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.
- 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.
- 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
- 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 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
- 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’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:
- Guidance on Preparing Workplaces for COVID-19 (Spanish)
- Prevent Worker Exposure to Coronavirus (Spanish)
- Worker Exposure Risk to COVID-19 (Spanish)
- Temporary Guidance on the enforcement of OSHA’s Respiratory Protection standard:
- March 14 Memo: on Healthcare Respiratory Protection Annual Fit-Testing for N95 Filtering Facepieces During the COVID-19 Outbreak
- April 3 Memo: on Respiratory Protection Equipment Certified Under Standards of Other Countries or Jurisdictions During the COVID-19 Pandemic
- April 3 Memo: on Respiratory Protection and the N95 Shortage Due to the Coronavirus Disease 2019 (COVID-19) Pandemic
- NEW Short video: Higher Risk Jobs Need Extra Protections to Keep Workers Safe
- NEW Poster: Steps All Workplaces Can Take to Reduce the Risk of Exposure to Coronavirus (Spanish)
- Visit OSHA’s Publications webpage for other useful workplace safety information.
ISEA Staff Contact
Dan Glucksman (703-795-6064; [email protected])
- Centers for Disease Control & Prevention (CDC): https://www.cdc.gov/coronavirus/2019-nCoV/index.html
- Occupational Health & Safety Administration (OSHA): https://www.osha.gov/SLTC/covid-19/ (and https://www.osha.gov/Publications/OSHA3990.pdf)
State & Local Governments
- National Governors Association: https://www.nga.org/coronavirus/
- National Conference of State Legislatures: https://www.ncsl.org/research/health/state-action-on-coronavirus-covid-19.aspx
- U.S. Conference of Mayors: https://www.usmayors.org/issues/covid-19/
- National League of Cities: https://www.nlc.org/program-initiative/covid-19-local-action-tracker
- National Association of Counties: https://www.naco.org/resources/featured/coronavirus-disease-2019
- National Safety Council: https://www.nsc.org/work-safety/safety-topics/coronavirus
- American Red Cross: https://www.redcrossblood.org/donate-blood/dlp/coronavirus–covid-19–and-blood-donation.html
- World Health Organization: https://www.who.int/emergencies/diseases/novel-coronavirus-2019
- American Industrial Hygiene Association (AIHA): https://www.aiha.org/
- Health Industry Distributors Association (HIDA): https://www.hida.org/
- National Association of Manufacturers: https://www.nam.org/coronavirus/
- National Federation of Independent Business: https://www.nfib.com/content/analysis/coronavirus/latest-on-coronavirus-from-nfib/
- 3M: https://www.3m.com/3M/en_US/company-us/coronavirus/
- Honeywell: https://www.honeywell.com/en-us/newsroom/news/2020/03/n95-mask-and-the-coronavirus-more-production-underway
- Moldex: https://www.moldex.com/resources/technical-briefs/novel-coronavirus-ncov-infection/
IN THE NEWS
- The Hill: A liability problem could delay supply of emergency respirator
- 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