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Suggested Citation:"Appendix A: Study Process." Institute of Medicine. 2006. Reusability of Facemasks During an Influenza Pandemic: Facing the Flu. Washington, DC: The National Academies Press. doi: 10.17226/11637.
×

A
Study Process

The committee reviewed and considered a broad array of information prior to making recommendations on the development of reusable facemasks for use during an influenza pandemic. Sources of information include primary scientific literature, books, and scientific reviews; presentations from researchers and representatives from federal agencies and the manufacturing industry; U.S. patents for respirators; news articles; standards for the testing methods of respiratory protection devices; and other relevant government guidelines. Compilation of this background material commenced in January 2006, the month the study was commissioned by the Department of Health and Human Services (DHHS), and ended in March 2006, shortly before the report was released to external review.

LITERATURE REVIEW

The committee and National Academies staff used an extensive online bibliographic search to compile a reference database of literature relevant to the topics of respiratory protection and pandemic influenza. This thorough review of the literature used relevant databases that included Medline, EMBASE (Exerpta Medica), NTIS (National Technical Information Service), BIOSIS, CINAHL (Cumulative Index to Nursing & Allied Health Literature), and Lexis-Nexis.

The literature review involved five stages. The first stage consisted of

Suggested Citation:"Appendix A: Study Process." Institute of Medicine. 2006. Reusability of Facemasks During an Influenza Pandemic: Facing the Flu. Washington, DC: The National Academies Press. doi: 10.17226/11637.
×

the IOM staff conducting general bibliographic searches on topics related to influenza and respiratory protection and compiling a list of references from presentations given at the committee’s first meeting and other conferences on respiratory protection and pandemic influenza. These references were categorized and annotated by the staff and then used as a source for a set of key indexing terms.

The second stage was an initial, simple search that used a basic combination of keywords to identify any articles that mentioned or discussed the N95 respirator: “N95” was combined with the terms “respirator” or “respirators” or “mask” or “facepiece” or “filter,” etc. This simple search strategy was used on the Medline, EMBASE, NTIS, BIOSIS, CINAHL, and Lexis-Nexis databases.

The third stage was to perform a second, and much more sophisticated, series of searches on the Medline database, which resulted in several sets of entries. A Medline search was first performed for articles using keywords that fell under a “mask terminology set” category. This category included “masks,” “face mask,” “surgical mask,” “respiratory protective devices,” “personal protective device,” “personal protective equipment,” and “personal protective gear” as search terms. Another search set for “prevention and control of diseases” was created by screening articles for use of terms such as “disease outbreak,” “cross infection,” “disease transmission,” “transmission,” and “prevention and control.” The mask terminology set was combined with the set on prevention and control of diseases. The common results from these two sets formed the basis for further refinement of the reference list.

Accordingly, the results from this combination search were then cross-referenced with more specific terms such as “guideline adherence,” “safety,” “equipment contamination,” “filtration” or “filter media,” “equipment design,” “particle size,” “permeability,” “health education,” “community health services,” and materials such as “wool,” “gauze,” “cotton,” “fabric,” etc. Search results could be further refined by selecting a specific publication date range and English as the publication language.

The fourth stage was to use the Medline searches as a template for searches on other databases, such as EMBASE, NTIS, BIOSIS, and CINAHL. The results of searches from the various databases were exported separately into ProCite, resulting in a total of 1,650 entries.

The fifth and final stage of the search involved a screen of the nearly 1,700 titles and abstracts to determine the most relevant articles for the committee’s use, resulting in a final count of approximately 320 entries.

Suggested Citation:"Appendix A: Study Process." Institute of Medicine. 2006. Reusability of Facemasks During an Influenza Pandemic: Facing the Flu. Washington, DC: The National Academies Press. doi: 10.17226/11637.
×

In addition to the staff-provided articles, the committee was provided articles for their consideration from several outside parties. Staff distributed these articles to the committee, and they are also listed in the committee’s public access file.

MANUFACTURERS OF CERTIFIED MEDICAL MASKS AND N95 RESPIRATORS

In order to thoroughly address the issues related to developing reusable facemasks and respirators for use during an influenza pandemic, the committee thought it was crucial to obtain input from industry. Thus, the committee solicited input from manufacturers of FDA-approved medical masks and NIOSH-approved N95 respirators.

A list of specific questions was posed to manufacturers in the form of a letter, with the expectation that the answers would help guide the committee’s discussion and facilitate the formation of recommendations. The full list of questions is displayed in Box A-1.

The list of manufacturers of NIOSH-certified N95 respirators and FDA–market-approved medical masks was compiled using the database available on the NIOSH and FDA websites. This search resulted in the names of 130 companies that produce medical masks and 67 manufacturers of N95 respirators. These lists were further culled down to a total of 70 companies after redundancies were eliminated (Box A-2).

