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Substandard pulse oximeters: Pulse rates rise, as authorities begin crackdown

04 Sep 2021

  • Success of CAA raids doubtful, as low-quality oximeters removed from shelves
  • NMRA assures quality of registered oximeters, as it followed strict evaluations
By Maheesha Mudugamuwa  A severe shortage of pulse oximeters was reported in the local market last week, as pharmacies have allegedly hidden stocks of substandard oximeters following the revelation of a large-scale scam where low-quality products were sold to consumers recently, The Sunday Morning learnt. Consumers alleged that the pulse oximeters they purchased at a cost of around Rs. 3,000 to Rs. 4,000 were giving inaccurate readings, while some had even given readings when connected to an object like a pencil or a pen. Additionally, some customers claimed they paid even more than the aforementioned amount. These allegations gave rise to serious concerns due to the increasing number of Covid-19 patients under home-based management during the past few weeks, as incorrect blood oxygen level readings could put the lives of those patients at risk. A pulse oximeter is a device that is used to measure the oxygen level (oxygen saturation) of the blood. It can be used at home without the need for a blood sample. Usually, a small clip is put on the tip of the finger to estimate the oxygen level by measuring the proportion of oxygenated haemoglobin in the blood in pulsating vessels. The oxygen level (or oxygen saturation, SpO2) shows on the display screen. When Covid-19 patients are under home-based management, most patients were advised to check their blood oxygen levels regularly and get to a hospital if the level dropped. Usually, low blood oxygen levels result in symptoms such as fatigue or shortness of breath. However, Covid-19 patients may not display these symptoms, and therefore, it is advised that oximeters be used to determine when patients need medical attention. In response to the revelation that low-quality pulse oximeters were being sold in the market, the Consumer Affairs Authority (CAA) last week launched islandwide raids. However, speaking to The Sunday Morning, National Medicines Regulatory Authority (NMRA) Food and Medicines Inspection and Legal Action Division Head Amith Perera alleged that the success of the raids was questionable, as the products were already taken off the shelves after a pharmacist had shared the names of the NMRA-registered oximeters with pharmacies around the country. “When the stocks are hidden, the corrupt sellers who have taken advantage of the pandemic situation while deceiving the public cannot be identified through the raids,” he stressed. He also shared that three businessmen, who had been importing and distributing substandard oximeters, were taken into custody together with 3,500 oximeters in Pettah on 12 June. Subsequently, another 1,700 oximeters had been seized from pharmacies through said raids. According to a notice issued by the NMRA to all pharmacy owners and community pharmacists, as seen by The Sunday Morning, two importers – namely, Medex Holdings (Pvt.) Ltd. and Sunway Holdings (Pct.) Ltd. – have been registered with the NMRA, while three other importers – namely, Digital Cells (Pvt.) Ltd., Mega Meditech (Pvt.) Ltd., and George Steuart Health – have been issued Waivers of Registration (WORs) for pulse oximeters. Accordingly, out of all available brands in the market, the NMRA stated that it had only approved products under the brand names of Edan, Rossmax Atlan Teen, iMDK C101A2 – OLED, iMDK C101A2, Lintemed LT F20, Lepu LOX100A, LOX100C, and LOX100A, and urged the public to check the brand name before they purchase the product. As per the NMRA, apart from one brand, all brands were being brought down from China. Additionally, the Authority had urged pharmacists to sell products approved by the NMRA. However, when contacted, All Ceylon Private Pharmacy Owners’ Association (ACPPOA) President Chandika Gankanda stressed that if the NMRA had publicised the approved brand names earlier, such problems would not have arisen. “There was a severe shortage of oximeters in the market, and several products were brought down during that time. The issue was with regard to those products that were brought down to the country illegally and distributed to pharmacies,” he stressed. Gankanda, however, alleged that faults were reported in registered products as well. “Now there is a shortage as the non-registered products have been withdrawn from the market. Current prices vary between Rs. 3,000 and Rs. 4,000, and there is one brand that costs around Rs. 11,000,” he stressed. According to the US Food and Drug Administration (FDA), although pulse oximeters are useful for estimating blood oxygen levels, the device has limitations and a risk of inaccuracy under certain circumstances that should be considered. Patients with conditions such as Covid-19, who monitor their condition at home, should pay attention to all signs and symptoms of their condition and communicate any concerns to their healthcare provider. Meanwhile, when contacted, NMRA Chief Executive Officer (CEO) Dr. Kamal Jayasinghe guaranteed  the quality of the products registered under the NMRA, as these were registered following strict evaluation by a team of experts approved by the Authority. “We send the product to the team of experts, and they check the product and give us the recommendations. Based on those recommendations, we give the approval,” he noted.   Dr. Jayasinghe said that any importer who wishes to bring down products can directly apply to the NMRA, and following an evaluation of the product, the Authority would issue a registration. “There is no limitation, and those who want to bring down the product have the freedom to do so,” he added. Meanwhile, a maximum retail price (MRP) of Rs. 3,000 has been set for pulse oximeters, State Minister of Production, Supply, and Regulation of Pharmaceuticals Prof. Channa Jayasumana stated on Thursday (2). He urged the public to purchase oximeters that are listed on the NMRA website to avoid purchasing faulty, substandard medical devices. When contacted by The Sunday Morning, the CAA Spokesman said the raids are now being conducted by the NMRA and the authority is not involved with those raids. Meanwhile, the Government last week announced a maximum retail price (MRP) of Rs. 3,000 for a pulse oximeter. According to Production, Supply, and Distribution of Pharmaceuticals State Minister Prof. Channa Jayasumana, the relevant gazette notification will be issued soon in that regard. He told the media that stern legal action would be taken against those who have imported fake equipment to the country without approval.


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