Why Annual Equipment Calibration Is So Important $0.00

Why Annual Equipment Calibration Is So Important

By: Morgan Gotthardt | Jan 27, 2020
Why Annual Equipment Calibration Is So Important

It is your responsibility to ensure that your medical equipment is in full working order and maintained through regular medical device testing and calibration. Used for monitoring and treatment of patients, this equipment requires periodic safety and performance testing to check for accuracy and precision. With accurate measurements, medical professionals can better diagnose diseases, monitor patients, and deliver treatments.

Learn more:

Equipment Requiring Annual Calibration
Send Your Equipment to Performance Health for Calibration
When Should You Have Equipment Calibrated?
Set-Up a Calibration Schedule


Calibration Reduces the Potential for Errors


Equipment calibration is the setting or correcting of a measuring device by adjusting it to match or conform to a dependably-known and unvarying measure. With repeated use, and over a period of time, all equipment degrades which affects accuracy and precision. Performing calibration on a routine basis will help maintain accuracy, producing results within the specified value and reducing the potential for errors.

Title 21 of the FDA's Code of Federal Regulations defines the calibration requirements for equipment. Manufacturers have to inspect, measure, and test equipment to ensure that it is suitable for its intended use and that it is capable of providing valid results.



Control of Inspection, Measuring, Test Equipment

Provide 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. Equipment is required to routinely practice calibration, inspection, and maintenance.


Calibration

Calibration procedures include specific directions and limits for accuracy and precision. When accuracy and precision limits are not met, there will be provisions for corrective action to reestablish the limits and to evaluate whether there was any conflicting effect on the device's quality.



Calibration Standards

Calibration standards used for inspection, measuring, and testing equipment must be traceable to national or international standards. If national or international standards are not practical or available, the manufacturer will use an independent reproducible standard. If no applicable standard exists, the manufacturer will establish and maintain an in-house standard.



Calibration Records

Equipment identification, calibration dates, the CCT (Certified Calibration Technician) performing each calibration, and the next calibration date must be documented. These records will be displayed on or near each piece of equipment and must be readily available to the personnel using such equipment and to the individuals responsible for calibrating the equipment.


As a medical professional, you have a responsibility to your patients to make certain that your medical equipment is safe, accurate, and reliable at the point of use. Calibration is done to provide that the item is functioning properly and to ensure that the results or readings it provides are accurate. Individuals completing calibration need to be trained and are required to document the process to ensure any mistakes can be traced back to the source.


Equipment Requiring Annual Calibration


Most certifying agencies and state regulations require annual safety checks and calibrations for all equipment to maintain patient safety and consistent therapy. Most manufacturers also require calibration once a year to maintain their warranties. The following medical equipment requires annual calibration:


Send Your Equipment to Performance Health for Calibration


We provide calibration for the following Jamar Hand Dynamometers and Pinch Gauges:





Jamar Hydraulic Hand Dynamometer

Jamar Hydraulic Hand Dynamomter





Jamar Smart Digital Hand Dynamometer

Jamar Smart Digital Hand Dynamometer





Jamar Plus Digital Hand Dynamometer

Jamar Plus Digital Hand Dynamometer





Jamar Hydraulic Pinch Gauge

Jamar Hydraulic Pinch Gauge


To calibrate any of the measuring instruments listed above, contact Customer Service at (800)-323-5547 or email customersupport@performancehealth.com


Blood Pressure Reading

When Should You Have Equipment Calibrated?


It is standard procedure to calibrate medical equipment upon purchase, and on an annual re-calibration basis. If your application demands a shorter period between calibrations, it’s often recommended to set-up an ‘automatic re-call’ procedure with a qualified laboratory technician.

Equipment calibration is often recommended on one of these four schedules.


Manufacturer Recommended Frequency

Medical equipment includes manufacturers’ recommendations responding to calibration frequency. For instance, equipment that is used to perform critical measurements may require different intervals.



Before Use of Equipment

Select measuring instruments and equipment required in advance and have them calibrated before the testing begins to improve accuracy.



After Each Use of Equipment

Send your measuring instruments after each use to keep them ready for future use. This also proves to be helpful as it allows you to confirm the accuracy of your results.



Pre-Decided Time Intervals

If you use certain equipment for critical measurements often, it is recommended to have shorter time span between calibrations. However, if you carry out a mix of critical and non-critical measurements, you can choose to calibrate your equipment annually or bi-annually.


Ultrasound

Set-Up a Calibration Schedule


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, consider doing so or sticking to the manufacturer’s recommendations to keep all your medical equipment running smoothly!

Resources

  1. https://www.medicaldesignbriefs.com/component/content/article/mdb/tech-briefs/29754
  2. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.72
  3. https://statbiomedical.net/bio-medical-equipment-calibrated/
  4. Medical Disclaimer: The information provided on this site, including text, graphics, images and other material, are for informational purposes only and are not intended to substitute for professional medical advice, diagnosis or treatment. Always seek the advice of your physician or other healthcare professional with any questions or concerns you may have regarding your condition.

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