The Food and Drug Administration (FDA) warned the public against purchasing and using unnotified, unregistered, and misbranded medical device products that have not been subjected to its stringent evaluation process.

The FDA has identified five medical device products as being "unsafe for use" as of Sept. 13.

A medical device product, the peak flow meter, has no corresponding product notification certificate, according to FDA’s post-marketing surveillance.

FDA also strongly advised against the purchase and utilization of unregistered medical device products, including oxygen mask with tubing (adult standard), nasal oxygen cannula (child), and nebulizer kit with mouthpiece tubing.

Its post-marketing surveillance has verified that these listed medical device products are not registered, and no corresponding product registration certificates have been issued.

In addition, the FDA asked healthcare professionals and the general public against the purchase and use of the “misbranded” medical device product known as the "Pulse Oximeter (in foreign characters)."

It confirmed through post-marketing surveillance that this medical device product is available for sale in the local market.

FDA’s warning is consistent with Section 19(c) of Republic Act (RA) No. 3720, also known as the Food, Drug, and Cosmetic Act, as amended by RA No. 9711, which is also known as the Food and Drug Administration (FDA) Act of 2009.

Section 19(c) requires clear and prominent labeling, saying that a device is misbranded if the key information needed by this Act is not easily readable and understood by the average consumer during normal usage and purchase.

The consumption of these illegal medical devices carries potential health risks, as the FDA cannot guarantee their quality or safety.

Consumers are urged to purchase medical device products only from FDA-licensed establishments to ensure their safety and efficacy. (Zekinah Elize Espina)