SILVER SPRING, Md. — March 28, 2020 — During this COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) is working around the clock to make sure that Americans have access to safe food and medical products. The agency is continuously examining the global supply chain to identify any concerns and assess the availability of the products Americans need most. We are also partnering with the Federal Emergency Management Agency (FEMA) on supply chain issues, including importation of needed medical products to support the U.S. response. Here is a status update and details on some of the latest actions we have taken:

Medical Devices

As a doctor, the situation with personal protective equipment (PPE) is very concerning. We are taking every possible action we can, but we know the situation is dire for many health care facilities. We want to share that the FDA, along with the private sector, FEMA and all of the U.S. Government, are working around the clock to address this issue as quickly as possible.

We are aware of shortages of respirators and have issued Emergency Use Authorizations (EUA) covering certain respirators to enable them to be used in health care settings. Via the EUA and the shortages mailbox, the team has directed stakeholders to CDC’s strategies for optimizing respirator supply and recommendations on the use of expired respirators.

Most recently, the FDA issued an EUA to help increase the supply of filtering facepiece respirators by authorizing the use of certain imported disposable respirators that are not National Institute for Occupational Safety and Health (NIOSH)-approved for use by health care professionals. We are continuing to work on strategies to increase the availability of these devices.

We are also working on mitigation strategies for other types of personal protective equipment including surgical masks, gowns, and gloves. We have issued information to health care providers and have provided recommended conservation strategies for these important PPE.

We are working with textile manufacturers, including clothing designers, about how we can repurpose their manufacturing product lines to put them to use to make masks. These masks can be used for surgical or other isolation procedures, as the benefits of using them outweigh the risks under current circumstances.

We are providing maximum regulatory flexibility where we can.

We are also open to importing PPE and other devices and have provided instructions to manufacturers to help us implement this necessity appropriately. The agency is taking steps to facilitate importation of PPE into the U.S. and we are ready and available to engage with importers to minimize disruptions during the importing process. This means that when products come in from overseas, their authorization via our EUA authority allows them to quickly enter the country. These products aren’t hindered from entry and we’ve already determined, among other criteria, that the known and potential benefits of these products being used in health care settings outweigh the known and potential risks.

The FDA has reached out to more than 1,000 device manufacturing sites worldwide, focusing on essential devices.  The outreach thus far has focused on two main types of essential devices: those that are in high demand due to the pandemic outbreak, such as PPE and ventilators, and devices that may be prone to potential shortage if there is a supply disruption.

We further recognize the need for ventilators, ventilator accessories, and other respiratory devices may outpace the supply available to health care facilities. We have issued an immediately in effect guidance outlining a policy intended to help increase availability of ventilators and their accessories as well as other respiratory devices. In addition to the guidance, the FDA has issued an EUA that authorizes the emergency use of ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as ventilators (collectively referred to as “ventilators”), ventilator tubing connectors, and ventilator accessories, that FDA determines meet the specified criteria for safety, performance and labeling. We anticipate this action will increase the number of patients who can have access to ventilators or similar machines for respiratory distress, which is important for critically ill COVID-19 patients

As with prior emergencies, the FDA has taken proactive steps to establish and remain in contact with medical device manufacturers and others in the supply chain, including hospitals and group purchasing organizations. The agency also encourages manufacturers and healthcare facilities to report any supply disruptions to the device shortages mailbox, deviceshortages@fda.hhs.gov. This mailbox is closely monitored and has proven to be a valuable surveillance resource to augment FDA efforts to detect and mitigate potential supply chain disruption.

Human Drugs & Biologics and Animal Drugs

We continue to work closely with manufacturers to make sure that they continue to notify the FDA, as early as possible, of a permanent discontinuance or any interruption in manufacturing that is likely to lead to a disruption in supply. This communication and the full cooperation of companies providing specific and necessary information is imperative in order for us to have an accurate understanding of the supply landscape and work to take proactive steps to mitigate shortages. To help human drug manufacturers submit timely and informative notifications, the agency is publishing a guidance for immediate implementation about the importance of these notifications, the timelines for manufacturers to follow when notifying the FDA, and the details for them to provide about the discontinuance or interruption of manufacturing. We recognize that while some supply disruptions and shortages cannot be predicted or prevented, early communication and detailed notifications from manufacturers to the agency play a significant role in decreasing their incidence, impact, and duration.

