Personal Protective Equipment & Durable Medical Equipment
Public Health Supply Chain and Industrial Base
During a public health emergency, PPE and DME serve vital roles in protecting patients, healthcare workers, and the public. Ensuring PPE and DME are readily available for patients and healthcare workers may help prevent a public health concern from evolving into a public health emergency. In the early months of the COVID-19 response, the United States faced challenges procuring sufficient supply and effective distribution of PPE. Private, federal, and SLTT acquisition organizations struggled to procure PPE because of increased global demand. With the rush to procure supplies from a limited market, many purchasers made decisions based on PPE availability rather than on performance and quality, which resulted in delivery of incorrect or substandard products.xii Investments in increasing industrial base capacity has enhanced the ability to produce and acquire effective PPE.
PPE supply chain challenges extend to DME such as: oxygen equipment, continuous positive airway pressure and bilevel positive airway pressure machines, nebulizers, and other respiratory assistive devices. Most notably, ventilators were initially in short supply during the spring of 2020. By November 2020, ventilators had reached target threshold levels, and the SNS currently has more than 158,000 ventilators on hand (a ten-time increase over pre-pandemic levels) and ~25,000 high flow nasal cannula kits available for deployment, which it did not previously stock.
The U.S. Government’s investments in key domestic manufacturing capabilities have improved the U.S. posture significantly since the COVID-19 pandemic began, both in quantities of PPE and DME stored in the SNS and domestic industrial manufacturing capacities. The most notable gaps were in raw materials, such as nitrile butadiene rubber (NBR) for pharmaceutical and medical glove manufacturing and man-made fiber for gowns and surgical masks. HHS reports and strategies highlighted the lack of raw materials, and the Department continues taking steps to address this problem.
The United States has sustained and expanded the PHIB through recent investments to ensure its viability during public health emergencies. This includes a $250M investment in expanding and sustaining the public health supply chain and industrial base to reduce dependency on foreign markets for all PPE including gloves, gowns, respirators, and raw materials. FDA has taken actions to get PPE and DME to patients and those impacted by COVID-19, including
- issuing 28 guidance documents (including 21 revisions) outlining policies to help expand the availability of medical devices needed in response to COVID-19;
- issuing Emergency Use Authorizations (EUA) or granting marketing authorization to nearly 2,000 medical devices for COVID-19-related uses;
- reviewing nearly 13,500 applications for medical product approval, clearance, or authorization between March 2020 and September 2021;
- authorizing the use of 269 PPE devices, including 51 surgical masks, 205 filtering facepiece respirators, and issuing 13 EUAs for face shields and other barriers intended to protect the user from bodily fluids, liquid splashes, or other potentially infectious materials.xiii
Early in the COVID-19 pandemic, a large influx of imported respirators led the CDC to develop an abbreviated filtration efficiency test for imported non-NIOSH-approved respirators. Testing revealed that approximately 60 percent of more than 780 international respirators performed below U.S. standards. These reports helped federal, state, and user communities identify substandard and counterfeit products. CDC and FDA continue their efforts to ensure availability of respirators and masks despite the emergence of the highly contagious Omicron variant.
During the pandemic, FDA has identified and implemented agile regulatory approaches including assigning additional staff to PPE premarket reviews, issuing EUAs, and releasing guidance. FDA also continues to actively engage public health and industry stakeholders to monitor respirator supply and demand and to communicate the status of supply and mitigation actions undertaken to facilitate access. Currently, the inventory of NIOSH-approved respirators and surgical masks are higher than at the start of the COVID-19 pandemic. Globally, there are approximately 90 NIOSH-approved N95 manufacturers; most masks are produced overseas, but largely by companies headquartered in the United States. However, vulnerabilities and the possibility of sub-standard or counterfeit goods still exist.
