A liability problem could delay supply of emergency respirator

A liability problem could delay supply of emergency respirator
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Imagine an Ebola epidemic is ravaging a community, or a dirty bomb goes off in a major city — but health workers can’t enter the affected area because they lack adequate respiratory protective devices (respirators) meant to protect them from airborne particles carrying disease or radiation.

Sound far-fetched? The World Health Organization (WHO) is struggling to control 19 pandemic, epidemic diseases, including Ebola, SARS and smallpox. No country, community or culture is safe from exposure, with the WHO recently declaring the current Ebola outbreak — which is already the second largest in history — a global health emergency.

We live in a very mobile world. Deadly diseases can rapidly jump from an isolated area to a densely populated city, then to an airport and on to anywhere around the globe. The U.S. is one flight, one cough, and one biological accident away from disaster.

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Huge risk

The problem: Companies called upon by the federal government to supply respirators that are needed to respond to a public health emergency are exposed to their own potentially catastrophic risk.

Right now, respiratory protection recommended by the Centers for Disease Control and Prevention (CDC) to keep health care workers safe during a public health emergency is not included in the Public Readiness and Emergency Preparedness Act (PREP Act).

The International Safety Equipment Association (ISEA) believes the liability protections afforded to drugs, biological products, and other FDA-approved devices under the PREP Act should be afforded to respirators during a crisis.

When the United States government issues a PREP Act declaration for a public health emergency, it assumes liability for any products listed in its declaration. That’s only fair, since the government is specifying what products should be used to protect health care workers.

The key goal of these declarations is to make certain the government can get quick deliveries of, rapid test kits, drugs and other items covered under the PREP Act to respond to the public health emergency.

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Also, during such health emergencies, there is an immediate surge in demand for respirators from all corners of the economy and the general public — some who have never used a respirator before.

But companies that supply respirators are put in a damned-if-they-do, damned-if-they-don’t position: Refuse to provide respirators and become a pariah, or provide respirators and hold their breath waiting for opportunistic lawsuits, with none of the liability protection the federal government provides to companies selling other categories of products needed in a public-health emergency. A lawsuit could mean the insurer no longer covers public health use of respirators or drops coverage completely.

Respirator suppliers deserve parity

Respirator providers should have parity with every other medical device or drug company protected under this law. It was wrong that they inadvertently got left out of the PREP Act in 2005.

A regulatory quirk allows PREP Act protection for a style of respirator that is certified by both the National Institute for Occupational Safety and Health (NIOSH) for its ability to filter particulates and by the FDA as a surgical mask. However, the same respirator that is certified only by NIOSH, but provides the same protection from airborne particulates is not covered under the PREP Act.

Furthermore, the PREP Act provides protection for pharmaceutical companies that provide a government-recommended drug during an emergency, even as the same government-recommended respirator would not be covered.

It’s an easy fix

We need to give medical and public-health heroes the personal protective equipment they need to minimize risks to their own health. Companies manufacturing and distributing respirators that are called upon to protect public health workers exposed to chemical, biological, radiological and nuclear agents should have the same PREP Act protection that is afforded to suppliers of other needed equipment that can be used against such hazards.

Addressing this parity issue is long overdue. Rep. Don Bacon (R-Neb.) has been developing legislation that will be introduced during the 116th Congress to extend PREP Act protection for NIOSH-approved respirators that are called upon to protect health care workers during federally declared health emergencies.

With the threat of Ebola growing globally and unknown risks on the horizon, this bill deserves bipartisan support, an expedited vote and quick passage. It’s a matter of principle and fairness. It’s a matter of urgent public safety and health-worker protection. And it’s a matter of common sense. 

Dan Glucksman is director of public affairs at the International Safety Equipment Association.