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) worked overtime to increase production in response to unprecedented international demand.

ISEA member companies and the workers who make PPE have been working hand in hand with the medical field and governments around the world to ensure demand is met for critical PPE. 

See all the work that’s been done…

IS THERE STILL A PPE SHORTAGE?

No. Following the surge in PPE demand at the onset of the pandemic, 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.

Increased Supply

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 partnered with the federal government, which placed orders for hundreds of millions of respirators, including N95s, surgical masks and surgical N95s. This addressed 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 ensure a shortage does not occur. The association fully supports SNS efforts 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  partnered with medical device producers to shift protection to products needed for outbreak response.
  • Manufacturers volunteered capacity for the effort, partnering with ISEA members to increase the volume of products that have been used for the response. 

Non-NIOSH Respirators No Longer Needed

To help address concerns about availability during the COVID-19 pandemic, the FDA issued Emergency Use Authorizations (EUAs) for certain PPE products including face shields, other barriers, and respiratory protective devices such as respirators.

Many have since been revoked given increased access to FDA-authorized and NIOSH-approved N95s. On June 30, 2021, the FDA announced the revocation of the following EUAs:

As of the effective date of the revocations, these devices will no longer be authorized for use by health care personnel in health care settings. ‘

For additional information, please see Update: FDA No Longer Authorizes Use of Non-NIOSH-Approved or Decontaminated Disposable Respirators – Letter to Health Care Personnel and Facilities.

Historical information regarding these EUAs can be found on Historical Information about Device Emergency Use Authorizations.

Current PPE EAUs:

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 OSHA RESPONDING?

OSHA’s primary resource is the OSHA COVID-19 Official Webpage, which is frequently updated. 

WHAT FEDERAL POLICY UPDATES SHOULD WE FOLLOW?

NIOSH Respiratory Protection
NPPTL has completed International Assessments for the products for non-NIOSH-approved respirators. These assessments were developed as an assessment of the filter efficiency for those respirators represented as certified by an international certification authority, other than NIOSH, to support the availability of respiratory protection to US healthcare workers and other workers due to the respirator shortage associated with COVID-19.

Results of efficiency are listed here. (April 30)

CDC Healthcare Guidance
On May 2021, the CDC reported the supply and availability of NIOSH-approved respirators have increased significantly. Healthcare facilities should not be using crisis capacity strategies at this time and should promptly resume conventional practices, including the use of only NIOSH-approved respirators where needed. Check the NIOSH Certified Equipment List to identify all NIOSH-approved respirators.

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.

FDA program to deem all NIOSH-certified respirators as Medical Devices and allow their use by healthcare professionals for COVID19 response (March 28)

IMPORTANT COVID-19 RESOURSES

ISEA members are listed here. Many have COVID-19 statements and resources available on their websites.

Federal Government

State & Local Governments

Nonprofit Organizations

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