Recent reports in the Algemeen Dagblad newspaper about a sudden increase in complications from eye injections require clarification and expertise. According to the article, the probable cause is the release of silicone particles from the syringes used. This news painfully underlines the crucial importance of choosing the right medical devices for the right application, a principle that is at the heart of patient safety.
What is going on? A summary of the situation
According to the article in the Algemeen Dagblad newspaper, there is a worrying development in ophthalmic care. The facts at a glance:
- Sudden increase in complications: At the end of the summer, eye clinics throughout the Netherlands reported a sudden wave of complications, such as irritation and inflammation.
- Link to medication injections: The problems occurred after medication was injected into patients' eyes.
- Probable cause: The main suspect is the syringe itself. Particles from the silicone coating may have come loose and entered the patient's eye.
- Response from the sector: A task force consisting of ophthalmologists, hospitals and pharmacists has been set up to investigate the situation and prevent further problems.
Why intraocular use requires special attention
An intraocular injection – an injection into the eye – is a highly specialised medical procedure that carries unique risks. The eye is an extremely sensitive and closed system, where the presence of foreign particles can immediately cause problems. This risk is precisely why STAXS explicitly warns against the consequences of off-label use in intraocular injections in the instructions for use of its products. We highlight the potential danger of silicone, which can lead to the development of ‘floaters’ in the patient's field of vision.
To indicate this potential danger, we specifically warn in our Instruction for Use (IFU):
‘The potential hazard is deposition of silicone oil (SO) droplets in the vitreous’.
Our responsibility: transparency and clarity about product use
As specialists in contamination control, our core task is to mitigate risks, such as those associated with off-label use, through proactive and clear communication. Patient safety is always our top priority. That is why it is our responsibility to be unambiguous about the intended use and limitations of our products.
We are completely clear about this in the product information for the DOTCH® Puru® Syringe. The datasheet states under “Indication for use”: 'Not validated for specific purposes, such as intraocular use'.
The Instruction for Use (IFU) is even more explicit and leaves no room for misinterpretation under “Warnings and Precautions”: ‘The DOTCH® Puru® Syringes are intended for general purpose below the surface of the skin and are not validated for specific purposes such as intraocular use. When syringes and needles are used for intraocular injections, the potential exists for “floaters” in patients' eyes due to silicone. The potential hazard is deposition of silicone oil (SO) droplets in the vitreous.’
The statement ‘not validated for specific use’ means that the product has been designed, tested and validated for general use (injecting fluids under the skin), but explicitly not for high-risk, specialist applications such as injections into the eye.
Our commitment to quality and safety
Our commitment to patient safety, the core of our role as Contamination Control Experts, is comprehensive. It goes beyond warning about the risks of material particles such as silicone. An equally crucial risk, invisible to the patient, is that of microbial contamination. Ensuring the sterility of a product until the moment of use is a fundamental pillar of product quality.
A reliable partner in contamination control
These recent incidents involving eye injections demonstrate how essential it is that medical devices are used exclusively for the purposes for which they were developed, tested and validated. Deviating from the intended use, especially in vulnerable patient groups and high-risk procedures, can have serious consequences.
At STAXS®, we consider it our duty not only to supply products of the highest quality, but also to provide our customers with clear and transparent information. Only in this way can healthcare professionals make informed choices and maximise patient safety. We are and will remain your reliable advisor and partner in contamination control.