Our efforts with federal partners and pharmacy groups continue to establish mitigation strategies and prevent long-term supply shortages. At this time, where there is an acute demand for certain products and disruption in the supply chain, we are taking proactive steps to make sure that patients can access the medications that are medically appropriate and necessary. Some retail pharmacies have begun implementing policies designed to limit the overprescribing and overdispensing of certain medications in order to preserve the supply nationally. We are also aware that a number of states have taken action to limit the dispensing of certain drugs, including chloroquine and hydroxychlorquine.

Our public drug shortages lists are up-to-date with human and animal drugs and biological products that we have determined to be in shortage. These shortages are not all results of COVID-19, with many existing prior to the pandemic as results of market changes and supply challenges. We are updating these lists regularly and communicating in real-time so that patients and healthcare providers have the most current information on product shortages in the U.S.

The agency has decided it does not intend to object to registered outsourcing facilities using hydroxychloroquine. Despite this action, it is important to note that there are currently no FDA-approved therapeutics or drugs to treat, cure or prevent COVID-19; however, there are FDA-approved treatments that may help ease the symptoms of COVID-19.

Lastly, we appreciate industry’s willingness to help supply hand sanitizer to the market to meet the increasing demand for alcohol-based hand sanitizers during the COVID-19 pandemic.  As part of our commitment to providing timely guidance to support continuity and response efforts during this pandemic, the agency has published guidances to provide flexibility to help meet the demand for hand sanitizer.

Blood Supply

Blood supplies have been dramatically reduced due to the implementation of social distancing and the cancellation of blood drives.  Maintaining adequate levels of our nation’s blood supply is critical.  People who donate blood are equivalent to those who work in critical infrastructure industries.  We continue to encourage individuals who are healthy and able to donate blood.  Donating is safe and takes only a little of your time.  At many blood donations centers, those who are interested in donating can make an appointment to minimize the time it takes to donate blood.  Contact information for local blood collection sites and for scheduling appointments can be found on FDA’s website.

Human and Animal Food

Overall, retail supply chains remain strong, and we are working with food manufacturers and grocery stores to closely monitor the human and animal food supply chain for any shortages. The agency is in close contact with industry and its trade associations, which are in touch with their members about supply chain issues.

Food production and manufacturing – for both people and animals – are dispersed throughout the U.S., and we are pleased to report there are currently no widespread disruptions reported in the supply chain. Empty grocery shelves are largely due to unprecedented demand – not a lack of capacity to produce, process and deliver.  Manufacturers and retailers are working around the clock to replenish shelves.

The same is true for animal food. The FDA is monitoring the availability of foods for livestock and pets. There are no shortages, and no current disruptions in the pet and livestock food supply chain.

I am grateful to workers in the food and agriculture sector filling critical and essential roles within communities. Their ability to continue to work during periods of community restrictions, social distancing, and closure orders, among others, is crucial to community continuity and community resilience. This was reinforced by DHS in its Guidance on the Essential Critical Infrastructure Workforce: Ensuring Community and National Resilience in COVID-19.

Veterinary Medicine

Our Center for Veterinary Medicine is working with veterinary stakeholder groups to alert veterinary professionals to adopt PPE conservation strategies to make the most of their current supply of items, such as masks and gloves. We’re also encouraging the postponement of non-urgent/routine veterinary medical procedures during this pandemic. In addition, we have been coordinating with veterinary medical supply manufacturers and distributors to explore how certain veterinary medical supplies, such as sterile swabs, and devices, such as ventilators, could be redirected to address critical shortages in human health care.

Posted March 30, 2020

Source:  U.S. Food and Drug Administration

NEW YORK CITY/SCRANTON, Pa. — March 30, 2020 — Chargeurs*PCC Fashion Technologies and Noble Biomaterials today announced that they have launched a strategic collaboration to produce urgently needed personal protective equipment (PPE) for the healthcare industry. Amid worldwide shortages of medical-grade equipment such as face masks and gowns, the two companies are working together to enable Chargeurs to manufacture PPE using Noble Biomaterials’ silver-based technologies.

