ASTM Mask Standards & IFU
INFORMATION FOR USE
Need information about best practices, shelf-life, donning and doffing?
Below you will find information and instructions for how to properly use PRIMAGARDTM Medical Face Masks.
Surgical and procedure masks are generally used to reduce the risk of pathogen transfer between individuals. Masks accomplish this by covering the mucous membranes of the nose, mouth, lungs with filtering materials and eyes where applicable with a visor. They can be used as protection for asymptomatic individuals or as a way to contain droplets from symptomatic individuals; however no mask completely eliminates the risk of exposure to blood or body fluids.
Masks are single use products and should be worn for one procedure or patient only. Surgical and procedure masks are not respirators and are not designed to create a complete seal or replace N95s. Masks should be regarded as contaminated after use and discarded according to hospital policies. When it is safe to do so, masks should be replaced if they become wet, soiled, torn, or dislodged in any way.
Draw the mask from the box with the color side of the mask facing out, and ensure the nosepiece is at the top. Open the pleats and form the nosepiece lightly across the nose and cheekbones. Note that for dye-free masks, often white on both sides, the layer grasped to pull the mask from the box should be facing out once donned. Once the nosepiece is formed, pull the earloops behind your ears. If donning a surgical mask, pull the top ties to the crown of the head and tie, followed by tying the bottom ties at the base of the neck. Ensure the mask pleats are opened enough to fully cover the nostrils and mouth. Once the mask is on comfortably, press along the nosepiece to form a snug fit against the face. If donning a visor mask, slide the index fingers between the mask and the bottom of the visor and press along the nosepiece to create the final fit.
Remove procedure masks by grasping the earloops and pulling out to clear the ears. When taking off a surgical mask, tightly grip the ties at the base of the neck and pull outward to break ties, followed by breaking the ties at the crown of the head. After earloops have been removed or ties have been broken, discard according to hospital policies ensuring not to touch the front of the mask as this should be treated as contaminated after use.
FREQUENTLY ASKED QUESTIONS
Do you have questions about PRIMAGARDTM Medical Face Masks and ASTM mask protection standards?
Below you will find the answers you need to the frequently asked questions we receive about medical face masks and ASTM standards.
What is ASTM?
ASTM refers to the American Society of Testing and Materials (ASTM). ASTM is an international standards organization that develops and publishes voluntary consensus technical standards for a wide range of materials, products, systems, and services—including those in healthcare.
How long is my medical face mask effective?
The filtration efficiency and protective ability of a medical face mask is compromised when the mask becomes wet, torn or dislodged. Generally speaking, the higher protection value of a mask the longer it will maintain filtration; however, there is no set rule for how long a mask should be worn as it depends on humidity levels, respiration rate, nasal discharge, talking, etc. A medical face mask should be worn for only one patient procedure or visit. If a mask gets wet or soiled it should be replaced.
What are ASTM standards for medical face masks?
ASTM standards are referenced by the Food and Drug Administration (FDA), as the endorsed standard in the United States. The current standard ASTM F2100-11 (2011) specifies the performance requirements for Medical Face Masks with five basic criteria:
1. BFE (Bacterial Filtration Efficiency): BFE measures how well the medical face mask filters out bacteria when challenged with a bacteria-containing aerosol. ASTM specifies testing with a droplet size of 3.0 microns containing Staph. Aureus (average size 0.6-0.8 microns). In order to be called a medical/surgical mask, a minimum 95% filtration rate is required. Moderate and high protection masks must have bacterial filtration rates greater than 98%.
Some manufacturers use the Modified Greene & Vesley method to determine the BFE rating. This method is NOT recommended by ASTM for product comparison or evaluating consistency.
2. PFE (Particulate Filtration Efficiency): PFE measures how well a hospital mask filters sub-micron particles with the expectation that viruses will be filtered in a similar manner. The higher the percentage, the better the mask filtration. Although testing is available using a particle size from 0.1 to 5.0 microns, ASTM F2100-11 specifies that a particle size of 0.1 micron be used.
When comparing test results it is important to note the size of the test particles used, as use of a larger particle size will produce a misleading PFE rating.
3. Fluid Resistance: Fluid resistance reflects the surgical mask’s ability to minimize the amount of fluid that could transfer from the outer layers through to the inner layer as the result of a splash or spray. ASTM specifies testing with synthetic blood at pressures of 80, 120, or 160 mm Hg to qualify for low, medium, or high fluid resistance. These pressures correlate to blood pressure: 80 mm Hg = venous pressure (Level 1), 120 mm Hg = arterial pressure (Level 2), and 160 mm Hg (Level 3) correlates to potential high pressures that may occur during trauma, or surgeries that include high pressure irrigation such as orthopedic procedures.
4. Delta P (Pressure Differential): Delta P measures the air flow resistance of the medical mask and is an objective measure of breathability. The Delta P is measured in units of mm H2O/cm2 and the lower the value the more breathable the mask feels. The ASTM standard requires that masks have a Delta P of less than 5.0 for moderate and high barrier masks, whereas low barrier masks must have a Delta P of less than 4.0.
5. Flame Spread: As hospitals contain sources of oxygen, heat, and fuel the ASTM F2100-11 standards include testing for flame resistance. Testing dictates that all hospital masks must withstand exposure to a burning flame (within a specified distance) for three seconds. All priMED masks meet this requirement.
5.5 In addition to the above tests, all medical face masks must be tested to an international standard (ISO 10993-5, 10) for skin sensitivity and cytotoxic tests to ensure that no materials are harmful to the wearer. Tests are conducted on materials used in construction of the mask which come in contact with the user's skin.
