[20925461]
Problem detected in relation to bacteria growing in eco gel ultrasound gel. The problem first arose when pt was admitted to medicine program with a diagnosis of sepsis. Results of a blood culture grew burkholderia cepacin. Since this was a very unusual organism, infection control began investigations the following day. They determined that this pt had underwent a trans-rectal prostatic biopsy two days prior to admission. The infection control group focused in on this procedure. The practice for ultrasound used a non-sterile ecogel 200. A 5 litre. Collapsible stock bottle was used to refill 250 ml squeeze bottles. These 250 ml bottles were refilled many times. A recommendation to switch to sterile gel for the interim was made. A physician spoke with the mfr and the mfr reassured him re: passing qa checks and informed the physician re: stabilizing agent methyl parabens. Apparently, on further checking, he has found that these particular bugs hydrolyse the stabilizing agent. Cultures of all stock (including unopened bottles) were made on 3/5. The results back on the 6th showed that a large proportion were positive for b. Cepacia and e. Cloacae. All use of the product was removed as it would seem to be a source in the mfg process. A replacement for the gel is unavailable until next tuesday. The supply of gel has no lot number or expiration date. There is a lot number of the original carton but of course they can't be sure of the lot numbers of the individual bottles. There have been four confirmed cases, all post trans-rectal prostatic biopsy. All have recovered, three had been admitted (one still is). This gel was for external use only but was used in this procedure and in vaginal ultrasounds. Sterile gel will be used from now on.
Patient Sequence No: 1, Text Type: D, B5