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.
ISEA’s companies and the workers who make PPE are working hand in hand with the medical field as they strive to increase productivity while struggling with the same challenges, risks, and fears as the general public.
Members of the International Safety Equipment Association (ISEA) are working hard to keep everyone safe — including their own employees — during this 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.
Here are the latest ISEA statements on:
- The Businesses Preparing for a Better Tomorrow Act (September 17)
- PPE Demand Signal to Better Prepare for Health Emergencies (July 1)
- Strategic National Stockpile Demand Signal (June 5)
- Restructuring the Strategic National Stockpile (May 22)
- Protection Level of Improvised Respiratory Devices (May 8)
- Fighting Fraudulent and Unauthorized Respirators (April 16)
- Ethical Pricing and Anti-Hoarding Efforts (April 15)
Marketing & External Affairs
WHY WAS THERE A PPE SHORTAGE?
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 that 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.
IS PPE AN ESSENTIAL INDUSTRY?
Yes. The Department of Homeland Security designated PPE an Essential 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.”
HOW IS THE INDUSTRY RESPONDING?
Manufacturers engaged in a historic effort to ramp up production of the vital equipment needed to respond to the coronavirus outbreak. While respirators like N95 masks have received the greatest attention from the public and 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.
Existing producers of vital PPE ramped up production, retooled existing lines, and partnered with government agencies to increase supply of the products they already make.
- ISEA members have partnered with the federal government, which has placed orders for 500 million respirators, including N95s, surgical masks and surgical N95s. This addresses respirator shortages in the Strategic National Stockpile (SNS), 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.
- PPE producers who specialize in products for other sectors such as industrial or construction protection have partnered with medical device producers to shift protection to products needed for outbreak response.
- Manufacturers at large volunteering capacity for the effort, partnering with ISEA members to increase the volume of products that can be used for the response.
Clearing More Supply for Use
To help address concerns about availability during the COVID-19 pandemic, the FDA has issued Emergency Use Authorizations (EUAs) for certain PPE products including face shields, other barriers, and respiratory protective devices such as respirators.
Additionally, the FDA has issued recommendations and policies about PPE which can be found here: Recent Final Medical Device Guidance Documents.
- Umbrella EUA for Surgical Masks
- N95 and Other Respirators EUAs
- Umbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs)
- Umbrella EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs)
- Face Shields and Other Barrier EUAs
The CDC published an equivalent use chart that provides vital information for the use of imported respirators that are labeled with international standards.
As new PPE solutions are cleared for use, the liability that might slow or confuse hospitals, distributors, and manufacturers, is being addressed by FDA.
When a novel infectious agent causes a public health emergency and the government calls for 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.
HOW IS OSHA RESPONDING?
OSHA’s primary resource is the OSHA COVID-19 Official Webpage, which is frequently updated. Recent guidance released and housed on this page includes:
OSHA is issuing temporary guidance on the enforcement of its respiratory protection standard:
- Expanded Temporary Enforcement Guidance on Respiratory Protection Fit-Testing for N95 Filtering Facepieces (April 8, 2020).
- Enforcement Guidance for Use of Respiratory Protection Equipment Certified under Standards of Other Countries (April 3, 2020).
- Enforcement Guidance for Respiratory Protection and the N95 Shortage Due to the Coronavirus Disease 2019 (COVID-19) Pandemic. (April 3, 2020).
- Temporary Enforcement Guidance – Healthcare Respiratory Protection Annual Fit-Testing for N95 Filtering Facepieces. (March 14, 2020).
WHAT FEDERAL POLICY UPDATES SHOULD WE FOLLOW?
1. Paycheck Protection Program
As of April 15, the Small Business Administration (SBA) is no longer taking applications for the Paycheck Protection Program.
Access resources for assistance to small businesses, nonprofits, veterans organizations, and tribal businesses—as well as to certain self-employed folks and independent contractors.
2. FEMA Open Purchase Order for PPE
The FEMA contract opportunity for COVID-19 PPE and medical supplies was last updated April 2. Access the active order.
FEMA’s requisition specifies that products under consideration meet the requirements of ANSI/ISEA Z87.1-2010, American National Standard for Occupational and Educational Personal Eye and Face Protection. ISEA has made ANSI/ISEA Z87.1-2010 available as a complimentary download to capture the widest distribution possible.
3. NIOSH Respiratory Protection
NPPTL Respirator Assessments: Results of efficiency listed here. (April 30)
4. FDA Approvals
FDA program to allow non-NIOSH respiratory protective devices manufactured in China. (April 3)
Other systems for decontaminating N95 respirators have received EUAs from FDA. These EUA letters and FAQs about each process can be found here.
This EUA states all NIOSH-certified respirators can be used in hospitals. FDA requires it be made aware of any adverse incidents of a respirator used in a medical setting.
No manufacturer has applied for this as of April 16.
5. COVID-19 PREP Act
PREP Act declaration for COVID19 (March 17, 2020)
The broad listing of what’s covered is here:
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.
This Federal Register notice anchors the government’s liability protections provided in the various FDA Emergency Use Authorizations (EUAs).
IMPORTANT COVID-19 RESOURSES
ISEA members are listed here. Many have COVID-19 statements and resources available on their websites.
- Centers for Disease Control & Prevention (CDC)
- Occupational Health & Safety Administration (OSHA) (and https://www.osha.gov/Publications/OSHA3990.pdf)
State & Local Governments
- National Governors Association
- National Conference of State Legislatures
- U.S. Conference of Mayors
- National League of Cities
- National Association of Counties
- National Safety Council
- American Red Cross
- World Health Organization
- American Industrial Hygiene Association (AIHA)
- Health Industry Distributors Association (HIDA)
- National Association of Manufacturers
- National Federation of Independent Business
IN THE NEWS
- The Washington Post: Consumer Masks Could Soon Come with Labels Saying How Well They Work
- The New York Times: Elastomeric Masks May Save Your Doctor’s Life
- The Hill: A liability problem could delay supply of emergency respirator
- Wall Street Journal: 3M Isn’t a Coronavirus Villain
- Wall Street Journal: Demand for Face Masks Is Booming, But Makers Have a Nagging Concern: Legal Liability
- CNN: Supply chain woes hit health care workers in need of gowns, masks and other protective equipment
- New York Post: Coronavirus bill will include liability protection for face mask sellers
- ABC News: Medical providers, fearing equipment shortages, tap into secret national supply network
- Politico: Squabble over mask shortage erupts as coronavirus spreads
- ABC News Washington: Not everyone needs to wear masks ahead of virus outbreak, Arlington safety company says
- The Atlantic: Why We’re Running Out of Masks