During the 2009-10 influenza season, amid the H1N1 pandemic, hospitals fearing a shortage of N95 respirators questioned whether surgical masks could be substituted in their place.

Brosseau described the distinction between what can be labeled as a respirator compared to a surgical mask. Surgical masks, she explained, were originally designed so that "the surgical wound would not become infected from gross contamination from the surgeon’s mouth during talking, sneezing or coughing." Even though a surgical mask was never intended to serve as a protection from airborne particulates, "it’s now become something way beyond what it ever was designed or what anybody ever thought it would do, to the point where we now think it will protect us from everything," she cautioned.

In order for a manufacturer to sell a respirator in the United States, it must pass filtration and other tests set by the National Institute of Occupational Safety and Health (NIOSH) allowing it to be labeled as a certified respirator. Types of respirators used in healthcare include particulate respirators, half- or full-face elastomeric respirators, and powered air purifying respirators (PAPR).

For surgical masks, Brosseau explained, the US Food and Drug Administration (FDA) provides 510(k) clearance for marketing, based on manufacturer-reported testing results for attributes such as fluid-resistance, anti-flammability and filtration efficiency.

According to the FDA, "A face mask is a loose-fitting, disposable device that creates a physical barrier between the mouth and nose of the wearer and potential contaminants in the immediate environment. Face masks may be labeled as surgical, laser, isolation, dental or medical procedure masks. They may come with or without a face shield.

"An N95 respirator is a respiratory protective device designed to achieve a very close facial fit and very efficient filtration of airborne particles. In addition to blocking splashes, sprays and large droplets, the respirator is also designed to prevent the wearer from breathing in very small particles that may be in the air."³

Key Surgical 4509 full face shield with splash guard

Options labeled as "surgical mask/N95" or "surgical mask respirator" are NIOSH-certified respirators that have also passed FDA clearance for marketing as a surgical mask, Brosseau explained.

"The FDA process gives you the assurance, for all medical devices, that the product has been regulated by a third party," commented Brigette L. Master, global product manager, 3M Infection Prevention Division, masks & respirators. "Both masks and N95 respirators are regulated as medical devices by the FDA and as such must meet required design performance testing and be reviewed and cleared for marketing by the FDA via the 501(k) process. There is a place for both surgical masks (face masks) as well as surgical N95 respirators in the healthcare setting."

Jeff Murphy, vice president of marketing, TIDI Products LLC, further clarified common terminology used to describe facemasks used in the healthcare field. "Facemasks marked as ‘fluid-resistant facemasks’ tend to give more protection, while facemasks marked as ‘procedure facemasks’ or ‘isolation facemasks’ tend to be less protective and not be as expensive," he said. "To help end-users determine what level of protection their facemask gives them, they should look to the ASTM F2100-07 which classifies them into High, Moderate, and Low levels of protection."

In addition to meeting minimum filtration requirements, a respirator must also be sized to fit the individual wearer in order to provide the intended benefits, and this is another way that respirators are differentiated from surgical masks.

"A respirator (for example, an N95 or higher filtering facepiece respirator) is designed to protect you from breathing in very small particles, which might contain viruses. These types of respirators fit tightly to the face so that most air is inhaled through the filter material. To work the best way, N95 respirators must be specially fitted for each person who wears one (this is called ‘fit-testing’ and is usually done in a workplace where respirators are used)," the CDC noted.   

"That’s another misunderstanding, I think, in the healthcare setting is that if you’ve picked [a respirator] that meets the basic criteria that it’s going to fit you, and that turns out to be unfortunately not true," cautioned Brosseau. "We’ve not come up with that design that will always fit every face. And that’s why we require fit testing with respirators. And even then there are some faces that can be hard to fit, smaller ones, ones with unusual characteristics, very wide faces, for example," she said. "Once you get a good filter, which is basically what is required now for every respirator, then the key aspect of protection is really going to be how well does it fit on your face?"

As detailed in OSHA’s Respiratory Protection Standard, a respirator must be used in the context of a full respirator program. Brosseau summarized what that entails. "Fit-testing is one part of that, but there are quite a number of other components to a full respirator program. Essentially, there needs to be one person in charge of the program, who is considered the program administrator. The next step is to identify who is really at risk of exposure, who should be enrolled in the program. So, that’s all the nurses, and many of the physicians, and the respiratory therapists and some of these others who are more likely to be exposed to infectious aerosols in a healthcare setting."

A risk assessment helps determine what situations pose a risk for employees and what level of risk. "That guides your selection of the kind of respirator they should wear," said Brosseau. She described how respirator selection came into play during last season’s flu pandemic. "One of the issues was, if you’re exposed to a patient with known or suspected H1N1 you wear one level of [respiratory] protection, but if you are intubating or doing aerosol-generating procedures you want to be wearing a higher level of protection. And that’s when we were recommending powered air-purifying respirators [PAPR] for people who were involved in those activities. That addresses the fact that the risk of exposure is a lot higher, the amount of aerosol they’re exposed to is a lot higher."

Ansell DermaPrene IsoTouch HydraSoft surgical glove

After being cleared by a physician to safely wear a respirator, the employee must be fit-tested to a specific model and size of respirator. "And that model and size has to be made available to them in the workplace," said Brosseau. "It’s important for purchasing [managers] to understand that they can’t just purchase any random respirator. You need to be purchasing the size, model, and manufacturer that has been designated. Often, what a hospital will do is try to find one manufacturer and designate the range of sizes, and those all should be stocked and available."

