Important Information About Counterfeit Respirators

Important Information About Counterfeit Respirators / Misrepresentation of NIOSH-Approval

Updated April 28, 2020

Counterfeit respirators are products that are falsely marketed and sold as being NIOSH-approved and may not be capable of providing appropriate respiratory protection to workers.

When NIOSH becomes aware of counterfeit respirators or those misrepresenting NIOSH approval on the market, we will post them here to alert users, purchasers, and manufacturers.

How to identify a NIOSH-approved respirator:

NIOSH-approved respirators have an approval label on or within the packaging of the respirator (i.e. on the box itself and/or within the users’ instructions). Additionally, an abbreviated approval is on the FFR itself. You can verify the approval number on the NIOSH Certified Equipment List (CEL) or the NIOSH Trusted-Source page to determine if the respirator has been approved by NIOSH. NIOSH-approved FFRs will always have one the following designations: N95, N99, N100, R95, R99, R100, P95, P99, P100.

Signs that a respirator may be counterfeit:

·        No markings at all on the filtering facepiece respirator

·        No approval (TC) number on filtering facepiece respirator or headband

·        No NIOSH markings

·        NIOSH spelled incorrectly

·        Presence of decorative fabric or other decorative add-ons (e.g., sequins)

·        Claims for the of approval for children (NIOSH does not approve any type of respiratory protection for children)

·        Filtering facepiece respirator has ear loops instead of headbands

Additional Tips for Spotting Counterfeit Respirators

Updated April 21, 2020

Before buying large quantities of respirators from third party market places or unfamiliar websites, look for the following possible warning signs:

Third-party marketplaces

·        If a listing claims to be “legitimate” and “genuine,” it likely is not.

·        Examine transactions history and feedback if possible

o   On auction sites or third-party distribution networks, most have a link to the seller of the item and their past sales. This is where buyers have the option to leave feedback regarding the experience with the seller such as if the buyer received the item as advertised, if they received it in reasonable amount of time, and if the buyer was unhappy with the product. Many reviewers will report if a product didn’t work or if it was cheap in construction.

·        Are there fluctuations of items traded over time (high or low periods of transaction?)

o   Is the seller marketing the same products over time, or are they primarily selling trendy items? Legitimate businesses and distributors typically sell what they know and stay consistent with their stock over time. A buyer should be able to discover this by looking into a businesses’ other products. Buyers should also be able to gain insight to sellers on big online platforms (reviews of the seller).

·        Are there price deviations and fluctuations (Is it too good to be true?)

·        Look at the quantity a buyer has in stock.

o   During a time of shortage, advertising “unlimited stock” could be an indication that the respirator is not approved.

·        Does the seller break marketplace policy and hide their contact information within images to circumvent filters.

o   Typical third-party marketplaces require interactions between seller and buyer to occur within an on-site messaging system. Sellers should not try to circumvent this system to display personal contact information.

On websites – look at the big picture

·        Is the primary contact email address connected to the website or is it a free email account?

o   Using a free email service may suggest the seller is not committed to the domain

·        Look for bad grammar, typos, and other errors.

·        Watch for cookie-cutter websites, where the sellers interchange several websites, making mistakes:

o   Mixing up names/logos

o   Leaving the site partially unfinished with dummy text

o   Blank pages

o   A nonsense privacy policy page and/or broken links.

o   Domain squatting type activity (misspell the domain).

Step by Step Compliance guide from Dr. Cesar Solano, Jr.

Dental Compliance in the Covid Era

All of you in the dental industry know this is like no other time we have experienced.  It is kind of scary as we are in unchartered waters dealing with Covid 19. 

Dentistry is one of the highest risk careers of exposure to the Covid 19 virus.  Given this possibility, newer guidelines for infection control prevention needs to be implemented in each office.

