COVID-19: List of FDA-Approved Products Safe for Public Use
Americans rely on the FDA to evaluate whether medical products such as medical drugs, diagnostic tests, and other medical equipment or devices are safe and effective. When a public health crisis emerges, like what we’re going through now with COVID-19, there may be an urgent need for products to prevent, diagnose, or treat the medical threat.
In certain types of medical emergencies, the FDA can issue an Emergency Use Authorization (EUA) to ensure timely access to drugs, diagnostic tests, and other critical medical products. This is not to be considered a substitute to the full approval of the FDA because in some medical emergencies there just isn’t enough time to conduct a full review of all evidence. When the EUA is invoked, the FDA quickly runs through all the available evidence and combs through all the available and potential risks before they give the product their (temporary) stamp of approval.
Face masks that are marketed for public and general non-medical related use such as those used in construction and other industrial settings, are not medical devices and are not regulated by the FDA. Face masks that are intended for medical use such as source control (including the ones used related to COVID-19) and surgical masks are the ones under their jurisdiction.
There are at least two types of masks being used for medical purposes. First is the surgical mask, the second is the N95 respirator. Although both devices cover the wearer’s mouth and nose, they differ in several aspects. For comparison, let’s include the regular, non-surgical face mask in the mix.
Face masks, including cloth masks, may not protect from fluids or may filter particles, needed to protect against pathogens, including viruses. They are not for surgical use. A study also states how different types of fabrics may affect a cloth face mask. It further states that in cotton (the widely used fabric for a face mask), the more the thread count, the better its performance is.
As for surgical masks, they are fluid-resistant, disposable, and loose-fitting that create a physical barrier between the wearer’s mouth and nose and the immediate environment the individual is in. Like face masks, they also do not provide full protection to the wearer against pathogens, including viruses.
N95 Respirators are considered personal protective equipment. Since they undergo a rigorous fittest, they tightly fit the face and filter airborne particles and thus provide a higher level of protection against viruses, bacteria, and other highly infectious pathogens.
If you represent your institution as a procurement specialist, then it’s worth to note that the FDA has compiled some basic how-tos in getting supplies. You can find it here.
For health care settings, the FDA, in conjunction with the Center for Disease Prevention and Control (CDC) and the National Institute of Occupational Safety and Health (NIOSH), suggests the use of NIOSH-approved air-purifying respirators and reusable respirators such as the elastomeric and powered air-purifying respirators (PAPRs).
To identify if the equipment you’re trying to procure is approved by the NIOSH, they conveniently compiled a list of products through the certified equipment list (CEL) which you can find here. The list includes both non-air powered (N95 or elastomeric) and PAPRs. Conversely, the NIOSH also has a list of counterfeit respirators to protect your interest and to ensure that the public will not be put into more health risks by utilizing fake equipment.
If in the event you cannot find a supplier among the names listed above, NIOSH also has a list of suppliers that you may import from who are not based in China. And if in the event you still cannot find a supplier in the second list, then you can try your luck with the FDA EAU authorized, but non-NIOSH approved respirator providers based in China.
One of the best ways to curb the spread of COVID-19 is to follow proper handwashing practices. This includes washing your hands often with soap and water. However, there are times when we find ourselves in situations where that is not possible, so the CDC recommends the use of alcohol-based sanitizers that contain at least 60% alcohol (ethyl alcohol).
It is within the realms of the FDA to regulate hand sanitizers as an over-the-counter drug and available without a prescription. There is a need for the same to be regulated as safety concerns arose from products that are contaminated with potentially toxic types of alcohol, not enough ingredients (ethyl or isopropyl alcohol), and labels containing false, misleading, and unproven claims.
For everyone’s convenience, it is safe to assume that the hand sanitizers being marketed passed the FDA’s standards except for the products found on this list.
Just type either the manufacturer, product/brand name, distributor, or National Drug Code (if available) on the search box provided to check if the hand sanitizer you’re planning to buy is one of those included in the do-not-buy list of the FDA. If you can’t find it there, then it’s safe and you may proceed to purchase it.
You may find more information about FDA advisories regarding hand sanitizers on their page here.
Gowns are also one example of personal protective equipment. They play a vital role in an infection-control strategy. In healthcare settings, gowns are used to protect the healthcare providers from the spread of infection or when they encounter liquid or solid material that is potentially infectious. Conversely, gowns are used to protect a patient suffering from immune deficiency or vulnerable patients, in general, from possible microorganisms that healthcare workers might bring.
There are several types of gowns used in a variety of healthcare settings. They include surgical gowns, isolation gowns, surgical isolation gowns, non-surgical gowns, procedural gowns, and operating room gowns.
Furthermore, gowns can also be classified based on the standard set by the American National Standards Institute/Association of the Advancement of Medical Instrumentation (ANSI/AAMI) based on their level of protection.
Level 1 can be used during basic care, a cover gown for visitors, or in a standard medical unit. Level 2 is used when there is a low risk such as when suturing, drawing blood, or working in pathology. Level 3 is used when there is a moderate risk of being exposed to potential infectious liquid elements such as drawing arterial blood, inserting an IV cannula, or tending to cases involving trauma. Lastly, Level 4 is used when there is a high risk such as assisting long, fluid intense surgical procedures or when infectious pathogens are suspected to be present.
Regardless of the name of the gown, what’s more important to note is to look for its intended use and the level of protection it offers to the above-mentioned risk levels. Product names are not standardized and therefore do not hold much bearing.
If you are still trying to figure out which type of gown is most useful in your institution, the CDC has prepared a guide that might be able to help make your task a bit more manageable. You can access it by clicking on this link.
When choosing gowns or any PPEs, considering these three key items will be important:
Type of anticipated exposure - consider the type of anticipated exposure such as touch, splashes, sprays, or large volumes of bodily fluids that might penetrate the clothing.
Durability - Concerning the first key item, you will also need to determine whether the material used for the gown will render it fluid-resistant, fluid-proof, or neither depending on how it’s intended to be used.
Fit - This is optional but highly encouraged. How many times have you seen a healthcare worker or equivalent that wore a protective gown only to be partially “protected” by it since the gown is too small of a size for him. That will render the donning of the gown useless in the first place.
Gloves are used to protect one’s hands from getting in contact with a potentially infectious element or surface. However, once the gloves already encounter the infectious material, then it also is a means to spread infection.
The CDC advises a few things regarding the proper DOs and DON’Ts as far as glove use is concerned including working from clean to dirty (touching a relatively clean area first before working towards the contaminated area and not the other way around), limit opportunities for “touch contamination” (refrain from touching your face with a contaminated glove and avoid touching other surfaces unnecessarily).
Consider the type of gloves used. If the packaging and type of glove indicate that it’s for single-use then dispose of it responsibly after use and do not ever try to reuse them. Another important aspect to take note of is possible allergic reactions to different materials that make a glove. However, there are different types of gloves out in the market and most likely, there’ll be one that will not cause any hypersensitivity reaction.