N95 filtering facepiece respirator levels remain reactive to COVID-19 case surges. Currently, no conservation strategies are in effect and, assuming COVID-19 mitigation protocols stay in place, current models project steady demand for surgical and procedural masks in the future. Assuming max production capacity continues, monthly N95 filtering facepiece respirator production requirements can be met domestically. If industry is unable to provide additional capacity in the case of another demand surge, federal and state stockpiles can provide time for manufacturers to ramp up production. Of note, N95 filtering facepiece respirator demand is vulnerable to changing CDC guidelines and additional modeling efforts are required to visualize the impact of changes in use among the general public.
Commercial inventories of medical-grade nitrile gloves across major distributors have risen over the last 12 months; volumes are now much higher than at the start of the pandemic. The supply chain for nitrile gloves depends on international sources for both manufacturing and key raw materials. Key medical-grade glove manufacturing is concentrated in Southeast Asia,14 which is geographically close to the precursor raw material supply chains, such as natural rubber. The United States cannot cost effectively produce sufficient supply to meet its own demand.
There are several types of surgical and non-surgical gowns, each with their own kind of barrier protection, complexity in manufacturing, and regulatory requirements. The global supply of medical-grade gowns could grow by billions of gowns per year due to greater supply and cost competitiveness from Asia and Europe. For certain gowns, these expansion efforts will likely satisfy U.S. demand in the near and long-term.15 U.S. demand is expected to decrease from approximately 3.5 billion (2021) to approximately 1.4 billion gowns (ongoing demand), which is an increase from 2019 levels but a decrease from 2020-2021 levels.
Approximately 80 to 90 percent of global manufacturing of finished gowns happens in Asia and some nearshore, but companies headquartered in the United States dominate, which provides opportunities to shape industry by increasing domestic production and decreasing international reliance.
DME encompasses a wide range of products that include any equipment and supplies ordered by a healthcare provider for everyday or extended use (e.g., oxygen equipment, testing equipment, wheelchairs, ventilators). Resin, a component of DME plastic equipment, experienced supply chain constraints during 2021. A series of natural disasters, including a winter storm and fires, caused power outages and plant shutdowns across the petrochemical industry in Texas and Louisiana. These shutdowns resulted in a marked decrease in the production of medical-grade resins, reducing allocations to the medical device industry. Demand fluctuations have compounded supply chain vulnerabilities created by limited suppliers and mitigation delays. Overall, resin availability for medical device and component manufacturing appears to have stabilized but will remain extremely fragile in 2022. A current exception applies to medical device packaging manufacturing, where resin-based adhesive or heat seal coating is used to create sterile barrier systems.
Current Actions to Address Supply Chain Vulnerabilities
The PHIB remains vulnerable without sustained commitment; the demand for PPE and DME will eventually decline as the threat from COVID-19 subsides, and with it the customer base for the PHIB. However, the U.S. Government has a vested interest in U.S. companies’ continued marketplace viability and has made significant investments to expand PPE production capacity.
Since the start of the COVID-19 pandemic, the U.S. Government has made large investments to expand domestic industrial base capacity to meet vital PPE needs, including investments in N95 respirators (filtering facepiece and elastomeric half facepiece), surgical and isolation gowns, gloves, and raw material inputs for these items. Ongoing activities to address PPE and DME supply chain vulnerabilities and to strengthen the industrial base include:
Growing the Nation’s Stockpiles: HHS works with industry and government partners to stabilize stockpile levels and enhance storage capabilities to improve the function, composition, and accessibility of the SNS. HHS led an interagency effort to address the early pandemic PPE supply shortage and resultant purchasing based on availability rather than quality or performance. The SNS, the Federal Emergency Management Agency, and SLTT governments have stockpiled more than one year’s supply of N95 respirators. In addition, since the onset of the COVID-19 pandemic, NIOSH has added 30 new domestic approval holders, which have significantly added to the national inventory of respirators. The SNS has awarded contracts for additional gloves, which will meet or exceed its stockpiling target by May 2022. In the future, additional PPE standards will facilitate broader access to higher quality PPE.
