The global coronavirus outbreak has tested people, industries, governments and supply chains unlike any crisis since World War II. Manufacturers and suppliers of personal protective equipment (PPE) have been working overtime to increase production in response to unprecedented international demand.

Despite criticism in the news media, and amid understandable expressions of anxiety on social media, ISEA’s companies and the workers who make PPE are working hand in hand with the medical field as they strive to increase their productivity while struggling with the same challenges, risks and fears as the general public.

Why have organizations faced shortages of PPE? The reasons are complex. Broadly speaking, no one knew a pandemic on this scale was coming. It has literally been a century since the last truly global health crisis.

In addition, over the past few decades, both for budgetary and efficiency reasons, healthcare organizations — just like most other sectors of the economy — adopted a “just in time” approach to ordering supplies. That philosophy worked, until this crisis hit. There are policy solutions that can help to supply equipment during a crisis, some of which have been partially successful at this time, and others which were not in place. These range from stockpiling equipment to subsidizing inventory. ISEA has worked in the past and will work in the future to ensure that our country’s policies provide for an efficient, and sufficient, supply of safety equipment.

Members of the International Safety Equipment Association (ISEA) are working hard to keep everyone safe — including their own employees — during this terribly difficult time. Our hearts, heads and hands are unified in responding mightily to help America and the world’s extended family of nations obtain the PPE needed by healthcare workers.

PPE PRODUCTION AN ESSENTIAL INDUSTRY

The Department of Homeland Security designated PPE an Essential industry industry in March 2020.

  • “Manufacturers, technicians, logistics and warehouse operators, and distributors of medical equipment, personal protective equipment (PPE), medical gases, pharmaceuticals (including materials used in radioactive drugs), blood and blood products, vaccines, testing materials, laboratory supplies, cleaning, sanitizing, disinfecting or sterilization supplies, and tissue and paper towel products” [Bolding added by ISEA for emphasis.]

MOBILIZING THE INDUSTRY

Right now, manufacturers are engaged in a historic effort to ramp up production of the vital equipment needed to respond to the coronavirus outbreak. While respirators have received the greatest attention from the public and the media, PPE needs also include protective garments, eye and face protection, gloves, and other components of the specialized ensembles health care professionals use to protect themselves from infection.

  1. Existing producers of vital PPE are ramping up production, retooling existing lines, and partnering with government agencies to increase supply of the products they already make.
  2. PPE producers who specialize in products for other sectors such as industrial or construction protection, are partnering with medical device producers to shift their protection to the products needed for outbreak response
  3. Finally, manufacturers at large, like Brooks Brother, Hanes, and others, are volunteering their capacity for the effort and are partnering with ISEA members to increase the volume of products that can be used for the response.

ISEA POLICY HIGHLIGHTS

  • Increasing Supply: Producers have ramped up production across the board.
    • ISEA members have partnered with the federal government, which has placed orders for 500 million respirators. This addresses respirator shortages in the Strategic National Stockpile, through the vital funding and contract guarantees.
    • ISEA has made aware to leaders of the Strategic National Stockpile that attention must be paid to the Stockpile’s respirator shortage. The association fully supports the current SNS effort to acquire millions of surgical masks, N95 respirators and surgical N95 respirators.
  • Clearing More Supply for Use: The broad supply of respirators for other industries and international markets is being cleared for use in the medical sector through agency actions such as the following:
    • The FDA has issued Emergency Use Authorizations for certain disposable and/or expired N95 respirators, for some reusable respirators, and for some respirators which are standardized under equivalent international standards.
    • The CDC has published an equivalent use chart that provides vital information for the use of imported respirators that are labeled with international standards.
  • Addressing Liability: As these new solutions are cleared for use, the liability that might slow or confuse hospitals, distributors, and manufacturers, is being addressed.
    • When a novel infectious agent causes a public health emergency and the government calls for personal protective equipment (PPE) not usually found in hospitals, ISEA believes all such needed PPE must receive temporary, limited legal protection. This is because legal action resulting from compliance with federal and end-user requests for PPE not usually found in healthcare workplaces would likely result in fewer options for the next public health emergency. This includes protective coveralls, gloves, eye and face protection and chemical protective aprons.
    • ISEA believes NIOSH-certified respiratory protective devices (respirators) must be part of the Public Readiness and Emergency Preparedness (PREP) Act. The association has held this position since 2005, when the PREP Act was signed into law, but omitted respirators.
    • ISEA and the PPE industry is seeking respirator inclusion in the Public Readiness and Emergency Preparedness (PREP) Act.
    • Efforts to fully address liability issues are still evolving, and ISEA continues to call on the government to fully protect industries and workers that are being directed to provide equipment for the crisis.

