China’s Liuzhou City Market Supervision Bureau recently released information on the 13th administrative penalty case in 2021. A hospital in Liuzhou City used disposable medical masks that did not meet mandatory standards, and 113,000 masks were seized and confiscated.
In November 2020, the bureau received a letter from the Guangxi District Drug Administration and a test report from the Guangxi District Medical Device Testing Center. The report showed that disposable medical masks purchased by a hospital in Liuzhou failed random inspections. The unqualified items were mask straps and ventilation resistance.
Unqualified ventilation resistance can easily lead to unsmooth human breathing and affect human health. However, the mask belt is unqualified and easily falls off, which affects normal use.
The masks were produced by Henan Shengyuan Medical Materials Co., Ltd., and the Liuzhou Hospital involved purchased them through another sales company. The manufacturer also carried out a re-inspection of the masks, but they were still unqualified.
The hospital purchased a total of 238,700 of the above-mentioned face masks, with a value of 78,000 yuan. After the recall procedure was initiated, 3,600 units were recalled, and approximately 113,000 units were sealed on-site, together with those kept in the warehouse.
Until the end of the investigation, the bureau did not receive any adverse reactions to the use of the aforementioned masks, and the hospital involved actively cooperated with the investigation and fulfilled the relevant purchase inspection obligations. After investigation, the unqualified ventilation resistance is mainly caused by high ventilation resistance, which is caused by the use of filter materials with high ventilation resistance in order to improve the filtration efficiency. The hospital involved was not aware of this.
The hospital used disposable medical masks that did not meet the mandatory standards and violated the medical device supervision regulations. About 113,000 unqualified masks were confiscated and exempted from punishment.
The reporter also inquired that the face mask manufacturer Henan Shengyuan Medical Materials Co., Ltd. has been repeatedly punished by the market supervision department. In October 2019, the company’s disposable medical masks were substandard and were fined 20,000 yuan; In August 2020, it was fined 53,800 yuan for producing medical devices that did not meet the technical requirements of the registered products. In July 2020 and January 2021, the company also issued two notices to recall 18,000 unqualified and non-compliant masks.
Source: Guangxi News