NIOSH is particularly interested in solutions which will allow healthcare workers to don PPE for extended periods in the harsh heat and humidity where Ebola has been able to thrive. Yet according to the Agency, healthcare workers in West Africa report that they can only wear PPE for 40 minutes at a time, and even in the U.S. where virtually all healthcare settings are air conditioned, NIOSH reports that “uncomfortable PPE is a common complaint and causes additional burden for healthcare workers.”
The issue is so important that President Obama addressed it directly in a speech late last year at the Global Health Security Agenda Summit: “And today, I’m pleased to announce a new effort to help health workers respond to diseases like Ebola. As many of you know firsthand, the protective gear that health workers wear can get incredibly hot, especially in humid environments. So today, we’re issuing a challenge to inventors and entrepreneurs and businesses of the world to design better protective solutions for our health workers. If you design them, we will make them. We will pay for them. And our goal is to get them to the field in a matter of months to help the people working in West Africa right now. I’m confident we can do this.”
Picking up on these comments, NIOSH—along with other CDC offices—has partnered with the U.S. Agency for International Development, the White House Office of Science and Technology, the U.S. Department of Defense, and others to kick off an initiative dubbed “Fighting Ebola: A Grand Challenge for Development.”
According to NIOSH, the Grand Challenge consists of several initiatives, including the development, testing and scaling for entirely new forms of PPE—or modifications to PPE already on the market—that address issues of protection, heat stress and comfort. Key components of the Grand Challenge include “broadly soliciting new ideas through social media” (i.e., crowdsourcing) as well as forging “public/private partnerships and providing critical funding for promising designs.”
Through crowdsourcing—which is a component of the ebolagrandchallenge.net website—NIOSH says it’s attempting to promote innovation, reviewing promising concepts that can be scaled to the field and setting performance, test and evaluation requirements based on eight “knowledge generation priorities” for protecting healthcare workers from Ebola.
Over the past nine months NIOSH says it has evaluated PPE “ensembles” that are currently used in West Africa and the rest of the world and has collaborated with partners in the U.S. and abroad to “develop solutions to improve PPE configurations in the future.”
Examples of these efforts include:
Use of a “sweating thermal manikin” along with human testing to evaluate several common ensembles used in West Africa and around the world in an effort to better understand factors associated with heat stress and design features that affect comfort and job performance; undertaking studies (including the “elbow lean test” and a “modified version of the ASTM F1671”) to better understand factors that affect penetration of microorganisms in blood and body fluids through protective clothing; and research on isolation gowns to evaluate their durability and ability to prevent penetration of viruses in blood and body fluids.
On April 11, 2013, NIOSH published a “Notice of Opportunity to Support Research” in the Federal Register calling for the voluntary submission of laundered and non-laundered isolation gowns for testing in the Agency’s National Personal Protective Technology Lab. The purpose of these tests, according to NIOSH, wasn’t specifically related to Ebola but, instead, is intended to support ASTM efforts to establish minimum performance requirements for isolation gowns used by health care workers generally.
In its request for sample submissions more than two years ago, NIOSH requested a minimum of 100 units for each single-use isolation gown model to be tested as well as at least 200 unprocessed, unused and unwashed reusable gowns for each model submitted.
The agency further stipulated that reusable gowns submitted for testing must include a labeling recommendation for the maximum number of laundering cycles to be included in this study. Half of the gown samples would be tested after one laundering/drying cycle and the other half would be tested after undergoing the maximum number of cycles claimed allowable by the manufacturer.
NIOSH recently presented the findings of its single-use review at an APIC conference in a poster with the following conclusions: 1) isolation gown strength properties show a wide range of distribution; 2) seven models of gowns out of 22 models test did not meet AAMI PB70 barrier claims made by their manufacturers; and 3) seam and/or tie construction may not be adequate for some isolation gowns to provide sufficient protection. These finding should be an alert to the nonwovens industry that stiffer ASTM standards for surgical and isolation gowns may be on the way, and a summary of the findings is available at tinyurl.com/o3oaqhp.
As for the laundered products being studied, NIOSH says that portion is “on going,” and they’re “hoping” to have it completed by the end of this year. The re-usable review is taking longer because the gowns have to be laundered to the maximum number of laundering/drying cycles recommended by the manufacturer (typically 75-100 times) and then their performance has to be evaluated. Right now, according to NIOSH, the Agency is evaluating the performance of one-time-washed reusable gowns.
One final question NIOSH says it’s trying to ask with all this research is, “What PPE constitutes an ’acceptable’ level of protection against pathogens like Ebola virus in blood and body fluids?”
While ASTM and ANSI standards are in place to evaluate surgical and isolation gown performance, NIOSH says a challenge for healthcare workers is “selecting the most appropriate protective clothing…based on the recommendations, practices and regulations.” The Agency goes on to note that this challenge is complex because “there is no industry consensus for using these terms,” and “Evidence-based guidance is needed in order to define these terms to improve communication among employers/purchasers and gown and coverall manufacturers/suppliers. “
Taken together all this appears to offer opportunities and challenges for the nonwovens industry, which will benefit from potential funding and a Presidentially-guaranteed market for more comfortable and higher performance PPE while possibly facing stiffer standards and backing up performance claims.