Influenza Pandemic and the Protection of Healthcare Workers with Personal Protective Equipment

38 comments on “Influenza Pandemic and the Protection of Healthcare Workers with Personal Protective Equipment”

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The article presents valid points. However, coming from an EMS pre-hospital setting where most units are required to have N95 masks, I wonder if any consideration was taken to outline the potential inneffectiveness of the masks in less than desirable environments.

Example, If N95’s are not the oil resistant type, and you are in an oily area, such as a machine shop, how effective are the masks if the oil is in the air. Just a point for future comment because I see alot of false sense of security out there regularly. Thanks.

Thank you for your comment. You make a good point about the appropriate use of PPE in less than desirable environments. It is always important for PPE users to use PPE appropriate for the hazards to which they are exposed in accordance with published guidance, recommendations, and regulations. (For respirator guidance see the respirator page on the NIOSH website.) This can be a challenge for EMS workers whose job takes them into different environments. Under the Action Plan, NIOSH plans on establishing measures to assess and compare the effectiveness of PPE.

No matter how much PPE we have to use, The worker (EMTs, Nursing, Fire Fighters, Doctors) have to assume a certain amount of risk. For that matter any person on any proffesion has to assume some risk. We can only wear so much equipment and complete our job to the best of our abilities, and the safety of the victom as well. There will always be factors that are not able to be over come.

Thank you for your comment. NIOSH is committed to reducing risk as much as possible in all occupations. As you reference, there are barriers to using PPE and the Healthcare Worker Action Plan addresses this through training and best practices. Additionally, state of the art equipment design can help reduce the burden on the user and will be explored in a PPT workshop being planned for fall 2008.

Thanks for a good plan for needed research into this important area. This nation must do the best possible to insure the safety and health of our healthcare workers. It is not acceptable to ask them to assume risks that can be controlled. We’ll need our brave healthcare workers to provide care in a flu pandemic, which they can’t do if they are sick themslves or if they fear working because their employers have not planned to protect their health.

I agree Timothy, but I’m seeing in our hospitals in Atlanta, that nurses do not wear much PPE…

Have you discovered a better mask filtration system in your research? If so, we would like to know about it.

Thank you for your comment. Current NIOSH certified respirators effectively protect the users at filtration efficiency levels of 95%, 99%, or 99.97% depending on the respirator type. These three efficiency levels were determined by testing with the most penetrating aerosol size until a maximum loading of 200 mg was reached.

The filters capture both smaller- and larger-sized particles more efficiently than the most penetrating particle size. Recent research demonstrates a shift in the most penetrating particle size:

◦Penetration of Nanoparticles through Respirator Filter Media
◦Nanoparticle penetration through NIOSH-approved N95 filtering-facepiece respirators

However, NIOSH research demonstrates the protection expected to be provided by certified respirators will not change significantly. We are concentrating our current research on comfort and overall efficiency. Overall efficiency is determined as Total Inward Leakage (TIL) by considering the particles passing through the filter and faceseal fit. Also, other research we are conducting with filtering facepiece respirators focuses on studying various antimicrobial products and decontamination methods on the efficacy on respirators.

I also commend the effort reflected in this reearch. I believe an interesting and essential question is a biological corollary to the industrial hygiene concept of “dose-response”. Our bodies have a natural defense against some pathogens, in the form our our immune system, as opposed to many chemical and physical agents. As we go about our daily lives, we are routinely exposed to organisms related to the “ordinary diseases of life”, and yet we do not get ill every time we come in contact with a limited number of these pathogens.

Understanding, as possible, some range of exposure for persons with average, healthy immune systems may illuminate what a reasonable level of protection is, that workers will use as opposed to rejecting because it is too uncomfortable or involves too much additional respiratory burden. I know infectious disease specialists have some broad ideas along these lines, and may be very helpful in this analysis.

Thank you for your comment. NIOSH is committed to reducing risks to exposure in all occupations. Determining the minimum level of respiratory protection for protection against infectious aerosols is an imprecise science, based on the estimated exposure hazard level and the infectious dose for the general worker population. Recommendations are established based on typically expected exposure and infectivity parameters. Factors such as the airborne concentration, aerodynamic size, and pathogen viability in exposure scenarios are considered in assessing the hazard level. The ability of the normal human immune system to resist infection and illness from a pathogen is one of the factors considered in estimating the infectious dose. It would be impractical to determine the effectiveness of each individual’s immunity system to resist infection by a given pathogen, or to develop recommended minimum levels of respiratory protection based on individual variations in exposure scenarios and immunity system status.

