Preparing for an Influenza Pandemic: Personal Protective

Equipment for Healthcare Workers

September 2007

Background• 2005— NPPTL requested that the Institute of Medicine

form a standing committee to address PPE issues for a wide range of workers

• 2006— IOM standing committee, in conjunction with NPPTL staff, identified the need for a focused study on PPE for healthcare workers during an influenza pandemic

• December 2006- September 2007—Ad hoc IOM study resulting in the report, Preparing for an Influenza Pandemic: Personal Protective Equipment for Healthcaare Workers

Study SponsorNational Personal Protective Technology Laboratory,

NIOSH, CDC

• Identify research directions to understand and improve the efficacy and effectiveness of personal protective equipment, particularly respirators, for an influenza pandemic with attention to improving functionality and addressing human factors such as wearability, compliance, communications

• Examine the necessary certification, testing, and standards development requirements, with attention to clarifying the roles of NIOSH NPPTL, FDA, OSHA, and nongovernmental standard-setting organizations

• Identify priorities and resources for research and certification efforts

Charge to the IOM Committee

IOM CommitteeLewis R. Goldfrank (Chair), New York University School of Medicine

Howard Cohen, University of New Haven Janine Jagger, University of Virginia Sundaresan Jayarman, Georgia Institute of TechnologyTalmadge E. King, Jr., University of California, San Francisco Donald Low, University of TorontoSharon Marable, Brown UniversityR. Kent Oestenstad, University of Alabama School of Public Health Trish M. Perl, Johns Hopkins University School of MedicineDavid Prezant, Albert Einstein College of MedicineM.E. Bonnie Rogers, University of North Carolina School of Public Health

Healthcare Workers • Approximately 13 million healthcare workers in the

United States• > 5.6 million employed in professional and related

occupations• > 4 million employed in service occupations• > 2.3 million employed in office and administrative

support occupations• > 570 thousand employed in management occupations

• Defined to include professional and support services including administration, patient care, and facilities care

• Includes emergency response and home healthcare workers

Defining Healthcare PPE • Equipment that is designed and worn to protect the

worker from exposure to hazardous agents

• Encompasses respirators, gowns, gloves, faceshields, eye protection, head and shoe coverings

• Does not include medical masks (surgical or procedure masks)

Opportunities for Action

Increase influenza transmission research• Current lack of knowledge greatly hinders prevention efforts

Enhance employer and employee commitment to worker safety• Healthcare facilities should establish and promote a culture of

safety

Understand PPE requirements of the healthcare worker• Develop the next generation of healthcare PPE to use

innovative materials and designs that meet the specific needs of healthcare workers

Estimated Impact of Moderate or Severe Pandemic Influenza on Episodes of Illness, Healthcare Utilization, and Mortality

in the United States

Moderate(such as 1958 and 1968)

Severe (such as 1918)

Illness 90 million 90 million

Hospitalization 865,000 9.9 million

ICU care 128,750 1.48 million

Deaths 209,000 1.9 million

Based on extrapolation from past pandemics in the United States.

SOURCE: DHHS, 2006. Pandemic Influenza Implementation Plan.

Research on Influenza Transmission• Paucity of data on how the virus is transmitted (airborne vs droplet vs contact

routes)

• Most of the research on influenza transmission was conducted 40 to 60 years ago, new technologies need to be applied

• Clarification is needed in the aerosol-droplet continuum in order to develop effective prevention strategies

• Resources cannot be focused to maximize preparedness until knowledge is gained on the different routes of transmission

• Much can be learned from studying seasonal influenza

• Need to prepare for research during a pandemic – developing research plans and protocols

Influenza Transmission – Immediate Research Needs

• Identify the extent to which each of the major modes (contact, droplet, aerosol) contributes to influenza transmission

• Determine the size distribution of particles expelled by infectious individuals, and how the continuum of sizes affects transmission

• Examine transmission potential through mucous membranes or conjunctiva exposure

• Examine role of fomites and virus viability in greater depth

• Identify the activities in the healthcare setting that are associated with minimal or increased transmission

• Determine the effectiveness each type of PPE in reducing the risk of influenza transmission (quantitative performance analysis)? How effective are medical masks? What innovations regarding PPE are needed to enhance effectiveness?

