Wednesday, September 21, 2011

Abstract: Safety of re-using Refresh Plus vials

This is an interesting study that raises lots of questions about re-use of preservative free eyedrop vials.

There are many eyedrops in "single-use vials" which are common used by people with dry eye, from OTC preservative-free lubricants to Restasis. Most are so costly and entail so much waste if used only once that they are often re-used. Many doctors support such re-use and some manufacturers may as well. In the early days of Restasis I seem to recall they even provided a little contraption to store them safely for re-use. We see debates now and then on the bulletin board as to whether refrigeration is appropriate.

This study basically says that for a vial of Refresh Plus (pretty much the most commonly used artificial tear on the market), if the common bacterium pseudomonas aeruginosa gets in it, it will thrive and could do some nasty things to your cornea. Not good.

At the very least this sounds like a cautionary word for users of unpreserved carboxymethylcellulose-based artificial tears, i.e. if you're re-using them, you may want to reconsider. I would be interested to know of it has implications for other polymer-based unpreserved drops. This is certainly enough to make me reconsider whether I suggest to anyone that they carefully re-use vials.

Pseudomonas aeruginosa Growth in Refresh Plus(®).

Abstract Purpose:
To assess Pseudomonas aeruginosa growth in Refresh Plus(®), a unit-dose preservative-free ophthalmic solution indicated for the treatment of dry eye and after laser-assisted in situ keratomileusis (LASIK) surgery, which contains carboxymethylcellulose 0.5% as its active ingredient.

Multiple test tubes of Refresh Plus were inoculated with 3 clinical ocular isolates of P. aeruginosa to achieve a target concentration of ∼100 colony-forming units (CFU)/mL. The tubes were incubated at 25°C and samples were aseptically removed at 6, 12, and 24 h. The samples were cultured to enumerate the population at each time point.

After 6 h incubation, the number of CFU/mL was 3,200 for isolate 1, 2,000 for isolate 2, and 6,480 CFU/mL for isolate 3. For all 3 organisms tested, the number of CFU/mL after 12 and 24 h incubation was >10(6) CFU/mL.

Under the conditions of this experiment, Refresh Plus appears to support P. aeruginosa growth, suggesting that if the solution in a unit-dose vial of Refresh Plus were contaminated with P. aeruginosa during use, the organism would survive and replicate in the solution over time. Noncompliance with the manufacturer's recommendations (i.e., reuse of an open vial) may result in contamination of the solution with P. aeruginosa, which may cause severe keratitis.

J Ocul Pharmacol Ther. 2011 Aug 12. [Epub ahead of print]
Pinna A, Usai D, Zanetti S.
1 Section of Ophthalmology, Department of Surgery, Microsurgery, and Medico-surgical Specialties, University of Sassari , Sassari, Italy .


kgering said...

So this proves that an innoculated vial of Refresh plus (meaning they put bacteria in there) does support growth of the bacteria. I'm not sure that's much of a surprise. However, what I'd like to see is how often that happens in real life. I do reuse Refresh plus, and often put the vial in my pocket. I always dispose of it by the end of the day if not used, but what are the odds of innoculation if the tip and cap are not touched? Certainly if the chances of contamination are high, I'd want to rethink this practice.

PTillman said...

Suffering from Sjogren's, (like Venus Williams), Refresh Plus is my drop of choice. I, too, use it many times throughout the day.

Recently my teen daughter showed me that once the top is twisted off of the vile, it can then be used to re-cap it again. Perhaps others already know this tip, but I didn't and neither did my older sister, (who also has Sjogren's), and she had been using these drops for years longer than I!

Thank you for sharing this study. I will keep it in mind and in the future I think I will dispose of my drops more frequently than I do now, ie: by the end of the day.

Anonymous said...

The nature of pseudomonas is that it grows in water. One of the first things I learned as working as a nurse about infection control was to always dry my hands well after washing them because of pseudomonas, which is very common in the secretions of intubated and trached patients who are on a ventilator. In this study they put psuedomonas in water and it grew. That's what naturally happens with psuedomonas.

Anonymous said...

Until they test single-use vials for bacterial contaminant after opening and over different time periods of multiple use, I'll continue to reuse my vials. Inoculating the vials with bacteria hardly seems like a fair real-world study. Are we sure the manufacturers of Refresh didn't pay for this study?