Enhanced and increased respiratory protection with improved user comfort and reduced physiological burden can be achieved with the use of novel and innovative technologies. For example, advancements in filter media technologies have allowed the introduction of high efficiency (HE or 100-level) particulate filter respirators with lower breathing resistance using electrostatic media developed since the implementation of 42 CFR 84 in 1995. Also, Powered Air Purifying Respirators (PAPRs) offer users lower breathing resistance and improved comfort from the airflow, while providing higher protection levels than non-powered or negative pressure respirators.

Your concern regarding the barriers to using respiratory protection such as comfort and physiological burden are being explored in some of our research activities. In one research project, physiological burden is being explored by investigating the effects on inhaled carbon dioxide, inhaled oxygen, and inhalation/exhalation pressures from the Automatic Breathing Machine Simulator with the treatment of N95 particulate filtering respirators, with and without surgical masks and under light, medium and heavy work rates (see http://www.cdc.gov/niosh/nas/ppt/QUADCharts07/Z6PV_FY07_QC.htm). An article entitled “Effect on breathing resistance of a surgical mask worn over an N95 filtering facepiece respirator” is currently in press at The Journal of the International Society for Respiratory Protection. Also, you may want to participate in a workshop being planned for Fall 2008 to address technology issues regarding respiratory protection. This workshop (November 2008 timeframe) should address comfort issues and innovative technologies available to improve comfort. Finally, NIOSH recently partnered with the Veterans Health Administration to initiate Project BREATHE (Better Respiratory Equipment using Advanced Technologies for Healthcare Employees). This project seeks to determine the ideal characteristics that would be required for healthcare worker specific respirator. These research initiatives should provide insight to some of the questions you raise and better inform us of the stakeholder needs and research possibilities.

The article seems to reflect a real and necessary effort to address key points, & it is much appreciated. It is however important to remember that wearing an N95 mask for any length of time or in a high energy level activity is problematic for some patient care providers and would provide additional stress in an already stressful situation. Route of transmission (droplet versus airborne) therefor becomes critical for this as well as a number of other reasons.

Since flu viruses are likely to be on the outside surface of any mask when worn in the vicinity of a flu patient it is likely not appropriate to re-use them, unless another protective mask is worn on top. This may lead to additional breathing problems for staff.

NIOSH agrees that current research has not, at this time, provided sufficient data to support the reuse of disposable filtering facepiece respirators. NIOSH is conducting research to examine the efficacy and effect of simple decontamination procedures for filtering facepiece respirators and to examine the risks associated with handling an FFR exposed to viral aerosols. NIOSH is using a breathing simulator to investigate the recommendation made by the Institute of Medicine (IOM) to examine the effects of the placement of a surgical mask over an N95 particulate filtering respirator. A subset of respirators and surgical masks will be tested to compare with a companion field study by the Department of Veterans Affairs.

The Association of Occupational Health Professionals in Healthcare (AOHP) supports NIOSH in the development and implementation of an action plan to address the PPE issues related to pandemic influenza. There are many unanswered questions and concerns among healthcare workers as to the type of PPE, especially respiratory protection for influenza. Implementation of the action plan as well as researching the additional questions that were identified would provide significant valuable information that can be used to support a safer work environment for healthcare workers during a pandemic.

Alterations in respiratory patterns in workplace define the approaches and parameters for worker protection. The advantages of respiratory protective devices (Personal protective equipment) are well documented. Their importance is increasing and will continue with the increase of enforcement policies as well as governmental regulations for safety in the workplace. The challenge is the need to ensure continuing compatibity between the health of workers and the conditions at work to institute preventive measures and to reduce absenteism and loss of productivity.

What position does NIOSH take on the resue of PPE when operating at Surge Capacity?