Influenza Transmission – Global Research Effort

• Effort needed similar to the collaborative effort at the outset of SARS – the World Health Organization asked 11 laboratories in 9 countries to participate in a collaborative multicenter research network with rapid sharing of information. Within a month of the network’s inception, the objectives had been achieved – identify the causal agent and develop a diagnostic test.

• Influenza Study Network (existing and new centers) could collaboratively conduct and oversee a range of animal and human studies to understand seasonal influenza and avian influenza transmission and refine prevention strategies. Efforts should also be made to develop research protocols and implementation plans for clinical studies during a pandemic.

Occupational Safety and Health ControlsEngineering and Environmental

Controls

• Ventilation—air exchanges

• Negative pressure rooms

• Isolation rooms

• Anterooms

• Filtration

• Waste disposal

• Cleaning

• PPE design

Administrative

Controls

•Culture of safety

•Availability of PPE

•Patient access restrictions

•Source control

•Policies regarding PPE, vaccination, etc.

•Education and training

•Enforcement, supervision

PPE and

Work Practices

•Hand hygiene

•Wearing PPE

•Vaccination

•Antivirals

•Adhering to other safety precautions

•Encouraging peers to follow safety precautions

Factors Influencing PPE-Related Behaviors and Adherence

OrganizationalFactors

•Management’s expectations and performance feedback,•Policies including those regarding quarantine, overtime•Compliance policies related to safety, including reinforcing factors,•Training and educational programs,•Expertise with respect to infection control and occupational health.

Individual Factors•Knowledge, beliefs, attitudes,•Perception of risk,•Past history,•Perception of organizational safety culture,•Sociodemographics

Environmental Factors•Availability of resources, equipment, and supplies (e.g., N95 respirators, sinks, hand hygiene products)•Negative pressure rooms,•Other ventilation and environmental issues

Behavioral Factors •Intention to comply with infection control-occupational health guidelines•Willingnesss to treat potentially affected patients

OrganizationalFactors

•Management’s expectations and performance feedback,•Policies including those regarding quarantine, overtime•Compliance policies related to safety, including reinforcing factors,•Training and educational programs,•Expertise with respect to infection control and occupational health.

Individual Factors•Knowledge, beliefs, attitudes,•Perception of risk,•Past history,•Perception of organizational safety culture,•Sociodemographics

Environmental Factors•Availability of resources, equipment, and supplies (e.g., N95 respirators, sinks, hand hygiene products)•Negative pressure rooms,•Other ventilation and environmental issues

Behavioral Factors •Intention to comply with infection control-occupational health guidelines•Willingnesss to treat potentially affected patients

Adapted from Yassi et al., 2004. Protecting the Faces of Health Care Workers. The Change Foundation.

Culture of Worker Safety

• Rates of PPE use are low in healthcare facilities • Need institutional commitment to worker safety

to promote habitual safety practice

• Employees should feel uncomfortable about not wearing PPE during appropriate situations

• Positive work safety culture described as a just culture, a learning culture, a reporting culture, and a flexible culture.

• Need to identify and disseminate best practices

Culture of Worker SafetyKey components in promoting a culture of safety:

Providing leadership and commitment to worker safety

Emphasizing education and training

Improving feedback and enforcement of PPE policies and use

Clarifying work practices and policies

Design Drivers for PPE

Cost

Product costTotal life-cycle

costMinimal

environmental impact

Functionality

Protect against influenza virusGuard against contact with contaminated fluids and aerosols

Maintenance and and Reuse

Easy to decontaminate and discard disposable elements

Easy to clean and replace parts in reusable PPE

Aesthetics

Variety of styles and colors

Customizable

Usability

Maintain biomechanical efficiency and sense of touch and feel

Odor freeHypoallergenicAccommodate wide range of

users (face and body profiles)Compatibility across various

elements of the PPE ensemble and with other equipment (e.g., stethoscope)

Non-startling to patients and families

Facilitate communication with others (verbal, facial)

Comfort and Wearability

Comfortable—no skin irritation or pressure points

Prolonged use without discomfort

Breathable—air permeable

Moisture absorbent—wickability

Low bulk and weightDimensional stabilityEasy to put on and

take off (don and doff)

Durability

Adequate wear life

Strength—tear, tensile, burst

Abrasion resistance

Corrosion resistance

Evidence-Based Performance Requirements

A Structured Approach to Evidence-Based Performance Requirements

• Functionality

• Usability

• Comfort and Wearability

• Durability

• Maintenance and Reuse

• Aesthetics

• Cost

Design and Development of Healthcare PPEImmediate Opportunities

• Closer collaboration between healthcare workers (end users), PPE manufacturers, and certification or regulatory agencies

