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By Richard B. Jaffe
By Richard B. Jaffe
Despite the fact that respirators are worn by more than 5 million U.S. workers at more than 1.3 million worksites across the county, mandatory face-fit testing remains an enigma; an enormous challenge faced on a regular basis by already over-burdened healthcare facilities. Yet little if anything has been done in the name of confronting this challenge. Rather than attempting to meet it head-on, respirator manufacturers and healthcare providers alike have instead chosen to quietly accept it as a necessary evil. Simply put, when it comes to the development, sale and purchase of N95 respirators, fit-testing is the elephant in the room.
At minimum, the fit-testing process costs healthcare facilities valuable time, money and human resources. At worst, however, it can stop innovation dead in its tracks, as the mere thought of having to conduct fit testing is often enough to discourage healthcare providers from embracing the latest advancements in N95 respirator technology. Yet fit testing is mandatory for a reason, and a good one at that: It ensures that healthcare workers are getting the protection they need when they put their trust in an N95 respirator.
For too long, the response from both sides of the industry to this unique challenge has been no response at all. In order to kick the elephant out of the room once and for all, this has to change. Healthcare providers and respirator manufacturers must work together to meet the challenges of fit testing head-on. By doing so, we can make fit testing less burdensome than ever before, in the process enabling a new wave of next-generation, N95 respirators to make their way into the marketplace and deliver a cutting-edge brand of respiratory protection to the nations healthcare workers.
The Fit-Test Basics
Required by the Occupational Safety and Health Administration (OSHA), fit-testing is a process used to determine whether a given product provides an adequate seal around the wearers face. It must be conducted before a new respirator can be worn in a workplace setting for the first time. There are two methods healthcare facilities can use to conduct fit-testing. The first, referred to as quantitative fit-testing, is a process in which a computerized system known as a PortaCount is used to measure the number of ambient particles inside and outside of a given respirator after it has been properly donned by the wearer.
Though effective, the time and money required to conduct quantitative fit-testing makes it an unrealistic option for most healthcare facilities. Most facilities instead choose to conduct qualitative fit-testing, a process in which atomized sweetener or bitrex is sprayed into a hood that has been placed over the wearers head. If after performing a series of activities, the wearer cannot taste or smell the testing agent, the respirator is deemed to have achieved an adequate seal and is approved for that individual.
A Considerable Set of Challenges
Though generally less expensive and less time consuming than its quantitative counterpart, qualitative fit-testing still represents a significant burden for healthcare facilities, according to renowned fit-testing expert Dr. Warren Myers, professor and associate dean for academic affairs at the West Virginia University College of Engineering and Mineral Resources.
"Qualitative fit-testing is one of the single biggest administrative challenges hospitals face," said Myers. "Any employee whose job requires them to wear an N95 respirator must undergo testing. For larger healthcare facilities, this means having to devote the time and resources to test thousands of employees. More importantly, the time those employees spend getting fit tested is time they arent spending caring for patients."
Depending on the size of the healthcare facility, qualitative fit-testing can take days if not weeks, and the costs, real or intangible, can pile up quickly. For starters, a healthcare facility needs to purchase the extra respirators needed conducting fit-testing. But thats the easy part, according to Myers.
"The hard part is determining who is going to physically conduct the testing," Myers added. "If you have internal staff members conduct it, youre taking important workers away from their jobs for a significant length of time. If you hire temporary workers to do it, youre incurring another additional cost, often a considerable one. And in either case, the individuals assigned to conduct fit testing will likely need some degree of training before they can begin."
Adding to the challenge for healthcare facilities is the fact that not all N95 respirators are donned the same way. Moreover, those individuals conducting qualitative fit-testing have usually not received formal training with regard to the specific donning instructions for a given product, and an improperly donned respirator can lead directly to a failed fit-test.
Whether caused by poor donning technique, poor respirator design, or both, failed fit tests are not without consequence. For an individual healthcare facility, a failed fit test means having to purchase a new respirator for each employee unable to achieve a satisfactory fit with a given model. For larger entity such as state of California, low fit-testing success rates meant having to order a major recall of its stockpile of 3M 800 respirators. In either case, time, money and human resources are wasted.
A Roadblock for Innovation
Unfortunately for healthcare workers, one of the unintended consequences stemming from the challenges created by fit testing requirements has been a lack of innovation in N95 respirator technology. Understandably influenced by their desire to minimize the burden caused by fit testing, healthcare providers have a tendency to gravitate toward N95 respirators with which they have prior fit-testing experience, often at the expense of more technologically advanced models.
Manufacturers have in turn become less willing to push the technological envelope, preferring instead to develop respirators that look and feel like those models healthcare facilities have experience fit testing. This may be one of the reasons that N95 respirator technology has remained largely the same for the past 20 years, and one of the reasons why most healthcare workers are still asked to wear constrictive cone-shaped respirators when newer products featuring a flat-fold design are capable of delivering a greater degree of comfort and breathability.
Working Together to Reduce the Burden
Fortunately, the remedy is a simple one: collaboration. Working together, healthcare providers and respirator manufacturers can take proactive steps to reduce the many burdens of fit testing. The first step is to accept that fit-testing is a challenge capable of being met head-on. Resolve to view it not as a necessary evil but as an important step in ensuring workplace safety, one that instead of being ignored until its too late will be made an integral part of the upfront decision-making process.
For manufacturers, this means setting out to develop cutting-edge respirators that fit an ever-increasing percentage of employee populations. One way to do that is to work with experts such as Myers, who conducts quantitative fit-testing on behalf of a number of large manufacturers, to measure and refine the fit-testing prowess of a product in advance of taking it market. For providers, this means seeking out products that will not only fit a large percentage of employees, but will also provide them with a variety of next-generation benefits such as enhanced levels of comfort and breathability.
Making Fit-Test Support Commonplace
Perhaps more importantly, respirator manufacturers need to stop looking at fit testing as the customers problem. Instead, they should implement support programs designed to help their customers with the fit-testing process itself. Safe Life recently launched a program which does just that, providing customers whose orders meet minimum certain volume requirements with a host of support services ranging from a fit-test training video to financial incentives to onsite, qualitative fit-testing support from trained company representatives.
This initiative has helped customers make the fit-testing process more streamlined and less burdensome than ever before. Such was the case for Scripps Health, a $2 billion, nonprofit community health system based in San Diego. Scripps made use of onsite support from trained Safe Life personnel to efficiently conduct fit testing on more than 10,000 employees at its five hospital campuses.
In order for support programs such as this to become commonplace, however, healthcare providers must begin to demand them from their vendors. They must establish fit-test support as a key criterion when determining whether to purchase a given N95 respirator from a given provider, weighted equally alongside availability, functionality and cost. By doing so, they will send a clear signal to manufacturers that the status quo with regard to fit-testing is no longer acceptable.
Delivering Better Protection for Healthcare Workers
In the end, the biggest winner will be healthcare workers and the patients they care for day after day. These workers deserve the opportunity to wear next-generation respirators that deliver the comfort and breathability the want without sacrificing the secure fit they need to stay protected. This wont happen until the path is cleared for innovative new products to enter the marketplace. By working together to ease the burden of fit testing, we can begin to clear that path.
Richard B. Jaffe is chairman and CEO of Safe Life Corp., a San Diego-based antimicrobial technology company that has developed a novel line of comfortable, breathable N95 respirators. He previously served as chairman, president and CEO of SafeSkin, which he co-founded, took public and sold to Kimberly-Clark in 2000. At the time of its acquisition, SafeSkin was manufacturing 6.5 billion gloves each year as the market share leader in medical examination gloves.