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KSR Publishing, Inc.
Copyright © 2016


February 2011

Personal Protective Equipment Guide

Infection Control Update

Research shows a percentage of healthcare professionals still reusing syringes

Although the majority of U.S. healthcare professionals are following recommended safe injection practices, some are putting patients at risk through the reuse of syringes and single-dose vials, according to a peer-reviewed study authored by the Premier healthcare alliance in December’s American Journal of Infection Control. Increasing reports of outbreaks of hepatitis B and C viruses and bacterial infections – more than 50 outbreaks nationwide – have resulted in infections in hundreds of patients and more than 100,000 have potentially been exposed. The majority of these outbreaks resulted from unsafe injection practices and lapses in basic infection control and aseptic technique.

Premier surveyed 5,500 U.S. healthcare professionals to gain a fuller understanding of current injection practice patterns and to guide outreach, education and prevention efforts. Results showed that: Six percent, or 318, "sometimes or always" use single-dose/single-use vials on more than one patient; nearly 1 percent, or 45, "sometimes or always" reuse a syringe, only changing the needle for use on a second patient; and fifteen percent, or 797, reported reuse of a syringe to enter a multi-dose vial. Of this group, 6.5 percent, or 51, reported saving vials for use on another patient, representing approximately 1 percent of all respondents. Half of the 51 reported working in hospital settings, and the other half reported working in non-hospital settings such as ambulatory surgical centers and physician offices.

Dr. Joseph Perz of the Centers for Disease Control and Prevention (CDC) said, "The survey revealed that a dangerous minority of providers engage in unsafe practices such as syringe reuse. This is not acceptable. Safe practice is not optional; it’s a basic expectation anywhere injections are delivered."

CDC guidelines recommend that single-dose vials should not be used for multiple patients. The guidelines also recommend syringes and needles should be used only once, not reused for another patient or to access a medication or solution that might be used for a subsequent patient. For example, when a syringe is reused to draw up additional medication for a single patient, the medication vial becomes contaminated. Any subsequent use of either the syringe or the vial on another patient places that second patient at risk of infection.

Premier’s study confirms that confusion regarding labeling of medication vials, lack of awareness and education about safe practices, and mistaken beliefs about the risks associated with syringe reuse all contribute to the problem. Premier also recommends reducing risks through partnerships among professional, governmental and non-governmental organizations with a focus on the redesign of devices, products and processes. More information is available from Premier at www.premierinc.com/

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Clinicians armor up with PPE to battle infections

by Jeannie Akridge

TIDI Products 8580 AAMI Level 2 SMS gowns and 9040 procedure facemasks

TIDI Products 8580 AAMI
Level 2 SMS gowns and 9040 procedure facemasks

Like Batman without his cape and utility belt, a healthcare worker without the appropriate personal protective equipment (PPE) is no match for the villainous pathogens and superbugs encountered on a daily basis. Keeping healthcare workers (HCWs) – and in turn, patients – protected from infectious diseases and other contaminants requires a bevy of PPE from gloves to gowns to respirators and more. Knowing which products and apparel to choose, and how much to keep in stock, can pose a challenge. Add the threat of emerging pandemics and the stakes rise even higher. 

The Occupational Safety & Health Administration (OSHA) defines PPE as "specialized clothing or equipment, worn by an employee for protection against infectious material", and mandates that healthcare facilities provide workers with the appropriate PPE to protect them from chemical and biological hazards in the workplace, as well as ensure that PPE is disposed or reusable PPE is cleaned, laundered, repaired and stored after use.

The Centers for Disease Control and Prevention also provides recommendations regarding PPE. For example, in its "Guidance for the Selection and Use of Personal Protective Equipment (PPE) in Healthcare Settings," the CDC discusses a range of PPE including gloves, gowns/aprons, masks, respirators, goggles and face shields.