Nine companies responded to the committee’s letter: 3M, Aeareo, Alpha Pro-Tech, Bacou-Dalloz, Cardinal Health, Kimberly Clark, Lab Safety Supply, Moldex-Metric, and Triosyn.

POULTRY INDUSTRY

The committee thought that representatives of the poultry industry might want to provide input to the committee because their employers are also concerned with respiratory protection. Representatives of the poultry industry community were therefore invited both to attend the March workshop and to participate in the open testimony in order to provide relevant information to the committee. The groups contacted were the National Chicken Council, Pilgrim’s Pride, Purdue, Tyson’s, and the chicken trade journal, WATT Poultry Industries. None of the groups participated in the workshop.

Suggested Citation:"Appendix A: Study Process." Institute of Medicine. 2006. Reusability of Facemasks During an Influenza Pandemic: Facing the Flu. Washington, DC: The National Academies Press. doi: 10.17226/11637.
×

BOX A-1

Questions Posed to Manufacturers in Advance of the Second Committee Meeting

  1. Whether the respirator/mask wearer might spread the flu virus to himself or others during the donning and wearing of a previously worn device

  2. Whether methods of disinfection—including those that use heat or chemicals—might damage or destroy the filter and/or other components of a currently existing respirator/mask

  3. What information you may share with the committee on how any existing products might respond to various cleaning and disinfection cycles

  4. Whether you are aware of any modifications to existing components, materials, or products that would both allow for disinfection and could be quickly brought to market

  5. What major steps you would need to take to make a respirator/ mask reusable, and whether you see it as something feasible

  6. Whether you foresee any potential increase in liability should respirators/masks begin to be reused

  7. What key challenges you face in terms of production and materials availability

  8. How many respirators/masks can be produced, and how quickly

  9. What sort of lead time is necessary to increase production

  10. What considerations would industry have as to whether there would be substantial enough market-driven demand for a reusable mask, or whether a government investment in these changes would be necessary

PUBLIC WORKSHOPS

The committee held two meetings over the course of the study to address the study charge, review the data collected, and develop the report. Both of those meetings included public sessions: January 23–24, 2006, and March 6–8, 2006. The agendas for both meetings are included at the end of this appendix.

The first meeting (Box A-3) included a session that covered the sponsor’s presentation of the statement of task, a panel discussion with

Suggested Citation:"Appendix A: Study Process." Institute of Medicine. 2006. Reusability of Facemasks During an Influenza Pandemic: Facing the Flu. Washington, DC: The National Academies Press. doi: 10.17226/11637.
×

government agencies, and talks from manufacturers of respiratory protection devices.

The committee held a public workshop (Box A-4) on March 6–7, 2006. During that workshop, the committee heard from 22 speakers who had expertise in influenza and respiratory protection, the production and design of both medical masks and respirators, and the reusability of medical masks and respirators.

In preparation for the second workshop, the committee developed a set of tentative underlying assumptions that served as talking points during the second meeting. These tentative underlying assumptions were grouped into four broad categories that roughly paralleled the order of topics planned for discussion in the workshop: influenza transmission, respirators, medical masks, and reuse of respirators and medical masks. These underlying assumptions facilitated the committee’s creation of a set of prudent and practical recommendations in response to its two-part statement of task.

Suggested Citation:"Appendix A: Study Process." Institute of Medicine. 2006. Reusability of Facemasks During an Influenza Pandemic: Facing the Flu. Washington, DC: The National Academies Press. doi: 10.17226/11637.
×

BOX A-2

List of Manufacturers Solicited for Input

  • 3M

  • Aearo Corp.

  • Allevex

  • Allsafe Services & Materials

  • Alpha Pro-Tech+Ammex Corporation

  • Apothecary Products Inc.

  • Bacou-Dalloz

  • Barnhardt Manufacturing Company

  • Berkley Medical Resources Inc.

  • Busse Hospital Disposables Inc.

  • Cardinal Health Inc.

  • Certol International LLC

  • Cintas Corp.

  • Coast Scientific, Inc.

  • Cook Urological

  • Crosstex International

  • Custom Kits Company Inc.

  • Cypress Medical Products Ltd.

  • Depuy Orthopaedics Inc./Chesapeake Surgical, Ltd.

  • Deroyal Surgical

  • Dispomed

  • Dukal Corporation

  • Dynarex Corporation

  • Emany Consulting Inc

  • Gateway Safety

  • Global Safety Connect, LLC

  • Gloves, Inc.

  • Industries of the Blind Inc.

  • Intec Industries, Inc.