Manufacturers at this time have no formal recommendations for reuse of disposable respirators in the event of shortages during a pandemic. Feasible methods for decontamination and reuse of N95 filtering facepieces that would result in minimal impact to their efficacy, comfort and fit have not been established. This is due in part to a lack of data as noted in the Institute of Medicine study on Preparing for an Influenza Pandemic: Personal Protective Equipment for Healthcare Workers done for NIOSH. NIOSH is currently conducting research into possible decontamination and reuse strategies that could potentially be used in times of short supplies during a pandemic. NIOSH is also working with stakeholders to define strategies that may allow the use of decontamination methods from the current research to be implemented responsibly if such shortages do arise.

Until acceptable decontamination methodologies and reuse practices are defined, current NIOSH policy is that you should follow the respirator manufacturer’s use guidance in their instructions.

I write on The Ionic Air Purifier Blog. It is a non-commercial site that collects useful information for users of air purifiers.

Does NIOSH have a view on the claims that ionic air purifiers are effective against the bird flu virus? If verified, the ionic air purifiers will be such an important tool at home and at the workplace in the event of a pandemic.

I speak from having experienced the terror of SARS in 2003 in Singapore. I vividly recall that it was almost impossible to keep the N95 respirator on for more than an hour. It was suffocating to say the least. And if memory serves me right, the medical professionals who fell victim to SARS were also using N95 and other respirators for protection.

Why wouldn’t anyone in authority look into this potentially useful tool?

Your feedback will be greatly appreciated.

NIOSH is not aware of any peer-reviewed scientific studies that demonstrate the effectiveness of ion generators/ionic air purifiers against viruses. NIOSH does not have any studies planned to evaluate these devices nor do we have a policy on their use.

On the ion generators, I believe it was concluded that large scale use gave too large an output of ozone. This makes it quite expensive to use if one is to corral the excess ozone and meet EPA requirements. UV-C remains the best bang for the buck that I have seen thus far.

On the subject of masks, does the NIOSH have a policy on valved N95 respirators? They are certainly much kinder to the user.

Thank you for your comment. NIOSH does test and approve particulate respirators with and without valves.

Some N95 respirators are also listed as surgical masks by the FDA. The FDA’s requirements do not allow valves on surgical masks.

All NIOSH-Approved Disposable Particulate Respirators (Filtering Facepieces) are identified on the NIOSH website. Those also cleared by the FDA to be listed as surgical masks are identified with red text. The FDA also has a site describing medical use of PPE including Surgical N95s.

Thank you for your reply on 30 April 2009.

As a layperson, I do not understand the why a personal protective gear like the N95 respirator is tested by NIOSH and FDA whilst an ion generator/ionic air purifier which provides protection on a larger scale should not get any attention at all.

I also do not understand what would constitute a peer review in the context of the ion generator/ionic air purifier. Would this be done by indoor air quality scientists as opposed to its peers i.e. other competing manufacturers in the ionic purifier industry.

The company in question had actually commissioned an independent and renowned UK virologist to affirm their findings with regard to the efficacy of their ion generator against the H5N1 virus. Presumably, the virologist was compensated for his review and for this reason his affirmation is disqualified as a peer review.

What I fail to understand is why the authorities, unless they have doubts about the virologist, would not want to verify this dramatic claim by commissioning a truly independent peer review.

As a mere user, I have no means of verifying the efficacy of the ion generator/ionic air purifier. Given the facts provided by the manufacturer, I can merely accept as a reasonable man would. In my case, the stakes are much smaller. But for the healthcare industry, your article mentions a workforce of 14 million. I would think that any tool that provides protection for even one-tenth of such vast numbers is worth investigating. If I’m a healthcare worker, I would certainly appreciate it.

To its credit, this particular company has to date not taken advantage of the current pandemic to push its technology. This is despite their deploying over 10,000 ion generators in their offices worldwide to protect their staff. This was done in Jan 2009, way before the Apr 2009 swine flu outbreak in Mexico. If I am one of their staff, I would surely appreciate the company’s efforts and feel a lot safer in reporting to work.

I hope you will publish my thoughts and enlighten me with the NIOSH rationale.

Thank you,
Min En,
The Ionic Air Purifier Blog

Initial limited testing by NIOSH revealed that ion generators can produce sufficient ozone that, in certain situations, e.g. small spaces with limited ventilation, could create a health hazard that outweighs any potential benefits. We do not plan to further test ion generators.

