How to Evaluate Respirators

ICT introduces a new, regular column in which members of industry suggest strategies for the evaluation and purchasing of infection prevention and control products. This month we take a look at respirators.

Participants:

— Grant Rowe, product manager for respiratory protection, Bullard

— Gregory Taylor, vice president of healthcare business development, Moldex-Metric, Inc.

— Michael Wang, marketing manager, Bio-Medical Devices Intl.

— Doug Durney, director of marketing and new business development, ILC Dover, LP

ICT: What is the biggest occupational safety and/or infection prevention and control-related advantage to using respirators/PAPRs over other protective gear?

Rowe: There are many advantages to using a PAPR in a hospital setting. First, I should mention that the two main other types of protective gear that are often used instead of a PAPR are surgical masks and N-95 respirator masks. Surgical masks offer the patient protection from liquid droplets coming from the healthcare worker but since they are not respirators they do not offer the healthcare worker (HCW) any respiratory protection against infectious airborne particles such as SARS, TB or various types of influenza.

The biggest safety advantage is the assigned protection factor (APF) offered by a PAPR. An APF is “the workplace level of respiratory protection that a respirator or class of respirators is expected to provide to employees when the employer implements a continuing, effective respiratory protection program [as stated in 29 CFR 1910.134]. A surgical mask does not have an APF since it is not a respirator, while an N-95 mask has an APF of 10. In contrast, a PAPR has an APF of 25 when configured with a loose-fitting facepiece, meaning that a PAPR provides 150 percent more protection than an N-95 mask.

Another occupational safety advantage of the PAPR is reduced heart, lung, and heat stress. A N-95 respirator requires the HCW to draw the air in through a resistive filter by virtue of his own heart and lung power. Very quickly the mask begins to become hot and moist causing heat stress; these increased stress factors can reduce focus on the critical tasks of patient care. In comparison, a PAPR employs a battery-operated fan to draw ambient air in through the purifying HEPA filter before it is delivered to the HCW’s breathing zone. Purified air continually flows into the facepiece, cooling the HCW so that he/she can work comfortably for several hours.

Still another advantage is that PAPRs with loose-fitting facepieces do not require fit testing. This is a financial, administrative and a safety advantage. Fit testing may cost between $75 to $125 per HCW per year and administrative responsibilities of scheduling, documenting, auditing and filing. Also, tight-fitting respirators not only require fit testing but require that the HCW be clean shaven, while a PAPR with a loose-fitting facepiece can be worn with facial hair. This keeps HCWs safer because there won’t be a scenario where an N-95 mask is incorrectly worn without a proper fit or in the presence of facial hair (which creates a leak path for airborne hazards to travel to the wearer’s respiratory system).

Finally, another advantage of the PAPR with a loose-fitting facepiece is improved communication. Non-verbal communication is sometimes as critical as the spoken word, and an N-95 hides the facial expressions while a PAPR with a loose-fitting facepiece allows patients to see warm smiles and other empathetic non-verbal cues. A calm patient can make the environment much safer for the HCW.

Wang: Key to insuring infection prevention is compliance. Without it, the risks of infection significantly increase — an incident will occur; it is only a matter of when. PAPRs’ inherently higher filtration efficiencies (versus N95 masks) provide the best protection. More importantly, they can lead to improved compliance versus N95s.

N95 compliance is confounded by high percentages of HCWs not passing fit testing. These personnel need alternate protection or must be “managed around.” Many who do use masks, re-use them, which is inappropriate. All this leads to cost and management burdens and poor compliance and safety. Many who are unfamiliar with PAPRs perceive they are too costly or too difficult. In practice, they find PAPRs can be more comfortable, better for patient communication, quite easy to use, and more cost effective to implement. More user and patient friendly PAPRs enhance compliance, which leads to better infection control.

Taylor: The main occupational safety/infection prevention or control advantage for using respirators, including PAPRs, is reduced risk of exposure to airborne hazards. A surgical mask may reduce risk of exposure to large droplets and or liquid-borne hazards but is not effective at filtering out small aerosolized hazards. A surgical N95 respirator will provide aerosol-, droplet-, and liquid-borne hazard protection when they are properly fitted to the individual user. Disposable or reusable respirator solutions generally offer a fiscally superior option to a PAPR for airborne particle/pathogen protection because more protection can be purchased for a given protection dollar investment.

Durney: The superior level of protection of PAPRs over other methods of respiratory protection affords the user the ability to perform any job function virtually without worry of becoming a victim of the function itself. PAPRs offer a dramatic increase in protection over N-95s while at the same time not requiring costly fit testing, inventorying multiple sizes of masks, or requiring facial hair restrictions. In addition, PAPRs reduce the physiological stress on the healthcare worker by virtually eliminating resistance and the heat build-up associated with exhaling into N-95s. Lastly, the use of reusable PAPRs will alleviate what we call “logistical strain,” which would reach its peak when trying to procure masks that are just not available in scenarios such as a pandemic, epidemic or biological/radiological terrorist attack.

ICT: What is your best advice to infection preventionists for evaluating and purchasing respirators/PAPRs — what specific features should they look for?

Rowe: My advice would be to evaluate at least three manufacturers of PAPRs in hands-on trials.

