Users facing health risk due to faulty diagnosis
Golam Mostafa Jibon:Fake and low quality medical instruments have flooded the market due to lack of quality verification by the authorities concerned that putting life of many people at risk.
Sources said, awareness has increased among the people due to rising of various diseases including diabetes and hypertension. Many people now keep pressure or blood pressure measuring machines, digital thermometers, weight measuring instruments, diabetes measuring instruments at home. But, the quality of those imported medical equipments is not being verified. There are also many questions about the results of these tests. However, it is important to make sure that the measurement of the disease tested by those devices is correct or not.
It is learned that, the National Metrology Lab (NML) department of the Bangladesh Standards and Testing Institution (BSTI) are responsible to carry out the calibration and verification of these instruments after import from abroad. But, most of the importers are avoiding the issue due to a cost of calibration. These equipments are being marketed only depending on the verification and calibration carried out by the manufacturing companies.
Public Health expert Benazir Ahmed said, “Calibration and verification of medical equipments are very important. If the equipments are not correct, the question remains about the result. At the same time, consumers are being deceived after purchasing these equipments.”
Abul Hossain, a resident of Badda said, “I have purchased a diabetes measuring machine or device (glucometer) from a drug store after being diagnosed with diabetes. But, the reading of diabetes was showing incredibly low in that device. I feel doubt and went to the hospital to check for diabetes. It shows that the amount of glucose in the blood was much higher in the hospital test than the device I bought.” Almas Uddin, Chief Pathologist of Pathology Department at Bangabandhu Sheikh Mujib Medical University (BSMMU) said, “In addition to calibration and verification of diagnostic equipment, regular QC (quality control) has to be done. If this is not done the same test will give different results in different labs.”
Health experts said, “In order to diagnose diseases in the developed world, the approval of various organizations has to be obtained before marketing imported medical equipment. For example, approval is required from organizations such as the Food and Drug Administration (FDA) in the United States,the European Union, and the CE. If quality verification is made mandatory after importing these equipments, the importers will be forced to comply with it.”
Country’s medical equipment is 100 percent import dependent. These equipments are imported from different countries including China, Thailand, Japan, Malaysia, Switzerland, Germany. However, the importers do not calibrate the equipment from the NML department of BSTI for fear of costing money. In this opportunity, they import and market substandard equipment. As a result, the buyers are being swindled. Not only that the users of these devices are facing health risk due to wrong reading or failure of diagnosis.
According to BSTI sources, the National Meteorology Lab was established in 2009. Since then, various organizations have verified and calibrated about 28,000 instruments from here.
BSTI Director (Administration) Taher Jamil said, “Three machines like pressure measuring machine, thermometer and weight measuring meter should be calibrated. However, the importers are taking the opportunity as there is no obligation. They do not calibrate to save money.”
According to sources, there was no authority to test the quality of medical equipments in the country. The Department of Drug Administration developed the Medical Device Guidelines in 2015. But the drug administration does not have the capacity to verify the quality of imported equipments. Verification and calibration from BSTI are required to know the exact measurement of the equipments.
Ayub Hossain, Director (acting) of the Department of Drug Administration said, “The importers are supplying the equipment in the market without calibration or verification from BSTI’s Metrology Lab. Therefore, low quality equipments are being flooded.”
Nur Hossain, Owner of Healthway, an importer of medical devices said, “A few number of weighing machines are being calibrated. But the pressure, thermometer, diabetes machine are not being calibrated. If the government makes it compulsory, everyone will do it. But, importers don’t want it as if it is made mandatory, their suffering may be increased.”
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