Regarding your questions about the peer review process, peer review happens before research begins. Study protocols are reviewed by experts in the field to assure that a valid study is conducted. When the study is completed, data analyzed, and interpretations presented, the proposed manuscripts are peer reviewed by scientific journals to assure that the analysis is appropriate based on the data obtained. This process provides credibility to the research and allows individuals like yourself to assume a degree of expert review of the findings presented.

In order to answer your questions about ion generators a scientifically valid study would need to be designed to test whether ion generators are effective in killing viruses to the extent that a hazard no longer remains, and that such technology does not by itself generate new hazards of its own, e.g., ozone or oxidized by-products. The design of such a study would be challenging.

NIOSH provides support for investigator initiated research. Should someone want to conduct such studies they may apply for funding by mechanisms available and described under “Funding Opportunities” at: http://www.cdc.gov/niosh/oep/. Proposals are funded annually based on availability of funds, relevance of the proposed work to the NIOSH mission, and the quality of the science proposed.

I refer to the comment by Dr. Edd Thomas on 6 May 2009. With due respect, I would be very grateful if Dr. Thomas would point out the source of his belief that “on the ion generators”¦”it was concluded that large scale use gave too large an output of ozone.”

The ozone issue with regard to ozone generators, which are designed to deliberately produce ozone, is clear-cut. At concentrations way above the 50 ppb limit stipulated by FDA, it is dangerous to human health. Why they continue to be available on the market is a mystery to me.

But as for ionic air purifiers, the issue remains unresolved, resulting in much fear of ozone poisoning. My concern is that this fear, if left unresolved, may lead to an important tool being overlooked in the event of a pandemic, such as the current one caused by the H1N1 virus.

Ozone is produced as a by-product in ionic air purifiers and at levels below the FDA 50 ppb limit (this limit applies only if the ionic air purifier is marketed as a medical device and few, if any, are marketed as such). This was the conclusion of a study on several popular ionic air purifiers in Feb 2008 by the California EPA Air Resources Board (Authors: Chris Jakober and Tom Phillips).

The authors did add a caveat that with longer hours of operation, the ozone concentration levels may increase above the 50 ppb limit. But they also highlighted that “these devices should be able to meet all relevant emission standards with small design adjustments”. As you know, California is the first state to reduce the permitted ozone level from 70 ppb to 50 ppb in the last quarter of 2008. That is commendable proactive monitoring by CARB.

To shed further light on the ozone issue, I would mention the Aug 2008 study entitled Effects of Exposure to 0.06 ppm Ozone on FEV1 in Humans: A Secondary Analysis of Existing Data (Authors : James S. Brown, Thomas F. Bateson and William F. McDonnell). This was a peer review of a study that concluded that exposure to ozone at 80 ppb had a significant effect on lung function whereas exposure to 60 ppb ozone did not significantly affect lung function. The authors’ conclusion was that “exposure to 0.06 ppm ozone causes a biologically small but highly statistically significant decrease in the mean FEV1 responses of young healthy adults”. As a layperson, I’m crying out for clarity from the experts.

The broad brush approach to the ozone problem in ionic air purifiers may cause us to miss the fact that technological advances may have substantially mitigated the ozone problem. My enquiries with the company indicated that their current technology results in ozone levels of less than 10 parts per billion, below the levels that their ozone detector was able to register a reading.

In ignoring the latest technologies, we may deprive ourselves from a useful tool in defending against a pandemic flu. Being in no position as a layperson to test the claims of manufacturers, I would urge NIOSH to do so, from the dual perspectives of:

(1) Do the beneficial reactive agents (negative ions, plasmacluster ions, etc) of the ionic air purifier / ion generator actually destroy potent viruses?

(2) Do the harmful by-products (ozone, ultrafine particles, etc) of the ionic air purifier / ion generator actually harm human tissue to the extent that they completely outweigh the benefits of the beneficial reactive agents?

In the final analysis, I realize that as with all other protective gear, there is no 100% guaranteed protection against harmful viruses. But some clarity and guidance would be very much appreciated.

Please see the response to comment 13 above.