• Decontamination strategies• Differences in protection of N95 versus N100 or

other respirators if exposed to human and avian influenza aerosols

• PAPRs that meet needs of healthcare workers • Nondisposable respirators--easily decontaminated

and cost-effective

Design and Development of Healthcare PPELong-Term Key Research Needs

• Technologies to improve fit and circumvent the need for fit testing

• Innovative designs to improve wearability

• Monitoring protection levels of PPE

• Impact of masking patients

• Best practices for donning and doffing PPE

Life Cycle Approach to PPE Design and Testing

• Design of PPE that takes functionality, wearability, and other factors in to account

• Pre-market testing that examines the wear and tear and use of PPE in the workplace

• Set of measures to assess and compare the effectiveness of PPE to improve PPE selection

• Post-market testing that evaluates use of PPE in healthcare facilities

Agencies and Organizations Involved in Healthcare PPE

• FDA – Medical device approval or market clearance• OSHA – Implementation in the workplace• NIOSH – Research and respirator certification• CPSC – Consumer products• Department of Homeland Security – Emergency response PPE• Department of Defense – PPE for military applications• EPA – PPE related to pesticide exposure and emergency response• Voluntary standard-setting organizations (ANSI, ISO) – Consensus

performance standards for testing and designing PPE products

Issues in Healthcare PPE Evaluation and Marketing

Standards Development and Dissemination• Increase the degree of independence and reduce conflicts of interest

in standards-setting committees• Increase input from end users and peer reviewers• Catalog and provide easy access to applicable standards,

regulations, and lists of certified or approved equipment

Certification and Approval• Increase pre-market testing in workplace conditions • Develop evidence-based certification criteria for gowns, gloves,

and other types of PPE

Issues in Healthcare PPE Evaluation and Marketing (cont’d.)

Marketing and Use in the Workplace• Develop and increase partnering efforts between OSHA and

healthcare accrediting organizations (e.g., Joint Commission) to ensure that appropriate PPE use is a priority and sentinel event

• Ensure oversight for PPE products sold commercially

Post-Marketing Evaluation• Increase resources for post-market evaluation and surveillance

Overview of the Report’s RecommendationsUnderstand Influenza Transmission• Initiate and support a global influenza research network

Commit to Worker Safety and Appropriate Use of PPE• Emphasize appropriate PPE use in patient care and in healthcare

management, accreditation, and training• Identify and disseminate best practices for improving PPE compliance and use• Increase research and research translation efforts relevant to PPE compliance

Innovate and Strengthen PPE Design, Testing, and Certification• Define evidence-based performance requirements (prescriptive standards) for

PPE • Adopt a systems approach to the design and development of PPE• Increase research on the design and engineering of the next generation of PPE• Establish measures to assess and compare the effectiveness of PPE• Ensure balance and transparency of standards-setting processes• Strengthen pre-market testing of PPE for healthcare workers• Strengthen post-market evaluation of PPE for healthcare workers• Coordinate efforts and expand resources for research and approval of PPE

Understand Influenza TransmissionRecommendation: Initiate and Support a

Global Influenza Research Network

The Department of Health and Human Services (DHHS), in collaboration with U.S. and global partners through the World Health Organization, should lead a multination, multicity, and multicenter focused research effort to facilitate understanding of the transmission and prevention of seasonal and pandemic influenza. A global research network of excellence should be developed and implemented that would• Identify and prioritize research questions with suggested possible study

designs;• Provide priority funding to support short-term (1 to 3 years) laboratory

and clinical studies of influenza transmission and prevention of seasonal influenza with particular focus on the effectiveness of types of PPE; and

• Develop rigorous evidence-based research protocols and implementation plans for clinical studies during an influenza pandemic.

COMMIT TO WORKER SAFETY AND APPROPRIATE USE OF PPE

Recommendations:

Emphasize Appropriate PPE Use in Patient Care and in Healthcare Management, Accreditation, and Training

Appropriate PPE use and healthcare worker safety should be a priority for healthcare organizations and healthcare workers, and in accreditation, regulatory policy, and training.

Identify and Disseminate Best Practices for Improving PPE Compliance and UseCDC and the Agency for Healthcare Research and Quality (AHRQ) should support and evaluate demonstration projects on improving PPE compliance and use. This effort would identify and disseminate relevant best practices that are being used by hospitals and other healthcare facilities.

