TGA recall – Proivine and Sandos propofol 1% emulsion for injection – all sizes and all batches. Somje vials may include some vials that have been contaminated with the bacteria Ralstonia pickettii.

[Glenys Harrington]

Dear All,

Find below the following:

*Links to Therapeutic Goods Australia(TGA) Alert – Safety Advisory
– Potential bacterial contamination and
*Addition information on Ralstonia pickettii, infections and
outbreaks.

Therapeutic Goods Australia(TGA) Alert

http://www.tga.gov.au/safety/alerts-medicine-provive-mct-lct-140502.htm#.U2S
I6PmSwSE

*Proivine and Sandos propofol 1% emulsion for injection – all sizes
and all batches
*”Health professionals, hospitals and health facilities are advised
that batches of a widely used intravenous anaesthetic drug, propofol, may
include some vials that have been contaminated with the bacteria Ralstonia
pickettii. To address this issue, AFT Pharmaceuticals, in consultation with
the TGA, has quarantined two batches of Provive MCT-LCT 1% (propofol 1%)
emulsion for injection in 20 ml vials. This action is being taken due to
potential contamination with the bacteria Ralstonia pickettii”.

What is Ralstonia pickettii?

Ralstonia pickettii (formerly called Pseudomonas pickettii or Burkholderia
pickettii) is a nonfermentative gram-negative bacillus that grows well in
moist environments.

R. pickettii has a long history of causing nosocomial outbreaks associated
with contaminated solutions used for patient care and pseudo-outbreaks
associated with contaminated solutions used for laboratory diagnosis.

These contaminated solutions have been associated with outbreaks of
respiratory colonisation, bloodstream infections and catheter related
infections.

Outbreaks

1.Ralstonia pickettii: a persistent gram-negative nosocomial
infectious organism. J Hosp
Infect. 2006 Mar;62(3):278-84. Epub 2005 Dec 6.

Abstract

Non-fermenting Gram-negative bacilli create a significant problem in
clinical settings, being a widespread cause of nosocomial infections. They
are opportunistic pathogens that take advantage of underlying conditions and
diseases. Ralstonia pickettii, a non-fermenting Gram-negative bacillus, is
regarded as being of minor clinical significance; however, many instances of
infections with this organism are reported in the literature. Infections can
include bacteraemia/septicaemia caused by contaminated solutions, e.g.
distilled water, water for injection and aqueous chlorhexidine solutions.
Cases of pseudobacteraemia have been recorded in association with R.
pickettii, as have many cases of unusual infections, some of which were very
invasive and severe, e.g. meningitis, septic arthritis and osteomyelitis.
Six cases of death in four separate instances have also been recorded
related to R. pickettii. This review illustrates that R. pickettii is a more
important pathogen than was thought previously.

2.Outbreak with Ralstonia pickettii caused by contaminated magnesium
vials

https://www.thieme-connect.de/DOI/DOI?10.1055/s-0033-1360059

3.Multistate Nosocomial Outbreak of Ralstonia pickettii Colonization
Associated with an Intrinsically Contaminated Respiratory Care Solution Clin
Infect Dis. (1999) 29 (5):1281-1286

http://cid.oxfordjournals.org/content/29/5/1281.full

regards

Glenys

Glenys Harrington

Consultant

Infection Control Consultancy (ICC)

PO Box 5202

Middle Park

Victoria, 3206

Australia

H: +61 3 96902216

M: +61 404 816 434

infexion@ozemail.com.au

ABN 47533508426

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