Oxoid antimicrobial susceptibility testing discs (AST) 를 위한 안전성 경고 / 현장 안전성 서한

Safety alert / Field Safety Notice

MDA/2013/014

CON251944

2013-03-20

2013-03-20

United Kingdom

MHRA

https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON251944?tabName=allTabs

The manufacturer has issued nine field safety notices since november 2011 recalling batches of ast disc, due to the presence of non-impregnated or ‘blank’ ast discs manufactured before december 2012. ast discs may, therefore, not perform to the expected specification. blank discs could lead to a false indication of antibiotic resistance, which in turn could lead to delayed reporting, reduced options for treatment or unnecessary changes to treatment. recent recalls of oxoid ast discs have been in response to the potential for the presence of non-impregnated or ‘blank’ discs within specific disc lots. the manufacturer estimates that the rate of occurrence of blank discs is less than 1 in 100,000. there have been nine field safety notices on this issue since november 2011, with four occurring in february 2013.  more information can be found on the mhra website.

When reviewing results which do not fit the clinical picture (i.e. unexpected pattern of resistance within classes of antibiotic, discrepant results with MIC testing or unexpected patient outcomes on empirical therapy) consider if blank AST discs are a possible cause.   Consider the need for repeat and/or further testing of resistant isolates, including, where appropriate, non-disc methods,  especially in clinically severe cases and where there are reduced options for treatment due to high levels of resistance in your patients. Report any suspected examples of blank discs observed in your laboratory to the MHRA and the manufacturer. Medical microbiologists and microbiology laboratory managers.