THIRUVANANTHAPURAM: Kerala’s Legal Metrology Department is set to make history as the first in the country to venture into metrological testing of medical equipment. Starting May 15, the department’s new laboratories at Legal Metrology Bhavan in Ernakulam will be testing clinical thermometers and BP apparatus (sphygmomanometers).
The establishment of the labs aims to ensure the accuracy of the crucial diagnostic devices, thereby enhancing the quality of healthcare in the state, said a source in the department. The lab for the BP apparatus was designed and set up by the National Physical Laboratory of India, while the one for thermometers was developed by the Fluid Control Research Institute, India, based in Palakkad.
Enforcement of testing procedures will be carried out in phases, starting with dealers, manufacturers, and importers. The source said an enforcement plan is being prepared, and the initial step may involve directing dealers and manufacturers in Kerala to obtain certification from labs for both types of equipment before sale. Factors like testing capacity will be considered when devising the plan. The thermometer verification lab, for instance, can test 200-250 pieces per day, while the sphygmomanometer lab can handle around 150 pieces.
Clinical thermometer
Testing protocols differ for mercury and digital thermometers. The common process involves accuracy testing by immersing the devices in a water bath. The test piece and a reference instrument are simultaneously immersed in a precisely controlled water bath. The test is considered successful if the test piece shows the same temperature as the reference piece.
BP apparatus
The test instrument will be verified against a reference instrument with the support of a pumping system. Instruments with errors above the permissible limit will be rejected. Another process is a leak test to verify that the pressure remains intact after the blood pressure cuff is fully inflated and until the operator releases the pressure.
Hardly any testing
Currently, medical equipment sold in Kerala do not undergo any quality testing apart from what is done by the manufacturer
The establishment of new labs aligns with the International Organisation of Legal Metrology’s directive to include robust measurement systems in the healthcare policies of member countries
Opening today
Minister for Food, Civil Supplies and Legal Metrology G R Anil will inaugurate the labs at Legal Metrology Bhavan in Kakkanad on May 15 at 10 am. Industries Minister P Rajeeve will inaugurate the solar plant at the office