Oximeter sales soar but there is no guarantee of accurate reading and ‘no govt regulations’

Oximeters, which measure oxygen levels in blood, have been available for home use for a long time, but sales have soared amid the Covid-19 pandemic.

A pulse oximeter | Wikimedia Commons

New Delhi: Nisha Saxena, a 60-year-old Delhi-based homemaker, is one of thousands of Indians who purchased oximeters as Covid-19 strengthened its grip on the country. But she says her experience has been less than savoury.

A small, clip-on device, oximeters assess your oxygen levels and heart rate. Since Covid-19 hits patients’ lungs, oxygen levels in one’s blood are believed to be a key indicator of whether one has the disease. 

The device has been available for home use for a long time, but its sales have soared amid the Covid-19 pandemic. However, people who have used it, like Saxena, complain that the readings often appear discrepant and vague.

“We purchased two oximeters, one was for Rs 1,800 and the other for Rs 1,500. When we use these oximeters, we never get similar readings from both the devices. There is always a difference of at least five points.”

This is a worrying discrepancy. The ideal blood saturation level should be 95. Anything below 90 is a cause for concern and the patient should be taken to the doctor. With the oximeters believed to have a margin of error of 1-2 points, a discrepancy like the one experienced by Saxena can mean the difference between good health and needing medical attention. 

Priyal Khattar, a Gurgaon resident, didn’t find the device helpful either. “We haven’t noticed any problems with the oxygen reading, but the reading of heart rate fluctuates a lot. I tried it while sitting and my heart rate reading was 68… The minute I stood up and tried again, it jumped to 105. I hadn’t done anything physically straining.”

Khattar said the family purchased the oximeter for about Rs 3,000 but does not trust it anymore.

A 30-year-old teacher residing in Mumbai faced a whole different problem altogether. “My parents are senior citizens. Since they have heart problems, we often check their vitals. We did buy an oximeter but it often goes blank in the middle of a reading. We have to remove the batteries and restart the device.”

All three families said their devices don’t bear a brand name, and cannot be replaced or repaired either.

Asked about the problems faced by users, industry insiders say at-home-oximeter sales in India remain largely unregulated, and are not governed by a quality-control framework. There’s a China factor too, they claim. 

Insiders say the recent tensions with China have hit oximeter imports, forcing Indian companies to fashion the devices from parts sourced from the neighbouring country, with no clear guidelines to help them through the process.

ThePrint reached the Ministry of Health and Family Welfare, which oversees the Central Drugs Standard Control Organisation — the regulator for drug and medical imports — by mail, but there was no response until the time of publishing this report. 

Sales at all-time high

At-home oximeters, used most often by patients of lung disease, asthma or pneumonia, work on the basis of infrared light, said a manufacturer. 

“One end has a source of light and the other a detector. When you put your finger inside, the infrared light passes through the finger. Some light is absorbed by the skin and the rest is transmitted to the detector. The difference between the two is the reading,” the manufacturer added.

The principle is that high levels of oxygen in the blood mean more light will be absorbed.

Speaking to ThePrint, wholesale oximeter dealers said sales had particularly picked up since June, and they are now selling as many as 15 pieces a day to 2,000 a week, up from around 100-200 a month in pre-Covid times.

Arav Singh Rajput, a wholesale dealer in Delhi’s Vikaspuri, said he sold anywhere “between 10 and 15 oximeters a day”. “The demand for this product jumped June onwards,” he added. 

The devices are also available on e-commerce platforms like Amazon, Flipkart and Snapdeal, in a wide array priced between Rs 800 and Rs 14,000. Amazon offers 300 options for buyers to choose from, Flipkart, 545, and Snapdeal, about 100. 

Flipkart has seen a growth in demand for oximeters by 23 times over the past six months, said a company spokesperson. A representative for Snapdeal claimed “thousands of customers are buying oximeters but all priced below Rs 2,000”. 

Jinang Dhami, the CEO of Mumbai-based Mitocon Biomed, an indigenous oximeter manufacturer, said they had sold “about 8,000 oximeters in the last 40 days”.

Doctor consultation key

Rajput said he sells each oximeter for Rs 400 with no warranty.

Asked where he sources his oximeter stocks from, Rajput said the “bulk are imported from China… since there are barely any local manufacturers anyway”.

Nirmal Patel, a wholesale dealer who owns a shop in the Nikol area of Ahmedabad, said he sells anywhere between 50 and 200 oximeters a day. He admitted the devices, each of which is priced at Rs 700, are imported, but did not wish to mention where they are from. “You need to understand that there are some countries that produce medical devices cheaper than in European countries,” he said. 

If there are complaints from customers, Patel said, he takes the responsibility of repair. He said the devices being imported now are of cheaper quality and don’t come with any information about quality check.

Dhami said the oximeters they produce go through three stages of testing and simulations, but added that most of the other oximeters in the Indian market “are white-labeled”. 

“This means they are imported from China and labeled ‘Made in India’. We expect government regulations and norms on quality control by 2021, until then there is zero market regulation,” he added.

Sandeep Nangia, president of the Retailers and Distributors Chemist Association, a Delhi-based organisation that oversees retail distribution/supply chain of pharma products, said a “lot of companies are assembling oximeters on their premises”. “With no guidelines, they make whatever they understand. No one can guarantee their working.”

Asked about the presence of Chinese oximeters in the market, he said, “We all know about the prevailing tensions between the two countries, so the imports are not as large as they were two months ago. Most companies are importing parts and assembling them at their units.”

Dr Vikas Maurya, a pulmonologist with Fortis Hospitals, said doctors need to guide their patients on purchases whenever they prescribe the use of this device at home. 

“The oximeters used in ICUs cost between Rs 50,000 and Rs 1,00,000. These devices measure blood oxygen levels, heart rate, ECG, respiratory rate, blood pressure and also have arterial waveforms,” he added. “These devices come with lithium ion batteries that are rechargeable and the sensors in these machines cannot go wrong. However, with so many cheap devices available in the market, doctor consultation is key to avoid unnecessary panic.”

Asked about the things that need to be kept in mind while buying an oximeter, he added, “First of all, people should learn how to understand the output of the device. They should buy products from genuine brands. Put your finger in and give it some time to start working.”

The numbers on the panel should be checked, but, more importantly, the strip at the bottom — which gives a reading in waveform (the wiggly lines that project ups and downs in key parameters in various medical exams) — should be checked. The waveform of a healthy person will be a pulsed waveform, ie, with every heartbeat there should be a spike to reflect blood flow. “This generally indicates whether the device is working properly or not,” he added.

This report has been updated with additional information