Amidst enduring uncertainties created by COVID19, personal protective equipment remains a critical need for communities across America. In the spirit of bridging essential supplies with the most vulnerable, Gnomedica partnered with Alice Lee, president of the Chinese Professional Club of Houston in donating 15,000 face masks to District F, a richly diverse community in the Houston metropolis.
The masks were received by City of Houston Council Member Tiffany Thomas, whose office is currently coordinating their distribution to the most vulnerable district residents through its network of community partners. Sized for youths and adults, the masks carry a particle filtration efficiency above 99% and are embroidered with cartoon patterns as a way of spreading messages of optimism.
Already, distribution efforts have begun with local childcare facilities. Senior homes and organizations that assist with income-constrained families will also be allocated masks for direct delivery to residents.
As these protective supplies reach the city’s most vulnerable, consistent with their founding principles, Gnomedica and the Chinese Professional Club will continue to help fulfill the diverse needs of Greater Houston during a critical time.
Indeed, everyone has an essential role to play in protecting our neighbors and communities. As COVID cases continue to grow, properly wearing a mask and practicing social distancing become more critical than ever. Like many others in the business community, Gnomedica is firmly committed to supporting the shared responsibility of protecting the wellbeing of our neighbors.
Inspired by Jessica’s late father and created with the goal of hastening the end of COVID-19, Gnomedica is dedicated to supplying reliable, affordable face masks and shields manufactured by Weimen’s family to communities in need. To date, Gnomedica has provided over 3.7 million masks to municipalities and public service agencies across 15 states.
Since March, the COVID-19 crisis had produced an unprecedented strain on the global supply chain for personal protective equipment and sanitation supplies. The pressure was particularly pronounced in the U.S., where 36% of healthcare institutions surveyed in an April TIME Magazine poll reported running out of at least one critical item. Against the backdrop of surging infection rates and a shrinking stockpile, governments across the country set out to do all they can to procure PPE – galvanizing the private sector, sole-sourcing emergency contracts, and even bidding against another for the critical supplies.
While the shortage of medical supplies persists in many parts of the country, since June, the containment of COVID-19 in much of Asia and Europe coupled with an exponential growth of PPE manufacturers and importers had significantly alleviated the strain on the PPE supply chain. In fact, in China alone, 70,802 new companies registered to make or trade face masks this year, while exports of medical equipment and supplies rose 89 percent between March and May. In June, reduced demand and increased scrutiny for product quality had significantly elevated competition for PPE manufacturers. Consequently, prices for all forms of PPE have been steadily on the decline for months after an initial surge, some decreasing by as much as 90%. This is particularly true for civilian use products such as non-medical disposable face masks, for which retail prices have even returned to pre-COVID levels. Indeed, such market changes are crucial to advancing the mission of affordable protection for all.
For all levels of government and public sectors agencies such as school and hospital districts, these market trends present a promising development. With reduced prices, improved quality, and expedited delivery, the PPE industry is increasingly turning towards a buyer’s market, especially for general-use products. What’s key to accessing these favorable market conditions are transparent, competitive bids that make PPE procurement opportunities widely available to the public.
Indeed, most public entities have legal requirements to host bids for purchases that exceed a certain monetary threshold. However, due to the initial supply and logistics chain disruptions brought on by the pandemic, many of those requirements were waived, resulting in sole-source contracts with vendors who could promise expedited delivery. While reasons exist for public sector agencies to continuing procuring from vendors with established relationships, the benefits of open-market competition largely outweigh the potential complexities of organizing a bid.
Compared to sole-source emergency contracts, bids strongly incentivize sellers to reduce their profit margins to a minimum, something that stands in stark contrast to the prolific practice of price-gauging that characterized the growth of the industry. Simply put, only the lowest responsible bidder will be awarded a contract, and anyone who aspires to make a handsome margin from such transaction will not see their hopes materializing. Since June, public municipalities across the country have held hundreds of open-market bids that not only yielded some of most competitive prices available, but also served to continuously drive down market rates for the commodity. For instance, in August, an open-market bid organized by Placer County, California, drew over 100 vendors and yielded winning bids for face masks and face shields at respectively $0.10 and $0.48 in unit price for a 16,700 piece order. Similarly, the City of Litchfield Park was able to procure face masks at $0.11 per unit and gloves at $0.074 per unit for two senior homes within its limits in a bid that attracted 113 submissions. In the same timeframe, municipalities that procured through no-bid, emergency contracts easily paid four or five times as much for identical products. One municipality in Virginia, for instance, paid $0.80 per mask in a sole source contract when the market prices went down to as little as $0.10 for the same mask. While there may certainly be circumstances that would justify an emergency purchase, the same dollar spent on this sole source contract could, in fact, have offered protection to eight times the number of people.
