Product Liability Insurance For Mask Manufacturers In Canada

What Product Liability insurance for mask manufacturers is available?

Don’t leave home without one. Mask wearing is one of the top pandemic mitigation strategies that individuals are adopting when they are in public spaces. As a result, mask manufacturing in Canada has exponentially increased.

However, a recent Public Health Ontario Synopsis notes the simple act of wearing a mask may potentially expose people to unforeseen risks. This is because, “mask use by the general public could be associated with a theoretical elevated risk of COVID-19 through decreased physical distancing and self-contamination.”¹

As a Canadian mask manufacturer, you are well aware of the high level of trust that people are putting in your products. People are wearing your masks to protect themselves and others against the potential spread of infectious droplets in the air. And when people are relying on your products – especially during a pandemic – it is critically important to know that you have the best product liability insurance in place.

As you focus on scaling up production, we’re focussing on sourcing product liability insurance options for Canadian manufacturers. To deconstruct the specific risks mask manufacturers are facing, here are some new insights about liability exposures.

Are you manufacturing medical masks for healthcare workers?

To combat potential COVID-19 transmission, manufacturers are making different types of masks. Firstly, there are masks that are intended for use by medical professionals. These are known as Class 1 devices. To produce these types of masks, Canadian manufacturers must hold what’s known as a Medical Device Establishment Licence.

Secondly, “for masks intended for medical use, Health Canada endorses compliance with a number of ASTM/ISO and CSA standards specific to face shields and masks (see here for Health Canada’s recommended list). However, conforming to standards is voluntary for manufacturers of medical devices. Manufacturers may choose to demonstrate compliance with a standard or may elect to address the safety and effectiveness in another manner. Health Canada’s recommended minimum standards continue to apply even in cases of urgent improvised production.”²

Related Matters: Product recall. Does your company have the coverage it needs?

Moreover, the materials that you are using in medical masks are also important to evaluate. This is because there are specific standards Health Canada is providing for mask manufacturers to consult listed on this page. In addition, you can access all of the ASTM International standards for COVID-19 face masks, medical gowns, gloves and hand sanitizing products here.

Specifically, the Government of Canada notes, “There are certain technical challenges associated with 3D printing certain PPE, such as face masks, to ensure safety and effectiveness. 3D-printed face masks may provide a physical barrier, but are unlikely to provide the same fluid barrier and air filtration protection as licensed surgical masks or N95 respirators.”³

Is your company manufacturing non-medical masks for the general public?

Shopping at the grocery store. Using public transit. Visiting a newly reopened retailer. There are now many places outside the home where Canadians are wearing non-medical masks. This is because wearing a “non-medical mask/facial covering in the community is recommended for periods of time when it is not possible to consistently maintain a 2-metre physical distance from others, particularly in crowded public settings.”⁴

Related Matters: Canada.ca: COVID-19: How to wear a non-medical mask or face covering properly

As well, the Government of Canada is advising that non-medical masks and/or face coverings should:

• “allow for easy breathing
• fit securely to the head with ties or ear loops
• maintain their shape after washing and drying
• be changed as soon as possible if damp or dirty
• be comfortable and not require frequent adjustment
• (is) made of at least 2 layers of tightly woven material fabric (such as cotton or linen)
• (is) large enough to completely and comfortably cover the nose and mouth without gaping
• …not be made of plastic or other non-breathable materials”⁵

As a non-medical mask manufacturer, these are important factors to consider when you are designing, making and testing your products.

5 ways to manage product liability risks related to non-medical mask manufacturing

A recent article published by Gowling WLG provides some insights into the potential exposures that non-medical mask manufacturers in Canada may face. Specifically, they note, “non-medical and industrial-use masks must not give the impression they can be used for medical purposes.”⁶

If you are making non-medical masks, there are actions you can take to mitigate risk exposures. In addition to purchasing product liability insurance, it is important to think about your marketing and communications.

For example:

1. “It is important to consider the general impression conveyed to the consumer by labelling, packaging and advertising.
2. To reduce the risk of a non-medical mask being mistaken for a medical device, manufacturers may want to include a clear non-medical consumer use for the product.
3. They should also consider the warning/disclaimer language noted above regarding protection limits and expected use.
4. Like any claim made with respect to the sale of a consumer product, those claims must be true, verifiable and not misleading. This is especially the case if the appearance of the mask or language advertising the mask may suggest that it is made from medical-grade materials or in accordance with some other manufacturing or industry standard.
5. It is also important to consider other regulatory requirements that might be applicable to the sale of a non-medical mask, including textile labeling requirements.”⁷

How product liability insurance for mask manufacturers can protect your business

Don’t start up without product liability. Adding medical and/or non-medical masks to your production line means you are also adding risk exposures to your business. As the demand for mask manufacturing increases, so does the need to safeguard your bottom line with the best product liability coverage.

This is why it is good to know that product liability insurance can deliver the protection you need as a mask manufacturer. Product insurance protects against liabilities for losses due to injuries caused by malfunctions or defects in your masks. Design defects or a failure to warn consumers about the dangers of using your products are also part of this coverage.

Related Matters: Product Liability Insurance 101

Across Canada, we are aligning the best insurance options for manufacturers making products that are protecting people during the pandemic. Our insurance experts know how to source product liability insurance for mask manufacturers that will respond to new and evolving risks.

Sources:

¹ Public Health Ontario.ca: Synopsis COVID-19 – What We Know So Far About…Wearing Masks In Public ; ^2,6,7 Gowling WLG.com: Manufacturing Face Masks During The COVID Pandemic ; ³ Canada.ca: 3D printing and other manufacturing of personal protective equipment in response to COVID-19 ; ASTM.org: ASTM Standards & COVID-19 ; ^4,5 Canada.ca: Non-medical masks and face coverings: About ; Canada.ca: COVID-19: How to wear a non-medical mask or face covering properly ;