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Research & Development

Calibration – a necessary practice for medical instruments



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We’ve seen huge advancements in biotechnology over the last few years, which have improved medical diagnosis and treatment immensely. However, one factor that sometimes gets overlooked is the calibration of medical instruments, despite growing awareness of its importance. Proper calibration ensures the highest level of accuracy for medical instruments and reduces costs too, making it a crucial part of biomedical cGMP and FDA compliance, as expert Edward Simpson works of RS Calibration Services explains

Calibration

Calibration refers to the process of comparing measurements made by an instrument against a known standard, to determine the accuracy of readings produced by it. Adjustments or repairs are conducted to correct errors, and a detailed calibration report shows measurements taken before and after the test.

These measurements also need to be traceable to an international standard. Given the impact of measurements from medical equipment on public health and safety, pharma and biotech companies need to follow ISO/IEC 17025:2005 requirements during testing, calibration and sampling activities.

Why do we need to calibrate medical instruments?

Here are some of the main reasons why equipment calibrations are so heavily regulated in the biotech and medical sectors:

  • The accuracy of medical devices has a direct impact on patient health and safety, but also plays a crucial role in determining the performance and efficiency of healthcare institutions.
  • All measuring devices lose their accuracy over time due to normal wear and tear, environmental changes, manufacturing defects and other factors, but regular calibration corrects inaccuracies.
  • High accuracy is especially important for instruments that come in direct contact with patients, or those which are used to determine a course of treatment, the state of a patient’s health, etc.
  • Inaccurate measurements can result in a faulty diagnosis, leading to unnecessary or ineffective treatment, wrong prescriptions, referrals to other specialists and numerous other issues.
  • For companies that manufacture medical devices, preventive inspection, maintenance and calibration of manufacturing and testing equipment can help prevent breakdowns in product quality.

Impact of poor measurements in the medical industry

The impact of measurements taken from out-of-calibration instruments affects efficiency in any industry, but it can cause specific dangers in the medical sector:

  • Doctors usually begin diagnosis of an illness with lab test results of patient samples, which are displayed as analytical data.

    calibration

    Edward Simpson

  • These results need to fall within acceptable ranges or thresholds, and treatment may be prescribed if they are outside of these.
  • Non-calibrated medical devices can shift test results, displaying data that’s above or below the true value or threshold.
  • This can alter diagnosis as well as treatment, causing over-detection or under-detection of medical issues.
  • Doctors could end up prescribing higher or lower doses of medication than needed (which is especially harmful for children).
  • Medical errors resulting from the use of non-calibrated instruments could lead to pain, disability and even death.
  • They also contribute to healthcare costs for patients, in the form of medication, follow-up tests and treatments, etc.
  • Poor measurements could also cause errors in drug packaging, dosage instructions and mass, leading to FDA recalls, penalties, etc.

Advantages of calibrating medical devices

There are many benefits to be enjoyed with proper calibration of medical instruments, like:

  • Accuracy – The assurance of highest accuracy is perhaps the most important advantage, since accurate measurements are critical at every stage of production and development (for both medical products and services).
  • Quality – Reliable measurements have a direct effect on quality control and quality assurance in medicine and biotech, building confidence in test results and improving compliance with industry standards as well.
  • Costs – Not only do accurate readings streamline production processes, but they also help minimize the risk of hidden costs (recalls, fines and other penalties in case of quality or safety concerns during FDA inspections).
  • Control – It’s easier for healthcare organizations and manufacturers to maintain control over their processes and systems when they receive accurate and meaningful monitoring data and test results.
  • Traceability – The traceability of calibration reports and results is a very important step towards receiving and maintaining product or service licenses, accreditation, and other industry benefits or requirements.

Key parameters for bio-medical equipment calibration

Here are some examples of key parameters to be considered for testing and calibration:

Defibrillators

  • Electrical safety tests
  • Biphasic energy measurement
  • ECG, performance and arrhythmia simulation
  • Charge and discharge time test
  • Waveform simulation

Pulse Oxymeters

  • Electrical safety tests
  • O2 saturation
  • Heart rate
  • Pulse amplitude
  • Selectable pigmentation and ambient light condition

Infusion pumps

  • Electrical safety tests
  • Flow rate
  • Occlusion alarm tests
  • Pressure

Patient simulators

  • Electrical safety tests
  • ECG
  • Blood pressure
  • Cardiac output
  • Respiration
  • Temperature
  • Pacemaker recognition

Ventilators

  • Tidal volume
  • Peep pressure
  • Minute volume
  • I/E ratio
  • Oxygen level
  • Inspiratory hold, peak flow and pressure, etc.

Foetal monitors

  • Electrical safety tests
  • Foetal ECG
  • Maternal ECG
  • Uterine activity
  • TOCO simulation

In conclusion, make sure your medical devices are calibrated on a regular schedule, by trained engineers from an accredited calibration lab. In addition, recalibrate after any change in location, environment or operating conditions, and always follow the manufacturer’s recommendations!

About the author

With well over 100 years experience between us, we've been around the editorial and medical blocks a few times. But we're still as keen as any young pup to root out what's new and inspiring.

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