Importance Of QC And Medical Standards For Image Diagnostic Devices

Ing Juergen Heckel, VP, Medical Business, Sales & Marketing, Global, Certified Medical Device Advisor, EIZO Corporation, gives an insight about contents of quality control process.

ACCURACY AND stability are the most important targets we have to achieve in healthcare industry for the best patient treatments. The visibility of cancer is very difficult and depends very much on the visible image contents and used equipment at the hospital. The doctors are only able to diagnose what is visible in special on the medical grade monitor so called image diagnostic device. Why Quality Control (QC) is important and what exactly will be controlled? For image diagnostic devices quality control means to check the ‘stability or also called constancy’ of the image device. Medical diagnostic monitors are already pre-calibrated at the factory side to DICOM Part 14 GSDF Standard in an optimum reading room environment (mainly dark rooms of 0lx). Most of the medical monitor manufactures offer their own optional special QC Software and sensors to periodically control and adjust the device onsite. Such QC is mandatory and highly recommended and unfortunately often forgotten. Having only the medical certification like CE mark label for medical or FDA510K certification does not replace the need of QC. It just shows the device is declared as medical device but does not show the accuracy.