Medical device calibration: guarantees accuracy and patient safety
Medical device calibration is a process to ensure that each medical device functions with maximum accuracy, thereby minimizing the potential for errors that could have fatal consequences.
For example, a machine incorrectly calibrated can give misleading results. This can be a severe problem in the medical world because even a tiny mistake can lead to the wrong diagnosis or medication administration. As a result, this could endanger the patient’s life.
What is Medical Device Calibration?
Calibration of medical devices is a process carried out to check and regulate the accuracy of medical devices. This process involves comparing the tool’s performance with an internationally recognized standard or benchmark.
The goal is to ensure that medical devices used in medical diagnosis or treatment function accurately and consistently. Accuracy means the tool can provide actual measurement results, while consistency means the tool can give the same results in repeated measurements.
Calibration usually involves several steps, from initial inspection and adjustments to documentation that includes data and results from the process. This process also ensures that the results of the diagnosis or treatment given to the patient are the best.
When Does Calibration Need to Be Done?
Calibration is ideally carried out at certain time intervals determined by the manufacturer or industry standards. However, some unique situations require immediate calibration.
- First, if the tool has been recently purchased or installed, initial calibration is highly recommended to ensure the tool is working according to specifications.
- Second, after the tool has undergone repairs or component replacement, recalibration needs to be carried out to ensure its accuracy.
- Third, if the device shows inconsistent results or is suspected of being inaccurate, immediate calibration needs to be performed.
Apart from that, there is also a routine calibration, which is usually carried out once a year, although the frequency can vary depending on the type of tool and the extent to which the tool is used. This routine calibration ensures that all medical devices function optimally and produce accurate and reliable data.
Why is medical device calibration necessary?
Here are five reasons why calibration is a necessity that must be met to ensure safety in health services.
1. To Comply with International Standards
When a medical device is calibrated according to international standards, the measurement results will be accepted worldwide. This is important, especially if your health institution wants to collaborate with international parties or wants to get accreditation from world health organizations.
International standards related to medical device calibration are ISO 17025 and ISO 13485. ISO 17025 is an international standard for testing and calibration laboratories.
This standard includes requirements for laboratory technical competence and consistent operations. Standards ensure that laboratories have adequate quality management systems and can produce valid test and calibration data.
Meanwhile, ISO 13485 is a standard for medical device quality management systems. Although the primary focus is not on calibration, this standard includes requirements that ensure medical devices meet patient needs and applicable regulations, including calibration.
Therefore, ISO 13485 emphasizes the need to maintain proper documentation regarding calibration, including schedules, methods, and other requirements.
2. To Increase the Level of Accuracy and Consistency
Accuracy and consistency in measurements are crucial in the medical world. Calibration helps ensure that medical devices can work with high accuracy and precision.
In this way, the diagnosis and treatment given to patients will be more accurate, reducing the risk of medical errors that can have fatal consequences.
3. To maintain tool quality
Medical device calibration also evaluates the suitability of the equipment used. Calibration will identify if a tool is no longer suitable or has experienced a decline in quality. You can immediately carry out repairs or replacements to maintain the quality of the equipment or service.
4. To minimize production failure rates
In the healthcare industry, production failure can mean many things, from a defective product to an error in a medical procedure. Calibration minimizes risks to patients. This is by ensuring that medical devices work by established standards.
5. To save operational costs
Regular calibration will minimize the risk of errors that can lead to expensive repairs or equipment replacement. In addition, calibration also helps you save on audit costs because calibrated equipment usually makes it easier to obtain standard certification.
5 Examples of Medical Devices that Need to be Calibrated
The following are five examples of medical devices that require calibration because they can affect the quality of research results and medical care.
1. Analytical Scales
Analytical balances are used to measure the weight of chemical or biological samples with a very high degree of precision. Without the right one, the risk of errors in drug dosage or chemical composition can be fatal, ultimately affecting research results or patient care.
2. Centrifuge
This is a tool used to separate components in liquids based on their density. Calibration of this tool ensures that the rotation speed is as set so that component separation can be carried out accurately.
Calibration also ensures that this tool functions appropriately and safely, reducing the risk of device failure, which could have fatal consequences in the research or treatment process.
3. Furnace Laboratory
Laboratory ovens are used for various purposes, such as sterilizing instruments and incubating samples. Calibration ensures that the temperature in the stove matches what has been set so that its processes run well.
Calibration of this medical device also helps ensure uniformity of temperature throughout the oven room so that the results obtained will always be consistent.
4. Micropipette
Micropipettes are used to collect and measure tiny volumes of liquid. Calibration of the micropipette ensures that the volume of liquid taken and removed is as regulated. This is especially important in biochemical and medical research, where appropriate fluid volumes are crucial for accurate results.
5. Spectrophotometer
A spectrophotometer is used to measure the concentration of a substance in a solution by utilizing the interaction between light energy and matter. Calibration of this tool ensures that the light intensity reading is accurate, thereby affecting the accuracy of measuring the concentration of substances in the solution.
From ensuring diagnostic accuracy to improving operational efficiency, the benefits of the calibration process are extensive and significant. Therefore, always ensure that your medical equipment has been calibrated and meets the established quality standards.
Want to ensure your medical equipment is always in top condition? Use medical device calibration services from Sucofindo. With a robust reputation for product testing and analysis, Sucofindo will ensure that your equipment functions to the highest standards. Contact us to find out more and schedule your medical device calibration today!
