Fluorescein

Fluorescein is a vital staining tool, used by many optometrists and contact lens opticians to identify corneal and conjunctival changes and assess the tear film. The use of fluorescein leads to improved outcomes in patients compared to the risks of not using fluorescein.

Withdrawal of Fluorets

In 2013, Bausch & Lomb withdrew Fluorets from the market – the only impregnated strips licensed as a medicine for use in the UK. The move left practitioners with two choices: to use 1% or 2% minims, which is not as satisfactory clinically, less convenient for patients, and significantly more expensive with shorter shelf life; or to use fluorescein-impregnated strips, which are not licensed in the UK as a medicine but are CE-marked as medical devices.

The use of fluorescein-impregnated strips as opposed to minims gives eye care practitioners much greater control of the quantity of fluorescein instilled in the eye and this leads to improved outcomes for patients. The risks of not using fluorescein outweigh the minimal risks of the use of CE-marked fluorescein-impregnated strips. We believe stains in impregnated paper-strip form should continue to be available to optometrists. This should include fluorescein-impregnated strips, as well as other staining agents, such as Lissamine Green and Rose Bengal.

Classification of fluorescein

Fluorescein’s legal classification varies across Europe. Fluorescein strips have long been considered as borderline products and regulated as medicines in the UK, whereas they are regulated as medical devices in much of the rest of the EU. European non-binding guidance (MEDDEV) issued in 2001 recommended their classification as medicines; however, this depends on their precise use. Notwithstanding this recommendation, several European national authorities continue to consider the strips to be medical devices. The European Commission is aware of the difference of opinion regarding the classification of fluorescein strips and the issue is being considered in further detail by the relevant European authorities. 

Under review

In response to lobbying from the profession, the Medicines & Healthcare products Regulatory Agency (MHRA) has permitted the supply of CE-marked medical device fluorescein strips to the UK market until its status has been agreed by the EU². If the EU working group don’t classify them as medical devices, we will lobby to have the current exemption extended and encourage a manufacturer to licence their product. Our medical malpractice insurance will cover members who follow this advice.

We continue to monitor developments, through the Optical Confederation (OC) and the European Council of Optometry and Optics (ECOO), and to seek a long-term solution to the regulatory dilemma surrounding fluorescein’s legal classification.

Find out more about Medical devices.

References

1. ECOO (2012) ECOO urges EU Member States and the European Commission that Fluorescein is safe for use in community eye care and should be classified as a medical device
2. Clinical Consensus Panel (2013) Use of fluorescein in primary care

Position statement published: December 2015

Read the rest of the AOP position statements.