I found the article very interested, traiting the problecmatic of the health immigrants workers. Many questions have no answers about the psychology and the social existence of this population who continue to live the real insecurity. There are an intersted article about the immigrants who live in France. The problematic of the institutional situation has been traited in one article wich has been writed by the sociologist Abdel-Halim Berretima, member of the IRIS, EHESS, Paris.
Thank you for this investigation about the immigrants who continue to suffer.
Carinho

The hospital I work at will not clear me to be fitted for a N95 respirator mask, because I have asthma, allergies, and C.O.P.D. The Employee health nurse instructed me to get a clearence from my doctor for how long I could be cleared to wear the mask. She felt I would only be cleared for one hour. They will then fit me and put restrictions on the time limit I could use the mask.

What difficulity in breathing does the mask cause? Is there any information I should be aware of or should the doctor know the risks and concerns?

The mask adds to the burden of breathing in two ways. First, when you breath through an N95 respirator mask there is an extra resistance (pressure drop) to breathing. Our rules require resistance to be less than 35 mm and 25 mm of H2O pressure for inhalation and exhalation resistances respectively. The actual resistance is often lower than the maximum limits of our test. The second extra burden is that some masks may increase the amount of carbon dioxide (from exhaled breath) that remains in the mask, reducing the amount of oxygen you get on each breath and increasing your blood levels of carbon dioxide.

You may want to ask your doctor to review the research on respirator wearing, in particular the following two papers;

Harber P, Bansal S, Santiago S, et al. Multidomian subjective response to respirator use during simulated work. J Occup Environ Med 2009;51:38-45.

Bansal S, harber P, Yun D, et al. Respirator physiological effects under simulated work conditions. J Occup Environ Hyg 2009;6:221-227.

The question came up as whether N99 respirators are being considered for novel H1N1. I have not seen any CDC recommendation about that. as a matter of fact, CDC only recommends N95 for aerosol generating procedures.

I recall that there has been some discussions about N99 during SARS and also during pandemic flu preparedness. Could you please advice whether N99 respirators are being considered as possible PPE for novel H1N1.
Thank you!

Thank you for your comment. CDC provides guidance in Interim Recommendations for Facemask and Respirator Use to Reduce Novel Influenza A (H1N1) Virus Transmission. The guidelines provide recommendations for PPE use for different settings where a person may be exposed to novel H1N1 virus. It recommends respirators, unless otherwise specified, to an N95 or higher filtering face piece respirator certified by the CDC/National Institute for Occupational Safety and Health (NIOSH). All NIOSH-certified particulate filtering respirators, including respirators with N99 filters, would be acceptable alternatives.

There is a planned Institute of Medicine workshop scheduled August 12-13th sponsored by CDC and OSHA to examine current data and expert judgment to determine if this guidance should be changed. The statement of Task for the Committee is provided below:

In response to a request from the Centers for Disease Control and Prevention and the Occupational Safety & Health Administration, an ad hoc committee of the Institute of Medicine (IOM) will conduct a study and issue a letter report to the CDC director and Assistant Secretary for Occupational Safety and Health by September 1, 2009. The committee will provide recommendations regarding the necessary personal protective equipment (PPE) for healthcare workers in their workplace against the novel influenza A (nH1N1) virus. Issues to be addressed to the extent feasible given available evidence and within the timeline for this letter report include: the potential for exposure to the nH1N1 virus among healthcare workers, which groups of workers are at risk, which patient care activities pose a risk of exposure and what degree of risk, and what is known and what is unknown about transmissibility, severity and virulence of the current virus and how transmissibility might change. The committee will base its recommendations on the available current state of scientific and empirical evidence about nH1N1 virus, as well its expert judgment. Economic and logistical considerations regarding PPE equipment will not be addressed in this letter report. In determining the appropriate PPE for the U.S. healthcare workforce, attention will be given to the current PPE guidance documents offered by the CDC and by the World Health Organization for novel H1N1 influenza and for seasonal influenza.

What are the time restrictions that they gave you for wearing your mask?? Curious why there are restrictions like that.

In india there is a huge shortage of N95 masks resulting in to what to wear as a protective mask. All kinds of commercial misleading non authentic info/junk available on the net. It will be highly appreciated by general public if you can give other alternate nose masks viz FFP and the sub catogory of nearest fit as well.

may i know what is the % effectiveness of PPE(not just the masks alone) in reducing transmission rates?

