[365728]
Reporter would like to report that two years ago they were faced with a dlk epidemic covering 3 series of pts. It is clear that in this case, and the clinical aspect images confirm it, the microsponges were the cause of toxic spreading on the stromal surface. It was not possible to prove the presence of endotoxins on the surface of the sponges, but reporter can eliminate the microkeratome knives and the blades as there was also evidence of dlk on cases of lasik relifts. In 2002 while removing the bandages of their lasik pts operated on the day before, it appeared that about 70% were suffering from an inflammatory infiltration of the interface, also known as dlk (diffuse lamellar keratitis) or sos syndrome (sands of sahara syndrome). The etiology of this infection is uncertain and its frequency rare. One or two of the cases the day before were very serious with the centre of the cornea becoming opaque. The eye itself was not in danger, but they declared the incident (it was not compulsory) because of the gravity of the phenomenon. Going through other files, reporter noticed that the week before there had also been two violent reactions that they had not been able to elucidate. Therefore, with the person in charge of the operating theatre, it was decided to carry out an inquiry to determine the causes of this problem by first postponing all surgery. It appeared that the inflammations were just as serious with the lasik enhancements, that is to say, where the microkeratome was not used. They could therefore immediately disregard the blades or the microkeratome (which was not the case on previous occasions). An inflammatory phenomenon was also disregarded as the evolution and the samples taken confirmed that the interface deposits were sterile. Reporter then suspected everything that had been used in rinsing the interface during surgery. This was more than probable as bioptics had been carried out at the same time and in these cases the corneas were perfectly clear and with no reaction of the interface (no cleaning or rinsing of the interface). One could also incriminate the betadine used on the surrounding skin because in certain cases the pt's tears can attract the betadine towards the conjunctiva by capillaritis. It is very diluted but there is nevertheless a potential risk. Three weeks later reporter carried out two lasiks and two enhancements keeping the same brand of syringes, serum and sponges but changing the batches whereas with the filters, they just changed the brand. They kept the betadine on the skin. The 4 pts also presented a reaction of the interface. As reporter was forewarned, reporter immediately prescribed a powerful steroid therapy that allowed them to control the inflammatory reaction and it evolved without any after effects. Another session was carried out two days later, changing the brand of the syringes, the serum, sponges and doing away with the filters. They changed the cutaneous betadine for ocular betadine on the skin (eyelids). The following day the corneas were perfectly clear. The session that took place the following day in the same conditions also had favorable results. Therefore, it appears that there are three main suspects: the syringes, the serum and the sponges. They can probably eliminate the filters because they had previously changed the brands and this did not prevent the inflammatory reaction 3 days prior. They can also question the betadine. It is therefore important to carry out a toxic test on the disposables incriminated in this affair; theoretically alcon's bss is unlikely to be suspect as it is used fairly extensively and no incidents have been reported. It is necessary to check that the batches of syringes and sponges concerned as well as their packaging be tested for residual ethylene oxide used during sterilization, or another toxic, or that their physicochemical composition has not been modified after sterilization by gamma rays. It is also necessary to check that all the security procedures have been respected during manufacturing. Reporter believes that the sponges are the most probable suspects as when reading the different publications concerning this syndrome, it looks like waves of sand as seen in the desert. Indeed, in the observations they have noted a ridge or streak aspect, a kind of sediment that one can compare to streaks left by a paintbrush when using fairly thick paint. During surgery, when drying the stromal bed, one uses the sponge like a paintbrush and the horizontal or slightly oblique streaks correspond exactly to this surgical gesture. However, the rules concerning sterilization of all the re-usables are very strict. In theory, all proteins must be destroyed during this sterilization. This should eliminate the risk of bacterial protein contamination irritating for the stroma.
Patient Sequence No: 1, Text Type: D, B5