Integration of FDA and NIOSH Processes Used to Evaluate Respiratory Protective Devices for Health Care Workers Proceedings of a Workshop (2017) / Chapter Skim
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2 Perspectives from Users, Manufacturers, and Distributors
2 Perspectives from Users, Manufacturers, and Distributors
Pages 7-16
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From page 7... ...
What are the priorities to be considered in the integration of FDA and NIOSH evaluation processes for N95s? USER PERSPECTIVE: MAYO CLINIC Jeffrey Nesbitt, Mayo Clinic, Minnesota The health care respiratory protection program at the Mayo Clinic is responsible for conducting annual fit testing1 of respiratory protective devices for nurses, nurse practitioners, residents, physicians, and other personnel who care for patients in both inpatient and outpatient settings, as well as for those who work in clinical laboratories and who conduct 1 Fit testing is the process by which the appropriate respirator model and size is identified for the respirator user.
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From page 8... ...
Additionally, there are significant monetary and staff costs associated with warehousing the requisite sizes and brands for meeting operational and emergency response needs and for keeping track of the expiration dates on the respirators and restocking as needed. Record keeping is also extensive and aims to inform managers about whether their employees are medically cleared for respirator use, have been fit tested, and have received the required training in their use.
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From page 9... ...
The many options create challenges for fit testing, storage, and record keeping as noted by the prior speaker. As far as the attributes of N95 respirators that need to be tested, Sood listed filtration ability, comfort, ease of proper use, fluid resistance, and self-contamination risks.
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From page 10... ...
The first is to protect staff from airborne infectious diseases, including tuberculosis, varicella, measles, and more recently, novel pathogens, including H1N1 influenza and Middle East respiratory syndrome; and the second is for protection from airborne hazardous medications. UMMC currently uses elastomeric respirators with P100 cartridges due to supply issues that began during the H1N1 influenza pandemic.
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From page 11... ...
Chang concluded his comments with three suggestions to improve the effective use of disposable N95s in health care settings: develop respirators with reliable and consistent fit that have a realistic means for users to check the fit, create guidance on the resistance to hazardous medication splashes, and prepare uniform guidance on the new antimicrobial-treated N95s to determine how effective they are at preventing cross contamination with and transmission of infectious agents. A MANUFACTURER'S PERSPECTIVE Craig Colton, 3M From a manufacturer's perspective, Colton noted, the N95 respirator attributes that need to be tested depend on where it will be used and the airborne hazards found in those settings.
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From page 12... ...
A DISTRIBUTOR'S PERSPECTIVE Akhil Agrawal, American Medical Depot Addressing supply chain issues, Agrawal noted that his company distributes products from more than 2,000 manufacturers to some 6,000 health care customers, including Department of Veterans Affairs and Department of Defense facilities. Globalization, he explained, has profoundly affected how supply chains are managed both strategically and operationally.
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From page 13... ...
Depending on the nature of future situations, health care facilities may have to give up part of their supplies to meet urgent needs of other facilities. The traditional strategies for managing supply chain risk are to stockpile inventory, diversify the supply of product, identify backup suppliers, manage demand, strengthen the supply chain by working with manufacturers, and more effectively use the existing supply of product (see Table 2-1)
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From page 14... ...
In response to a question about how big of a problem occupational illness is in the health care setting, Sood said the numbers in normal endemic hospital functions are small and that in 10 years she has seen at most three cases of occupational transmission. Tuberculosis is very nontransmissible and while varicella has a bigger potential to pass from a patient to a staff member, most health care workers have been vaccinated and so it is seen infrequently in health care workers.
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From page 15... ...
"They were uncomfortable and people would not wear them because they were uncomfortable," she said. Another issue raised by David Prezant from the New York City Fire Department was the extent of the evidence regarding expiration dates on respirators, particularly in the context of supply chain problems.
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From page 16... ...
Agrawal highlighted the issue of reusability and the potential for a positive impact on the supply chain. Rosen noted that the Joint Commission's guidance on implementing hospital respiratory protection programs highlights the Texas Center for Infectious Disease's protocols for successfully reusing N95s in the tuberculosis setting (Joint Commission, 2014)
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