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Keeping track of equipment calibration will ensure you’re not falling behind and risking FDA non-compliance. Equipment that is out of calibration may not deliver accurate results, allowing the risk of potential error in diagnoses and treatments. With standard use, your equipment can lose its calibration causing the device output to become inconsistent. It is important to make certain that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results. If you haven’t already set up a calibration schedule.

Medical equipment calibration is performed for many reasons, but most importantly, it is performed to ensure the overall functionality of the equipment is accurate and reliable. Comparable to manufacturing equipment, medical equipment is prone to drifting and damage over time which impacts its performance. In order to retain medical equipment’s effectiveness, calibration needs to be completed on a regular basis. By doing so, the equipment will have minimal performance risks and reduced uncertainties. Accuracy of medical equipment is especially important because it effects the overall output, relating to both quality and patent safety.

The impact of calibration on medical devices performance and patient safety

Altayyar Saleh S 1* , Mousa MA 2 , Alfaifi AM 2 , Negm AE 2  and Ali MO 2

1: Department of Biomedical Technology, College of Applied Medical Sciences, King Saud University, Riyadh, Saudi Arabia
2: Healthcare Technology Management Administration, King Fahad Medical City, Ministry of Health, Riyadh, Saudi Arabia