PPE: Buyer Beware

  • Jul 21, 2020

PPE: Buyer Beware

 

PPE or Personal Protective Equipment is such a common phrase right now it’s probably coming up in your family dinner conversation and everyone in the family is able to contribute to the conversation.

There is a lot about PPE and FDA (Food and Drug Administration) that you are likely not aware of that you need to know if you are shopping for PPE, so let’s get to it.

As you have probably heard, the Centers for Disease Control and Prevention (CDC) are recommending that:

“To reduce the spread of COVID-19, CDC recommends that people wear cloth face coverings in public settings when around people outside of their household, especially when other social distancing measures are difficult to maintain.”

 There is a distinction between PPE and Cloth face masks

PPE is protective clothing, helmets, goggles, or other garments or equipment designed to protect the wearer's body from injury or infection.  PPE is used in medical settings to protect both the medical staff as well s the patient infection, that’s why a surgeon wears a surgical mask.  The FDA sets strict standards and regulations for PPE that used for infection control, and manufacturers normally must show that the products meet standards and specific criteria.

 

Cloth face masks are not designed to be PPE, nor are they a substitute for proper PPE in a medical setting, they are just not designed to be used for medical purposes. The CDC has stated that cloth face masks are an effective preventive against the spread of the COVID-19  (CDC Reference), with preventive being the key word. The general public as a whole does not need the level of protection that a medical  provider needs as they are routinely exposed to infected patients by way of their profession, and we all need to Thank them for what they do.

 

        Authorized by the FDA or Approved by the FDA, what does it mean?

 

Due to the Coronavirus pandemic, the FDA relaxed some of its rules for importing  into and producing PPE in the United States under an Emergency Use Authorization (EUA).  This was necessary because manufacturers have not been able to keep up with the demand since the US supply was already low at the beginning of the pandemic. 

Just because a manufacturer states that a product has been

                  “authorized by the FDA under an EUA”,

does not mean that the item is “FDA approved”.  It only means that the FDA has authorized the manufacturer to sell the items as PPE based on information that the manufacturer has submitted to the FDA under the Emergency Use Authorization, instead of the manufacturer having to actually prove or demonstrate that the items actually meet the FDA standard.

You may also see an FDA logo next to a product, which is extremely misleading, but it will not say “FDA APPROVED”It’s merely another way companies are attempting to legitimize the products they sell.

Even if you don’t purchase from us, please be careful when purchasing any kind of PPE or face masks.

 

Bottom line: Be careful with what you purchase, know the limitations of the items you are purchasing and in what setting they will be used, to determine how effective they will be.

 

For more information on the FDA’s Enforcement Policy for Face Masks and Respirators during the Coronavirus Disease (COVID-19) Public Health Emergency, please click HERE.

 

Click HERE to brose some of our Facemasks they we offer to keep you safe.

 


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