“We use only the best materials for the couture customers that we service out of our Paris manufacturing facility,” said Angela Chan, managing director and president, worldwide, of Chargeurs*PCC Fashion Technologies. “As we quickly pivot from fashion to healthcare in order to help alleviate the shortage around the globe, we also want to ensure we’re making products using the best materials available. Noble Biomaterials has long supplied critical antimicrobial components to the healthcare and military sectors, and we’re pleased to work with the company to make high-quality products for those on the frontline of the healthcare fight.”

Chargeurs*PCC Fashion Technologies is well known as a  global provider of interlinings — the technical components that give garments their shape and structure. In France, parent company Chargeurs Group has already begun producing hydro-alcoholic solutions for healthcare professionals and mission-critical sectors as well as producing and importing protective masks in industrial quantities. The company has set a target of producing more than 1 million face masks a week within coming days. Chargeurs’ textile innovation laboratories in France, Asia and the US will also be developing new prototypes of masks that can be mass produced to meet current health and safety requirements and to keep pace with changing needs over the long term.

“Multiple studies have shown that soft surfaces in the healthcare and community environments are contaminated and that cross-contamination from soft surfaces occurs frequently,” said Jeff Keane, CEO of Noble Biomaterials. “Our technology has been clinically proven to reduce microbes and protect the surface of textiles, and with Chargeurs we’ll be able to help provide more critical PPE to healthcare employees around the globe. This is right in our wheelhouse — we’ve already begun prototyping these products, and we couldn’t be prouder to help in this worldwide fight.”

Noble Biomaterials has decades of experience supplying advanced materials to the healthcare market. The company’s X-STATIC® Technology is already used in infection-prevention textiles to reduce the growth of microbes and protect soft surfaces such as privacy curtains, bedding, scrubs and lab coats. Noble Biomaterials is a registered FDA medical device facility, an essential sole-source technology supplier of medical components to the US Military and a US EPA–registered antimicrobial manufacturer. Leading companies such as 3M, Systagenix and KCI rely on the products manufactured by Noble Biomaterials for the medical market.

X-STATIC® is made by bonding high-purity silver to the surface of a polymer, making it permanent for the life of the product. It is also OEKO-TEX® Standard 100 certified.

Posted March 30, 2020

Source:  Chargeurs*PCC Fashion Technologies

ALEXANDRIA, Va. — March 30, 2020 — As the effects of the COVID-19 virus empties restaurants and hotels, healthcare and other Critical Infrastructure operations such as food and agriculture, energy, water and wastewater, transportation and logistics, manufacturing, public works and essential functions struggle to maintain or meet demands. TRSA, the association for linen, uniform and facility services identified a need for these varied market sectors to share information on best practices and swiftly launched a series of market-specific teleconferences pertaining to COVID-19 response and operations.

Recordings of these four events, hosted during the week of March 23, are now available under the “COVID-19” header in TRSA’s On Demand Library at  www.trsa.org/ondemand. All four market-sector teleconferences emphasized the importance of ongoing, transparent and regular communications with employees and customers to reduce anxieties and with business partners such as suppliers, banks, unions, government officials and other critical partners.

Jim Buik, TRSA chair and president, Roscoe Co., emphasized the importance of these meetings and industry information sharing from an operator’s viewpoint. “These calls are very important because they offer a range of perspectives and operational best practices,” Buik said. Highlights of the four teleconferences, in the order they were held, appear below:

Hospitality Sector

Outsourced laundries servicing hotels exchanged ideas for managing though the crisis that has halted most operations. They also discussed plans to ramp operations back up in the coming months. Despite dire near-term predictions, participants remained hopeful to begin serving customers again soon. While much of the discussion centered on seeking financial relief and staying connected with their laid-off or furloughed employees, they did identify several potential post-COVID-19 crisis opportunities such as increased interest in out-sourcing laundry and switching from customer-owned goods (COG) to linen rental to help offset the costs of reopening shuttered hotels. Several participants also discussed servicing properties that have been converted to temporary hospitals. TRSA thanks the more than 120 linen, uniform and facility services operators and suppliers that participated in the teleconference and especially the industry leaders Harry Kertenian, CEO, Magic Laundry Service and Chair of TRSA’s Hospitality Committee; Steve Miller, vice president, Victor Kramer Co.; and Keith Pooler, vice president, Sacramento Laundry Co., who facilitated the discussions, presented a variety of perspectives and answered questions.

