[1195739]
Per the request of a physician, the named product was purchased. Upon receipt to the facility, the manufacturer's instructions and directions for use was reviewed. Initially, the instructions stated to clean the product with 96% ethanol. After contacting the manufacturer for confirmation, i was told i had received the version of the instructions. The rep then faxed me the usa version, which stated to clean the product using distilled water and an ultrasonic machine. Having clarified this, the sterilization instructions for the product remained the same: to use a 121 degree celsius (250 degree fahrenheit) cycle with a 20 minute exposure time. The sterilization instructions, however, did not specify whether to use a prevaccuum or gravity cycle. So i was referred to the quality assurance department at amo and after they contacted the plant, i was told that the product was validated using the prevaccuum cycle. So the manufacturer wants our facility to sterilize their product using a 250 degree f prevaccuum cycle, which according to aami, is not a validated cycle in the us. I furthermore spoke with the product manager from amo, and i was told that they have been contacted by another facility with the same question and that they are working on getting this matter clarified. But for the time being, this is the validated cycle to use. According to the manufacturer (amo), this product has been on the market since 2004, but the only premarket notification number i could find in the database was for the geuder injector for morcher capsular tension ring, not the amo brand. The geuder injector's manufacturer's instructions also omit the type of cycle to be used. Dose or amount: na. Frequency: na. Route: na. Dates of use: product not used. Diagnosis or reason for use: insertion of capsular tension rings during cataract surgery.
Patient Sequence No: 1, Text Type: D, B5