The Australia Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning ViewPoint 6 versions 6.2, 6.2.1, 6.3 and 6.31 including OB Pro-Expert Reporting (ultrasound image management software) manufactured by GE Healthcare.
GE Healthcare has become aware of a potential safety issue due to the incorrect calculation of the pulsatility index value (PIV) for venous flow measurements. The ductus venous PIV measurement can be incorporated into the first trimester risk assessment for chromosomal abnormalities. In case of negative flow patterns, the ViewPoint calculated Doppler PIV for veins could be incorrect, leading to a false high risk for trisomy 13, 18, and 21.
GE Healthcare is advising users to discontinue use of venous PIV for making any clinical decisions, in particular, discontinue use of the ductus venous PIV for first trimester risk assessment. In addition, GE Healthcare will be providing a software upgrade as a permanent fix.
For details, please visit the following TGA website: http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00812-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 5 August 2013