Advancing Domestic Raw Material Manufacturing: HHS is assessing opportunities to advance nitrile and key chemical manufacturing in the United States. In addition, HHS is seeking opportunities to facilitate warm-base manufacturing opportunities. Warm-base manufacturing refers to the capacity to be operationally ready quickly to manufacture MCMs during a response.
FDA is working to address silicone shortages. Silicone is a new area of concern in the supply chain because it is essential to medical technology manufacturing. It is in great demand because it is used to produce medical device components, on-device printed ink, and as a bonding agent in device component sealing and assembly. FDA has received and is currently investigating several silicone shortage signals. It is working to identify key silicone suppliers and will work with suppliers and manufacturers to better understand the supply chain.
Expanding PPE Research and Innovation: CDC has developed plans to expand the Nation’s capabilities and capacity for PPE research and innovation via a nationwide network of personal protective technologies (PPT) Centers of Excellence (COE). It has identified PPT priority topic areas for the COEs and defined the structure for their core components: planning and evaluation, research, and outreach.
CDC has also developed plans for an aggressive Broad Agency Announcement (BAA) Program for PPT. Based on a socio-technical systems approach, the BAA uses technology developers, engineering firms, research scientists, suppliers, and manufacturers to develop and evaluate innovative designs and test methods to improve the availability, acceptability, comfort, fit, and usability of domestically produced PPE.
Improving PPE and DME Comfort, Utility, and Protective Capability: ASPR, in partnership with NIOSH and the National Institute of Standards and Technology, created the Mask Innovation Challenge to improve the comfort, utility, and protective capabilities of masks for the public to combat COVID-19 and to reduce the transmission of influenza and other common infectious diseases in non-medical settings. During the first phase, the Challenge identified 10 innovative concepts for next-generation face coverings to protect against respiratory disease pathogens.xiv The next phase will accelerate the development of next generation masks that have multi-hazard protection.xv
Preventing Counterfeit Products from Entering the U.S. Market: FDA, in coordination with NIOSH and the Occupational Safety and Health Administration (OSHA), communicated the transition away from crisis capacity strategies, such as respirator decontamination and use of non-NIOSH approved respirators.16 NIOSH has worked to identify possible counterfeit respirators and to coordinate with federal partners such as the U.S. Customs and Border Protection Agency (CBP) and the U.S. Patent and Trademark Office to establish strategies to manage counterfeit products, such as registering the “N95” trademark. FDA has also worked to identify possibly counterfeit PPE and works with device manufacturers and other government partners to communicate about these issues. FDA, CDC, and OSHA continue to coordinate their overlapping responsibilities and authorities about PPE, particularly respirators. A draft memorandum of understanding has been established to coordinate activities among these agencies. FDA, OSHA, NIOSH, and the CBP have worked closely together to detect and prevent counterfeit medical products from entering the market and have continued discussions as to how the agencies can continue to effectively work together to eliminate counterfeit and substandard products from entering the U.S. market. Regulations and laws, such as the Make PPE in America Act, can be used to expand domestic production and promote greater use of PPE made in the United States. Addressing the problem of counterfeit and substandard products offered for sale within the United States will ensure the domestic consumer is able to access high-quality PPE.
Analyzing Semiconductor Shortages and its Impact on Medical Devices: FDA has been working with medical device manufacturers to gain greater visibility into the semiconductor supply chain. U.S. Government outreach to device manufacturers is ongoing. In addition, FDA is actively working with ASPR and DOC to analyze the semiconductor shortage and its impact on the medical device industry, patients, and U.S. healthcare systems.
Updating PPE Standardization System: Through NIOSH, HHS is addressing and updating the U.S. PPE product standardization system to improve the efficacy, usage, effectiveness, safety, supply stability, and accessibility of PPE designed for use in U.S. healthcare settings, by critical infrastructure workers, and for general public protection to protect workers and reduce exposure to infectious diseases in workplaces and community settings. NIOSH is establishing a Product Standardization Task Force to promote innovative approaches and technologies to streamline PPE manufacturing and to address availability and standardization gaps and limitations for PPE and the technical methods, processes, techniques, tools, and materials that support PPE development.
