Medical Devices Calibration is performed to reduce measurement uncertainty, reduce mistakes, and bring measurements to an acceptable level. All equipment degrades over time and with frequent usage, which has an impact on its accuracy and precision. In the medical device sector, a measurement drift is considered inappropriate. Calibration of equipment on a regular basis ensures that industry set criteria are met and that the equipment is operational, resulting in accurate output.
The health and safety of patients is a major focus for hospitals and clinics. Doctors and nurses rely on the accuracy and precision of the tools they use to monitor patients as a result of this. As a result, the precision and accuracy of a device are critical. The medical device industry is controlled by tight standards, including FDA's 21 CFR Parts 11 and 820, Quality System Regulation (QSR), and ISO 13485, to service users and guarantee public health and safety is not jeopardized.
Medical equipment, like any other machine, is subject to wear and tear over time, which has a direct impact on its accuracy and effectiveness. Periodic calibration is required to maintain the equipment's performance and reduce the chance of causing injury to a patient. All medical device firms must have processes in place that include instructions and acceptable accuracy and precision limits, according to the FDA.
Manufacturers must document all points of calibration, according to Part 21 CFR 820.72, which includes the following:
According to industry, federal, and state regulations, calibration should be done in conjunction with annual testing and services. However, depending on the extent and scale of its use, each piece of equipment has its own set of needs. The administrator must develop a calibration schedule as part of biomedical equipment management. When choosing the optimal schedule for each piece of equipment, there are a few things to keep in mind.
Some of the factors to consider for calibration, annual testing and services include:
You must have the equipment calibrated as soon as possible if it has been damaged by an impact or an internal overload. Keep note of any calibration work done outside of yearly testing and service for complete medical equipment management. Good record-keeping is essential for ensuring that everything is properly tested and running as it should.