Dr. Cesar Solano, Jr. has given a step by step compliance guide to help you deal with the Covid 19 situation in your office.  Please see his recommendations below:

 

Standard Precautions will be the first thing everybody in the office would need to be reminded of:

1.    Hand hygiene

2.    Use of personal protective equipment (e.g., gloves, masks, eyewear) 

3.    Respiratory hygiene / cough etiquette 

 4.    Sharps safety (engineering and work practice controls

 5.    Safe injection practices (i.e., aseptic technique for parenteral medications)

 6.    Sterile instruments and devices

 

7.    Clean and disinfected environmental surfaces

But this will not be enough, not even close to enough. Changes will start from here on out. 

Some changes that may minimize risk: (this is in addition to what we already do)

 

Patient Check in and Scheduling

·       All paper work should be filled out online, before showing up to the office

 ·       In the event the patient does not have access to a computer, she or he will be given a form to be filled in a separate room with the door closed or the patient’s vehicle

  ·       Patient should be asked in a specific form if he or she has contracted Covid 19 or has been in contact with anybody diagnosed with Covid 19

 ·       Patients should come alone to their appointments unless they are being sedated or need a companion (Minors, special needs, etc.)

 ·       Anybody that is in waiting for a patient does not need to be in the operatory should wait in their vehicle

 ·       Patients should not spend more time than necessary in the waiting room

 ·       Patients should be scheduled with enough time that warrants complete sanitation of operatories – no double scheduling

  ·       Patients coming in the office should be offered hand sanitizer before touching anything  

 ·       They should spray the soles of their shoes and use shoe covers

 ·       Pens can be gifted in case the need to sign anything

 ·       Temperature should be taken before going back to the operatory

·       Patient should be evaluated for any flu like symptoms and signs. No patient with symptoms, no matter how mild, should be seen for elective treatment

 ·       Staff can walk the patient to the operatory room already using all mandatory, clean PPE

 ·       Once in the operatory with the patient, the assistant must stay in the room until the procedure is completed, discarding the PPE before leaving the room

 ·       Separate staff may be used only to bring in the operatory any material or instrument that may be needed to avoid having to change PPE

 

In the Operatory

·       Patient will be walked into the dental operatory and given a mandatory pre-rinse with a peroxide at minimum of 1% concentration for 60 seconds before starting any procedure (Colgate Peroxyl or Listerine Whitening)

·       No paper material of any kind should be in the operatory during treatment that uses sprays or aerosols

 ·       Every staff members and or provider in the operatory should be wearing all PPE once entering and should REMOVE SOILED PPE BEFORE EXITING

·       Once the patient is seated, it is recommended that no one should leave the operatory until the procedure is finished

 

Grooming of Dentist and Staff

·       No facial hair – according to the CDC, certain type of facial hair reduces the filtering capacity of respirators and masks

 ·       Long hair should be put up or shortened

 ·       Nails should be trimmed

 ·       No use of jewelry

  

Personal Protective Equipment

·       Critical masks: N95 respirators need to be custom fit when performing any treatment with aerosols and used in context to the complete Respiratory Protection Program

 ·       Non-critical masks: level 3 surgical masks may be used if it is a procedure with no aerosols

  ·       Gloves: Double Glove Technique should be used for all dental procedures – the outer glove should be disposed of before removing all other PPE.

 

  ·       Eye and Face Protection for Critical Tasks: Face Shield and Protective Glasses should be the standard in any procedure where aerosols are produced- should be cleaned with soap and water and when visibly soiled, disinfected with a disinfectant wipe between patients

 

·       Eye and Face Protection for Non-Critical Tasks: Protective glasses are fine 

  ·       Head Covers and Feet Covers: should be used while treating patients and discarded before leaving the operatory

 

·       Gowns for Critical Tasks: surgical gowns should be used with a level 3 or greater protective barrier

·       Gowns for Non-Critical Tasks: Non-surgical gowns should be used with a level 2 protective barrier

 

 Other Clincal Layer Precautions

·       Restorative treatment should be performed with a rubber dam or extra suction device

 ·       Disinfecting the teeth with hydrogen peroxide prior to treatment is recommended

 ·       Working in quadrants is recommended

  ·       High volume evacuator should be functioning during all treatment where aerosols are being generated

 ·       Amount of water should be reduced as much as possible

  ·       Equipment such as extraoral suction should be used

 

 ·       Operatory doors should be closed if possible

 ·       The use of UV lamps or negative pressure rooms would be ideal.

