MedTech – Barrier Mask Update

HRB CRCI are actively working with the Department of Health, Health and Safety Authority and Enterprise Ireland as well as other invested parties to generate appropriate information on face masks.

In summary there are 3 categorizations of face masks:

  1. Medical/Surgical face masks: Regulated by the Health Products Regulatory Authority (HPRA)
  2. PPE face masks, shields, PPE: Regulated by the Health and Safety Authority (HSA)
  3. General public: Regulated by the Competition and Consumer Protection Commission (CCPC)

The official definitions are:

A medical face mask (also known as surgical or procedure mask) is a medical device covering the mouth, nose and chin ensuring a barrier that limits the transition of an infective agent between the hospital staff and the patient. They are used by healthcare workers to prevent large respiratory droplets and splashes from reaching the mouth and the nose of the wearer and help reduce and/or control at the source the spread of large respiratory droplets from the person wearing the face mask. Medical masks comply with requirements defined in European Standard EN 14683:2014.

A respirator (PPE) or filtering face piece (FFP), is designed to protect the wearer from exposure to airborne contaminants (e.g. from inhaling infectious agents associated with inhaling small and large particle droplets) and is classified as personal protective equipment (PPE). Respirators are mainly used by healthcare workers to protect themselves, especially during aerosol-generating procedures. Valved respirators are not appropriate for use as a means of source control as they do not prevent the release of exhaled respiratory particles from the wearer into the environment. Respirators comply with requirements defined in European Standard EN 149:2001+ A1:2009.

Non-medical face masks (or ‘community’ masks / artisan) include various forms of self-made or commercial masks or face covers made of cloth, other textiles or other materials such as paper. They are not standardised and are not intended for use in healthcare settings or by healthcare professionals.