What is the issue?
Ralstonia species are a rare group of infections that have been linked in the past to contamination of medical therapeutic agents. Concern was raised when this organism was identified in three patients in South Australia who had procedures in April 2014. The only common exposure was the administration of Provive propofol. Across Australia, a further five cases were identified in patients who had received propofol in the month prior to the detection of Ralstonia species in blood culture samples.
The TGA has conducted a detailed review of the manufacturers’ processes for propofol 1% emulsion and have tested samples from 25 batches of propofol 1% emulsion for sterility and bacterial endotoxins. No deviations from approved manufacturing processes were found and all tested samples passed the criteria for sterility and bacterial endotoxins.
As a result, the TGA has advised health professionals, hospitals and health facilities that all sizes and batches of the AFT-distributed Provive and Sandoz Propofol 1% products are no longer under a precautionary supply restriction.
For further information, including extensive detail on testing undertaken, please see the TGA .
Contact the Communicable Disease Prevention and Control section at the Department of Health on 1300 651 160.