The U.S. Food and Drug Administration (FDA) places Personal Protective Equipment under its regulated medical device category. The Agency describes PPE as equipment designed to protect the wearer, usually the heath care provider, from injury or the spread of infection or illness.
Examples of PPE according to FDA:
- Protective Clothing
- Face Shields
What the FDA has done to help address concerns about availability during the COVID-19 pandemic is to issue EUAs for certain Personal Protective Equipment products such as respiratory protective devices, face shields and other barriers. The agency has also issued recommendations and policies on PPE.
PPE as medical devices can be further categorized into three classes, depending on the risk they control: class I (low risk), class II (moderate risk), and class III (high risk). The FDA considers face masks as non-medical devices.
Medical gloves are an integral part in clinical procedures and patient examinations where COVID-19 is of concern. This type of PPE can be used to protect the health care provider from the spread of illness or infection.
The umbrella emergency use authorization (EUA) for certain surgical masks (disposable or single-use) was issued in response to availability and insufficient supply of such PPE. Under the EUA, surgical masks need to meet certain performance requirements for them to be used by health care personnel as PPE in healthcare settings.
The performance requirements include:
- Provide a physical barrier to fluids (fluid resistance)
- Provide a physical barrier to particulate materials (filtration efficiency)
- Prevent the wearer from exposure to large particles and respiratory droplets
- Provide flammability and biocompatibility protection
As of the end of October 2020, the FDA had authorized 8 surgical masks under this Umbrella EUA for emergency use during the COVID-19 pandemic.
For US manufactured respirators, The FDA has only authorized particulate-filtering air purifying respirators (APRs) and disposable filtering facepiece respirators (FFRs or respirators) from the National Institute for Occupational Safety and Health (NIOSH) for emergency use during the COVID-19 pandemic.
For imported respirators to qualify for an EUA for distribution to healthcare personnel for use in healthcare settings, the PPE should prevent exposure to pathogenic biological airborne particulates. This EUA only permits the use of authorized respirators by healthcare personnel (HCP), and not the general public.
Currently, the FDA had approved 167 Non-NIOSH Respirators for emergency use during the COVID-19 pandemic. Similarly, there are only 11 imported, non-NIOSH-approved disposable filtering facepiece respirators (FFRs) that have been received EUA from the agency. These respirators that have been authorized for emergency use are to be used as per the CDC recommendations.
Face Shields and Other Barrier EUAs
Under this FDA’s EUA category you will find a type of PPE designed to protect the HCP from bodily fluids, liquid splashes, or potentially infectious materials when attending to patients with confirmed or suspected SARS-CoV-2 infection. During the COVID-19 pandemic, Face shields and other protective barrier enclosures are crucial in routine patient care.
There are two PPE under this category:
- Face shields
During the Coronavirus Disease 2019 (COVID-19) pandemic, Face shields play a major role in patient care. Face shields are recognized as PPE for emergency use by medical personnel in healthcare settings and are to be used as per the CDC recommendations.
You will need a face shield as a caregiver to protect your eyes and face from bodily fluids and liquid splashes, or potentially infectious materials. They are also effective as minimal or low barriers in preventing HCP exposure to fluid biological airborne particulates.
This type of personal protective equipment is used by medical personnel in healthcare settings to them and patients from the transfer of SARS-CoV-2. They are to be used in accordance with Centers for Disease Control and Prevention (CDC) recommendations.
Gowns and other apparel meant for medical use are designed to provide protection from the transfer of microorganisms, in our case it is the COVID-19 virus. In terms of protection, they can fall into one of the four national consensus standards Levels: minimal risk (level 1), low risk (level 2), moderate risk (level 3), and high risk (level 4).
These are gowns that are intended for medical purposes. They can either be surgical apparel or examination gown. The gowns are classified as either Class I or Class II depending on the level of barrier protection and the intended use. Currently there is no available alternative to the FDA EUA approved gowns and other apparel.
