5

Potential Next Steps and Priorities

Prior to the workshop’s final session, workshop participants split into three breakout groups to discuss one of three topics and address specific tasks assigned to each group. The topics and tasks were

• Breakout 1—Next Steps in Research for Improving Test Methods
  • Identify research gaps for test methods used to evaluate N95 respirators for use by health care workers
  • Identify three to five research priorities
  • Outline next steps for filling the research gaps
• Breakout 2—Issues in Improving and Streamlining the Integration of FDA and NIOSH Processes for N95s Used in Health Care Settings
  • Identify outstanding issues in the integration of FDA and NIOSH processes
  • Discuss the strengths and weaknesses of various approaches to testing (i.e., third-party testing, government lab testing, manufacturer attestation of testing) as relevant to N95s used in health care settings
  • Identify priorities and delineate potential next steps for completing the integration of the evaluation processes
• Breakout 3—Priorities for Health Care Workers
  • Discuss whether the attributes needed for respiratory protection for health care workers differ from the attributes needed for respiratory protection for other workers (e.g., agriculture, industry)
  • Identify priorities for improving N95s for use by health care workers

After each breakout group’s facilitator reported on the discussions to the entire workshop, an open discussion followed.

NEXT STEPS IN RESEARCH FOR IMPROVING TEST METHODS

Howard Cohen, Yale School of Public Health

Cohen noted four areas warranting further research that were discussed during the breakout session. The first area concerned inward leakage of respirators, which the group said should be part of aerosol testing. NIOSH is working on the total inward leakage issues, and that the American National Standards Institute (ANSI) has formed a committee to develop a total inward leakage standard that NIOSH could potentially adopt. The group discussed whether 0.3 micron diameter particles are the most penetrating particle for N95 respirators because N95 filters do not solely rely on mechanical filtration. Cohen reported that there was agreement that the current NIOSH test method is more than adequate to demonstrate whether the filter medium is effective.

There was general agreement in the group, Cohen reported, on the need to conduct hazard assessment for fluid resistance. He noted that more information is needed on the fluid hazards that health care workers deal with and to inform decisions regarding the utility of the ASTM test method. “It is unknown whether this jet of synthetic blood is appropriate for testing the hazards,” said Cohen. Research in this area could lead to better test methods or verification that the current test methods are adequate. The discussion on fluid resistance also noted that any test methodology needs to focus on the entire respirator and protective equipment ensemble, not just the filter or solely the respirator.

Flammability was the third topic of discussion, and many in the group agreed that the current test, developed by the CPSC, is adequate. The group discussed the risk of flammability regarding N95 respirators but many participants did not see this as a high-priority issue given the information the group was aware of regarding operating room fires. The discussion group participants did acknowledge that they would not want respirators to be flammable but felt that this is a test that manufacturers could conduct and provide the approving federal agency with the data.

Similarly, Cohen noted that the group discussed the importance of biocompatibility testing as an area where manufacturers can conduct the testing and provide the data. Cohen noted that several in the group said that biocompatibility testing “could be done without NIOSH having to

adapt new test procedures and could be done by simply asking manufacturers to show the data that they have done on this type of testing.” According to some breakout group participants, most manufacturers already do biocompatibility testing to avoid liability issues.

Jim Johnson, a member of this breakout group, added that the potential to harmonize the FDA and NIOSH processes looks promising to him based on what he had heard at the workshop. Cohen said he would go one step further and say that not only is harmonization possible, but that it can be achieved without manufacturers having to have two types of N95s (standard and surgical). The end result, he said, would be to have a larger number of respirators available in the market and not having users and purchasers trying to separate out surgical and nonsurgical (standard) N95s. In a discussion on the need for hazard assessment, David Prezant noted that he did not see the value of hazard assessment focused on N95s. In his opinion, a hazard assessment will show either there is no problem, in which case testing does not need to be done because there is no risk supporting the epidemiology, or that there is a huge problem, in which case one would not rely on N95 respirators to solve it. For example, if fluid penetration is a huge problem, a face shield would be in order. If flammability was a huge problem, a flame-retardant hood would be in order.

ISSUES IN IMPROVING AND STREAMLINING THE INTEGRATION OF FDA AND NIOSH PROCESSES FOR N95S USED IN HEALTH CARE SETTINGS

Kerri Rupe, College of Nursing, University of Iowa

This group’s robust discussion, Rupe reported, centered on the goal of having one N95 respirator for use in the health care setting and on the current confusion about what the designation of surgical N95 means for users. Participants differed in their views of whether surgical N95s are intended only for use in surgical suites and similar health care settings or if they are intended to be used throughout all health care environments. Rupe noted that, in general, the group agreed that the respirators should continue to be certified by NIOSH and felt that flammability and biocompatibility testing could be done by the manufacturers with data provided to NIOSH, similar to what is done now with the FDA clearance process. In such a scenario, NIOSH could add requirements for flammability and biocompatibility testing. Many in this group agreed that biocompatibility and flammability appear to be minor issues in the health

care setting, as was also mentioned in the first breakout report. This group also discussed that OSHA has a broader set of standards that apply to workers across industries and that there are a range of personal protective products that are considered in meeting worker protection needs.

PRIORITIES FOR HEALTH CARE WORKERS

Cecile Rose, University of Colorado Denver

With regard to the question of whether the attributes needed for respirators for health care workers are different than for workers in other industries and professions, Rose reported that there was general agreement in this group that there are not many differences in terms of the respirators themselves or in the attributes needed for health care workers versus those in other industries. What is different, however, is the culture of safety in health care that puts the patient ahead of the worker. In addition, the hazardous exposures in health care settings are often unpredictable and hard to monitor. As she noted, it is the difference in measuring for microbial bioaerosols versus measuring for coal mine dust.