  • Jaisons International Inc.

  • Kentron Health Care Inc.

  • Key Surgical Inc.

  • Kimberly Clark Corporation

  • Lab Safety Supply, Inc.

  • Liberty Glove

  • Lighthouse for the Blind

  • Louis M. Gerson Co.

  • Magid Glove and Safety

  • Maytex

  • MCR Safety

  • Medco Supply Company Inc.

  • Medline Industries

  • Medspring Group Inc.

  • Medsurge Group Inc.

  • Medtek Devices Inc.

  • Mine Safety Appliance Co.

  • Moldex-Metric, Inc.

  • Nelson-Jameson, Inc.

  • Northern Safety

  • Op-D-Op Visor Shields Inc.

  • Pac-Kit Safety Equipment Company

  • Peerless International Inc.

  • Precept Medical Products Inc.

  • Pyramex Safety Products

  • Safety-Med Products Inc.

  • Safety Zone, LLC

  • SAS Safety Corp

  • Sellstrom

  • Stryker Iinstruments

  • Superior Uniform Group Inc.

  • Total Source Manufacturing

  • Triosyn Corporation

  • Uline

  • U.S. Safety and Supply Co.

  • Zee Medical Inc.

Suggested Citation:"Appendix A: Study Process." Institute of Medicine. 2006. Reusability of Facemasks During an Influenza Pandemic: Facing the Flu. Washington, DC: The National Academies Press. doi: 10.17226/11637.
×

BOX A-3

Agenda: Committee Meeting Number 1

11:00 am

Discussion with Sponsor on the Statement of Task and Committee

 

Lily Engstrom

 

Senior Policy Advisory to the Assistant Secretary for Public Health Emergency Preparedness, DHHS

Panel Discussion with Government Agencies

1:00 pm

Denise Cardo

 

Centers for Disease Control and Prevention

1:30

Les Boord and Roland Berry Ann

 

National Institute of Occupational Safety and Health National Personal Protective Laboratory

2:00

Chiu Lin

 

Director, Division of Anesthesiology, General Hospital, Infection Control and Dental Devices, Food and Drug Administration

2:30

Kathie McCracken

 

Infrastructure Analyst, Department of Homeland Security

Panel Discussion with Manufacturers

3:45

Janice Comer Bradley

 

International Safety Equipment Association

4:15

Robert Weber

 

Minnesota Mining and Manufacturing (3M)

4:45

Jeffrey Birkner

 

Moldex-Metric, Inc.

Suggested Citation:"Appendix A: Study Process." Institute of Medicine. 2006. Reusability of Facemasks During an Influenza Pandemic: Facing the Flu. Washington, DC: The National Academies Press. doi: 10.17226/11637.
×

BOX A-4

Agenda: Committee Meeting Number 2 and Public Workshop

March 6, 2005

SESSION 1: Overview of Mask and Respiratory Protection

9:45 am

Presentation 1: Influenza Transmission and Pandemics

Rashid A. Chotani, M.D., M.P.H.

Global Infectious Disease Surveillance & Alert System

Johns Hopkins School of Public Health

10:45

Presentation 2: Facemasks in Context for Fighting Flu—Health Care Workers and the General Public

Richard L. Garwin, Ph.D.

IBM Fellow Emeritus

Panel 1: The Users’ Perspectives on Respiratory Protection

12:30 pm

Global Health Perspective

David Bell

Centers for Disease Control and Control

12:45

Use of Masks in Asia During SARS

Linda Chiarello

Centers for Disease Control and Control

1:00

Health Care Worker Perspective

Michael Bell

Centers for Disease Control and Control

1:15

General Public Perspective—Key Questions Related to Reusable Facemasks

Jeffrey Levi, Ph.D.

Senior Policy Advisor

Trust for America’s Health

Suggested Citation:"Appendix A: Study Process." Institute of Medicine. 2006. Reusability of Facemasks During an Influenza Pandemic: Facing the Flu. Washington, DC: The National Academies Press. doi: 10.17226/11637.
×

1:30

Community Public Health System Perspective

Jeff Duchin, M.D.

Chief, Communicable Disease Control, Epidemiology & Immunization Section–Public Health Seattle King County

SESSION 2: Surgical Mask Production and Design

2:00

Surgical Facemasks: Materials and Design

John Jensen

Alpha Pro-Tech

2:15

Manufacturing Process and Production and Capacity

Stacey McCarver

Research Manager–Facial Protection

Kimberly-Clark Corporation

2:30

The China Experience

Jiang Jiang, M.D.