Another equally important benefit from competitive bids is the simultaneous gain in the scrutiny and quality of products yielded. Most well-constructed bids require extensive paperwork, including proof of financial capability, product specifications and certifications, questionnaires on delivery ability, and personnel qualifications. The task of putting together such a bid, in of itself, greatly enhances the prospect that only legitimate vendors with demonstrated competencies in commodity logistics will participate. In fact, municipalities, such as Jefferson Parish, have disqualified the apparent lowest bidder when product specifications and quality couldn’t be sufficiently demonstrated. Additionally, given the legal provisions for bid transparency, all submissions from vendors are released to the public and oftentimes scrutinized by the press. With reputation being a key element of success for any business, the prospect of public disclosure of inauthentic, questionable information is a significant deterrence for bad actors.
As we approach another “surge season,” while the pressures of time may favor the most convenient procurement options, it is more important than ever that buyers, especially public entities, make the choice to host competitive bids as much as possible for the greater good. Ultimately, each dollar spent on PPEs could spell a magnitude of difference in the number of people protected if not wisely used. Governments, occupying some of the most powerful purchasing positions in the country, have the unique ability to attract only the most qualified, competent vendors with high ethical standards. Exercising this power, especially against the prospect of a resource-constrained economy, is both the most judicious and responsible course of action.
As you’re buying masks in these uncertain times, the last thing you want to do is to spend a lot on products that aren’t up to par. We hope to shed some light on how to determine whether the mask in your hands has, at least on paper, met the right standards.
First, we need to draw a distinction between masks manufactured for medical use and those for general use. Any product intended for medical use, such as in hospitals or in alternative care facilities, is screened and approved in the United States by the FDA. For the duration of the COVID-19 crisis, so that we save the critical supplies for healthcare workers on the frontlines, the general public is not encouraged to purchase products intended for medical use.
However, if you are buying masks for medical use, whether it is because you are procuring on behalf of a healthcare entity or municipality or you’re looking to make a donation, here are some documentations you need to look for:
A FDA-issued 510(k) clearance summary certificate – note, this is NOT a “FDA facilities registration” and should be specific to the product being sold. A facilities registration with the FDA is not sufficient. In fact, this registration can be purchased by any manufacturer for $5,236 and simply puts them in FDA’s database to begin the process of product approvals.
A FDA-issued letter of 510(k) clearance – if the certificate is not available for any reason, buyers should look for a FDA-issued letter of clearance with the product precisely stated.
Listing on FDA’s EUA appendix of manufacturers – for the duration of the COVID-19 crisis, if you’re looking for procure respirators (N-95, KN-95, FFP2, etc.) for medical use from manufacturers who don’t yet have the full-out 510(k) clearance, verify that they are listed here. This is the list of manufacturers that have received an emergency use authorization (EUA) based on third-party lab reports or equivalent certifications from other jurisdictions. Note, a similar list doesn’t yet exist for surgical masks.
Now, let’s talk about masks made for general use. One important note is that many general-use masks in fact are made from the same medical-grade polypropylene and melt-blown fabric and carry much of the same properties as medical masks. However, the lack of “for medical use” designation means that the product has yet to undergo the FDA’s approval process. As a significant portion of manufacturers (including our family) that are producing PPEs came from industries far-removed from medical devices, they may not yet have had time to go through the reviews, which takes about six months. Given the mask shortage we are facing, how do we make sure that their products are made to standard?
Let’s start with disposable face masks. In the United States, there is no standard applicable for general use face masks. However, buyers looking to assure that the quality of general-use masks they purchase is on par with that of a medical-use mask, they should look for products assessed against a standard developed by the American Society for Testing and Materials (ASTM). This standard, ASTM-F2100, provides key performance metrics that medical face masks must meet.
ASTM permits manufacturers to self-represent that they meet the F2100 standard; manufacturers may take this step after they have self-tested their product per the procedures outlined in the standard. To improve their customers’ confidence in the product, they may also send their masks to a 3rd-party laboratory such as ICS Laboratories to obtain a test report.
There are generally five required components to the ASTM disposable mask test, and depending on its performance, the product will be assigned a “grade” from 1 to 3. Here are the five tests outlined by ASTM:
Bacterial filtration efficiency – essentially, how well the mask filters bacteria.
Differential pressure (breathability) – this makes sure your breathing won’t be affected.
Flammability – Masks should not catch on fire when exposed to open flames or other high heat sources.
Particle filtration efficiency – how well the masks filters 0.1 micron particles.
Synthetic Blood Penetration – essentially how well the mask resists fluids such as blood “seeping” through the mask.