Establishing Essential Medical Device List: FDA is leading an interagency effort that includes broad representation from public health experts and clinicians in the government, non-profit, and private sectors to develop recommendations for an essential medical device list (including device materials, components, parts, or accessories) that are clinically essential for patients, healthcare workers, and the U.S. public.
Increasing Visibility to Prevent Disruptions and Shortages: FDA is currently building a data analytics and predictive modeling platform to support visibility and prevention of supply chain disruptions and shortages of medical devices.
Planned Actions to Address Supply Chain Vulnerabilities
HHS is incentivizing domestic raw materials production of NBR and key chemicals for gloves and of man-made fiber for gowns and N95 filtering facepiece respirators through investment, public-private partnerships, collaboration with industry, regulation, and proposed legislation in order to onshore or near-shore production capacities and reduce reliance on foreign production.
The risks associated with a lack of medical-grade PPE and DME directly impact the Nation’s ability to protect frontline medical professionals. The PHIB must be able to sustain operations as PPE demand drops post-COVID-19. The following are additional actions that could support these goals:
Increase Capacity Using Emerging Technologies: Invest in artificial intelligence, robotics, and automated assembly practices and technologies (e.g., shelf-life extension) for existing manufacturers, including extruders for increasing production of man-made fibers and computer numerical control/robotic automation assets for sewing and finishing gowns, and advanced humanlike headforms to expedite respirator development timelines. Industry can also use new and emerging technologies to address potential domestic and foreign manufacturing shortages and to develop a conformity assessment scheme for protecting the public during a pandemic.
Optimize Industry Collaboration: Collaborate with industry to identify untapped domestic manufacturing potential or strategies to spread end-to-end risk across manufacturers and address the lack of vertically integrated domestic manufacturers.
Stimulate and Sustain Demand: Investigate other avenues to establish domestic demand through U.S. Government partnerships, increasing stockpile inventory, and establishing a revolving fund for SNS with Buy American provisions.
Collaborate with the Interagency: Collaborate with other departments to share market intelligence or shape procurement strategies. FDA will continue to work collaboratively with U.S. Government partners, such as DOC, to stay informed about semiconductor supply chain vulnerabilities, risks, and shortages, and their impact on manufacturing of life-sustaining and life-supporting medical devices. FDA can also collaborate with other U.S. Government agencies to assess potential scalability of domestic foundries and semiconductor chip producers identified in the public DoD Trusted Foundries Program.
Ensure Strategic Contracting: Incorporate language into new contracts to require scale up of production in a specified number of days in the event of a public health emergency or other contingency response. Partner with industry to ensure continuity of distribution and delivery that anticipates supply chain disruptions in the event of a public health emergency or other contingency response.
Incentivize and Invest: Invest in and incentivize reshoring of raw materials processing, such as NBR and its key starting chemicals. Assess the potential to invest in mitigation strategies targeting the resin and semiconductor chip shortages. Planned improvements to PPE raw materials capacity include investments in key chemicals for NBR, N95 respirators (filtering facepiece and elastomeric half facepiece types), and medical gown production. These strategies and investments have the potential to greatly strengthen the PHIB, ensure a viable economic base, and could be quickly executed.
14. The four manufacturers with the highest share of the global nitrile glove market are based in Malaysia.
15. There are four levels (L1-L4) and two types (surgical and non-surgical) of gowns. The gowns market is expanding with many entrants in L2 isolation gowns and global expansion efforts in L2 and L3 disposable gowns.
16. This transition ultimately resulted in the revocation of EUAs for respirator decontamination systems and for non-NIOSH approved respirators, the withdrawal of immediately in effect guidance (IIEs) related to respirator decontamination, updates to the NIOSH-approved respirator EUA, and the continued evolution of the respirator and facemask IIE.