Special thanks to Victor Zhao for his assistance.
The COVID crisis has precipitated an urgent and unprecedented need for Personal Protective Equipment ("PPE"). In parts of the US, physicians have reportedly started wearing ski goggles for protection. To increase PPE supplies in Canada, Health Canada has implemented a variety of temporary measures, including an interim order that alters the regulatory requirements for a number of products. Despite changes to the regulatory scheme surrounding face masks, safety and label clarity must still be top of mind for manufacturers in order to prevent product liability claims and regulatory consequences.
This update will set out a number of regulatory and product liability considerations for face mask or shield manufacturers in Canada.
Are face masks/shields regulated medical device? Intentions are key
PPE includes gowns, gloves and masks that are intended to provide a barrier against infectious micro-organisms. PPE for facial protection comes in a variety of forms, including face shields, respirators and face masks. Many of these devices have applicable standards and regulatory requirements, as described below.
Most PPE - including face shields, masks and respirators - are Class I medical devices if they are represented for use for a medical purpose, such as prevention of infectious disease transmission (including uses related to COVID-19). In this environment, manufacturers should be clear if a mask is not intended for medical purposes (further described below).
Masks intended for medical use
Prospective manufacturers of masks/shields intended for potential medical use should be aware that licensing requirements continue to apply to their product even in the face of the COVID-19 pandemic. There are currently two new expedited licensing pathways that allow for the distribution and sale of Class I devices in relation to COVID-19:
- Manufacturers may submit an application under the provisions of the Interim Order to be granted authorization to import or sell COVID-19 medical devices; or,
- The manufacturer must hold a valid Medical Device Establishment Licence (MDEL). Health Canada is fast-tracking the Medical Device Establishment Licence (MDEL) application process for companies that want to manufacture, import or distribute certain Class I medical devices.
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.
Non-medical masks are also in high demand in Canada, as Canada's chief public health officer Dr. Theresa Tam recently advised that wearing a non-medical mask may reduce the spread of COVID-19 to others. Health Canada has similarly published a notice about homemade masks, stating that such homemade-type masks are "not medical devices". However, Health Canada notes that the use of homemade masks poses a number of limitations:
- they have not been tested to recognized standards
- they may not provide complete protection against virus-sized particles
- the edges are not designed to form a seal around the nose and mouth
- the fabrics are not the same as used in surgical masks or respirators
- they can be difficult to breathe through and can prevent you from getting the required amount of oxygen needed by your body
Generally, masks not intended for medical purposes are not subject to the same regulatory requirements as medical devices. However, non-medical and industrial-use masks must not give the impression they can be used for medical purposes.
Health Canada has not published public guidance or an enforcement policy specific to non-medical masks which are being manufactured and sold/donated to the public during the pandemic. In contrast, the US Food and Drug Administration, recently issued an updated Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency. The US FDA policy indicates that, while face masks are medical devices when they are intended for a medical purpose,
"[t]o help foster the availability of equipment that might offer some benefit to health care providers and the general public during the COVID-19 outbreak, for the duration of the public health emergency FDA does not intend to object to the distribution and use of face masks, with or without a face shield (not including respirators), that are intended for a medical purpose (whether used by medical personnel or the general public), without compliance with [specific] regulatory requirements where the face mask does not create an undue risk in light of the public health emergency."
In years prior to the COVID-19 pandemic, Health Canada issued guidance with respect to other types of PPE, including gloves, which similarly can have a medical purpose or a non-medical purpose. This guidance advises that manufacturers should make it clear on the label and in advertising that the mask does not have a medical use:
- Do not rely on terms such as "general purpose" or "multi-purpose" (Health Canada has found that this is not clear enough as consumers can misunderstand these words).
- Health Canada recommends using terms such as:
- "Industrial use only"
- "Not for medical use"
- "Not a medical device"
- Ensure the brand name or company name associated with the non-medical mask does not imply a medical use.
- Take steps to ensure that non-medical masks are not retailed to consumers in settings that imply medical use, e.g. in proximity to health care products or in medical supply stores.
It is important to consider the general impression conveyed to the consumer by labelling, packaging and advertising. 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. They should also consider the warning/disclaimer language noted above regarding protection limits and expected use.
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. 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.
Could I be liable?
Whether or not facial protections are classified as medical devices, manufacturers may still be liable for injuries arising from negligent design, manufacture, or labelling/marketing of the sample products (i.e. a failure to warn). There may also be liability under the Canada Consumer Product Safety Act and other consumer protection legislation.
Manufacturers owe a duty of care to avoid risk to consumer safety and must manufacture products that are reasonably safe for intended purposes. They also owe a duty of care to see that there are no defects in manufacture that are likely to give risk to injury in the ordinary course of use. Manufacturers must warn consumers of risks inherent in the use of the product and about which it has or ought to have knowledge.
In determining liability, courts will consider whether the manufacturer fell below the appropriate standard of care owed by it to the consumer, taking into account the nature and extent of the risk associated with the intended use of the product. At this time, it is unclear how the expedited response to the COVID-19 pandemic will impact the standard of care analysis for manufacturers expanding into production of PPE. Employing appropriate supplier screening and quality assurance processes will still be expected of manufacturers. The Ontario Superior Court of Justice previously considered the urgency of public health concerns in assessing the standard of care of a pharmaceutical company that released a vaccine for the H1N1 influenza prior to the completion of clinical trials. The Court found that the defendant met the applicable standard of care, despite the expedited distribution, as the vaccine at issue was administered due to public health concerns and with government approval.
Even if a manufacturer's actions fall below the standard of care, a potential plaintiff would still need to prove that the manufacturer's breach caused the harm suffered by the plaintiff. Causation is likely to be a challenge in the case of COVID-related face protection as virologists across the globe are still determining the exact mode(s) of transmission of COVID-19. Further, face masks are just one aspect of protection during a pandemic. Proving that the alleged harm was caused by the use of a particular face mask may be difficult in the circumstances.
As we described in an earlier update, the US has legislated product liability protection for face mask manufacturers, in addition to implementing the more relaxed regulatory enforcement policy described above. Canada does not yet have broad legislation protecting face mask manufacturers against product liability claims in relation to the COVID crisis. This is in contrast with the United States, where the Public Readiness and Emergency Preparedness Act protects certain manufacturers of medical countermeasures from civil liability.
A bright spot during these difficult times has been the incredible efforts of manufacturers to assist frontline healthcare workers and everyday Canadians. These efforts are commendable. However, as manufacturers move to fill the need for face masks during the COVID-19 crisis, and as facial masks for non-medical use become important to help protect consumers, careful consideration should be given to applicable regulatory requirements. While regulatory compliance does not act as a shield to a possible finding of liability in the manufacture and sale of a face mask/shield found to be faulty in design, manufacture or labelling, it can provide for the foundation of a strong defence. Even in the midst of this COVID-19 crisis, a manufacturer is required to act with reasonable care in the circumstances, regardless of whether products are donated or sold. A first-time manufacturer may also want to speak with an insurance broker about arranging appropriate coverage before donating or selling any products. Gowling WLG will be following regulatory changes closely.