Medical & Healthcare Technology Insights: Calibration, Validation, and Instrument Drift Management

Advancements in medical and healthcare technology have transformed the industry, offering precision, speed, and accuracy in diagnosing and treating patients. However, these instruments require stringent service, calibration, and validation protocols to maintain their accuracy and reliability. This article delves into the importance of maintaining healthcare instruments, the benefits of ISO/IEC 17025 accredited calibration over the ISO 9001 standard, and the significance of identifying instrument drift over time.

Service, Calibration, and Validation

The quality and precision of healthcare services depend heavily on well-maintained and accurately calibrated instruments. Equipment such as electrocardiograms (ECGs), ventilators, infusion pumps, patient monitors, centrifuges, pipettes, temperature monitoring systems and diagnostic imaging tools play a critical role in patient care. Any deviation in the performance of these devices can lead to inaccurate diagnoses, delayed treatments, or even life-threatening consequences.

1. Service and Preventive Maintenance:
   Routine service ensures that equipment remains in optimal working condition. Preventive maintenance tasks, such as cleaning, lubrication, and replacement of worn parts, extend the lifespan of instruments and reduce downtime. Periodic inspections also help detect minor issues before they escalate into critical failures.
2. Calibration:
   Calibration is the process of comparing the measurements of an instrument with a reference standard traceable to national and/or international standard to ensure accuracy. Regular calibration ensures that devices consistently meet the manufacturer’s specifications and/or customer’s expectation and regulatory requirements. In medical environments, even small deviations in readings can have serious consequences, so calibration guarantees the reliability of diagnostic and therapeutic procedures.
3. Validation:
   Validation verifies that equipment performs as intended under real-world conditions. For example, in laboratories and pharmaceutical production, instruments used in clinical trials or drug manufacturing must meet strict performance criteria to ensure data integrity and compliance with regulatory bodies like the FDA or TGA.

ISO/IEC 17025 vs. ISO 9001: Which Calibration Management Standard is Better?

While both ISO 9001 and ISO/IEC 17025 are internationally recognized standards, they serve different purposes. Understanding these differences helps healthcare providers make informed decisions about instrument calibration.

1. ISO 9001:
   ISO 9001 focuses on quality management systems and ensures that organisations follow processes to meet customer and regulatory requirements. It promotes consistent service delivery and continuous improvement across all areas of operation. However, it does not specifically address technical competence in calibration.
2. ISO/IEC 17025:
   ISO/IEC 17025 is specifically designed for testing and calibration laboratories, emphasizing both quality management and technical competence. Laboratories accredited to this standard must demonstrate the ability to produce technically valid results and ensure traceability to national or international measurement standards.
3. Benefits of ISO/IEC 17025 Calibration over ISO 9001:
   • Traceable Measurements: Instruments calibrated under ISO/IEC 17025 follow international traceability standards, ensuring consistency and reliability across different healthcare facilities.
   • Measurement Uncertainty: ISO/IEC 17025 requires calibration labs to assess and report measurement uncertainties, giving users confidence in the precision of their instruments.
   • Competence Assurance: This standard ensures that calibration personnel are adequately trained, and the equipment used for calibration is suitable and regularly maintained.
   • Regulatory Compliance: Many regulatory agencies mandate ISO/IEC 17025 accredited calibrations, especially in pharmaceutical and healthcare sectors.

While ISO 9001 offers a broad quality framework, ISO/IEC 17025 provides the technical rigor required for medical device calibration, making it the preferred choice for healthcare providers seeking the highest level of accuracy and reliability.

Instrument Drift: Identifying and Managing Deviation Over Time

Instrument drift refers to the gradual deviation of an instrument’s readings from the true value over time. This phenomenon is common in healthcare devices due to wear and tear, environmental factors (such as temperature and humidity changes), or electronic component degradation. Identifying and managing drift is essential to prevent compromised patient care and ensure regulatory compliance.

Causes of Instrument Drift:

• Environmental Conditions: Instruments sensitive to temperature, humidity, or pressure can experience gradual changes in performance.
• Aging Components: Sensors and electronic components may degrade over time, leading to inaccurate readings.
• Usage Frequency: High-frequency use can cause mechanical wear, affecting precision in instruments like infusion pumps or centrifuges.

Detecting and Managing Drift:

1. Regular Calibration Intervals: Establishing calibration schedules ensures that instruments are checked for drift and corrected before their performance deviates significantly.
2. Trend Analysis: Recording calibration data over time helps identify patterns in drift. If an instrument shows consistent deviation, it may need more frequent calibration or repair.
3. Control Charts: These charts help track calibration results over time, providing visual indicators of drift trends. If data points start falling outside the acceptable range, corrective action can be taken immediately.

The Role of Technology in Managing Calibration and Drift

Technological advancements have enabled calibration service provides to automate calibration and drift management processes. Cloud-based calibration management systems allow facilities to track calibration schedules, store historical data, and generate reports for regulatory audits. Furthermore, usage of QR coded calibration labels provides direct access to calibration reports and even history of the instrument right at the fingertip of the user.

Conclusion

In the healthcare sector, where precision and accuracy are paramount, the service, calibration, and validation of medical instruments play a crucial role in ensuring patient safety and regulatory compliance. While ISO 9001 provides a solid quality framework, ISO/IEC 17025 accredited calibration offers the technical rigor necessary to maintain the highest level of accuracy. Additionally, monitoring and managing instrument drift through regular calibration, preventive maintenance, and trend analysis helps maintain optimal performance over time. By adopting robust calibration practices and leveraging modern technologies, healthcare providers can ensure the continued reliability of their equipment and enhance patient outcomes.

By Hardik Mavani, Metrologist of CISCAL 

Author

Hardik Mavani,

Metrologist,

CISCAL Pty Ltd

Background on Author

Hardik Mavani holds a Master of Professional Engineering from the University of Wollongong. Since April 2016, he has been working with CISCAL Pty Ltd, where he has developed extensive expertise in managing and calibrating measuring instruments across diverse sectors, including laboratories, healthcare, medical, and manufacturing industries.

Through this role, Hardik has gained in-depth knowledge of calibration processes and compliance standards, with proficiency in meeting the stringent requirements of NATA (National Association of Testing Authorities) for accreditation. With a solid technical background and hands-on experience, he is dedicated to ensuring precise measurements and supporting industries in maintaining the highest standards of quality and accuracy.