Supporting information for oral care providers related to the COVID-19 pandemic

More information can be found on our 3M Oral Care PPE website

You can contact us directly via our website: www.3M.co.uk/dental-contact

3M is responding to the rapidly changing COVID-19 outbreak by working with local governments and health authorities to provide supplies where they are needed the most. We recognise your urgent need for PPE products and are working hard to ensure availability as soon as possible.
To register your interest and keep updated on availability please subscribe to our 3M Oral Care mailing list: www.3M.co.uk/dental-sub

Please refer to the NHS England Standard Operating Procedure.

3M™ Aura™ 1862+ and 1863+ Respirators are only available in one, universal size.

3M masks and respirators are not reusable. More information can be found here: WHO-2019-nCov-IPC_PPE_use-2020.3 (PDF)

Fit testing should only be carried out by a trained fit tester.

More information can be found at www.fit2fit.org
Customers can also contact safetyservices.uk@mmm.com for more information.

You should do everything possible to avoid cross contamination. Please refer to the NHS England Standard Operating Procedure.
Dental standard operating procedure: Transition to recovery

There are no specific stipulations on wearing make-up. However, excessive make up which may compromise the seal of the respirator should be avoided.
Guidance-on-RPE-Fit-testing (PDF)
Guidance-document-Qualitative (PDF)

If you have symptoms of COVID-19 you should follow the UK Government’s latest guidance.

3M PPE is sold through distributors. Please contact your usual dental supplier for availability and pricing. 3M has not changed the prices we charge for 3M PPE as a result of the coronavirus outbreak, but we cannot control the prices distributors charge for 3M respirators

Please refer to the NHS England Standard Operating Procedure.
Dental standard operating procedure: Transition to recovery

We recommend you only purchase 3M PPE through an authorised dental supplier to help ensure authenticity. More information can be found here:
Fraudulent Activity and Counterfeit Products Letter

3M respirators do not have ear loops as these can compromise fit. Please refer to the NHS England Standard Operating Procedure.
Dental standard operating procedure: Transition to recovery

Most disposable and reusable respirators will have a 5-year shelf life from date of manufacture. It is not recommended to use a respirator after the expiry date.

No, dental masks have differing levels of fluid resistance depending on the material they are made of.
It is important to read the specifications to determine which type is suitable for oral care procedures.
In addition to protecting patients from particles expelled by the wearer, fluid resistant masks provide a barrier to help keep saliva or blood splatter from reaching the wearer’s mouth and nose.

According to the CDC Infection Control Standard Precautions, Dental Professionals should wear appropriate personal protective equipment, including masks, when splashes or sprays of blood and body fluids are likely.

When choosing a mask, a health care professional should consider fit, fluid resistance, filtration ability and breathability.

According to the CDC’s Interim Infection Prevention and Control Guidance for Dental Settings During the COVID-19 Response, dental health care personnel should select the highest level of personal protective equipment (PPE) available.

For additional information please visit:

• Choose the Right Protection For You - 3M™ Face Masks Guidance document (PDF, 805 KB)
• Summary of Infection Prevention Practices in Dental Settings - Basic Expectations for Safe Care (PDF, 834 KB, www.cdc.gov)
• Centers for Disease Control and Prevention - Interim Infection Prevention and Control Guidance for Dental Settings During the COVID-19 Response (www.cdc.gov)

Surgical/medical masks are designed to reduce the risk of large particles expelled by the wearer - such as saliva and mucus - from reaching patients.

In Europe, the requirements and test methods for surgical masks are specified in the standard EN 14683:2019+AC:2019 for Medical face masks (surgical masks). Surgical masks are CE marked as class I medical devices according to the European Medical Device Regulation.

In accordance with the standard, surgical masks have to be tested for their:

• Bacterial filtration efficiency (BFE) which is tested in vitro
• Breathability
• Splash Resistance (optional)
• Microbial Cleanliness
• Biocompatibility

Based on the result of the BFE tests, masks are divided into two types.

• Type I masks have a minimum bacterial filtration efficiency of 95%,
• the so-called Type II masks need to have a minimum bacterial filtration efficiency of 98%.

In the standard, it is also mentioned that Type I surgical masks should only be used for patients and other persons to reduce the risk of spread of infection particularly in epidemic or pandemic situations. Type I masks are according to the standard NOT intended to be used by healthcare professionals in operating rooms or medical settings with similar requirements, but instead are for use by patients and other persons to reduce the spread of infection.

According to the standard, Type II masks (e.g. masks with a minimum BFE of 98%) can be tested and classified as splash resistant. Splash Resistance is indicated with the capital "R". This means that Type IIR surgical masks are Splash Resistant masks with a minimum BFE of 98%.

Masks often fit loosely, leaving large gaps between the mask and face. Check the specifications of the mask to identify the level of fluid resistance.

Respirators are designed to reduce the wearer’s exposure to airborne particulate hazards. Respirators also require both fit testing and user seal checks.

In Europe, respirators are tested in accordance with the test standard EN 149: 2001+A1:2009.

When respirators are tested in accordance with EN 149, the so called “Total Inward Leakage” (TIL) of the device is measured. TIL is defined as the sum of: ¹²

• the filter efficiency,
• the efficiency of the seal between the mask and the skin of the face of the wearer (facial seal)
• the performance of an existing exhalation valve (if fitted).

