IPU Guide on Face Masks V2
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IPU Guide on Face Masks V2
The European Centre for Disease Prevention and Control (ECDC) has defined three categories
of face masks.
Medical face masks – (also known as surgical or procedure masks) create a
barrier between staff and patients by covering the mouth, nose and chin. They
are used by healthcare workers to prevent large droplets and splashes from
reaching the mouth and nose of the wearer. They also reduce and/or control
the spread of large respiratory droplets from the person wearing it.
Non-medical face masks – (community masks) include various forms of self-
made or commercial masks and face covers made of cloth or other textiles.
They are not standardised and as such are not intended for use in healthcare
settings or by healthcare professionals. These do not have to comply to any
particular standards, so less stringent requirements are needed when sourcing
for resale to the public.
Respirator face masks – (or filtering face pieces (FFP)) are designed to protect
the wearer from exposure to airborne contaminants (small and large
droplets). Healthcare workers mainly use filtering face pieces during aerosol-
generating procedures.
Additional information on facemasks from ECDC can be accessed here.
HPSC Guidance on the Use of Surgical Masks in the Healthcare Setting in the Context of the
COVID-19 Pandemic can be accessed here.
This HPSC guidance applies to pharmacy staff and in pharmacy settings:
• Surgical masks should be worn by healthcare workers when providing care to patients
within 2m of a patient, regardless of the COVID-19 status of the patient.
• Surgical masks should be worn by all healthcare workers for all encounters, of 15
minutes or more, with other healthcare workers in the workplace where a distance of
2m cannot be maintained.
The HSE and IPU issued joint guidance entitled Frequently Asked Questions Relating to COVID-
19 and Pharmacy Staff V2 which can be accessed here. This guidance covers the use of face
masks within a pharmacy setting. The WHO recommends surgical face masks should have
good breathability, internal and external faces which can be clearly identified, and meet EN
14683 or ASTM F2100-11 standards.
Version 2: 15 May 2020Mask Types and Standards
Respiratory and surgical masks are medical devices and as such will be CE marked. These
masks are defined by two main ISO standards: EN 14683 and EN 149, and all such masks
should have a certificate of conformity to indicate they comply with these standards. The two
standardised mask types are evaluated differently.
IEN 14683 Medical face masks
These are also referred to as surgical masks and are assessed in the direction of exhalation
(from inside to outside); the tests on these masks take into account the efficiency of bacterial
filtration.
A surgical mask does two things:
1. Prevents droplets of saliva or secretions from the upper respiratory tract when the
wearer exhales. If worn by the caregiver, the surgical mask protects the patient and
his or her environment (air, surfaces, equipment, surgical site). If worn by a contagious
patient, it prevents the patient from contaminating his or her surroundings and
environment.
2. Protects the wearer from infection transmitted by droplets or from the risk of splashes
of biological fluids. In the latter case, the surgical mask must have a waterproof layer.
These masks come in different grades, and different activities within a healthcare setting will
require different grades.
• BFE (Bacterial Filtration Efficiency) indicates the amount of bacteria released through
mask into the air. Two classes are available:
➢ Type I BFE = > 95%
➢ Type II BFE = > 98%
• Breathing resistance is also determined and this is important for the wearer as it
indicates the effort it takes to force air through the mask material. The lower the Delta
P, the more breathable and comfortable the mask. Two types are available, and these
types can be splash resistant or not, which is denoted with an R:
➢ Type I & II (non-splash resistant) = < 29.4Pa/cm2
➢ Type 1R & IIR (splash resistant) = < 49.0Pa/cm2
EU Standard Class Bacterial Filtration Breathing Splash Resistance
Efficiency Resistance Pa/cm2 (mmHg)
Type I 95%American standards for medical face masks are detailed in the ASTM F2100-11 standards.
The table below outlines the different levels; ASTM Level 1 is appropriate for use within a
pharmacy.
EN 149 Respirator masks (not recommended for pharmacy staff)
Respirator masks are assessed in the direction of inspiration (outside to inside). The tests for
these masks take into account the efficiency of the filter and leakage to the face. In Europe,
the EN 149 standard has three classes of disposable particulate respirators: FFP1, FFP2, FFP3
(where FFP is filtering face piece).
