Medical Equipment Calibration is carried out to minimize the uncertainty in measurements, reducing errors and bringing measurements to an acceptable level. With repeated use and over a period of time, all equipment begins to degrade and that affects its accuracy and precision. In the medical device industry, a drift in the measurement is found to be unacceptable. Regularly calibrating equipment will ensure that industry defined standards are met and that the equipment is functional thus providing accurate output.
For hospitals and clinics, the health and safety of patients remains the top priority. With this, doctors and nurses rely on the accuracy and precision of the instruments they are using to monitor patients. Therefore, the precision and accuracy of a device is of utmost importance. To serve the users and ensure that public health and safety isn’t compromised, the medical device industry is regulated by strict standards, including FDA’s 21 CFR Parts 11 and 820, Quality System Regulation (QSR) and ISO 13485.
What’s the point of medical equipment calibration services?
The maintenance of medical equipment is crucial as it is prone to wear and tear over time, which can impact its accuracy and performance. To maintain effectiveness and minimize risk, regular calibration of the equipment is necessary. The FDA mandates that all medical device companies must have proper procedures in place, including guidelines and acceptable limits for accuracy and precision to ensure that the equipment remains effective.
What is Part 21 CFR 820.72?
Part 21 CFR 820.72 states that manufacturers must document all the points of calibration, including the following:
- The date the device was picked up for calibration.
- The name of the staff /company who performed the calibration.
- When the next calibration is due.
For an instrument to remain in compliance with FDA, it is important to maintain a calibration schedule and keep all documentation easily available. Missed calibration cycles can compromise the quality of the product, resulting in non-compliance.
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How often should medical equipment be calibrated?
Please refer to the manufacturers guidelines. If you don’t have those available you can check online or call ERD today.
ERD certified technicians have extensive knowledge in medical equipment calibration programs in highly regulated industries and will provide you with innovative solutions to optimize even the most complex equipment to keep you compliant.