F&B/Linen Supply

For the nearly 130 food-and-beverage (F&B) laundry operators and suppliers who participated in TRSA’s market-specific teleconference, the F&B market sector has felt the most profound impact from the COVID crisis with most restaurants either closing or limiting their services to curb-side pickup. Participants shared stories, strategies and tactics for managing through the crisis, including improved inventory management and accounts receivable (AR). The majority have laid off all or most of their employees and are uncertain when, or if, they can restart operations or what the new, post-pandemic F&B market will look like. Participants also discussed tactics for ensuring the health and safety of their employees, customers and communities whether working or at home. Those plants that are still operating have implemented measures to reduce health risks for production and route service representatives (RSRs), including increased personal protective equipment (PPE) such as gloves, rotating breaks/lunches and limiting contact with customers to maximize social distancing. They’ve also increased efforts to disinfect hard surfaces and vehicles. The teleconference was led by Ken Koepper, director, TRSA Membership and Industry Outreach; and included panelists Phoebe Ellis, owner, Lace House Linen Supply; Jesse Jassny, director of sales and service, service linen supply , MediCleanse Linen Service; and Mark Lewis, corporate sales manager, Dempsey Uniform & Linen Supply.

Healthcare Sector

Nearly 200 operator and supplier laundry executives participated in the healthcare market sector discussion facilitated by TRSA Director Randy Bartsch, owner, Ecotex Healthcare Service Linen Corp. The healthcare market has a different set of challenges as compared to the other markets as they prepare for the peak of the pandemic in the coming days/weeks. Surprisingly, many of the laundries servicing both acute healthcare — hospitals and long-term care facilities — and non-acute, such as outpatient surgery centers and medical facilities, are operating below normal volumes due to early-discharge policies and cancellations of elective surgeries. In addition, the healthcare sector has been most impacted by supply chain shortages as hospitals attempt to shift to reusable isolation gowns, surgical scrubs and PPE following the depletion of their disposable products.

Before the crisis, healthcare facilities had switched 90 percent of their isolation and surgical gowns to disposable products, despite evidence of additional cost and waste. The new demand for reusables, while more sustainable, has created shortages and an inventory backlog of months. It also underscored the importance of the Hygienically Clean certification, as other laundries, including on-premise and non-healthcare operators attempted to reduce risks to their employees and customers by changing standard operating procedures (SOPs) already followed by certified laundries such as OSHA’s Universal Precautions and increased disinfecting and cleaning protocols. To further mitigate the potential for transmission of the COVID-19 virus, healthcare laundries emphasized the importance of PPE, handwashing and social distancing in the plant and at home, as well as increased education for those handling soiled linens.

The teleconference closed with a detailed question-and-answer session facilitated by Bartsch with panelists Murray Cohen, PhD, MPH, CIH, FAIHA, retired CDC (Center for Disease Control) and WHO (World Health Organization) Epidemiologist and chairman, Frontline Healthcare Worker Safety Foundation, and David Goldsmith, Epidemiologist, George Washington University.

Industrial/Workwear Sector

Jim Buik also offered an owner’s perspective (industrial launderer, the Roscoe Co.) during this teleconference. He spoke in-depth about dealing with the impact of COVID-19. “Our first step was to educate ourselves and our team, relying on credible sources such as the CDC (U.S. Centers for Disease Control and Prevention) and the World Health Organization (WHO), as well as OSHA (U.S. Occupational Safety and Health Administration),” Buik said. He commended the industry’s efforts to help the industry manage during this crisis. “The information TRSA provided at www.trsa.org/covid19 was timely and invaluable. We printed and posted CDC flyers on handwashing and shared information about best practices to ensure we followed them closely. Buik also discussed the impact of Roscoe’s decision to earn Hygienically Clean certifications several years ago which put Roscoe in a better position to serve its customers.

While a slightly smaller group with nearly 100 participants, the teleconference addressed the importance of operations as “essential services” for Critical Infrastructure customers, especially manufacturing of medical supplies and food services, as well as transportation and public services. Discussions focused primarily on employee and customer health and safety, as this sector does not typically handle and process potentially virus-contaminated products.

