Since the coronavirus pandemic, the sales of oximeters have shot up steeply as they are a key medical device for a COVID-19 patient in home quarantine.

Doctor checks a mans oxygen levels using a finger tip pulse oximeter during a door to door survey to identify spread of the coronavirus disease Source: Picxy
Delve Medical Devices Wednesday, October 14, 2020 - 12:30

In July, Shradda* a resident of Rajendranagar in Hyderabad bought three oximeters for members of her family, who tested positive for the coronavirus. “My mother is 64 years old and has pre-existing conditions. She had a bad case of COVID-19, and we used the oximeter to take her vitals at least four times a day, especially to monitor her oxygen levels,” says Shraddha who even maintained a chart, noting down her mother's SpO2 (oxygen level in blood hemoglobin) levels.

“The readings varied greatly. The device gave different readings depending on whether my mother was sitting or lying down when the readings were taken. The readings fluctuated a lot in the first week of treatment. My mother was panicking. Also, the devices stopped working after two months. I recently checked and it showed my SpO2 level as low as 75, which can't be accurate. We bought the devices from an e-commerce website and from a medical store,” she added.

As part of COVID-19 treatment in India, those who have tested positive for the coronavirus but are asymptomatic or with mild symptoms, are encouraged to isolate at home during treatment. Almost all hospitals providing COVID-19 treatment also offer home quarantine kits, which almost always includes a fingertip pulse oximeter. The device is worn on the fingertip and apart from reading blood pressure, temperature and other statistics, the medical device also records the blood oxygen level of patients. Doctors advise COVID-19 patients that if their oxygen level drops below 92 SpO2 (considered a sign of hypoxaemia), they should be hospitalised.

Despite the oximeter being a key medical device that could ensure timely hospitalisation for COVID-19 patients, doctors, health activists question the quality of the ones that are commercially available in the country, and the readings shown by these devices.

Since the start of the pandemic in March, several pulse oximeters under different brand names have flooded the Indian markets, both offline at medical stores and online at e-commerce websites. Some claim to have approvals from the United States Food and Drug Administration (US FDA) but don’t show up in the list of manufacturers of these approval agencies. Some also sport the Conformitè Europëenne (CE) mark of the European Union on their packages, but unlike US FDA, the EU does not have a list of approved manufacturers on the public domain.

The Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health & Family Welfare is tasked with quality checks and claims of approval of these devices being sold in India. Regulations laid down by the Quality Council of India (QCI) and the National Accreditation Board for Certification Bodies (NABCB) ensure that the products, if being manufactured in India, conform to international quality standards. The National Pharmaceutical Pricing Authority’s (NPPA) job is to ensure no disparity in the pricing of medical devices between those manufactured locally and those that are imported.

In India, manufacturers of these oximeters and other medical devices must comply with Drugs & Cosmetic Act, 1940 & Rules, 1945 and the Medical Devices Rules, 2019. However, the rules are yet to be implemented fully in India as the regulations are voluntary and in cold storage. There is also a disparity in pricing between local and imported medical devices, making local manufacturers unable to compete, say those from the Association of Indian Medical Device Industry (AIMED).

In the absence of oversight, observers say it's a free market for medical device imports such as oximeters to flood Indian markets, and there is no assurance on whether the devices sold are fit for medical use.

Can commercial oximeters be trusted?

Abishek Mutian is a start-up coach and an entrepreneur, who reviewed several stand-alone pulse oximeters available on e-commerce websites in India. He found most of the oximeters are not fit for medical use. "The so-called US FDA approved ones in India do not make the same claim on their USA website. Most are not even listed on the US FDA website. Some products sold in India claim to have been designed in a western country but will not be listed on the e-commerce sites of those countries," he points out.

He further added that some of the oximeter products found in Indian e-commerce sites are listed abroad under different brand names with poor ratings, saying, "There are oximeters claiming to be made locally, but are rebranded and are of low quality. Cheap pulse oximeter sensors are known to be inaccurate at lower readings (where it matters). There's a reason for why actual medical equipment costs a premium..”

Abishek alleges that the sellers are exploiting consumers due to the lack of awareness on the subject and enforcement of the regulations.

"When a trillion-dollar company, which has poured billions into research and development for a pulse oximeter, is not confident about its accuracy, should we trust $100 pulse oximeters with our life?" asks Abishek.

 

 

TNM reached out to several brands selling pulse oximeters online in India, but none of the importers were responsive.

E-commerce websites like Amazon and Flipkart were unresponsive when asked about quality checks of medical devices sold on their platforms. A source from one of the two firms said, “Since the start of the pandemic in March, sales of these devices have gone up two to three-fold.”

