人员关注的问题，最重要的是不良反应，因此，有必要在市场上有专门用于眼内使用的无硅胶注射器。使用眼内注射器和针头的安全性和合法性对于保证眼部完整性和患者健康至关重要。