Important features of the PAPR blower include:

— Low battery or low alarm: This warns the HCW when to recharge their PAPR batteries. Some PAPRs have audible or visual alarms or indicators while some have none.

— On-board batteries: Some PAPRs have external batteries with cords that may be snagged on equipment or unplugged by agitated patients. This would cause a loss of power by the PAPR and a loss of protection to the HCW.

— Battery technology: Some PAPRs still use NiCad technology which can be susceptible to “memory” issues, meaning that the battery will hold less and less charge with each successive cycle

— Charger technology: Some chargers require that the PAPRs and/or their batteries be taken off of the charger every few weeks and rotated on a battery maintenance schedule. Other chargers have trickle charge features with voltage and temperature monitoring which allow PAPRs and/or their batteries to be plugged in indefinitely.

— Hazard to be purified: The typical HCW only needs particulate protection but some hospitals may want a PAPR that can provide both particulate and chemical protection. Some PAPRs are particulate only and some offer both particulate and chemical protection.

— Airflow: The higher the airflow, the more comfortable a HCW usually feels and the more it keeps the airborne hazards at bay.

Other questions to consider:

How easy is the unit to put on?

How easy is the unit to remove?

How balanced is the weight distribution?

How easy is it to assemble all the

components?

How easy is it to clean the components?

Many hospitals have HCWs share the blower but use personal-issue facepieces which can be attached quickly. Some PAPRs have the blower and facepiece integrated which requires people who share to either share the facepiece (which may have been sneezed or coughed in) or to disassemble, disinfect, and then reassemble the unit (which may be very tedious and time-consuming).

Taylor: When evaluating respirators or PAPRs for purchase we suggest that you consider the following factors: Type(s) of hazards, number of people requiring protection, length of exposure time, comfort, ease of use, NIOSH and/or FDA 510(k) clearance, and point of manufacture (in the event of a pandemic or other large-scale emergency, replenishment supplies may be sequestered off-shore by foreign governments for non-domestically manufactured products)

Wang: Five key parameters in evaluating PAPRs are:

1. Donning and doffing ease. How much time and paraphernalia do they require? Less is better.

2. Comfort. Not restrictive to breathing with air-flow adjustment matching activity level; not hot to wear for long periods; not too close-fitting to cause claustrophobic feelings; quiet, so communication is not hampered.

3. Bulk and weight. Interference with maneuverability. Check for components extending away from the body for catching or snagging or make moving around the patient’s bed and other equipment a hazard.

4. Universal between uses and between HCWs. Eliminate the need for variable and unreliable results and costs of fit testing; easily decontaminated between users so all HCWs can always be protected with minimal training and no fit testing.

5. Ensure confidence in HCWs’ safety in hazardous environments. N95s are always suspect; one isn’t sure of the fit of the mask donned on any given day. Many PAPRs conceal filters and batteries, so HCWs can’t tell, without disassembly, if filters are installed and installed properly, and checking and swapping a run-down battery for one fully charged is a chore. These key components should be visible and easily assessable — they insure proper air filtration and flow. Look for real-time visual indicators that provide airflow and battery status continuously during use. This adds confidence to convenience and comfort; together they facilitate compliance, and improve infection prevention.

Durney: Each facility and user has unique needs and therefore different features may be of more or less importance for that specific application or individual. However, some of the most important issues we hear from talking to infection control professionals and safety personnel include the following:

— Is the system “friendly” for both the wearer and the patient? Many practitioners acknowledge the protective benefits of PAPRs, but are concerned about the reaction of their patients to the system. Considering systems that offer colorful prints on head covers can help reduce patient anxiety in much the same way colorful scrubs do. User feedback indicates that these types of systems seem to “belong” in a hospital – they look like healthcare! In addition, systems that offer wide field of vision, glare-free visors help the patient see the facial expressions of the healthcare worker. PAPR hoods should simply make the healthcare worker look more “human” to the patient than older methods of protection by allowing the patient to see the entire face of the user, not just the eyes. This is accomplished while protecting the user’s eyes, ears, mouth and head from blood borne and airborne pathogens.

Some additional features to look for:

• Does the system offer a belt that is easily removed, easily cleaned, and easy donned? Many healthcare workers have said donning times are important in emergency situations, so a belt that is easily adjusted and a system that can be donned in seconds matters.

• Are the filters easily and safely accessed? Do you have to tear a unit apart to get to the filters?

• Are the filters “proprietary” in nature? What will you do if that company can not supply you filters in a long-duration event?

• What kind of battery life is available in the rechargeable system? How many times a shift do we want to change out the battery? Is the battery technology modern (such as NiMH) or older (such as NiCad)?

5. Ensure confidence in HCWs’ safety in hazardous environments. N95s are always suspect; one isn’t sure of the fit of the mask donned on any given day. Many PAPRs conceal filters and batteries, so HCWs can’t tell, without disassembly, if filters are installed and installed properly, and checking and swapping a run-down battery for one fully charged is a chore. These key components should be visible and easily assessable — they insure proper air filtration and flow. Look for real-time visual indicators that provide airflow and battery status continuously during use. This adds confidence to convenience and comfort; together they facilitate compliance, and improve infection prevention.