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Copyright © 2008

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INSIDE THE CURRENT ISSUE

October 2008

Infection Connection

Infection Control Update
Infections linked to premature births more common than thought

Previously unrecognized and unidentified infections of amniotic fluid may be a significant cause of premature birth, according to researchers at the Stanford University School of Medicine. An analysis of amniotic fluid from women in preterm labor indicated that 15 percent of the fluid samples harbored bacteria or fungi - an increase of 50 percent over previous estimates. The heavier the burden of infection, the more likely the women were to deliver younger, sicker infants.

"If we could prevent these infections in the first place, or detect them sooner, we might one day be able to prevent some of these premature births," said research associate Dan DiGiulio, MD, who conducted the study in the laboratory of senior author David Relman, MD. About 12 percent of all births in this country are premature and the frequency of premature birth is increasing.

"To find that this amniotic compartment, which we have traditionally viewed as somewhat sacrosanct, is infected significantly more often than we thought is a little shocking," said Relman, professor of infectious disease and of microbiology and immunology. Previous analyses of the same samples using a different, more conventional method had concluded that only about 10 percent were infected.

DiGiulio and Relman collaborated with researchers at Wayne State University in Detroit, the Detroit Medical Center and the Eunice Kennedy Shriver National Institute of Child Health and Human Development to conduct the research.

Infection of the amniotic fluid likely contributes to preterm delivery by causing an inflammatory response in the pregnant woman. It occurs most commonly either by microbes from the vagina that infiltrate the amniotic sac, or by microbes that travel through the mother’s bloodstream from other parts of her body, such as the mouth. In fact, both gum disease and bacterial vaginosis have been shown to increase a woman’s risk of delivering her baby prematurely.

Finally, as the burden of infection increased, the average gestational age of the newborns decreased. That is, a woman with many copies of bacterial or fungal rRNA, which suggests the presence of many bacterial or fungal cells, was likely to deliver a very young, very sick infant. Relman and DiGiulio are now collaborating with Dr. Roberto Romero’s group on a much larger study of fluid collected during routine amniocenteses at about the 20th week of pregnancy. They hope to determine whether infections can be detected before the onset of preterm labor, which could lead to new prevention or treatment strategies.

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Unmasking the coverup: surgical mask or respirator?

by Susan Cantrell, ELS

The prospect of pandemic influenza and other disasters, natural or otherwise, have focused attention on the need for preparedness. An important part of disaster preparedness is having available an adequate supply of masks and respirators for given situations. Disaster or not, it’s important to know which kind of protection is appropriate for which situations, so as not to waste resources or compromise healthcare workers’ and patients’ health and safety.

Surgical mask or respirator?

Surgical mask

Kimberly-Clark’s FluidShield surgical mask

Surgical masks and N95 respirators are not interchangeable. Specific circumstances are appropriate for use of each. Surgical masks are designed to protect the patient from the wearer’s microorganisms during, for example, surgery or other procedures and also to protect the healthcare worker from splashes of the patient’s blood or body fluids. Surgical masks encompass masks used not only for surgery but also for other medical procedures such as dental and laser work. They’re also used in situations where isolation of a patient is necessary. Surgical masks are not required to be fitted to the individual; so, gaps between the face and the mask are a given.

Carl Hall, director of marketing, clinician apparel, Cardinal Health, McGaw Park, IL, explained further: "Surgical face masks are worn to address the risk of splashes or sprays of blood, body fluids, secretions, and excretions from contacting the healthcare worker’s mouth, nose, and mucosa during a surgical procedure. They are also designed to protect the patient from the healthcare worker’s spit and mucous that may be created by sneezing, coughing, or talking. Surgical masks should be discarded after each procedure but are commonly re-used. Additionally, healthcare workers rarely don their masks correctly, rendering them less effective. This is partly due to lack of awareness of risks associated with improper face mask use."

Cardinal Health’s Secure-Gard
multi-color  fluid-resistant
surgical mask

Jeffrey S. Birkner, PHD, CIH, vice president, technical services and quality assurance, Moldex-Metric Inc., Culver City, CA, added: "Surgical masks can be thought of as a barrier that separates the wearer’s contaminants from the environment. Surgical masks are designed to help prevent contamination from the wearer to the patient, medical equipment, sterile field, or work environment. They do not have sufficient filtering or fitting characteristics to protect the wearer from airborne particulates. Some surgical masks have fluid-resistance attributes. They prevent fluid that lands on the mask from touching the wearer’s nose, skin, or lips."

