TGA Identifies Defects in Face Masks

A Post-Market review of face masks included on the Australian Retister of Therapeutic Goods (ARTG) has seen product defect alerts for four brands.

The Therapeutic Goods Administration (TGA) has issued alerts for - 

1. Wuhan Topmed Trading Co’s Softmed disposable face mask (ARTG No: 333133);
2. Chengdu Xinjin Shifeng Medical and Apparatus and Instruments Co Ltd’s Shifeng surgical face mask (ARTG No: 333739), and
3. Masks from Henan Gore Medical Instruments Co Ltd (ARTG No: 334004 and ARTG No: 332939).

Reasons for issuing the alerts included “indications of systemic failures in quality control measures, an absence of batch numbers and inconsistent testing results” in the case of the Wuhan Topmed masks, while the TGA reported their was “insufficient evidence to support claims for bacterial filtration efficiency, differential pressure or splash resistance”, relating to the other manufacturers’ masks.

A product notification was also issued for Wuyishan Jiean Medical Device Manufacturing Co Ltd’s Korango Disposable Surgical Mask (ARTG No: 333778), as it had the “incorrect ARTG classification”.

Source: Pharmacydaily.com.au, Wednesday 20 January 2021