Participants from the industrial/workwear sector also shared best practices on social distancing in the plant, boosting employee morale and reducing anxiety during these difficult and stressful times. In addition to Chairman Buik, TRSA thanks moderator Israel Cartagena, chair TRSA Industrial/Uniform Committee and Maintenance/Fleet/Utility Team Leader, Roscoe Co.; and panelists Jeff Delazzer, service team leader, Roscoe Co.; and Michael Shulevitz, president, Cadillac Uniform & Linen Supply Inc.

Members expressed appreciation of TRSA’s facilitation of the opportunity that brought the industry together for the greater good.  “I attended all webinars and thought they were well done and informative,” said Greg Brown, of Mickey’s Linen. Tom Yohn of Gurtler Industries agreed. “Very informative. Contributions between competitors that enlighten one another with the sole purpose of EVERYONE in their market segment surviving and working through this together is unbelievable. I’m proud to be associated with TRSA.”

For more information and guidance related to COVID-19, visit TRSA’s COVID-19 Resource Center at http://www.trsa.org/covid19 and register for TRSA’s April 2 COVID-19 Update:  State/Federal Relief Update, Market-Sector Reports and Business Pulse Reports.

These four teleconferences set the stage for TRSA’s organization of Market Sector Business Recovery Task Forces for all market sectors, groups that will strategically examine the potential, long-term impact of the pandemic on each sector and opportunities for the linen, uniform and facility services industry in the new, post-COVID business environment. We need your help! Please contact Ken Koepper at kkoepper@trsa.org for details and to participate in TRSA’s Market Sector Business Recovery Task Forces.

Posted March 30, 2020

Source: TRSA

ALEXANDRIA, Va. — March 26, 2020 — Long before COVID-19 became a pandemic, Hygienically Clean certified facilities serving acute and nonacute healthcare, food processing and service were properly trained to meet the safety needs of its customers, employees and the public. In recent weeks as the pandemic has spread, Hygienically Clean has kept watch on this crisis and continues to provide resources that inform and help properly educate employees and customers. As state guidelines for combatting the spread of this virus unfold, linen, uniform and facility services companies have been consistently recognized as “essential services” supporting the Nation’s Critical Infrastructure safety, sanitation and operations including healthcare, first-responders, food and agriculture, energy, water and wastewater, transportation and logistics, public works, communications and information technology and other community-based essential functions and government operations.

The Hygienically Clean website (www.hygienicallyclean.org) has been updated with a wealth of resources covering the specifics of the COVID-19 Pandemic including:

• Webinars, including communication of best practices for employees, customers and leadership teams, led by experts such as Catalina Dongo, Director of Human Resources, UniFirst Corp., Todd Logsdon, partner, Fisher & Phillips LLP and Hygienically Clean Advisory Board member Murray L. Cohen, PhD, MPH, CIH, FAIHA, Chairman, Frontline Healthcare Worker Safety Foundation, Retired Infectious Disease Epidemiologist, Centers for Disease Control (CDC) and World Health Organization (WHO
• Both the Six Cs of Handling Soiled and Clean Linens in a Healthcare Environment Training (videos)
• Posters, handouts and other print and digital (in English and Spanish) to be shared with leadership teams, employees and customers
• Links to dozens of resources including state-by-state essential services designations and Frequently Asked Questions (FAQs), HR and legal guidance, global and national government agencies such as WHO, CDC, DOL, SBA and more

Hygienically Clean values the voice of its members and relies on continuous communication to rapidly educate and prepare its certified facilities of quickly evolving issues like COVID-19. Regularly scheduled Users Group and Advisory Board calls are taking place as the pandemic progresses, providing Hygienically Clean-certified laundries with valuable sharing of resources such as best management practices (BMPs), Quality Assurance (QA) manuals and standard operating procedures (SOPs) for combating COVID-19.

The Coronavirus has heightened our awareness of handwashing and sanitizing hard surfaces. Every facility that has earned the Hygienically Clean Certification, 223 across all markets, has been inspected to OSHA regulations and CDC guidelines for environmental infection control. The inspection includes the review of each facility’s cleaning schedule and a verification that they follow Standard and Universal Precautions ensuring the protection of employees with the proper usage of PPE’s and handwashing.

