FDA regulations for medical devices require
manufacturers to develop and monitor production practices to ensure that
the end device conforms to its specifications. A calibration program is
a major part of this quality system to verify the accuracy and
precision of measurements. Walt describes the techniques, tools, and
equipment used to calibrate a disposable medical device.
Medical
devices that rely on one or more embedded sensors not only need
testing, but also sensor calibration. Digital circuits can be subject to
pass/fail testing. However, sensors require precise testing or
calibration to be accurate. Calibration ensures that different
individual devices give the same result. Sensors needing calibration
include temperature, pressure, acceleration, strain, and displacement.
Medical
devices must meet FDA regulations regarding device traceability and
validation. The calibration process must ensure traceable measurements
where the start and end of a calibration chain can be followed.
Disposable devices add another constraint because the cost must be kept
low without sacrificing accuracy and traceability.
The
following discussion explains how the temperature and pressure sensors
in a disposable catheter met accuracy requirements while maintaining low
cost and meeting FDA requirements for traceability to the National
Institute of Standards and Technology (NIST).
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