"Then there is training," she continued. "You should do annual training of people. This is really important in healthcare, I think, because people don’t wear their respirator very often and they will forget how to put it on properly. It’s infrequent use, so training is important because it helps remind people every year."

She referenced a study from British Columbia that showed healthcare workers in many cases were not selecting their recommended respirator size or model, whether they forgot, or were purposely choosing a respirator they deemed most comfortable or otherwise preferred.

Program evaluation is another component of a respirator program, said Brosseau. "The program administrator is supposed to figure out a way to see whether or not their program is working. Are respirators available to people? Are they using them properly? Are they using them when they should? Are they experiencing any sort of problems with their respirators? Do the managers support the program? Those are the main elements of a respirator program."

Kaitlin Donohue, marketing manager, Tronex Company, added, "to ensure that the N95 mask is providing the intended levels of protection, each user should receive proper training and practice time on the application, seal check, and removal/disposal procedures. Tronex also offers N95 Fit Instructions to ensure the best fit and seal for each user." 

A Cone NIOSH N95 approved Particulate Respirator from Tronex is available in both Unisize and now Small sizes to provide superior fit and seal for a wide range of facial sizes and structures. Donohue noted that while the Unisize is designed to fit most facial frames, "in the event that the Unisize is too big for the user’s facial frame, Tronex carries an N95 Particulate Respirator, Cone Style in a Size Small." 

The Tronex Unisize and Small Cone N95 Respirators are part of a complete line of Tronex N95 Respirators which help to protect against the transmission of airborne pathogens such as avian & swine influenza, tuberculosis (TB), dust, and pollen.

Donohue described unique features of the Tronex Fold-Flat N95 Respirator and Surgical Mask. "Tronex N95 Particulate Respirators are carefully designed and meticulously manufactured for exceptional performance and fit. The specialized fold flat design provides a superior combination of portability and superior fit and seal due to a number of important design factors. The shape of the respirator when fully opened, combined with the loop-through dual headbands ensure a uniform seal around the respirator for various face and head shapes and sizes. The malleable nosepiece with foam strip helps to minimize air leakage across a wide range of nose bridge shapes and heights."

PPE also includes apparel such as isolation gowns, and like respiratory protection these are available in a wide range of styles and materials and provide varying protective benefits. The Association for the Advancement of Medical Instrumentation (AAMI) offers a series of tests to rate gowns according to their level of fluid permeability.

"We had no standard [for isolation gowns] for so long, and then AAMI came along and provided some guidance," recalled Kelley Terrell, marketing manager, Techstyles Products for the Encompass Group LLC. She described the distinction between "protective" gowns that are AAMI-rated and non-AAMI rated "precaution" gowns. "It has to be AAMI rated [to at least Level 1] to be considered protective," she said.

Precaution gowns, on the other hand, "have different thresholds of fluid resistance all the way up to impervious, but they go through traditional testing standards," said Terrell. For example, Encompass carries an impervious "half-back" gown designed to be more comfortable for the wearer, but because it lacks a full back it wouldn’t qualify under AAMI standards.

In order to receive an AMMI rating, "isolation gowns have to be qualified 360 [degrees] top to bottom. They have to [have a] full back, and [the entire gown, including] all the seams must pass," related Terrell. "It’s more stringent than for a surgical gown. With a surgical gown, you know you’re going to get hit in the chest and the arms. With an isolation gown, the critical zone is the whole gown."

Encompass AAMI compliant isolation gowns

Offered Donohue, Tronex, "Isolation gowns are needed in a variety of AAMI levels because of an OSHA regulation that the ‘employer provide the healthcare worker with protective apparel that is commensurate with the task and degree of exposure anticipated.’ A level 3 gown might be a better choice when the probability exists that a clinician will come in direct contact with bodily fluids during a procedure. A level 2 gown would be a good choice for a phlebotomy, starting an IV or perhaps an injection."

Terrell described an independent survey in which clinicians named potential care scenarios for various levels of AAMI-compliant gowns. Respondents noted that likely uses for a Level 2 gown included radiology, nursery, blood draw, dialysis, cath lab, GI, and IV procedures. "Basically anything with low to moderate risk," she said. AAMI Level 3 gowns, which provide additional fluid resistance, are often used in obstetrics, ICU, ER, trauma and burn units, the survey showed.

Terrell noted that many facilities tend to standardize on gowns as much as possible, and an AAMI Level 2 isolation gown provides a good option for medium-risk situations, with the addition of a smaller stock of Level 3 gowns for higher-risk scenarios.

Encompass recently added AAMI Compliant Level 2 and Level 3 isolation gowns to its extensive line that includes materials from spunbond to impervious polyethylene with a variety of features including knit and elastic cuffs, thumb loops and generous sizing for comfort. "We’ve always had the Level 1 [gowns], just to make sure we offered something that met the criteria for being a protective gown. Now with the new threats that are coming into the industry more people are looking at higher protection. There is way more exposure at this point and they’re trying to minimize cross contamination as much as possible."

A new line of limited-use heat reflective jackets and vests from Encompass are made of lightweight Thermoflect which is inherently impervious and retains the body’s endogenous heat providing warm, comfortable protection.

In 2010, TIDI added two new isolation gowns to its offering, along with several chemotherapy items, as well as acquired Timely Medical Innovations (TMI) which provides disposable eyewear. Murphy noted that TIDI will continue to add new PPE items this year.