The priorities that individual participants in the breakout group identified for improving N95s for use by health care workers included a need to improve comfort, fit, and usability and to finalize a total inward leakage test. There was strong support in this breakout group to improve training and education on the proper use of N95s, which will require management commitment to respiratory protection and worker involvement, and for addressing the issues raised earlier in the workshop around fit testing, particularly its time-consuming nature. The group discussed concerns about communication that occurs while wearing respirators and ensuring that a properly fitted respirator does not impede communication between health care workers and patients.

A high-priority research area for many participants in this group was the nonuse of respiratory protection in health care. It is important, these participants noted, to determine if failure to use a respirator when warranted is related to risk perception, respirator accessibility, comfort, or all of the above. Rose noted that the group discussed the areas for more research and guidance on respirator reuse. “When and when not to reuse the respirators remains a problem,” said Rose. Some breakout participants also noted that while standards are wonderful, they are not of much use if there is no enforcement. “If people are not doing fit testing properly, then we are not doing a good enough job thinking about this,” said Rose. What could help, she said, was to link programs for respiratory protection with surveillance programs for reporting cases.

The final concern that Rose raised based on her group’s discussion was on stockpiling and the availability of respirators in the event of a pandemic. The discussion, Rose said, pointed to the importance of focusing on the day-to-day operations as they relate to planning and stockpiling. She said that participants in the group had ongoing concerns about making sure that the pandemic and stockpiling issues are not lost in the challenge of running a health care system. Rupe noted that participants in her breakout group expressed the same concern about stockpiling and accessibility issues as they relate to a pandemic. Several participants in her group wondered how the regulatory issues could be streamlined to provide better access to respirators during a pandemic.

DISCUSSION

Clever opened the general discussion by calling out stockpiling as a main research and implementation priority, particularly with regard to storage, reuse, and expiration issues. James Zeigler added distribution to be another component of the bigger issue of getting respirators where they are most needed during a pandemic, noting the supply chain problems that arose after the September 11, 2001, attacks. Clever agreed and called this a national security issue given that 90-some percent of the respirators and materials that go into respirators are made overseas. Jonathan Rosen noted that the stockpiling issue goes beyond supplying the needs of health care workers as evidenced by the problems with mold exposure that homeowners and volunteers experienced after Hurricane Katrina.

Anugrah Shaw from the University of Maryland, Eastern Shore, said that comfort and fit are universal issues for all respirators, regardless of whether they are for use in health care or by pesticide applicators. She suggested that many of the issues discussed at the workshop could be examined at a universal level with an emphasis on those used in the health care setting. “I think that would add to the overall ability to be able to respond to these questions,” said Shaw. Clever added that broadening the scope of the discussion could provide the opportunity to bring a new set of voices and ideas to the table that might lead to new solutions.

Along the lines of bringing new ideas to the table, Mark Shirley proposed issuing a global challenge with prize money, such as the one issued in response to Ebola that resulted in an innovative containment suit developed at Johns Hopkins University. “That sort of thing might help spur some innovation,” said Shirley. “There are many groups out there that are small, but smart and creative. Why not challenge them with some

priorities?” Clever added that such a challenge might identify new approaches to improving the respirator seal, perhaps even borrowing a solution from nature. “There are answers there. We have to figure out how to excavate or imagine them,” said Clever.

Cohen also stressed the importance of improving the seal components so that they can fit a wider range of facial structures. “Once you do that, you reduce your fit testing needs,” said Cohen. Sergey Grinshpun, who discussed one approach to a universal seal in his earlier presentation in the workshop, said there are a myriad of different materials available today that would mimic the changing shape of the face and provide a better, more universal seal. He also noted that filter material efficiencies are so good today that collection efficiency could be maintained while improving comfort and reducing the pressure drop across the filter, which would by itself reduce faceseal leakage.

Clever asked for some clarification on whether hazard assessment is a priority research topic. Cohen answered that it is because it determines the attributes that are truly necessary to protect workers but also emphasized that there are often multiple types of protective equipment being used by workers so it is important to consider the options, protective ensembles, and tradeoffs in the requirements. It could be, he said, that meeting flammability and fluid resistance standards is compromising other functions of the respirator, such as the pressure drop across the faceseal. David Prezant stated that he is not against risk assessment, but what he is against is waiting for a risk assessment to be finished before NIOSH and FDA harmonize approval processes for N95 respirators. Risk assessment could point to protective needs that would not mean the need for new respirators or respirator requirements but for different protective ensembles to protect health care workers and different tests to assess performance of the ensembles.

The discussion raised a few additional points. D’Alessandro pointed to the importance of highlighting the supply and distribution issue and sustaining efforts to study and address that problem. Rosen highlighted a 2013 paper by Janssen and colleagues that notes how education and training on respirator fitting for health care workers does work (Janssen et al., 2013). He also raised a question that hospitals are struggling with as to whether everybody in a hospital should receive protective equipment training to prepare for a pandemic or if training should be limited to specified individuals. An unidentified participant suggested that labeling of the respirators that noted which tests the product had passed could be an area in which harmonization would be relatively easy.

To finish the discussion, Clever reviewed what she believed were the key messages from the day’s proceedings:

• Ensuring the health of health care workers is paramount.
• Reducing confusion and duplication, which means increasing the use of respirators and decreasing waste, is an important priority.
• Harmonization and integration are needed, and it will take goodwill and intent on the part of FDA and NIOSH to make that happen.
• Major challenges include respirator comfort, fit, faceseal integrity, contamination, effectiveness, stockpiling, expiration dates, supply lines, and hazard assessment.
• Increasing the opportunities to provide feedback on issues regarding respirator performance is critical and NPPTL’s post-market surveillance program and FDA’s MedWatch system could both contribute to that effort.

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