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Manila Bulletin devider Philippines devider National devider FDA raises concern, issues warning vs 'unsafe' medical devices

FDA raises concern, issues warning vs 'unsafe' medical devices

Published Sep 19, 2023 07:27 am

The Food and Drug Administration (FDA) on Tuesday, Sept. 19 issued a warning regarding the purchase and use of “unnotified, unregistered, and banned” medical device products.

In an advisory, the FDA named 10 medical device products that are deemed "unsafe for use.”

Among these medical device products, seven are classified as “unregistered,” including the following: Surgitech Chromic Catgut Sterile, Medical Depot Disposable Syringe, Icare® Infrared Thermometer, Chromic Catgut Suture Sh Round Bodied, Chromic Catgut Suture Sh1 Round Bodied, Chromic Catgut Suture Fs Curved Cutting, and Mersilk Black Braided Suture Non-boilable.

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Photo courtesy of FDA

These medical device products are not properly registered, and no corresponding Product Registration Certificate has been issued, according to the FDA's post-marketing surveillance.

According to Republic Act No. 9711, also known as the Food and Drug Administration Act of 2009, the manufacture, importation, sale, and distribution of health products without proper authorization is strictly prohibited, the FDA said.

It emphasized that the FDA cannot guarantee the quality and safety of these unregistered medical device products due to the lack of FDA evaluation.

Furthermore, all healthcare professionals and the general public are urged not to buy or use two "unnotified" medical device products, namely "Nonwoven Plaster Hypoallergenic" and "Vinyl Synmax Exam Gloves."

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Photo courtesy of FDA

Post-marketing surveillance has revealed that these products lack the necessary notification, and no corresponding Product Notification Certificate has been issued.

The FDA also warned against the purchase and use of "banned" medical device products, such as "Merufa-top Latex Examination Gloves."

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Photo courtesy of FDA

Pursuant to FDA Advisory No. 2017-180 and FDA Memorandum 2017-016, the importation, distribution, manufacture, storage, and use of certain products have been prohibited since Jan. 1, 2019.

Violation of these regulations constitute a direct breach of Republic Act No. 9711, it added.

The FDA stressed the strong encouragement for consumers to purchase drug items from FDA-licensed facilities to guarantee safety and efficacy.

It warned that failure to comply with these regulations may result in regulatory actions and sanctions. (Zekinah Elize Espina)

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