Respirator

The Food and Drug Administration (FDA) regulates surgical masks and N95 respirators, evaluating the devices’ performance in areas such as fluid resistance and filtration efficiency, encouraging manufacturers to observe specific performance standards for their masks, and requiring that masks and respirators be produced using good manufacturing practices.1 "Respirators may also be certified by NIOSH (the National Institute for Occupational Safety and Health) in accordance with regulations in 42 CFR part 84. When a mask is both cleared by FDA as a surgical mask and certified by NIOSH as an N95 respirator mask, FDA calls it a ‘surgical N95 respirator.’"1 

 A surgical N95 respirator needs to be fluid-resistant, said Birkner, Moldex. "Surgical N95 respirators can serve as either a surgical mask or simply an N95 respirator. A proper fit ensures that the inhaled air is drawn through the filter media of the disposable respirator. The specially designed filters prevent even very small particles from entering the wearer’s respiratory system, and the fluid-resistance attributes prevent fluid that lands on the mask from touching the wearer’s nose, skin, or lips."

Moldex 1500 N95 healthcare particulate respirator and surgical mask

A respirator may come in the form of a protective facepiece, a hood, or a helmet.2 Unlike surgical masks, respirators must be fitted to the wearer’s face and must form a seal to the wearer’s face. The "fit test" determines the size of respirator needed, and the "user seal check" determines whether the respirator has been donned properly and whether it has been adjusted to fit and form a seal.2,3 The fit test should be performed before wearing the respirator the first time and at least annually thereafter or when the face has changed, as in the case of noticeable weight loss, facial scarring, cosmetic surgery, or dental changes.  

When using surgical N95 masks, employers and users are required to follow the Occupational Safety and Health Administration (OSHA) Respiratory Protection Standard, 29CFR 1910.134. Surgical N95 masks have specific use instructions, warnings, and limitations for use in healthcare environments. They must be certified by NIOSH. Fit and seal are so crucial that OSHA insists healthcare facilities have a program devoted to it. "Employers must establish and implement a written respiratory protection program with worksite-specific procedures and elements for required respirator use. The provisions of the program include procedures for selection, medical evaluation, fit testing, training, use and care of respirators."2

One of the differences between surgical masks and N95 respirators is the level of bacterial filtration. An N95 respirator is designed to filter out much smaller particles than a surgical mask. Judson Boothe, marketing director of medical supplies, Kimberly-Clark Corporation, Roswell, GA, noted: "The Centers for Disease Control and Prevention recommends that NIOSH-certified respirators (N95 or higher) be used for Airborne Precautions.3 Airborne Precautions should be utilized when there is a possibility that a disease could be transmitted by an airborne agent (eg, "naked" virus) without the need to be transported in human droplets created by activities such as sneezing and coughing. Droplets are much larger and thus are generally thought to fall within 3 feet of the patient. Airborne agents not suspended in respiratory droplets are so small and light that they can stay suspended in air currents much longer and are more difficult to capture in masks or other filters. High-risk situations that have a likelihood of generating infectious respiratory aerosols include direct care for patients with confirmed or suspected tuberculosis or pandemic influenza-associated pneumonia. The only NIOSH-certified respirators appropriate for use in a patient setting are those also labeled as surgical respirators."

Hall, Cardinal Health, added: "Respirator use is quite low compared to surgical mask use, as many healthcare professionals erroneously believe that respirators only need to be worn when working with tuberculosis patients. Respirators offer healthcare workers protection from small inhale-able contaminants, including bio-aerosols such as mold, Bacillus anthrax, Mycobacterium tuberculosis, and severe acute respiratory syndrome (SARS) virus, among others."

PAPR

2000-700 Cuff System, Bio-Medical Devices Intl, provides the user with head and face protection.

Another form of respirator is the powered air-purifying respirator (PAPR). These respirators also must be approved by NIOSH. In contrast to the surgical N95 respirators, PAPRs don’t require fit testing, and they can be used with facial hair. Because it’s a helmet or hood rather than a mask, facial hair, weight loss, glasses, or scars don’t interfere with fit.

