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Quality Assurance Action On Facemasks

A quality assurance check showing some face masks used in the health sector don’t fully meet specifications won’t have any impact on national supply, the Ministry of Health said.

The Ministry of Health has today advised DHBs to put on hold their stocks of one type of face mask, as they do not fully meet the agreed standards for use in New Zealand healthcare settings.

Independent testing of Duckbill N95/P2 particulate respirators (face masks) made by QSi and produced in 2018 and 2019, show they protected the user as expected but did not meet the standard for protecting others from the person using the mask.

“The Ministry is asking that all these face masks be withdrawn from use and has placed a hold on further ordering. Initial replacement stock of around four weeks supply has already been shipped to DHBs,” Sue Gordon, Deputy Chief Executive, COVID-19 Health System Response said.

“Testing confirmed the face masks protect the wearer by preventing small droplets from being inhaled, which is key for health sector use. In most instances masks are used by health professionals to prevent them being infected by their sick patients.

“The testing also showed the masks provide some protection for preventing exhaled droplets passing through the mask – but not to the required standard.

“Placing this stock on hold will not place wider N95/P2 mask supply in the health sector at risk as there are plenty of alternatives currently available in the national supply and more masks on order,” Sue Gordon said.

New Zealand has good supplies of face masks and PPE and we receive new stock regularly.

“The Ministry estimates that up to 600,000 of these masks are available in the health sector, many of which are held in reserve. Total usage of N95 face masks from the national stock is usually around 6000 masks a week,” Kelvin Watson, Group Manager – Testing, Immunisation and Supply said.

“Overall, current national reserves of the N95/P2 masks mean we have the equivalent of 40 weeks supply when at a mid-level alert level, as we were in August.

“Face masks that don’t meet agreed standards for use in healthcare settings may still be able to be used in other settings – for instance in industrial use,” Kelvin Watson said.

Today’s actions are part of the Ministry’s quality assurance programme of regularly checking PPE fully meets the appropriate standards.

“It’s timely we are able to make these checks and place the stock on hold at a time where there is not any additional pressure on the health system. 

“We do not have community transmission in New Zealand, and our healthcare workers undertake significant other measures to protect themselves and those around them.

“Our assessment of COVID-19 having been spread through the use of these face masks in healthcare settings is considered as being low to no risk.

“The Ministry will continue to strengthen our quality assurance processes to ensure New Zealand’s healthcare workers have access to the highest standard of PPE,” said Sue Gordon.

Many countries have faced global challenges during COVID-19 in terms of securing quality PPE that meets standards.

QSi is a New Zealand-based company which sources raw material supplies for PPE from overseas and has been critical to providing masks to New Zealand when there was difficulty accessing masks off-shore in the early stages of the pandemic.

“QSi is working with the Ministry on managing the current call to put these masks on hold. QSi is also undertaking their own investigation and has implemented their internal quality assurance processes. We are working together in good faith, to resolve this matter as quickly as possible. While the matter is being addressed, the current production of masks by QSi for the Ministry of Health has been paused.

“The Ministry’s testing programme for masks being supplied in New Zealand continues and we expect more test results, including on QSi Duckbill N95/P2 masks produced in 2016, 2017 and 2020, early next year. However, as a precaution the masks from these years are also being placed on hold,” Sue Gordon said.

The Ministry of Health has advised DHBs that it will collect supplies of the impacted masks in the New Year.

Face masks are only one measure to keep people safe during COVID-19. Staying home when sick, frequently washing hands or using hand sanitiser, good cough or sneeze etiquette and regular cleaning of high touch surfaces have the biggest impact.


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