As a vendor of both N95 masks and tight fitting half or full facepieces with N95 or P-100 filters, I find the available information very misleading and confusing to lay people. It would be nearly impossible to get the same fit test from a paper N95 filter and a elastomeric tight fitting mask with 1/2″ wide elastic or heavier head harness. However, if you read the recomendations it appears to suggest the N95 has the same value to the user. Up front expense for the paper filters is less, however over time the replacement filters for the reuseable elastomeric becomes lower cost, more efficient way to go. Also, if a user wears “their own” mask, it seems there would be some value in knowing they would be more likely to clean and sanitize their mask to specifications offered.

Can you please provide some update to the information I see regarding the value of elastomeric half-masks or full facepeices (as APR or PAPR)compared to N95 respirators? Thank you.

One of the repeated concerns relayed to my state agency is that N95 respirators are not available or there is a considerable back-order for their respective N95 respirator. Many healthcare institutions insist that the only respirator they can purchase is an FDA approved respirator.

There are multiple respirators that are NIOSH approved, however, there are limited N95 respirators that are both NIOSH and FDA approved. Does NIOSH have any supporting documentation to assist with educating or providing guidance to the healthcare industry regarding the difference between a NIOSH approved and FDA approved respirator? This may alleviate “supply and demand” issues and may assist healthcare providers with choosing alternate respirators when the NIOSH/FDA approved respirators are in short supply or unavailable.

The Interim Guidance on Infection Control Measures for 2009 H1N1 Influenza in Healthcare Settings, Including Protection of Healthcare Personnel recommends isolation precautions that incorporate the use of Standard Precautions as well as respiratory protection for healthcare personnel who are in close contact with patients with suspected or confirmed 2009 H1N1 influenza. CDC continues to recommend the use of respiratory protection that is at least as protective as a fit-tested NIOSH-approved, disposable N95 respirator for these instances. Standard Precautions include the use of gowns along with eye protection for any activity that might generate splashes of respiratory secretions or other infectious material. A faceshield is one form of eye protection that can be used in conjunction with a NIOSH-approved N95 respirator for protection during for splash-generating activities.

The FDA provides guidance to the healthcare industry regarding the difference between a NIOSH-approved and FDA-approved respirator on their website.

Roland Berry Ann is the Deputy Director of the NIOSH National Personal Protective Technology Laboratory.

An N95 or better respirator is recommended to protect against the H1N1 flu virus but is fit testing for this type of disposable mask really effective and needed. It has been my experience that these masks don’t fit that tight to begin with. Also if the use of this mask is only a recommendation does the 1910.134 apply?

Yes, fit testing is required and needed for tight-fitting N95 respirators. NIOSH recommends and OSHA requires fit testing for tight-fitting respirators and conducting a User Seal Check each time a respirator is put on. These are the only recognized methods to assure the respirator is properly sized and worn correctly.

If the N95 respirator that you selected is not fitting your face tightly, then it is unlikely that it would pass a proper fit test, and you might need to try another model that better fits your face.

You also asked “if the use of this mask is only a recommendation does the 1910.134 apply?” The OSHA respiratory protection standard at 29 CFR 1910.134 applies to the CDC recommendations in the CDC’s Interim Guidance on Infection Control Measures for 2009 H1N1 Influenza in Healthcare Settings, Including Protection of Healthcare Personnel. OSHA recently issued a compliance directive for health care workers. In the OSHA News Release from November 20, 2009, it prescribes: “Where respirators are required to be used, the OSHA Respiratory Protection standard must be followed, including worker training and fit testing. The directive also applies to institutional settings where some workers may have similar exposures, such as schools and correctional facilities.” The full text of the News Release and the Directive is available at: http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=NEWS_RELEASES&p_id=16749 . The OSHA regulations at 29 CFR 1910.134 would also apply to you and your employer if your employer recommends or requires that you use an N95 respirator in the performance of your job duties, even though that is a higher level of protection than recommended by the the CDC document for those activities. The voluntary use provisions of 29 CFR 1910.134 would also apply if the CDC guidance document does not recommend the use of N95 respirators for your work activities, respirator use is not required by your employer, but you want to voluntarily wear one (without fit testing) for your work situation.

PPE is not enough to rely on one’s protection when in an area with risk involved. Us health worker’s should also adhere to proper aseptic techniques in order to prevent any contamination specially nosocomial ones. The PPEs provided are just means to help us. It is up to us to practice proper ways in preventing infection/contamination.

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