Michael Wang, marketing manager, Bio-Medical Devices International (BMDI), Irvine, CA, outlined more points in favor of PAPR, claiming that their positive-pressure MAXAIR system:

• provides equal to or higher filtration efficiency

• is a hose-free, all-in-the-helmet design, eliminating the traditional PAPR’s long, vacuum-sweeper--like hose

• eliminates bulky waist-mounted blower/filter/battery units of traditional PAPRs

• provides high air flow to maintain positive pressure

• provides user-selectable air flow from 6 to 9 cubic feet per minute

• provides always-on, always-visible safety status indicators for air-flow/filtration performance and run-time/battery charge

• provides complete visibility and direct access to the filter and the battery

• is designed against CO2 buildup within the facial-seal area

• provides a lightweight 8- to 10-hour lithium-ion, no-memory standard battery and an optional 16- to 20-hour lithium-ion, no-memory battery for extended and emergency-preparedness use

• has fewer parts, making it easier and less costly to decontaminate

• provides bump-cap—like head protection; full-helmet design provides more comfortable head room and convenience in donning and doffing

• is easily donned and doffed by the user without need for assistance

• requires less than a minute to disassemble or assemble

• has a lower noise-level system compatible with stethoscope use

• converts from a cuff to a hood (shroud) configuration by replacing the bottom facial seal

• is interchangeable among users, since no fit testing is required

Common complaints

Cardinal Health’s double-strap
N95 series respirator

Surgical masks and surgical N95 respirators can be uncomfortable. Users complain they’re hot and hard to breathe through. DeAnn Hammer, market development manager, 3M Health Care, St. Paul, MN, observed: "With masks, the biggest concern is comfort. Standardization is something we all strive for, but with masks, having a variety on hand is really important. Workers need to be able to focus on their job and not be distracted by their mask. That’s why hospitals carry so many different kinds. We work with users to find the mask that meets the wearer’s comfort needs. Often, the mask that meets the wearer’s needs is already carried by the hospital; the user just hasn’t tried it yet."

Vendors realize the importance of addressing the comfort and breathability issues. Boothe explained Kimberly-Clark’s approach: "The FLUIDSHIELD products contain a layer of proprietary LONCET technology, which prevents the passage of fluid to the wearer while allowing for comfortable breathability. Kimberly-Clark respirator products are made in our unique DUCKBILL shape, which provides a superior seal for protection from airborne infections and a larger breathing chamber for comfort. We also utilize formable nose wires in all our face masks to enable the wearer to adjust the mask across the bridge of the nose and create a proper fit."

Birkner, Moldex, connected the dots between comfort and compliance. "Comfort and appearance drive compliance in personal protection. To address these common challenges, Moldex introduced the patented molded-nose—cushion design. This unique design element provides a more comfortable and consistent fit than ordinary disposable respirators with a required user-adjusted metal nose band that must clamp on the nose to achieve a fit. To minimize the heat build-up common to fitted respirators, we offer a deeper filter area in conjunction with our Dura-Mesh, which gives our masks added crush resistance. We offer up to five different color-coded sizes to select from."

Wang, BMDI, believes that PAPRs offers superior breathability and comfort: "MAXAIR brings in ambient air, filters it, then passes a cooling stream of safe air gently down in front of the user’s face. Airflow not only cools the user but guarantees against fogging of the contact- and splash-protecting lens. It provides ample air flow, user selectable from 6 to 9 cubic feet per minute."

What to look for

If you’re in the market for masks, surgical N95 respirators, or PAPRs, what should you look for? How do you balance efficiency with comfort? That’s something the experts are working on endlessly, and they have plenty of advice to share.

Kimberly-Clark’s
N95 respirator face mask

Hall, Cardinal Health, advised: "The two main qualities that purchasers should look for in surgical masks are comfort and protection. From a protection standpoint, surgical masks should be reviewed for particle filtration efficiency, bacterial filtration efficiency, fluid resistance (mmHg), flammability, biocompatibility, and breathability (Delta-P). Comfort is more subjective. Cardinal Health has built key features into its Secure-Gard multi-color fluid resistant surgical mask to ensure clinician comfort. This mask is made from a silky smooth fabric and features horizontal and vertical ties to enhance fit."

Boothe suggested purchasers look for quality in materials and manufacturing processes: "Face-mask materials should be made of consistent quality, with minimal lint, and enable the wearer to perform their duties without concern of product failure. Purchasers should request test data from manufacturers to show that the masks follow performance standards. These tests should be conducted by a third party and using American Society of Testing Materials (ASTM) standard test protocols."

Another factor Boothe advised purchasers to keep in mind is the ability to supply during a crisis. "The manufacturer should be able to respond quickly with additional supplies in periods of high market demand."

Hammer, 3M, offered this suggestion: "Facilities need to buy a variety of masks to make wearers happy. With surgical masks, if you don’t hear anything from the wearers, that’s a good sign. When considering changing masks, it’s important to poll the people who wear them. Respirators are similar in that you look for comfort and intuitiveness: is it easy to wear?"

