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    By Angie Perry 25 May, 2020
    As discussed in the previous article titled, "FDA and CDC Authorized Reuse and Sanitation of PPE Reduces Medical Waste and Benefits Businesses", we have gained a broader understanding of the country's responses to the COVID-19 pandemic. Though there is certainly chaos, people are determined to come together and innovate in the midst of it. In this instance, The Better Business Bureau (BBB) took initiative and developed a free app to help connect businesses to the sources they need to get a hold of Personal Protective Equipment (PPE) . It was designed to act as a support to the reopening businesses in Michigan, however, it appears to be a great aid and example source to businesses nationwide. The app connects companies with suppliers who can get them the PPE material they need to lawfully reopen. The app also provides resources for loans, safe workplace guidelines, and industry specific guidance. With innovation and quick thinking, the BBB was able to take a huge step in the right direction to aid businesses with their reopening. These times can be overwhelming and all of the different guidelines confusing, however the new app will be a fantastic source for those eager to reopen their businesses in Michigan. It will also help companies buy in confidence amidst the many scams within the PPE supply industry. "As businesses reopen and welcome staff and customers it is important they have the supplies necessary to ensure their equipment and environment are clean and safe,” says Phil Catlett, President of the Better Business Bureau Serving Western Michigan. “This app can help organizations connect with local businesses. This not only helps companies reopen in a safe way, but it helps the local economy.” Hopefully, states across the country will follow in the BBB's footsteps and also create tools and resources similar to the free app to also support their local businesses during reopening. In order to combat this pandemic, it is crucial that businesses follow the guidelines strictly and employ PPE properly and efficiently. Creating an app is a great way to build a useful and easy to navigate platform for these purposes. The COVID-19 pandemic is surely tragic and an alarm to all. However, there are more signs nationwide of the "glass half full mentality", which is something to be proud of. The country has come together and surged forward in the industries of technology, medical, and e-commerce. The coronavirus certainly caused many setbacks, however, as mentioned above, has propelled the nation forward in many ways as we collectively have been forced to innovate.
    By Angie Perry 23 May, 2020
    The overwhelming shortage in personal protective equipment (PPE) for medical workers during the crisis has been an intimidating challenge for response teams. Large mask production companies such as 3M have been scrambling to catch up to the severe demand increase . Though they are racing to increase production output to match the new heightened needs this year, many health providers debate whether they can potentially reuse the equipment they already have. “If I can sanitize it and it still fits and performs the same form, fit and function, why not reuse it,” said Michael Ingle, CEO and founder of the mattress cleaning business Clean Sleep. “We pushed to start sanitizing masks, and we’re doing that now. So we were able to keep operations going and keep our employees, and, you know, expand the opportunity. Plus, we’re also serving a good cause.” The CDC released recommendations for extended use and limited reuse of the N95 respirator. The Food and Drug Administration has also issued new approvals for companies developing innovative ways to sanitize PPE. The FDA issued emergency use authorizations (EUA) for organizations to be able to sterilize and reuse personal protective equipment. Reusing the equipment cuts down on medical waste, making it economically beneficial as well as more eco friendly. Only 12 emergency use authorizations have been recorded on the FDA’s website regarding PPE . The administration issued a reminder that machines using ozone gas or UV light, such as Clean Sleep’s, have not yet been officially approved as a decontamination method. “When the FDA authorizes the use of the system, then they also make available the specific instructions,” said Nicole McCullough, global occupational health and safety leader at 3M. “So you can imagine it’s not just any UV light. You couldn’t put them in a tanning bed or something. It has to be a certain light and the respirators have to be placed in there, a certain way to make sure all the surfaces receive the light.” Ingle's mattress company applied for an EUA to start sanitizing medical devices. He told CNBC the CDC approves his method to sanitize masks, however not medical devices because the UV light system has the ability to disrupt the RNA and DNA of other viruses. In the meantime, the business owner said, the company is glad to be able to innovate and help clients such as senior living facilities in the time of crisis, while simultaneously keeping his business open. “If you’re in this space and you recognize and capture the opportunities to help create a sanitized environment, I think that we stand to to continue to grow and to continue to serve,” he said. Despite being in the middle of such a large, and tragic pandemic, there is silver lining. People, though physically apart, are still finding ways to come together, innovate and help one another. This world emergency , though devastating, has pushed people into thinking and understanding in new, remarkable ways.
    By Angie Perry 17 May, 2020
    On May 07, 2020, the U.S. Food and Drug Administration (FDA) along with the Center for Disease Control (CDC) announced the subsequent action taken in its ongoing response effort to the COVID-19 pandemic. The FDA revised EUA guidelines for non-NIOSH-approved respirators factory-made in China. The eligibility criteria was updated by making a few principle changes, including revising one of the criteria requiring an accredited and independent lab test to now mandate that certain respirators previously listed in the whitelist must pass CDC/NIOSH testing. This is described in detail in the EUA. As part of the government’s continuous quality assessment of these respirators, the CDC, working alongside the FDA, conducted additional tests which resulted in findings that some of the respirators authorized under the previous April 3, 2020 EUA were not up to par with performance standards. According to CDC.gov , "NIOSH has been informed that many legitimate manufacturers in China have been counterfeited. In such cases, NIOSH has no way of verifying which products are counterfeit and which are authentic. While the manufacturer listed...is shown as the manufacturer of the product evaluated, NIOSH has been informed that some of these are actually counterfeit products. Some products with legitimate manufacturer names, showing poor filter penetration results (<95%), are counterfeit products. A number of manufacturers have also informed NIOSH that they did not produce the products associated with their name. NIOSH urges purchasers of masks and respirators that may have questions about the authenticity of these products to contact directly the manufacturers and others in the supply chain as needed to verify that they are obtaining legitimate products." As a result, the FDA revised and reissued the EUA to remove all firms that were authorized based on the independent lab test criterion. Additionally, the FDA, in collaboration with CDC NIOSH, is increasing monitoring and sampling of all respirators imported from China – all respirator imports from China that come into the U.S.A. will be subjected to random sampling and testing by CDC NIOSH to determine legitimacy and whether the materials meet acceptable filtration standards. The FDA provided an update on its efforts to combat the disconcerting actions by companies and individuals that are exploiting the widespread fear among consumers during the COVID-19 pandemic. According to the FDA, "In response to scammers on the internet selling unproven medical products, the FDA has taken – and continues to take – a number of steps to find and stop those selling unapproved products that fraudulently claim to mitigate, prevent, treat, diagnose or cure COVID-19. The [Agency] is committed to helping health care providers navigate this dynamic situation, and issued a Letter to Healthcare Providers with considerations for all health care facilities that have respirators in their inventory." The "new list" or "whitelist", formally referred to Appendix A, has been shaved down to a total of fourteen approved manufacturers, whereas previously there was a total of forty-four. What does this mean for PPE distribution in the U.S.A? With the list of approved manufactures of personal protective equipment material cut down by nearly 70 percent, hospitals and government agencies are now even more stretched for supplies than they were before. The shortage of compliant materials from overseas is overwhelming, and new protocols to conserve these materials are being exercised. It is crucial that these groups be supplied with the proper protective materials, therefore this adjustment had to be made. However, it is taking a toll on each party as there is a vast shortage in supply as only fourteen manufacturers are approved to supply the entire U.S.A.'s hospitals and government agencies. With 1.52 million cases of COVID-19 in the U.S., and the death toll climbing closer and closer to 100,000 mark, the shortage in PPE could prove troublesome, until a solution is provided. To view the updated Appendix A whitelist, click here .

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