There are different types of gowns and other apparel, here are some:
- Shoe (conductive or operating-room)
- Shoe cover
- Surgical apparel accessory
- Surgical helmet or cap
Healthcare providers need sufficient PPE to reduce the risk of infection and to make patient care more available to individuals suspected of having COVID-19. There are various FDA recommendations and policies that govern the use of EUA PPE.
Each of the FDA EUA Personal Protective Equipment plays a crucial part of patient care during the COVID-19 pandemic. Besides reducing the risk of illness or infection from body fluids, or respiratory secretions, they also increase their availability to provide care to suspected or affected COVID-19 patients.
With the severe shortage of PPE for frontline responders, you should purchase large quantities of such medical devices from trusted and reputable distributors such as Rapid Connect Medical. The company can supply millions to billions of affordable FDA EUA personal protective equipment such as gloves and N95 and Invisi Smart masks (non chemical – 5 and 30 days models) as well as respirator needs. The 30 day version of the Invisi Smart mask has cloth straps which help you stay comfortable while breathing easier. Also, take note that this product is a nano mask is not chemically treated; it uses a natural mineral coating. The construction of this mask covers your mouth and nose well in a comfortable manner. Countries and agencies around the world look for manufacturing companies that can supply masks in large quantities. We can fill orders in the hundreds of millions and even billions of units according to your needs and specifications.
The FDA’s assessment of all medical devices was ramped up in March when Covid-19 exploded. Legislation for the EUA helped reduce the barrier of entry for applicable critical PPE and equipment. The agency wanted to help impact the spread of the virus and meet the demands of the public. The FDA’s website link explains this in detail and has common questions and answers about the EUA. You may want to head over to the FDA website to educate yourself on the regulations that have been enacted to help you ensure your purchase the best products on the market.
Rapid Connect Medical is now Cranberry & Cardinal Global Direct. We can supply Cranberry Evolve as well as Cardinal Health nitrile gloves in the billions of boxes. We have OTG (On The Ground) as well as production options. There are also private pools around the world that we have access to. We have a standard SOP that we can share with you. The initial step is to get an NCNDA in place with us so you can share the LOI, LOA, and PO with us for vetting. There are many individuals who claim to have access to stock; we are a real seller group that actually delivers. If you are looking for gowns, sanitizer, or N95 masks we have access to large lots of these items as well that can fit in your budget.
Rapid Connect Medical supplies all types of PPE including eye protection that will protect against a patient’s fluids eye splash. Not only is a mask important but also protecting your eyes with goggles or a shield is crucial. Keep yourself and employees properly protected from the hazards of being in close contact with patients. The proper training and wearing equipment and PPE products while following CDC and osha guidance will keep workers as well as the public and local community safe during this coronavirus outbreak. These items are designed to keep the body of the worker safe and protect exposed areas. Through the practice of keeping things clean of contaminants, PPE worn safely, and best hygiene routines will help stop the spread of COVID-19. Best practices are required and essential for keeping medical professionals safe.
Donning this apparatus is not only limited to keeping U.S. workers safe from exposure, but also can keep the European region as well as global healthcare workers and professionals, ems, hospital staff, and doctors safe who wear PPE correctly. Including the right equipment and carefully training staff on how to wear PPE will keep your facility and workplace safe. If you want to remove viruses in the air and help with filtering at your facilities, our sourcing includes solutions for these requests as well. Our current selection of products include sanitizer and facemask options to keep people safe. In this current time, we have seen an increase in demand as well as shortages of supplies, but we have the inventory and capacity directly from manufacturers; providing you an effective means to acquiring PPE.
We have a standard operating procedure that follows conformity with PPE manufacturers distribution and order fulfillment. If you have a specific need based on local or county regulation, we have an acceptable solution that suits you. Our sales personnel have the advice and resources necessary to answer your questions. With our efforts we strive to met the demands of our clients.
To request more information, feel free to submit an email our sales department at [email protected].