Expert panel approves fluorescein strips use
A panel of experts convened by the Optical Confederation has given the go-ahead for use of paper impregnated fluorescein strips in clinical investigations in primary care until further notice, stating that the CE marked medical devices possessed minimal risk.
The clinical consensus panel decision will bring relief to practitioners for whom the use of controlled amounts of fluorescein is essential for assessing the health of the anterior eye surface, for tonometry and for some contact lens fitting.
In March 2013, Bausch+Lomb decided to withdraw Fluorets from the market globally for business reasons, rather than product safety concerns. In May the Confederation issued advice to use 1 per cent fluorescein minims while these problems were resolved, but according to the Confederation, B+L recently announced that supply of 1 per cent fluorescein minims had also run out and would not be resumed until later this autumn.
Though CE marked fluorescein impregnated strips were available, the UK MHRA had classified Fluorets as a medicinal product and its withdrawal meant that in the UK there was no longer a licensed fluorescein strip available.
In anticipation of a further ruling in October, the MHRA, recognising the potential consequences of the withdrawal of Fluorets, decided not to take enforcement action against suppliers of CE marked medical device fluorescein strips to the UK market until the EU position was clarified, therefore permitting their sale in the UK.
The consensus panel stated that ‘failure to use fluorescein when clinically indicated in a primary care setting due to non-availability of a suitable pharmaceutical preparation will put patients at risk through a failure or delay to recognise sight threatening ocular conditions’.
It was also noted that paper strip instillation made the best clinical practice of minimal instillation more achievable. Furthermore, any risk of infection with paper strips was far outweighed by the risk of failure to use fluorescein. Also, infection risk was identified with unit-dose fluorescein use. The statement ‘that optometrists and contact lens opticians in the UK may within their scope of practice use a CE marked medical device fluorescein strip permitted to be supplied in the UK by MHRA as an alternative to a fluorescein sodium unit dose eye drop formulation for clinical investigations in primary care until further notice’ would be reviewed should new information come to light on the classification, clinical use or safety of fluorescein.
Panel member Nick Rumney said of the outcome: ‘It’s a clinical consensus panel so we are all in agreement. I feel relieved we can present a view that people can use and very positive that it is unanimous. Mark Nevin has done a great job as well.’
Fellow member, Professor John Lawrenson, added: ‘This issue has illustrated just how vulnerable we are in our niche area of practice, with ophthalmic drug manufacturers having a monopoly on the supply of particular diagnostic or therapeutic agents. It has also exposed some strange anomalies in medicines/medical device legislation.’
By Bill Harvey