Assessment of the Bexen Medical Col system to prepare autologous serum eyes drops

Object
Autologous eye drops (ASC) are mainly prescribed fo dry eyes syndromes. The usual dosage is 3 to 10 drops per day ASC are manufactured by the pharmacotechny sector from patient serum diluted to 20% with 0.9% NaCl and transferred into 21 PEBD eye-drops bottles. Due to the increased demand for production, the aim is to maintain patient safety while at the same time increasing the preparation comfort of the preparers. Following benchmarking, the Bexen Medical Col system (BMC) was selected for further testing with 5 criteria to be evaluated: economic criteria, preparation time, ease of use for the preparers, maintenance of microbiological safety and ergonomics of use for the patients.

Materials and method
A medico-economic study was carried out between the current process (CP) and BMC based on the price of the different consumables. 6 Media Fill Tests (MFT) were performed with Oxioid® thyoglyconate culture medium at +32°C for 14 days. A visual check was carried out at D1, D3, D7 and D14. Another MFT was performed and 6 ampoules were opened and put back in the fridge 6 times : 3 ampoules were handled according to the recommendations given to the patient and 3 others were handled without paying attention to the hygiene rules. A visual check was carried out at D3. Finally, a satisfaction questionnaire between CP and BMC was given to the preparers and to the patients

Results and discussion
The medico-economic study showed a gain of 8,500 to 12,000€ per year depending on the number of preparations made with the BMC system for an active file of 60 patients. 6 preparers tested the BMC system, which allows 20 ampoules of 1.45mL to be filled simultaneously. The manufacturing time was initially on average 24min for the CP and was 23min with the BMC. After 2 months of routine use of the BMC system, the average manufacturing time is now 17min. The preparers’ questionnaire showed that 100% of them preferred the BMC, which allows production in a closed system and reduces pain at the end of the manufacturing process. The 6 MFTs have enabled the BMC system to be microbiologically qualified and to prove its microbiological stability for 24 hours after opening. The active file of patients using the BMC system is progressively increasing since the return of the patient satisfaction questionnaires with, after 2 months of trials, only one patient wishing to keep the CP because of the difficulty of closing the BMC system.

Conclusion
The new BMC system allows production in a closed system, improved manufacturing comfort for the operators and savings for the hospital. The objective is now to put as many patients as possible on the BMC system in the next few months in order to increase our active file.

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