NIOSH Respiratory Protective Device Priorities - Opportunities for International Collaboration Maryann D Alessandro, Ph.D. Director, NPPTL PPT Program Manager ISRP Keynote Address September 22, 2014 1
The MISSION of the NIOSH/NPPTL and the PPT program is to prevent work-related injury, illness and death by advancing the state of knowledge and application of personal protective technologies (PPT). More than 20 million U.S. workers use PPE on a regular basis to protect themselves from job hazards.
United States Respiratory Protective Device Priorities Pandemic Preparedness Conformity Assessment Integration of ISO Standards
HHS sponsored IOM Pandemic Preparedness studies related to RPD conservation were initiated in 2005. REUSABILITY OF FACEMASKS DURING AN INFLUENZA PANDEMIC Facing the Flu (2006) PREPARING FOR AN INFLUENZA PANDEMIC PPE for Healthcare Workers (2008) RESPIRATORY PROTECTION FOR HEALTHCARE WORKERS IN THE WORKPLACE AGAINST NOVEL H1N1 INFLUENZA A A Letter Report (2009) UPDATE PPE for Healthcare Workers (2010)
Recent threats have increased the national emphasis on the respiratory protective device supply issue.
In April 2013, the CDC Director requested a report of near term priorities for RPD conservation in healthcare settings. Near term activities associated with each priority were identified and are being addressed.
Survey Results show that a variety of NIOSH-approved respirators are used in health care environments. RPD models reported (FFRs, PAPRs, elastomeric RPDs) 100% of all facilities reported using NIOSH-approved FFRs 78% of all facilities reported using NIOSH-approved PAPRs 31% of all facilities reported using NIOSH-approved elastomeric RPDs
Research and development efforts are underway to formulate effective strategies for using available supplies. Guidelines for extended use and reuse Elastomeric RPD strategy PAPR RPD strategy
Respiratory protective device core competencies were developed and incorporated in nursing education.
Effective and efficient inventory management systems for respirator stockpiles are being developed. Progress: The federal government is revising its respiratory protective device stockpiling strategy. Next steps: Public and private sector parties are sharing knowledge and experiences and identifying options for future stockpile management approaches. Existing inventories of stockpiled respirators have shelf-life issues.
The 2014 public health tragedy of the Ebola virus outbreak is a CDC priority. Dr. David Kuhar of the CDC wears the protective suiting needed to prevent Ebola infections at Hospitals from Time Magazine, Aug 25, 2014, p. 35
How many of you have similar concerns in your nation? What can ISRP do to align the international RPD community to tackle RPD challenges?
United States Respiratory Protective Device Conformity Assessment Priority Pandemic Preparedness Conformity Assessment Integration of ISO Standards
NIOSH/NPPTL protects workers from job hazards by developing standards and certifying over 9000 respirators. Australia Brazil Canada Chile China Columbia Denmark England Finland Germany India Italy Japan Korea Mexico New Zealand Taiwan Thailand Sweden U.S.A. 93 approval holders 130 manufacturing sites 20 countries Approximately 400 approval decisions made annually.
The CA framework will incorporate all conformity assessment approaches as components of the framework.
An evidence-based PPT conformity assessment framework will encourage standards that keep pace with technological advancements and user needs. 1. Define health & safety requirements 2. Identify PPE needed & PPE specifications and standards 3. Define CA requirements 4. Conduct post-market surveillance
United States Respiratory Protective Device Priority to Integrate ISO Standards Pandemic Preparedness Conformity Assessment Integration of ISO Standards
NIOSH is integrating respirator certification requirements with national and international consensus standards.
Going forward, NIOSH is leading several ISO activities as we determine the direction for U.S. RPD Standards. Participation on ISO Working Groups Validation of ISO Technical Requirements Integration of ISO standards into U.S. RPD standards Validation of test procedures
What approach will ensure that the intent behind ISO standardization is integrated internationally? Classification Classification challenges - Many countries have governmental regulations that mandate specific marking, labeling, information and ongoing compliance. ISO represents a move from product specific Standards to worker performance-based standards Performance Selection In the U.S. selection is based on OSHA APFs determined from SWPF and WPS studies not a limited laboratory fit test The planned implementation of ISO has slipped from 2015 because of substantial comments received.
NIOSH/NPPTL has a priority to explore approaches to integrate national and international standards. FFR Laboratory Fit Test Design focused on healthcare worker needs Powered respirators
Ongoing international collaboration will move us forward. 23
Quality Partnerships Enhance Worker Safety & Health Maryann D Alessandro bpj5@cdc.gov 412-386-4033 Disclaimer: Visit Us at: http://www.cdc.gov/niosh/ppt/ The findings and conclusions in this presentation have not been formally disseminated by the National Institute for Occupational Safety and Health and should not be construed to represent any agency determination or policy. 24