Beijing Health Department (via teleconference)

SESSION 3: N95 Respirator Production and Design

Panel 2: Respirator Production and Design

3:30

Fitting the N95

Jeff Peterson

NPPTL

4:00

Design, Materials, and Components

Robert Weber

3M

 

Pierre Jean Messier

Triosyn

 

Roger R. Forrest

National Product Sales Manager–Respiratory

Bacou-Dalloz

Suggested Citation:"Appendix A: Study Process." Institute of Medicine. 2006. Reusability of Facemasks During an Influenza Pandemic: Facing the Flu. Washington, DC: The National Academies Press. doi: 10.17226/11637.
×

4:40

Manufacturing Process and Production and Capacity—Panel Discussion

Julie Tremblay

Senior Director, Respiratory Protection

Aearo Technologies

 

Jeff Birkner

Moldex-Metric, Inc.

 

Robert Weber

3M

 

Roger R. Forrest

National Product Sales Manager–Respiratory

Bacou-Dalloz

March 7, 2006

8:45 am

Evidence of Contamination

Craig Colton

3M

9:15

Decontamination and Cleaning—Halamine Chemistry and Its Application in Medical Textiles

Gang Sun, Ph.D.

University of California, Davis

9:45

OSHA Perspective

John Steelnack

Industrial Hygienist

Directorate of Standards and Guidance

 

Andrew Levinson

Health and Safety Specialist

Directorate of Standards and Guidance

Suggested Citation:"Appendix A: Study Process." Institute of Medicine. 2006. Reusability of Facemasks During an Influenza Pandemic: Facing the Flu. Washington, DC: The National Academies Press. doi: 10.17226/11637.
×
Page 69
Suggested Citation:"Appendix A: Study Process." Institute of Medicine. 2006. Reusability of Facemasks During an Influenza Pandemic: Facing the Flu. Washington, DC: The National Academies Press. doi: 10.17226/11637.
×
Page 70
Suggested Citation:"Appendix A: Study Process." Institute of Medicine. 2006. Reusability of Facemasks During an Influenza Pandemic: Facing the Flu. Washington, DC: The National Academies Press. doi: 10.17226/11637.
×
Page 71
Suggested Citation:"Appendix A: Study Process." Institute of Medicine. 2006. Reusability of Facemasks During an Influenza Pandemic: Facing the Flu. Washington, DC: The National Academies Press. doi: 10.17226/11637.
×
Page 72
Suggested Citation:"Appendix A: Study Process." Institute of Medicine. 2006. Reusability of Facemasks During an Influenza Pandemic: Facing the Flu. Washington, DC: The National Academies Press. doi: 10.17226/11637.
×
Page 73
Suggested Citation:"Appendix A: Study Process." Institute of Medicine. 2006. Reusability of Facemasks During an Influenza Pandemic: Facing the Flu. Washington, DC: The National Academies Press. doi: 10.17226/11637.
×
Page 74
Suggested Citation:"Appendix A: Study Process." Institute of Medicine. 2006. Reusability of Facemasks During an Influenza Pandemic: Facing the Flu. Washington, DC: The National Academies Press. doi: 10.17226/11637.
×
Page 75
Suggested Citation:"Appendix A: Study Process." Institute of Medicine. 2006. Reusability of Facemasks During an Influenza Pandemic: Facing the Flu. Washington, DC: The National Academies Press. doi: 10.17226/11637.
×
Page 76
Suggested Citation:"Appendix A: Study Process." Institute of Medicine. 2006. Reusability of Facemasks During an Influenza Pandemic: Facing the Flu. Washington, DC: The National Academies Press. doi: 10.17226/11637.
×
Page 77
Suggested Citation:"Appendix A: Study Process." Institute of Medicine. 2006. Reusability of Facemasks During an Influenza Pandemic: Facing the Flu. Washington, DC: The National Academies Press. doi: 10.17226/11637.
×
Page 78
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Any strategy to cope with an influenza pandemic must be based on the knowledge and tools that are available at the time an epidemic may occur. In the near term, when we lack an adequate supply of vaccine and antiviral medication, strategies that rely on social distancing and physical barriers will be relatively more prominent as means to prevent spread of disease. The use of respirators and facemasks is one key part of a larger strategy to establish barriers and increase distance between infected and uninfected individuals. Respirators and facemasks may have a role in both clinical care and community settings.

Reusability of Facemasks During an Influenza Pandemic: Facing the Flu answers a specific question about the role of respirators and facemasks to reduce the spread of flu: Can respirators and facemasks that are designed to be disposable be reused safely and effectively? The committee—assisted by outstanding staff—worked intensively to review the pertinent literature; consult with manufacturers, researchers, and medical specialists; and apply their expert judgment. This report offers findings and recommendations based on the evidence, pointing to actions that are appropriate now and to lines of research that can better inform future decisions.

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