Preface to the Ninth Edition
In the 9th edition all sections of the Manual have been reviewed and a number of major and minor corrections, additions and deletions have been made. The major changes are listed in the “What’s New” section on the CDS website. The NATA document setting out the requirements for TGA registration of antibiotic susceptibility testing as an in vitro medical device (IVD) has been deleted. The latest TGA requirements are described in 3.1 in Quality Assurance in this edition. An upgrade of all the reference strains used in the CDS method was undertaken by the CDS Laboratory in the latter part of 2017 and the resultant changes in the relevant areas were previewed in Newsletter 41 in “What’s New” on our website in October 2017. The CDS team at Kogarah has been joined by Dr. Pratibha James an experienced medical microbiologist and they have been actively engaged in the study comparing 3 methods of MIC determination. Despite this they have managed to complete a first class revision of the manual. My congratulations and thanks to them.
Syd Bell
April 2018