FEDERAL POLICY UPDATES

April 2, 2020: FEMA guidelines for critical PPE, specifically eye and face protection, amid COVID-19 pandemic  

April 1, 2020:  NIOSH Guidance on Decontamination of Disposable Respirator

March 31, 2020: FedEx update on COVID-19 PPE imports

Anti-Hoarding and Anti-Price Gouging Regulation

March 30, 2020:  https://www.govinfo.gov/content/pkg/FR-2020-03-30/pdf/2020-06641.pdf

March 29, 2020: FDA Approval for Battelle’s Vaporous Hydrogen Peroxide decontamination program for disposable respirators

  • Staff note: No other decontamination system has received FDA approval.  However, other decontamination methods do not involve the type of process included in the Battelle program.

FDA Approval of Powered Air Purifying Respirators (PAPRs) and all other NIOSH-certified respirators for Hospital Use

March 28, 2020: https://www.fda.gov/media/135763/download

ISEA Staff Notes:

  • This EUA states that all respirators in the NIOSH-certified equipment list can be used in hospitals. FDA still wants to be made aware of any adverse incidents of a respirator used in a medical setting.
  • This language meshes with the PREP Act. Now, there’s double protection: Not only are NIOSH-certified respirators allowed to be used in hospitals, but also, the devices have PREP Act coverage.

FDA Letter on FFR Imports from Australia, Brazil, EU, Japan, Korea and Mexico

April 3, 2020: https://www.fda.gov/media/136664/download

March 28, 2020: https://www.fda.gov/media/136403/download

ISEA Staff Notes:

  • China is not on this list.  See pages 4 – 5.
  • Those seeking FDA approval for importation of respiratory protective devices compliant with another nation’s standard for respirators should submit an EUA to FDA via the following email address: [email protected] and provide the information required in pages 4 – 5.

COVID-19 PREP Act Declaration

Also, here is the March 17, 2020 PREP Act declaration for COVID19. The broad listing of what’s covered is toward the end of the notice:

  • Covered Countermeasures 42 U.S.C. 247d–6b(c)(1)(B), 42 U.S.C. 247d–6d(i)(1) and (7). Covered Countermeasures are any antiviral, any other drug, any biologic, any diagnostic, any other device, or any vaccine, used to treat, diagnose, cure, prevent, or mitigate COVID–19, or the transmission of SARS-CoV–2 or a virus mutating therefrom, or any device used in the administration of any such product, and all components and constituent materials of any such product. Covered Countermeasures must be ‘‘qualified pandemic or epidemic products,’’ or ‘‘security countermeasures,’’ or drugs, biological products, or devices authorized for investigational or emergency use, as those terms are defined in the PREP Act, the FD&C Act, and the Public Health Service Act. 

OSHA

OSHA’s primary resource is the OSHA COVID-19 Official Webpage. This page is being updated routinely and we encourage you to review it frequently.  Recent guidance released and housed on this page includes:

ISEA Staff Contact

Dan Glucksman (703-795-6064; [email protected])

 

IMPORTANT LINKS

Federal Government

State & Local Governments

Nonprofit Organizations

Industry

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