recently updated on 20th Sept 23
In our previous article, we focused on lab equipment maintenance and its importance. Similarly, we indicated the effect of the calibration of lab instruments. This article puts under a microscope the concept of calibration instructions of medical equipment.
Medical diagnostic equipment used in laboratories needs regular maintenance and calibration. We covered the topic of Maintenance of medical equipment thoroughly in our previous blog. The following important part is the calibration of lab instruments. Calibration involves adjusting the equipment to ensure that it is producing reliable and accurate results. In contrast, maintenance refers to routine maintenance and repair of equipment. Maintenance and calibration instructions are required to ensure that medical diagnostic equipment operates reliably and consistently. Let’s study the concept of calibration separately.
Medical equipment calibration is a crucial procedure that tries to lower measurement uncertainties, minimize errors, and improve measurements to an acceptable level. Medical equipment tends to deteriorate with usage, harming its accuracy and precision. Hence, routine calibration of lab instruments is necessary to guarantee that the machinery operates at peak efficiency while retaining precision and dependability.
Regular calibration in measuring instruments can increase a lab’s profitability in addition to assisting in ensuring the reliability and accuracy of medical equipment. Adequately calibrated equipment can boost efficiency by lowering the need for repeat tests, saving waste, and preventing the expense of rework due to unwanted errors. Before we conclude how calibration instructions helps your diagnostic lab business, let’s understand what calibration is.
What is calibration in the laboratory?
Calibration involves comparing the readings of medical equipment to a known standard or reference and making adjustments as necessary to ensure that the equipment is accurate. So, calibrated instruments enable medical personnel to make a better-informed diagnosis and treat patients more successfully by maintaining precise and accurate measurements.
One may ask why calibration is important for measurement? Hence the answer is simple as It’s critical to calibrate medical equipment used in diagnostics to ensure it operates precisely and consistently. Measurements must be accurate for diagnostic devices like blood glucose meters, blood pressure monitors, and ECG machines, to produce reliable results. Non calibration can lead to inaccurate measurements and potentially incorrect diagnosis and treatment.
Clinicians and lab technicians are well aware of the concept of calibration. The essential aspect that can optimize calibration policies for your lab is to set up a calibration plan. A comprehensive plan encompassing all activities, procedures, and compliances can become a task. The next part gives you a 5-step plan for setting up a calibration process in your diagnostic lab.
Here is a 5-step plan for setting up a calibration process in a medical diagnostic lab:
1. Identify the equipment:
The first step is to identify all the medical diagnostic equipment that needs calibration instructions. The list may include instruments for diagnostic testing, such as blood glucose meters, blood pressure monitors, ECG machines, analyzers, etc.
2. Determine the calibration frequency:
After identifying the equipment, ascertain how frequently it needs calibration. Based on the manufacturer’s recommendations, legal regulations, or internal policies of the facility.
3. Develop calibration procedures:
Create written calibration protocols. The procedure should outline the precise procedures to calibrate each piece of equipment and the required instruments and reference standards.
4. Train staff:
Staff members should receive training on calibrating methods and be made aware of the necessary tools and equipment. Make sure the team knows the value of calibration and how incorrect readings can affect patient care.
5. Document calibration results:
Keep a record of the calibration results and calibration instuction for each piece of equipment. Record the calibration date and name of the technician who carried out the calibration. The calibration outcomes should all be in this record. Document any modifications that were made during the calibration procedure.
Some of the standard documentation a lab must maintain are as follows:
- Monthly, quarterly, and yearly calibration plan
- Calibrations SOP or steps in the calibration
- Calibration results datasheet
- Error measurement of the equipment
- Updated Instructions Manual or user manuals.
So, now that we have a simple 5-step calibration plan to optimize the process in your lab, let’s identify common situations in which you should perform calibrations.
Perform calibrations in these situations.
Perform calibration upon installation of new equipment in the lab to ensure it produces reliable results.
To guarantee the equipment’s continuous accuracy, most manufacturers advise regular calibration, usually semi-annually or annually.
After repairs and modifications:
Recalibrate the Equipment that has undergone repairs or alterations to ensure it is still producing reliable results.
Recalibrate the Equipment to consider any environmental variations that could affect its performance if you move the equipment to a new location inside the lab or another.
Change in operating conditions:
Recalibrate the equipment if the operating conditions change, such as the power supply or temperature change. To ensure that the equipment is still producing accurate data.
Calibrate the equipment when you replace the reagent used in diagnostic tests. The variation in the chemical composition may affect the test result. To consider any such variations in chemical composition or characteristics, perform calibration.
Software and hardware upgrade:
Every time there is a software update for equipment such as analyzers or other equipment. The lab must refer to the instructions manual from the manufacturer to perform the correct calibration process. Similarly, after any hardware upgrade, complete the calibration process vigilantly.
Regular calibration helps maintain equipment’s accuracy and reliability, improving patient outcomes and reducing the risk of errors. Similarly, a calibration plan can increase the throughput of a diagnostic lab in various ways mentioned below.
How a calibration plan increases the throughput of a diagnostic lab
Identifying the equipment and figuring out how frequently it has to be calibrated are the initial steps in the calibration strategy. Giving technicians a clear and consistent procedure and standardizing the calibration process can decrease errors and boost efficiency.
As part of a preventative maintenance program, routine calibration can lower the likelihood of equipment failure and unplanned downtime. Ensuring that the equipment is running as efficiently as possible and minimizing the need for maintenance or replacement can boost throughput.
By minimizing the time it takes to conduct calibrations, training personnel on the calibration procedures and the equipment can boost efficiency. Staff members will be able to carry out calibrations more swiftly and precisely since they will be more skilled and confident in their abilities.
Developing written procedures for the calibration process can optimize workflow and reduce the time it takes to complete calibrations. By standardizing the process, reducing errors, and streamlining workflow, One can perform the calibration quickly and efficiently, increasing overall lab throughput.
If the calibration of the equipment is as per regulatory guidelines and manufacturer’s recommendations can help to maintain compliance. Compliance can reduce the risk of fines, penalties, or even the loss of accreditation. Following regulatory procedures can increase the lab’s throughput by reducing the need for retesting, additional calibrations, or other corrective actions that can take up valuable time and resources.
Implementing a comprehensive calibration strategy that incorporates process standardization, preventative maintenance, staff training, workflow optimization, and adherence to regulatory requirements is crucial to maximizing lab efficiency and output. Labs can reduce errors and increase efficiency by standardizing the calibration process and providing technicians with clear and consistent methods.
Regular calibration can lower equipment failure and unscheduled downtime as part of a preventative maintenance program, ultimately increasing throughput. Written procedures can optimize productivity and reduce completion times, while proper staff training can reduce the time needed for calibrations. Following regulatory requirements can lower the possibility of fines and retesting, ultimately increasing lab throughput.
Faster diagnosis and treatment can improve patient outcomes and higher customer satisfaction. Accurate measurements can help with these results. By spending money and setting up policies on calibration, labs can maintain the precision of their equipment, raise the level of their general customer service, and possibly boost their income and profitability.
Now that we have covered best practices for maintaining and calibrating medical equipment. We also saw how compliance with laws and regulations is essential. As penalties and legal complications may hamper the business of medical labs, Our next blog is a thorough understanding of international standards and regulations for medical equipment.