Transcript IOM Presentation - Society for Healthcare Epidemiology of

Preparing for an
Influenza Pandemic:
Personal Protective
Equipment
for Healthcare Workers
September 2007
Study Sponsor
National Personal Protective Technology Laboratory,
NIOSH, CDC
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
Charge to the IOM Committee
• 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 standardsetting organizations
• Identify priorities and resources for research and certification
efforts
IOM Committee
Lewis 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 Technology
Talmadge E. King, Jr., University of California, San Francisco
Donald Low, University of Toronto
Sharon Marable, Brown University
R. Kent Oestenstad, University of Alabama School of Public Health
Trish M. Perl, Johns Hopkins University School of Medicine
David Prezant, Albert Einstein College of Medicine
M.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
Illness
Moderate
Severe
(such as 1958 and 1968)
(such as 1918)
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 Controls
Engineering 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
Organizational
Factors
•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.
Behavioral Factors
•Intention to comply with infection controloccupational health guidelines
•Willingnesss to treat potentially affected
patients
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
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 Safety
Key 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
Evidence-Based Performance Requirements
Functionality
Protect against
influenza virus
Guard against
contact with
contaminated fluids
and aerosols
Usability
Comfort and Wearability
 Maintain biomechanical
efficiency and sense of touch and
feel
 Odor free
 Hypoallergenic
 Accommodate 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)
 Comfortable—no skin
irritation or pressure
points
 Prolonged use without
discomfort
 Breathable—air
permeable
 Moisture absorbent—
wickability
 Low bulk and weight
 Dimensional stability
 Easy to put on and
take off (don and doff)
Cost
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
 Product cost
 Total life-cycle
cost
 Minimal
environmental
impact
Durability
 Adequate wear life
 Strength—tear,
tensile, burst
 Abrasion resistance
 Corrosion
resistance
A Structured Approach to Evidence-Based
Performance Requirements
• Functionality
• Usability
• Comfort and Wearability
• Durability
• Maintenance and Reuse
• Aesthetics
• Cost
Design and Development of Healthcare PPE
Immediate 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 PPE
Long-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 Recommendations
Understand 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 Transmission
Recommendation: 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 Use
CDC 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 Compliance
NIOSH, 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 Processes
Federal agencies (e.g., FDA, NIOSH, OSHA) should use standards developed
through a consensus-based transparent process that sets specific and clearlydefined limits regarding conflicts of interest (financial or other) and involves
broad representation of all affected parties.
Strengthen Pre-market Testing of PPE for Healthcare Workers
FDA, 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 Workers
NIOSH, 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