Hygienically Clean’s BMPs and SOPs align with OSHA and CDC guidelines for safety and infection prevention to minimize community spread and removes viruses from linens and that while all reusable linens, uniform and textiles should be considered as contaminated with COVID-19, they should NOT be considered Hazardous Medical Waste, creating additional costs and shortages. The Hygienically Clean certifications instill confidence that processed linens, uniforms and other textiles are safe for hospitals, surgical centers, food processing plants and other critical businesses and that every precaution is taken throughout the production, transportation and delivery of Hygienically clean linens.

As the quantified, validated standard and measure for hygienically clean textiles serving all linen, uniform and facility services market sectors, even during this crisis, Hygienically Clean has received applications and inquiries from laundries and their customers with a 100 percent recertification of every plant eligible for renewal. These are an acknowledgment that Hygienically Clean certified laundries continue to offer their customers peace of mind that their stocks of reusable linens, uniforms and other products are laundered and delivered under a higher standard of cleanliness.

“To ensure the safety of its employees, employees’ families, their customers and the public, every facility should seek Hygienically Clean Certifications,” said Cohen, a highly regarded expert infection- control expert and a member of the Hygienically Clean Advisory Board. “Minimally they should follow Hygienically Clean best management practices.”

Posted March 27, 2020

Source: TRSA

RAPID CITY, S.D. — March 27, 2020 — In an effort to help local healthcare providers overcome a global shortage of personal protective equipment (PPE) due to the COVID-19 pandemic, South Dakota School of Mines & Technology is 3D printing masks for Monument Health and other local healthcare providers.

The project began following a meeting between Mines alumnus Brad Haupt, vice president of Supply Chain and Contract Management at Monument Health, Mines President Jim Rankin and others on Saturday, March 21. Haupt expressed a concern over the long-term shortage of masks at Monument Health, especially in light of the COVID-19 outbreak, and President Rankin offered Mines resources’ to help.

The effort, which quickly ramped up this week, currently includes faculty and students in the South Dakota Mines departments of industrial, mechanical, chemical, biological, and biomedical engineering as well as chemistry, biology, and health sciences. The departments are printing about 50 masks per day using up to 15 printers running nonstop. “We hope to print as many as we can,” said Dr. Jeffery Woldstad, head of the Department of Industrial Engineering. “Right now, we believe that we have the material on campus for about 1,000 masks. However, we are ordering more materials and will keep going.”

The 3D-printed masks can be used by surgeons, nurses, and other staff. In some hospitals around the world, medical staff are being forced to reuse masks rather than dispose of them after each use. Doing so exposes healthcare workers and patients to increased risks. These 3D-printed masks have insertable filters that can be changed as often as needed. The masks are printed with approved material that is safe for use in medical facilities.

These masks were first developed in Montana last week, and that design was shared with the public though the Billings Clinic Foundation. The foundation credits the design of the masks to neurosurgeon Dusty Richardson, in collaboration with Billings-area dentist Spencer Zaugg, and his son Colton. A YouTube video from KTVQ news shows more.

Mines faculty took the design and worked with officials at Monument Health to print protypes earlier this week. They have since ramped up as many printers on campus as can be made available for this endeavor.

“Because of our project-based learning approach to engineering education, we have the facilities and experience needed to put engineering into practice,” says Dr. Pierre Larochelle, head of the Department of Mechanical Engineering at Mines. “In just a couple of days we have brought together multiple departments on campus, faculty, staff, and student workers to address a dire need in our community.”

The 3D printers are running nonstop. The printers are being monitored by two students and a faculty member who are coming in on shifts and leaving before the next person arrives to maintain social distancing. “When I reached out to students, Zac Hogan and Jake Steffen volunteered immediately,” said Dr. Aaron Lalley, a lecturer of mechanical engineering. The printers can run for a time on their own, but they need some monitoring. Lalley, takes the night shift from 10 p.m. to 6 a.m. while his students cover the day shifts. “We’re very happy to help,” he said.

Monument Health is also seeking PPE from any other members of the local community who may have extra on hand.

Posted March 27, 2020

Source: South Dakota School of Mines & Technology