Based on the test results, respirators are divided into 3 categories; FFP1, FFP2 or FFP3. (FFP stands for Filtering Face Piece). The minimum performance criteria for TIL are:¹²

• FFP1 respirators must have a TIL not greater than 22%
• FFP2 respirators must have a TIL not greater than 8%
• FFP3 respirators must have a TIL not greater than 2%

Differences between Surgical Masks and Respirators in summary;

• Surgical masks are NOT intended and developed to protect the wearer of the mask against airborne biological hazards in the air. Respiratory Protective Devices are intended to protect the wearer against airborne and respirable biological hazards
• Surgical masks can protect a patient or the environment from exhaled potentially contagious particles.
• A filter which has lost the electrostatic charge will be less efficient against filtering out certain particles from the air.
• Microbial cleanliness (bioburden), breathability and BFE are important requirements for surgical masks
• TYPE IIR surgical masks do NOT offer respiratory protection
• TYPE I surgical masks are according to EN14683 are meant to be used for patients and other persons to reduce the risk of spread of infections particularly in epidemic or pandemic situations.
• Based on Total Inward Leakage and filtration efficiency, Respiratory Protective Devices are classified in FFP1, FFP2 and FFP3

For additional information please visit:

Respirators and Surgical Masks: A Comparison - Technical Bulletin (PDF, 309 KB)

Differences between EN149 and N95

The most important test protocols and classification systems for Respiratory Protective devices are the (European) EN149 test standard and the (USA) N95 test protocol.

• 
• Respiratory Protective Devices which are sold on the European market need to bear a CE mark. The CE-mark for a Respiratory Protective Device actually exists out of 4 components which need to be printed on every individual product as well as on the packaging of the product. The 4 components are:
  
  

  1. The CE-mark
  2. The test standard (EN149)
  3. The FFP class (FFP1, 2 or 3)
  4. The 4-digit identification number of the Notified Body

The N95 standard

The National Institute for Occupational Safety and Health (NIOSH) is the US organization responsible for testing and certifying Filtering Facepiece Respirators (FFRs). Depending on the test results, they classify Respiratory Protective Devices in 9 categories. Which are: ¹⁴

• N95, N99, N100
• P95, P99, P100
• R95, R99, R100

The numbers in the NIOSH classification indicate the minimum filter efficiency

N stands for Not resistant to oil (suitable for use in healthcare settings)

R for Resistant to oil.

P for oil Proof.

Standard and surgical FFP2 respirators are both designed to help reduce the wearer’s exposure to airborne particulate hazards.

FFP2 respirators are typically used in industrial settings and are not considered fluid resistant while surgical N95 respirators are fluid resistant and typically used in health care settings.

For additional information please visit:

• Respiratory Protection FAQ: Healthcare - Technical Bulletin (PDF, 370 KB)

Fit Test

• Conducted by a trained fit tester.
• Verifies that the respirator can achieve an acceptable fit on a wearer’s face.
• Must be conducted annually or more often if the wearer’s face changes in a way that could impact the fit.

User Seal Check

• Performed by the wearer each time the respirator is worn.
• Confirms that the respirator is worn correctly and has sealed to the face.

Medical masks and respirators are designed and regulated as disposable devices. However, supplies of all have become limited due to the COVID-19 pandemic.

The European Center for Disease Prevention and Control published in their “Technical Report March 2020” some guidance on how to deal with a potential shortage of PPE. ²

On page 2 of that report we can read:

• The use of PPE for the different procedures to be performed should be considered on a case-by-case risk assessment
• Healthcare workers performing the first assessment without direct contact; the patient should wear a surgical mask and keep a distance of at least 1 meter.
  If possible, a physical barrier such as glass or a plastic teller window can be used to avoid direct contact and keep the distance; in such case no PPE is necessary.
• If available, provide a surgical mask for patients with respiratory symptoms (e.g. cough)
• Healthcare workers performing aerosol-generating procedures (AGP), such as swabbing, should wear the suggested PPE set for droplet, contact and airborne transmission (gloves, goggles, gown and FFP2/FFP3 respirator)
• If there is a shortage of FFP2/FFP3 respirators, healthcare workers performing procedures in direct contact with a suspected or confirmed case (but not at risk for generating aerosol) can consider wearing a mask with the highest available filter level, such as a surgical mask, in addition to gloves, goggles and gown.
• In order to maximize the use of PPE if there is an insufficient access to stocks of PPE materials, staff should be assigned to carry out procedures, or a procedure, in designated areas. For example, assign staff to swabbing procedures in a dedicated swabbing area.
• While swabbing patients, healthcare personnel can use the same respirator for several patients for a maximum of 4 hours without having to remove the respirator, as long as it is not damaged or soiled, unless the manufacturer explicitly advises against this.

For additional information please visit:

• https://www.ecdc.europa.eu/sites/default/files/documents/COVID-19-infection-prevention-and-control-healthcare-settings-march-2020.pdf

3M is collaborating with several sterilization companies and institutions that are investigating ways for hospitals to safely decontaminate respirators.
To that effect, 3M is committed to testing 3M respirators regarding the effect of the decontamination processes on fit and filtration performance.

We are in the process of testing treated 3M respirators from multiple sterilization companies and institutions.
We do anticipate that additional information will be available as this work is completed and reviewed with regulatory agencies.

Current information supports the following conclusions for all 3M filtering facepiece particulate respirators:

• 3M does not recommend the use of Ethylene Oxide due to significant concerns associated with off-gassing.
• 3M does not recommend the use of Ionizing Radiation due to degradation in filter performance.
• 3M does not recommend the use of Microwave due to melting of the respirator near metal components resulting in compromise of fit.
• 3M does not recommend the use of High Temperature, Autoclave, or Steam due to significant filter degradation.

For additional information please visit:

• Decontamination Methods for 3M Filtering Facepiece Respirators such as N95 Respirators - Technical Bulletin (PDF, 192 KB)
• Decontamination and Reuse of Filtering Facepiece Respirators (www.cdc.gov)