 

 Staff and Work Environment

·       No staff should come to work if sick or having flu like symptoms

 ·       Practice social distancing at work

 ·       Everybody should disinfect their shoes before entering the building

 ·       No one should wear their clinic attire or clinic shoes home

 ·       If office has an on-site washer and dryer, launder clinic attire at the office

 ·       If no onsite washer and dryer, clinic attire must be removed and placed in a sealed bag and washed separately with a disinfectant like Lysol for the laundry

 ·       Clinical staff should take a shower immediately when arriving home to remove any possible contaminates so as to not expose the family

 The main objective is to minimize risk of contamination.  By standard procedures to reduce the new encountered risk of Covid 19 infection.  By containing risk within the operatory during the dental procedure.

8 Tips to Become Compliant Easier and Faster

Looking for help with compliance?

8 Tips to Become Compliant Easier and Faster

 Click http://dentalosha.net for help.

Have you found it hard to navigate the requirements of Dental Compliance?  Have you been confused when trying to find all the OSHA requirements an office must implement as well as the state requirements? Are you looking for help with your compliance? Here are 8 tips to make your compliance journey easier and faster:

   1.  Create a Culture of Compliance. 

The dentist or the owner of the practice should set the expectation of compliance.  They are the Captain of the ship.  The leader whom everyone looks to for guidance.  If the Captain believes in safety protocols and systems, the crew will also.

 2.  Assign a Compliance Coordinator for your office.

This is usually  someone who works in a clinical capacity or an office manager.  This person is like the navigator of the ship plotting the course of the journey. This person is in charge of directing the process.  They will make sure all deadlines are met, all documentation is recorded, all training is completed and all systems are in place.  They should delegate key responsibilities to the staff to make sure things get done in a timely manner.

3.    Hire the right Compliance Consultant.

This person should be there to answer questions after the training is finished.  Many times, a trainer comes into your office or you go to hear them speak at a continuing education course and you never hear from them after the training.  You can’t reach them. They won’t call you back and they won’t respond to your emails. A good Compliance Consultant will take the time to help you through the compliance process by being accessible when their clients need them.

 4.   Set a realistic timeline to complete office compliance.

I have seen this many times.  An office wants to get everything done in two weeks. They become overwhelmed and confused. If you are just starting your compliance journey, it will most likely take you several months to have everything in place.  There are a lot of tasks to complete.  This takes time.  The best thing you can do is be realistic with the project so you won’t be crushed under the weight of the requirements.

 5.    Make it a team effort.

 

Everyone on the team has a role to play and a job to do.  Just like the crew on a ship, everyone participating and contributing will get the job done…. FASTER.  And more effectively. 

 6.    Use your checklists.

Your Compliance Consultant should give you a list of tasks and duties to complete.  When you follow a checklist, this makes it easier and more efficient to complete the project. The checklist is like the ship’s compass.  It will give you a direction with systems organization and guidance. 

 7.    Do the small tasks first.

This way when you complete several of the many requirements, it feels like you have accomplished something.  You get the smaller and easier tasks out of the way to focus on the bigger items.  It will not feel as if you have as much looming over your head.  This helps you to not become overwhelmed.

8.    Have regular compliance meetings.

In the beginning, I recommend having one training session, and then updates once a month until all tasks, plans and documentation are completed.  After that, then have your annual training and then a subsequent compliance meeting to go over and maintain your systems and records.

 If you follow these steps and adhere to the system, I promise it will make the process of becoming compliant easier to navigate.