Manufacturers that have tested their product to ASTM F2100 will happily advertise that, and you may find the resulting performance data on the product’s labeling or the manufacturer’s website. Note, however, that meeting the ASTM-F2100 standard does not automatically qualify the face mask as a mask intended for medical use. To market their products as being intended for medical use (e.g. as a “surgical”, “dental”, or “procedure” mask), manufacturers must still go through the FDA’s 510k process.
Of course, across the world, there are other standards for the performance of face masks. In the EU, there is EN-14683. In China, YY/T 0969 is a less stringent standard for face masks for medical use, whereas YY 0469 is a more stringent standard, and GB/T32610-2016 standard applies to face masks for general use. To provide reassurance, manufacturers who’ve had their products validated will typically print the standard and relevant labels on their box. You should feel free to ask the manufacturer or distributor for laboratory documentation showing that the product meets the standards that are claimed!
Important to note – general use masks ARE NOT regulated by the FDA. Products distributed to the public that are labeled with a FDA logo are not authentic. In other words, the FDA has nothing to do with approving general-use masks and in fact, specifically forbids the use of its logo in any commercial product.
Now let’s move on to N-95 grade respirators. In the United States, the efficacy of all N95 respirators is assessed against a standard developed by the National Institute for Occupational Safety and Health (NIOSH). All NIOSH-certified manufacturers of N-95 respirators are listed here, where you can easily verify their claims. As with disposable face masks, during a time of shortage, even if they aren’t NIOSH-certified, N95 respirators can be screened for adherence to NIOSH standards by third-party laboratories. Since the NIOSH certification process is also quite time-consuming, having masks validated by a lab to a NIOSH standard may be the best we can get. Here are the four tests that validation to a NIOSH N-95 standard would require:
Sodium Chloride (NaCl) aerosol challenge
Dioctyl Phthalate (DOP) particle penetration
Inhalation and Exhalation (breathability)
Valve Leak Test
Important note: Unlike with ASTM-F2100, manufacturers cannot legally self-attest that their mask is NIOSH N-95 compliant, even with lab tests. The product itself must be fully certified by NIOSH for a manufacturer to make this claim.
If you’re buying in bulk and the product is not NIOSH certified, carefully reviewing the lab validation data for these four tests will be crucial. These reports should reflect the numerical value tested, and not just simply state “pass” or “fail.”
Stay tuned for our next post on a few simple experiments you can perform at home to verify if your mask is effective or not.
As simple as they look, masks actually come in a myriad of types and classifications, depending on the materials and techniques used in production. Amidst the PPE shortage that the world is confronting, it is critical to understand what distinguishes different categories of masks so that we can save the appropriate stockpiles for our healthcare workers on the front lines.
To start, disposable face masks are typically comprised of one layer of filter material sandwiched between two layers of non-woven fabric. These face masks provide protective covering for the user’s mouth and nose. Depending on the quality of the filter material deployed inside the mask, these face masks may or may not provide protection against liquids or large droplets (be it bodily fluids, hazardous liquid chemicals, etc). Typically, face masks that serve as barriers against liquids and have received FDA validations attesting to this extent are also called “surgical masks.” As the name suggests, surgical masks are considered medical devices and are typically worn in healthcare settings where there’s a higher risk of exposure to bodily fluids. Important to note, while many face masks are constructed from medical-grade polypropylene and do provide protection against liquid droplets, they will not be labeled as a “surgical mask” without a FDA approval. These masks are not considered a medical device and will be available for general use. To determine whether your face mask has “surgical-mask like” properties, check out our soon-to-come post on how to interpret data and certification labels on mask packaging. Finally, while many disposable face masks offer high bacterial and particulate filtration rates and can make a difference in slowing the spread, higher grades of PPE are recommended if you expect to be in close contact with a COVID-19 carrier, which brings us to N-95s.
N-95 respirators will be able to filter out 95% of particles equal to or larger than 0.3 microns in diameter. If you’re curious, COVID-19 viral particles are typically 0.06-0.15 microns in diameter. To achieve this filtration efficacy, N-95 respirators are typically made out of four or more layers melt-blown fabric, with some layers given an electrostatic charge during the production process. This electrostatic charge adds a level of filtration beyond what the fabric can achieve by itself. Important to note, the “N-95” label is derived from a US Government Standard developed by NIOSH. N-95 equivalent products from other jurisdictions exist, such as the FFP2 respirator from the EU or the KN95 respirator from China. So long as the product’s certifications, performance specifications, and labeling are authentic and accurate, a FFP2 or KN95 respirator will offer similar levels of protection as a N-95 respirator.
Imaginably, due to the global pandemic, the demand of both types of masks has surged exponentially. Per recommendations from the CDC, masks are an effective tool against viral spread. This is particularly true if you live or work in a place with high population density. Feel free to contact us or submit a FAQ if you would like to learn more about where to get masks and the science behind them!