Doctors have no say

TNM spoke to a couple of doctors from Telangana and Karnataka who oversee COVID-19  patients, asking them about how reliable commercially available oximeters are. The doctors said that the hospital managements had tasked their sales team to procure devices, and they have no say in the final purchase.

“If we have a clinical mismatch between what the machine shows and what we see clinically when we observe a patient’s symptoms, we can ask for an arterial blood gas (ABG) test that can estimate oxygen percentage,” a doctor from Telangana said.

“Doctors are not technical people. We only use available medical knowledge for the betterment of patients. Our job is to recommend patients who have COVID-19, to monitor their SpO2 levels to avoid unnecessary hospitalization. Doctors have no say or control over which company’s oximeters are used for that,” said another doctor from Karnataka.

Lack of regulations

Rajiv Nath, convener with the Association of Indian Medical Device Industry (AIMED), alleges that some of these products are making a fool out of everyone.

“They tell their friends abroad to open an office and get registered there. They then use fake documents to sell the product in India and other countries, claiming to be from the US or EU. It's the job of the regulator (CDSCO) to check if it’s a manufacturer or a marketing company that's selling the product. Are the regulators even checking the shipments?” he asks.

“The medical devices used to fight COVID-19 need to be brought under regulation immediately,” says Rajiv, who adds that it's the task of the CDSCO to ensure that all medical devices being imported from China into India are not using fake US FDA and CE approvals.

Additionally, the certification, Indian Certification for Medical Devices (ICMED), that Indian manufacturers of medical devices have to adhere to ensure product quality, is voluntary. ICMED is a quality certification for all medical devices sold in India and was formulated in 2016 by QCI in association with AIMED and the NABCB.

“These rules are voluntary in nature and the latest amendments to these rules made in 2018 are yet to be implemented,” says Rajiv, who adds that these rules, if implemented, will ensure quality standardisation of medical devices in India. “But the regulations are only for Indian manufacturers and not for imports. It's comical,” he added.

In an email response to TNM, the Chairman of QCI, Adil Aainulbhai said that the ICMED Scheme was launched as a voluntary initiative on March 15, 2016 when there were no Medical Devices Rules in place.

“Medical Devices Rules were launched by the government in 2017 which is mandatory for the manufacturer now,“ he said, adding that since 2016, as many as 26 Indian manufacturers got certified voluntarily.

Asked about bringing medical devices that are being imported under the government's quality control plans for medical devices, the chairman said, “There are still many categories of medical devices which are not covered under MDR 2017 which the government is actively considering to include as mandatory requirements.”

Relaxed time frame to register causing harm?

The website of the CDSCO says that the department has received 10,236 applications so far, from medical device manufacturers across India, and have processed 2,208 and have approved 39,202 medical devices.

The Medical Devices Rules, 2019 came into effect only in April this year and the amendments give all manufacturers time until 2023 to get all medical devices made in India, registered. They are, however, allowed to sell their products in the meantime. Observers say that the time to get registered should be shortened to six months or a year.

“It will take up to two years for many of these devices to get regulated. Right now we are in a transition period and it is quite pathetic, because we have kept the highest-risk devices to have the longest transition,” says Malini Aisola, co-convenor of All India Drug Action Network (AIDAN), adding, “The industry is not conforming to any standardisation yet.”

AIMED is also concerned about Indian manufacturers losing out in the meantime as the markets are potentially getting flooded with cheap quality oximeters.

“The components are cheaper in China. The retailers in India change the MRP sticker, add their own price and sell oximeters for anywhere between Rs 3,000 and Rs 6,000. There is no customs duty on these imports, hence they are cheaper than Indian products. For the retailers, there is no profit margin while selling Indian products and thus, they lose out on the competition. Many of the claims of approval by these importers are fake,” alleges Rajiv.

At one point in March this year, the Union government did raise concerns over the quality of oximeters and its pricing. The NPPA, as part of a move to control prices, asked manufacturers to submit data on pulse oximeters but the findings are yet to be made public.

CDSCO officials from southern states of Tamil Nadu and Telangana say that they got instructions to start inspecting medical devices only in February this year. The officials have not received any training on what to or how to inspect medical devices and are hesitant to speak to the media. At the moment, the CDSCO is only testing the quality of RT-PCR testing machines being imported. The remaining medical devices, including oximeters, will likely have to wait in line for quality checks.

According to AIMED, there are only four Indian manufacturers in the pulse oximeter sector. “In the absence of quality checks, anyone can sell,” says Malani, adding that it was a matter of life and death as, “people are relying on these devices to decide if they should go to the hospital or not."

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