Use registered oximeters to ensure accurate readings, says regulator

 

The Medical Device Authority (MDA) has urged the public to make sure that their pulse oximeters are registered with the authority to ensure that they obtain accurate measurements.

This came amid increased public interest in using pulse oximeters to monitor one’s condition amid the Covid-19 pandemic, particularly after a policy shift towards monitoring Covid-19 patients with mild or no symptoms at home instead of a healthcare facility.

“There is so much news we heard about oximeters nowadays, right? But don’t forget, only a registered oximeter will help you to get accurate results.

“As a (member of the) public you must know it is important to find the registered oximeter,” the MDA said in a public service announcement yesterday.

A pulse oximeter is a small medical device that can be worn on a fingertip to measure the heart rate and estimate the oxygen saturation (SpO2) in the blood.

A normal SpO2 reading should be 95 percent and above. A reading below that is suggestive of hypoxemia, which is a symptom of severe Covid-19 cases and an indication that hospitalisation may be necessary.

It should not be the sole consideration on whether to seek hospitalisation, as there may be other signs and symptoms that a patient’s condition is worsening and should seek help.

In the US, the Food and Drug Administration (FDA) had issued guidelines in February spelling out recommendations on how to use oximeters and their limitations.

Among others, it made a distinction between “prescription oximeters” that are registered with the FDA following clinical testing, and “over-the-counter oximeters” that are not FDA-registered and should not be used for medical purposes.

The testing for prescription oximeters requires test participants with a range of skin pigmentations, since some oximeters are less accurate when used on people with darker skin tones.

Meanwhile, the MDA said members of the public can check whether an oximeter is registered with the authority by asking a seller or pharmacist for the device’s product registration number, and then checking the MDA Registry website.

In the comments section in one of its Facebook posts, it also suggested those looking for a list of registered oximeters to run a search in the MDA Registry with the search terms such as “pulse” or “oximeter”. - Mkini

✍ Credit given to the original owner of this post : ☕ Malaysians Must Know the TRUTH

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