According to the CDC, "When you are selecting PPE, consider three key things. First is the type of anticipated exposure…such as touch, splashes or sprays, or large volumes of blood or body fluids that might penetrate the clothing. PPE selection, in particular the combination of PPE, also is determined by the category of isolation precautions a patient is on. Second, and very much linked to the first, is the durability and appropriateness of the PPE for the task. This will affect, for example, whether a gown or apron is selected for PPE, or, if a gown is selected, whether it needs to be fluid resistant, fluid proof, or neither. Third is fit."1

3M 1870 N95 particulate respirator surgical mask

3M 1870 N95 particulate respirator surgical mask

In its "Transmission-Based Precautions" guidance, the CDC categorizes anticipated exposure as either "contact", "droplet" or "airborne" transmission-based risks. HCWs caring for patients who have been placed on airborne precautions are required to wear respirators which are designed to protect the respiratory tract from airborne infectious agents, as opposed to face masks or surgical masks which protect the wearer from splashes or sprays.

CDC’s "Prevention Strategies for Seasonal Influenza in Healthcare Settings" further describes how they distinguish between droplet versus airborne transmission related to the spread of influenza. "Traditionally, influenza viruses have been thought to spread from person to person primarily through large-particle respiratory droplet transmission (e.g., when an infected person coughs or sneezes near a susceptible person). Transmission via large-particle droplets requires close contact between source and recipient persons, because droplets generally travel only short distances (approximately 6 feet or less) through the air. Indirect contact transmission via hand transfer of influenza virus from virus-contaminated surfaces or objects to mucosal surfaces of the face (e.g., nose, mouth) may also occur. Airborne transmission via small particle aerosols in the vicinity of the infectious individual may also occur; however, the relative contribution of the different modes of influenza transmission is unclear. Airborne transmission over longer distances, such as from one patient room to another has not been documented and is thought not to occur."2

Lisa M. Brosseau, ScD, CIH, University of Minnesota, School of Public Health, challenged this notion in a presentation at the 2010 3M Infection Prevention Leadership Summit, titled, "Protecting Employees from Airborne Transmissible Diseases," in which she discussed how infectious diseases are spread and the role of PPE including respirators. Brosseau has suggested the adoption of an alternative paradigm separating the source of the transmission from the route of exposure – one that considers inhalation of small particles (droplets and droplet nuclei) at close range.

As Brosseau reasoned, it’s only logical to conclude that there are not only large droplets in a cough or sneeze, but also a fine mist of very small biological particles that are released as well. "People will say, ‘airborne transmission is very rare,’ and by that they mean being exposed to really small particles that you can breathe in is a really rare occurrence. And I say to them, ‘that’s not true,’ because every time you’re exposed to a spray that contains large particles, it also has small ones; and you’re standing nearby and you’re exposed to particles that are small enough to be inhaled." Brosseau refers to this method of transmission as "aerosol transmission," and contends that seasonal flu is most likely a problem of near-range aerosol transmission exposure.

Tronex Brand N95 Respirator Fold Flat

Tronex Brand N95 Respirator Fold Flat

Surgical masks or N95s?

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

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."

Fit-tested for 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

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."

Isolation gowns

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

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.

Concluded Brosseau, "The issue really in healthcare, is to protect yourself, because you don’t want to be infected, and you don’t want to pass those infections on to the people that you care for. The healthcare worker becomes the mode of transmission of infection to the people that they’re caring for who can’t withstand an infection, even a minor infection," she said, adding a final caveat: "In the grand scheme of things, respirators are at the bottom of the hierarchy of controls. At the top of the hierarchy of controls in the infection world really needs to be vaccination." hpn dingbat


1. http://www.cdc.gov/ncidod/dhqp/pdf/ppe/PPEslides6-29-04.pdf

2. http://www.cdc.gov/flu/professionals/infectioncontrol/healthcaresettings.htm

3. http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospital

4. OSHA Fit Testing Procedures: http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=9780

5. OSHA Fit Testing Requirements: http://www.osha.gov/pls/oshaweb/owadisp.show_document?

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