Are there different levels of protection with ASTM-rated medical masks?
Yes there are three unique levels of protection with ASTM-rated medical masks. Level 1 masks have the lowest barrier of protection, while Level 3 masks have the highest barrier of protection. For greater clarity on the differences, refer to the information in the charts below:
ASTM PROTECTION VS. INTENDED USAGE
|LEVEL 1 (LOW) BARRIER:
80 mm Hg
|LEVEL 2 (MODERATE) BARRIER:
120 mm Hg
|LEVEL 3 (HIGH) BARRIER:
160 mm Hg
|Light / minimum BFE & PFE protection||High BFE & PFE protection||High BFE & PFE protection|
|Used for general procedures and respiratory etiquette||More breathable than high barrier mask|
|Designed to resist a splash or spray at venous pressure||Designed to resist a splash or spray at arterial pressure||Highest fluid resistance – designed to resist a splash or spray during tasks like orthopedic surgery or trauma|
ASTM F2100-11 (2011) REQUIREMENTS FOR MEDICAL FACE MASKS
|TEST||LEVEL 1 (LOW) BARRIER: 80 mm Hg||LEVEL 2 (MODERATE) BARRIER: 120 mm Hg||LEVEL 3 (HIGH) BARRIER: 160 mm Hg|
|BFE (Bacterial Filtration Efficiency)
at 3.0 micron ASTM F2101
|≥ 95%||≥ 98%||≥ 98%|
|PFE (Particulate Filtration Efficiency)
at 0.1 micron ASTM F2299
|≥ 95%||≥ 98%||≥ 98%|
|Delta P (Differential Pressure)
MIL-M-36954C, mm H2O/cm2
|< 4.0||< 5.0||< 5.0|
|Fluid Resistance to Synthetic Blood ASTM 1862, mm Hg||80||120||160|
16 CFR part 1610
|Class 1||Class 1||Class 1|
What is the purpose of a medical face mask?
In the Operating Room (OR), surgical masks protect the sterile field from possible contamination, primarily as a result of coughing, sneezing or talking. A mask may also protect clinicians from the byproducts of surgical procedures such as bone chips, splashes of body fluids, and smoke plume resulting from laser or electrosurgical techniques.
Outside of the OR masks are used for standard precautions to protect clinicians and patients from pathogens that may spread by blood or other body fluids, secretions or excretions. Surgical and procedure masks are effective against droplet transmission.
What is the difference between a surgical mask and a procedure mask?
A surgical mask is used inside the operating room or within other sterile procedure areas to protect the patient environment from contamination. It also protects the clinician from contaminated fluid or debris generated during the procedure. Surgical masks have ties so that they can be adjusted for fit, and are tied over top of a surgical cap or a bouffant cap.
A procedure mask is used for performing patient procedures, or when patients are in isolation to protect them from potential contaminants. Procedure masks are used to protect both patients and staff from the transfer of respiratory secretions, fluids or other debris. Procedure masks are used for generally "respiratory etiquette" to prevent clinicians, patients and visitors from spreading germs by talking, coughing, or sneezing. Procedure masks have ear loops for quick donning, and since they do not slide on the hair, they can be worn without a surgical cap.
Why is the fit of a medical face mask important?
A medical face mask is only as effective as its fit. There should be no gaps along the side, around the nose or under the chin that would allow air and droplets to bypass the filter medium. The mask should always be properly adjusted to fully cover both the mouth and nose. A well-fitting mask stays in place over the nose and cheeks and even a regular mask will prevent fogging of eyeglasses if it fits properly. Masks should not be worn underneath the nose or dangling around the neck – they should either be fully on, or disposed of.
How do I ensure a good fit?
There are several things that contribute to a good fit. The most important consideration is the nose piece. It should mold over the nose and cheeks and maintain its shape over time. It should not kink or break when adjusted. Individuals with wider faces should select a mask that ensures full coverage over the face and under the chin. The upper tie should sit at the crown of the head, and the lower tie should be tied behind the neck to hold the sides of the mask against the face to prevent any gaping.
How do I know if the medical face mask is on correctly?
Generally, there are three things you should look for to ensure your mask fits correctly:
1. The aluminum nose piece is at the top,
2. The white (or smoothest side) is on the inside against the wearer’s skin—the colour always faces out,
3. The pleats fall downwards and away from the nose (called a “waterfall” pleat).
What tests or ratings should I rely on to ensure my mask is safe?
Specifications developed by the American Society of Testing and Materials (ASTM) are generally accepted as the industry standard. Beware of mask ratings that do not follow ASTM guidelines. Some manufacturers may refer to “filtration rates” or the “number of layers” as an indication of effectiveness. These vendors may not be adhering to the ASTM standards and should be questioned for specific test data.
What else should I know about medical face masks?
All individuals using medical face masks must be aware of the protective capabilities of the mask being worn. Healthcare workers should assess their risk of exposure to blood, body fluids, excretions and other potential hazards—and choose their mask accordingly.
A medical face mask is considered to be contaminated once it has been used, and should be discarded immediately. A mask should be removed by the edges or the ties rather than the front panel.
As part of Personal Protective Equipment (PPE), medical face masks with integrated visors are recommended to ensure compliance with eye protection. PPE includes all equipment and apparel that prevents potentially infectious material from contaminating clothing, skin, eyes, mouth, nose, or other mucous membranes.