Increase Research and Research Translation Efforts Relevant to PPE ComplianceNIOSH, the National Institutes of Health (NIH), AHRQ, and other relevant agencies and organizations should support research on improving the human factors and behavioral issues related to ease and effectiveness of PPE use for extended periods and in patient care-interactive work environments.

INNOVATE AND STRENGTHEN PPE DESIGN,TESTING, AND CERTIFICATION

Recommendations:

Define Evidence-Based Performance Requirements (Prescriptive Standards) for PPE

NIOSH, through the National Personal Protective Technology Laboratory (NPPTL), in collaboration with extramural researchers, manufacturers, and regulatory agencies, should define a set of evidence-based performance requirements or prescriptive standards for PPE to facilitate their design and development that optimally balances the cost, comfort, and degree of protection of PPE and enhances the compliance with their use in the field.

Adopt a Systems Approach to the Design and Development of PPE NIOSH should promote a systems approach to the design, development, testing, and certification of PPE using evidence-based performance requirements or prescriptive standards and fostering closer collaboration between the users, manufacturers, and research and regulatory agencies.

INNOVATE AND STRENGTHEN PPE DESIGN,TESTING, AND CERTIFICATION (cont’d.)

Recommendations:

Increase Research on the Design and Engineering of the Next Generation of PPE

NIOSH, the Department of Homeland Security, the Department of Defense, manufacturers, and other relevant organizations and agencies should fund research directed at the design and development of the next generation of respirators, gowns, gloves, and eye protection for healthcare workers that would enhance their safety and comfort.

Establish Measures to Assess and Compare the Effectiveness of PPE NIOSH, through NPPTL, should develop and promote a validated set of measures for comparing the effectiveness of PPE products. The goal is a set of measures that would allow users to compare and select appropriate PPE commensurate with the assessed risk and desired level of protection. Particular attention should be paid to disseminating information to healthcare workers on PPE effectiveness relevant to influenza.

INNOVATE AND STRENGTHEN PPE DESIGN,TESTING, AND CERTIFICATION (cont’d.)

Recommendations:

Ensure Balance and Transparency of Standards-Setting ProcessesFederal agencies (e.g., FDA, NIOSH, OSHA) should use standards developed through a consensus-based transparent process that sets specific and clearly-defined limits regarding conflicts of interest (financial or other) and involves broad representation of all affected parties.

Strengthen Pre-market Testing of PPE for Healthcare WorkersFDA, NIOSH, and other relevant agencies and organizations should strengthen pre-market testing requirements for healthcare PPE by requiring field testing of PPE prior to approval and by reevaluating the FDA medical device classification for healthcare PPE. Testing requirements should use rigorous standards while also providing expeditious review of innovative approaches.

Strengthen Post-market Evaluation of PPE for Healthcare WorkersNIOSH, FDA, and other relevant agencies and organizations should support and strengthen adverse event reporting and post-market evaluation studies and surveillance regarding the effectiveness of PPE used by healthcare workers.

INNOVATE AND STRENGTHEN PPE DESIGN,TESTING, AND CERTIFICATION (cont’d.)

Recommendation:

Coordinate Efforts and Expand Resources for Research and Approval of PPE

Congress should expand the resources provided to NIOSH to further research efforts on the next generation of PPE and to coordinate and expedite the approval of effective PPE. Efforts to coordinate PPE testing, certification, and approval across all relevant federal agencies should include developing evidence-based performance standards for all types of PPE for healthcare workers.

Additional Issues• Substantial gaps in knowledge regarding the design and

implementation of PPE for family members and others during an influenza pandemic

• Challenges include the benefits of minimizing or negating fit testing of respirators, protecting people with a wide range of face sizes (including children), protecting people with respiratory impairment

• Limited oversight of PPE sold in the retail marketplace

Related National Academies Reports

Reusability of Facemasks During an Influenza Pandemic: Facing the Flu (2006)

Assessment of the NIOSH Head-and-Face Anthropometric Survey of U.S. Respirator Users

(2007)

Measuring Respirator Use in the Workplace (2007)

For Further Information

Study website (www.iom.edu/healthcareppe)• Report brief - 4 page summary• Link to report

National Academies Press (www.nap.edu)

• Free PDF download of the executive summary• Purchase of the IOM report