EN 149 is one of the European standards for masks while N95 masks are certified by the US
National Institute for Occupational Safety and Health (NIOSH). Both types of masks are
designed to reduce the wearer's respiratory exposure to airborne contaminants such as
particles, gases, or vapours.
The EN 149 masks are classified into three classes, depending on the ability to separate air-
borne particles:
Class Separation ability at 95L/min airflow
FFP1 Filter separates 80% of airborne particles
FFP2 Filter separates 94% of airborne particles
FFP3 Filter separates 99% of airborne particles
FFP2 masks that meet the EN 149 standard are the closest to N95 masks in the ability to filter
particles.
This mask type is not recommended for use in a pharmacy and is reserved for use in hospital
environment with COVID-19 patients where aerosol-generating activity is taking place.
Version 2: 15 May 2020Safe Use of Masks
It is very important that staff are trained on the safe use of masks. The HPSC has developed a
poster which we recommend displaying in your pharmacy. A video detailing this guidance can
be accessed here.
Do
• Clean your hands properly before you put it on;
• Cover your mouth and nose with the mask and make sure there are no gaps between
your face and the mask;
• Tie the mask securely;
• Replace the mask as soon as it is damp;
• Replace if removed to eat, drink or use a phone.
Don’t
• Do not touch the mask while wearing it – if you do, clean your hands properly;
• Do not use a damp or wet mask;
• Do not reuse a mask;
• Do not allow to dangle around your neck.
Taking off a mask
• Remove it from behind – do not touch the front of the mask;
• Put it in a bin straight away (if it has not been used to treat a COVID-19 patient it can
be discarded in normal domestic waste);
• Clean your hands properly.
Use of masks is in addition to, and not a replacement for, other methods to reduce the risk
of transmission of infection, i.e. hand hygiene, social distancing and respiratory etiquette.
Considerations when Buying Masks
Purchasing for internal use by staff within your pharmacy
The mask type recommended for use is a surgical grade mask that meets EN 14683; this mask
type is considered a medical device and therefore falls under medical device legislation which
is regulated by the HPRA. The HPRA has developed a clear guide of what you need to consider
when purchasing a medical device which can be accessed here. Check the following prior to
purchasing:
• Ensure the device you are planning to buy has a CE mark;
• Devices that are CE marked and sold on the European market must come from a
registered business premises in Europe (look for a European address);
• Try to buy directly from the manufacturer or an authorised dealer;
• You may wish to consider asking to see the certificate of conformity (confirmation that
mask conforms to the EN 14683 standards) for the masks prior to purchase to ensure
the quality.
Version 2: 15 May 2020We are aware that counterfeit products are being place on the market within the EU and
that caution is needed when dealing with a new supplier.
VAT considerations
The Revenue Commissioners will allow the application of the zero rate of VAT to the supply
to the HSE, hospitals and other healthcare settings of Personal Protection Equipment (PPE)
and medical equipment for use in the treatment of patients with COVID-19. The zero rate may
only be applied to supplies to hospitals, nursing and care homes, GP practices and the like;
supplies to any other operators, even if they are intended for onward supply to a healthcare
provider, are liable at the standard rate. This concessional treatment will apply from 9 April
2020 up to 31 July 2020, subject to review. More information can be found here.
Purchasing of masks for onward distribution
If you are purchasing masks for onward distribution, you will need to decide if VAT is
applicable. In relation to masks for onward distribution or resale to customers in your
pharmacy business:
• VAT should be applied (some exceptions are listed above);
• If you are selling medical grade masks, the packaging should have an EU distributor
listed on the packaging. If you have imported from outside the EU, you will be
considered the distributor and need to adhere to the EU medical device legislation
and requirements for distributors. The HPRA has produced a guide outlining your
responsibilities which can be accessed here;
• If you are selling respirator masks, these fall under the European Harmonised
Standards for Respiratory Protective Equipment EC Personal Protective Equipment
Directive (89/686/EEC). This Directive is implemented in Ireland as the European
Communities (Personal Protective Equipment) Regulations 1993. Only equipment
which meets these requirements is entitled to carry the CE mark and be sold for use
in the EU/EEA. Information on the standards applicable for these masks can be found
on the Health and Safety Authority website here.
The NSAI has produced a useful Quick Guide to Manufacturing and Importing Personal
Protective Equipment and Medical Devices for the COVID-19 Pandemic to ensure
Compliance. The guide summarises all the main considerations for importation of PPE and
can be accessed here.
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