No question, the bottom line in masks and respirators is comfort. As Birkner mentioned earlier, there is a definite connection between comfort and the rate of compliance. Boothe agreed: "Comfort encourages compliance and is particularly important for healthcare workers who are expected to don facial protection for extended periods of time, such as in surgery. These masks should provide a high level of protection, but also provide breathability to the wearer. Purchasers should look for masks with low differential pressure. Other features such as anti-fog and anti-glare visors allow the wearer to perform their duties without distraction."

3M Filtron 1900 tie-on duckbill
surgical mask

What’s in the works

What’s in the works for masks and respirators? Vendors often are not at liberty to discuss products in development, but there is plenty of talk about other issues pertaining to masks and respirators.

One of the issues concerns inhalation of smoke from lasers or electrocautery in the operating room. Is it more appropriate to wear a surgical mask or a surgical N95 respirator? Currently there are no recommended guidelines, so perhaps a consensus will be reached in the future. Hammer pointed out that there are a number of new articles and chat room discussions exploring the question. Hall, Cardinal Health, also advised that "AORN has created a Smoke Task Force to investigate the effects of smoke plume on a healthcare worker. The results of this kind of research will likely lead to new innovations in surgical masks."

Hall also indicated that surgical masks are often worn incorrectly and/or re-used for multiple procedures, providing "an opportunity to develop new masks that further increase clinician and patient protection. It also points to a need for improved clinician education regarding the compliant use of surgical masks."

Boothe noted that disaster preparedness continues to be an issue. "Surgical masks and respirators have been the focus of much discussion and debate due to heightened awareness of the need for respiratory protection from diseases that have the potential for widespread impact such as SARS and pandemic influenza. As a result, a number of studies have been completed or are underway to better understand the effectiveness of face masks and respirators and how to improve protection, fit, comfort, and compliance. It has also raised the need to better define the category and types of masks available and improve labeling of the products to assist customers in making appropriate choices."

Improvements are on the horizon for PAPRs, too, said Wang, BMDI. "New benefits for respirator users in the future are likely to include higher performance filtering characteristics, the closer to 100% filtration efficiency, the closer to 0% risk; greater emphasis on eliminating CO2 buildup within the respirator; continued evolution of safety and operational status: monitoring, controlling, and display; more integrated systems design, ie, fewer components; easier, more cost-effective decontamination between uses; more movement, flexibility, versatility; virtual elimination of getting snagged on objects in the work environment; lower cost PAPR disposables to continue to improve the cost-effectiveness for long-term, daily use."

Standardization of test methods is another area that Hammer thinks will see increased attention. "A change in the industry that some may not be aware of is that, in years past, manufacturers could use a variety of test methods to claim fluid resistance. It was confusing when trying to compare mask A to mask B when different test methods for fluid resistance had been used. Now it is widely accepted that the ASTM F1862 test method for fluid resistance is now used."

"The other thing coming into play," continued Hammer, "are European Union (EN) standards. They are implementing a lot of standardized test methods that affect the U.S. market in that most mask manufacturers sell globally; so, you may see some products on the market that reference EN standards, which typically are a little higher in expectation than some of the standards in the U.S. It often doesn’t affect the wearer in the U.S., but it affects those developing and selling masks in the U.S. market.

References

1. U.S. Food and Drug Administration. Personal protective equipment (PPE) and patient care: masks and N95 respirators. http://www.fda.gov/cdrh/ppe/masksrespirators.html#1

2. U.S. Department of Labor. Occupational Safety and Health Administration. Respiratory protection: frequently asked questions. http://www.osha.gov/dcsp/ote/trng-materials/respirators/faq.html

3. U.S. Department of Labor. Occupational Safety and Health Administration. Regulations (Standards - 29 CFR). Fit testing procedures (mandatory). - 1910.134 App A. http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=9780

Suggested Reading

1. U.S. Food and Drug Administration. Guidance for industry and FDA staff: surgical masks-premarket notification (510K) Submissions. Washington, DC: US Department of Health and Human Services, Food and Drug Administration, Centers for Devices and Radiological Health; 2004.

2. Centers for Disease Control and Prevention. Guideline for Isolation Precautions:
Preventing Transmission of Infectious Agents in Healthcare Settings 2007. http://www.cdc.gov/ncidod/dhqp/gl_isolation_airborne.html. Last modified October 12, 2007.