1Maryann D’Alessandro, Ph.D.Director, National Personal ProtectiveTechnology Laboratorybpj5@cdc.govSeptember 17, 2013Toward a National Framework for ConformityAssessment of Non-respiratory PPTPersonal Protective TechnologyConformity Assessment PublicMeetingOverviewConformity assessmentand market surveillanceprocessesBasis for draftframework scopeNext stepsMultiple activities contributed to the draftframework scopePCAWG activitiesBenchmarkingNational PPTCA ProgramsPPT CADraftFrameworkScopeQuestions for discussion today1.Who defines the basic health and safetyrequirements (BHSRs) for your industry?2.How should the BHSRs be established?3.Who should address what PPE is needed to meetBHSRs?4.Who determines the technical standards thatdemonstrate the BHSRs are met?5.How are conformity assessment requirementslinked to PPE types?This is the process needed to further define theconformity assessment frameworkBHSRs should be established as a basis of anational conformity assessment system•BHSRs define theprotection results to beattained•BHSRs can be used toguide standardsdevelopment•Example – PPE to protectagainst mechanicalvibrationPPE should be identified to address BHSRs•Voluntary consensus standardsshould reference applicable BHSRs•Address priority areas of researchinterest based on risk and nationalinterest in areas that address theBHSR gaps•Decisions about the technicalapproaches for achieving therelevant BHSRs for a product aremade by the supplierConformity assessment activitiesshould be based on ISOconformity assessment standardsA federal authority is needed toprovide oversight of nonrespiratory occupational PPT CAConformity with the BHSRs is theresponsibility of the supplierConformity assessment should provide usersconfidence that product complies with the standardTechnical documentationProduct testingSupplier’s Declaration of Conformity (SDoC)Conformity markingType-examinationThird-party certificationQuality systemPost-marketsurveillanceThe appropriate CA components should bedetermined based on BHSRs and associatedhazardHazards – corresponding tothe BHSRs – should beplaced in tiered categoriesConformity assessmentrequirements should beassigned to each categoryof hazard.Requirements should beconsistent with internationalstandards and practices tofacilitate tradeConformity assessment should be based on BHSRsrepresenting tiered, hazard based approachesExample: OSHA Occupational RiskPyramid for Pandemic InfluenzaOSHA 3327-02N (2007)Next steps to move the conformity assessmentprocesses of the draft framework scope forwardDetermine approach to maintain the products andstandards databaseDevelop a systematic approach and strategy todocumenting and disseminating information aboutPPE use with an emphasis on PPE use for highand medium risk workplace hazardsDetermine which hazards are medium to high riskConduct an impact assessment regarding thedraft framework scopeMarket surveillance will provide information on fielduse by collecting data from many sourcesRoutine surveillanceComplaints about a productMedia reports Authorities in other countriesA federal market surveillance authority should beestablishedMarket surveillance should follow the ISO standards.Market surveillance plans should be based on hazardand riskPlans should be monitored, evaluated & adapted asneeded.An online, publicly accessible database of all thirdparty market surveillance bodies should be establishedMarket surveillance guidelines and authorities1.Inspect manufacturing facilities2.Conduct documentary checks3.Randomly select sample products,either onsite or from the openmarket4.Make initial physical checksof the products5.Conduct laboratory tests6.Make assessmentsAccredited third-party marketsurveillance bodies should:Provide PPT users and customers a vehicle for reportingPPT failures or requesting PPT evaluationExpand an existing reporting system to include PPT, e.g.:CPSC’s Publicly Available Consumer Product Safety InformationDatabase (SaferProducts.gov)FDA’s Manufacturer and User Facility Device ExperienceDatabase (MAUDE), orFDA’s MedWatch ProgramThe market surveillance authority should alert the publicwhen actions have been taken against products notconformingAdverse event reporting system1.Official warnings and fines2.Alerts to consumers3.Sales bans4.Product withdrawals5.Product recallsThe market surveillance authority should beauthorized to enforce corrective actions.•Evaluate from both an effectiveness and acost/benefit perspective•Third party market surveillance authoritiesshould be required to provide data on outputindicatorsThe market surveillance authority should beindependently evaluatedEvidence for prioritizing surveillance projects includes:Census of Fatal Occupational Injuries (CFOI)Survey of Occupational Injuries and Illnesses (SOII)MHSA’s Mine Accident Injury and Illness databaseNational Electronic Injury Surveillance System —Work Supplement (NEISS- WORK)OSHA’s Data Initiative (ODI)Worker’s Compensation dataSurveillance data for market surveillance planningExpand existing data collection program(s) to includereports of unsafe PPT & PPT-related injuries andillnessesDevelop registry of third-party conformity assessmentand market surveillance bodiesExplore expanding consumer alert system(s) to includePPTDevelop data reporting requirements for third-partybodies to support monitoring & evaluation of theconformity assessment and market surveillancesystemsNext steps to move the surveillance and databaseactivities of the draft framework scope forwardNear-term activitiesBegin cost-benefit study of proposedCA market surveillance programsReview docket comments receivedthrough December 11st Quarter FY 20142nd Quarter FY 2014 4th Quarter FY 2014Reconcile comments andsubmit framework for publicationPost updated framework scopeConduct 2ndpublic meetingPublish final report on CA frameworkContinue implementing strategy3rd Quarter FY 2014Oct 2013Jul 2014Questions for discussion today1.Who defines the basic health and safetyrequirements (BHSRs) for your industry?2.How should the BHSRs be established?3.Who should address what PPE is needed to meetBHSRs?4.Who determines the technical standards thatdemonstrate the BHSRs are met?5.How are conformity assessment requirementslinked to PPE types?Quality Partnerships Enhance WorkerSafety & HealthThank youVisit Us at:http://www.cdc.gov/niosh/programs/ppt/http://www.cdc.gov/niosh/npptlMaryann D’Alessandro412-386-4033bpj5@cdc.govDisclaimer: The findings and conclusionsin this presentation have not beenformally disseminated by the NationalInstitute for Occupational Safety and Health and should not be construed to represent any agency determination or policy.