What is Calibration?
Maybe you are not familiar with the meaning of calibration
of medical devices, which is an activity to determine the conventional truth of
the value of the designation of measuring tools and materials.
This is done by comparing traceable measuring standards to
national and international standards. This activity is important for every
medical device, especially those that are routinely used (used every day) in
health facilities.
Government regulations are very clear in setting the
criteria for medical equipment that must be calibrated. The following are the
criteria for medical equipment in health care facilities that must be
calibrated at least once a year:
- Do not have certificates and marks of passing
the testing or calibration of medical devices.
- The certificate has expired and has passed the
test.
- The designation or output or performance or
safety of the medical device is no longer appropriate, even though the
certificate and test pass are still valid.
- Medical devices have been damaged and repaired,
even though the certificate and test pass are still valid.
- Has been transferred from one agency to another,
even though the certificate and test pass are still valid.
- If the certificate and the test pass are lost or
damaged so that information from medical equipment cannot be obtained.
The criteria for medical equipment that have passed
calibration and are suitable for use are as follows:
- The deviation value of the measurement results
when compared with the value enshrined in the medical equipment does not exceed
the allowable deviation value.
- The work safety measurement value is included in
the normal/allowed threshold value.
By performing periodic calibrations, the performance and
accuracy of medical devices can be maintained properly. Thus, the quality of
health services to patients can also be maintained.
Why Medical Devices Need Calibration?
Calibration of medical devices is an activity that must be
carried out, especially when medical equipment has entered the 6 criteria
mentioned above. The purpose of this calibration activity is to:
- Ensure Conformity of Characteristics
Specifications: The first objective is to ensure the
characteristics of the specifications of an instrument/tool or measuring material. If there
is a discrepancy, then the permit or certification letter cannot be issued.
- Determine the Deviation Value: Calibration of medical devices also aims to
determine the deviation or deviation of the conventional truth from the
designation value of the measuring material/instrument, as well as the
deviation of the nominal dimensions that should be for a measuring material.
- Maintain the Accuracy of the Values Produced: The next goal is to maintain the accuracy
of the value produced from medical devices so that the results do not deviate
far from the specified threshold (according to the standard).
- Guarantee Standardized Measurement Results: In addition, calibration will also ensure
that the measurement results of a medical device are in accordance with
national and international standards.
A medical device used for services at a health
facility needs to be calibrated from time to time, even though it still has a
certificate of eligibility. Especially if the medical equipment is widely used,
the feasibility test must always be carried out.
If you want to test various medical devices, you can entrust them to Stark Medical. Stark Medical provides medical equipment calibration services and has obtained a medical equipment test and calibration operation permit from AS3551:2012.