Why do you need to calibrate your medical devices?
Calibration refers to the method of balancing measurements made by an apparatus against a known standard, to define the correctness of readings produced by it. Alterations or repairs are carried to correct errors, and a full calibration report shows measures taken before and after the test.
These items also need to be visible to a universal standard. Given the impact of measurements of medical devices on common health and safety, pharma and biotech firms need to follow ISO/IEC 17025:2005 conditions during testing, calibration, and sampling projects.
Why do we need to calibrate medical instruments?
Here are some of the principal reasons why machine calibrations are so heavily controlled in the biotech and medical divisions:
- The efficiency of medical tools has a direct impact on patient health and safety but also plays a crucial role in managing the production and effectiveness of healthcare institutions.
- All weighing devices lose their accuracy over time due to normal wear and tear, environmental changes, building defects, and other factors, but regular calibration corrects errors.
- High efficiency is especially critical for instruments that come in direct contact with subjects, or those which are used to determine a course of medication, the state of a patient’s health, etc.
- Incorrect measurements can result in a wrong diagnosis, leading to further or ineffective treatment, wrong prescriptions, referrals to other professionals, and numerous other issues.
- For businesses that manufacture medical devices, preventive inspection, maintenance, and calibration of manufacturing and testing equipment can help prevent failures in product quality.
Impact of poor measurements
The impact of measurements taken from out-of-calibration instruments affects efficiency in various industries, but it can cause particular dangers in the healing sector:
- Experts usually begin the diagnosis of an illness with lab test results of patient samples, which are displayed as analytical data.
- These decisions need to fall within acceptable ranges or entrances, and treatment may be ordered if they are outside of these.
- Non-calibrated medical things can shift test results, presenting data that are above or below the true value or inception.
- This can alter analysis as well as treatment, causing over-detection or under-detection of medical problems.
- Doctors could end up ordering higher or lower doses of medicine than needed (which is especially harmful to children).
- Pharmaceutical errors occurring from the use of non-calibrated instruments could lead to pain, injury, and even death.
- They also add to healthcare costs for patients, in the form of medicine, follow-up tests, and treatments, etc.
- Poor grades could also cause errors in medicine packaging, dosage instructions, and mass, leading to FDA recalls penalties, etc.
Advantages of calibrating you medical devices
There are many advantages to be enjoyed with proper calibration of medical instruments, like:
- Accuracy – The assurance of the highest correctness is perhaps the most important advantage since accurate measures are critical at every stage of production and growth.
- Quality – Good measurements have a direct impact on quality control and place assurance in medicine and biotech, building confidence in test results, and improving compliance with industry standards as well.
- Costs – Not only do accurate versions of streamline production processes, but they also help reduce the risk of hidden costs (r.
- Control – It’s more accessible for healthcare organizations and manufacturers to maintain control over their methods and systems when they receive proper and meaningful monitoring data and test results.
- Traceability – The traceability of calibration reports and results is a very significant step towards receiving and managing product or service licenses, accreditation, and other industry benefits or requirements.
In conclusion, make sure your corrective tools are calibrated on a regular schedule, by trained technicians from an accredited calibration lab. Also, recalibrate after any change in place, context, or operating conditions, and always follow the manufacturer’s instructions!