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A Agendas of Public Meetings INSTITUTE OF MEDICINE Board on Health Sciences Policy COMMITTEE ON THE CERTIFICATION* OF PERSONAL PROTECTIVE TECHNOLOGIES The National Academies Keck Center Room 109 500 Fifth Street, NW Washington, DC AGENDA Open Session Thursday, January 28, 2010 10:30 a.m. Welcome and Introductions Howard J. Cohen, Committee Chair Sponsor’s Charge to the Committee and Background Information ______________________________________________ * Certification is defined broadly to encompass the entire conformity assessment process. The workshop and study are focused on non-respiratory personal protective technologies. 127

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128 CERTIFYING PERSONAL PROTECTIVE TECHNOLOGIES Maryann D’Alessandro, Associate Director for Science, NPPTL, NIOSH Les Boord, Director, NPPTL, NIOSH Discussion 12:00 p.m. Lunch 1:00 p.m. Context for the Study 1:00–1:45 Overview of Product Conformity Assessment and Examples of Various Approaches to Certification Gordon Gillerman, NIST Discussion 1:45–2:30 ASTM International—Certification Program Tim Brooke, ASTM Discussion 2:30–2:45 Break 2:45–3:30 Certification of Personal Flotation Devices Samuel E. Wehr, Independent Consultant Discussion 3:30 p.m. Adjourn Open Session

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129 APPENDIX A COMMITTEE ON THE CERTIFICATION* OF PERSONAL PROTECTIVE TECHNOLOGIES WORKSHOP The National Academies Keck Center Room 100 500 Fifth Street, NW Washington, DC Tuesday, April 13, 2010 8:00 a.m. Welcome and Opening Remarks Howard J. Cohen, Committee Chair 8:10 a.m. Overview and Terminology Gordon Gillerman, National Institute of Standards and Technology 8:30 a.m. Session 1: Current Certification Efforts in PPT: Firefighter Ensembles Facilitator: Roger L. Barker 8:30–8:40 Overview of the Process Roger L. Barker 8:40–8:50 Richard M. Duffy, International Association of Fire Fighters 8:50–9:00 Diane Haithcock, Underwriters Laboratories 9:00–9:10 Eric Beck, MSA, Inc. 9:10–9:30 Discussion with the Committee Questions: • Overview of the conformity assessment process for firefighter protective equipment: Who sets the standards? What products or materials are tested? Who does the testing? Who accredits the testing labs? Who provides the certification? • Why was this process developed? What is or should be the role of government in the

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130 CERTIFYING PERSONAL PROTECTIVE TECHNOLOGIES certification process? What factors were considered in establishing the process as a third- party testing process? • What is the typical time line? What is the typical fee structure? What is the duration of validity of the certification? What post-marketing surveillance activities are conducted? What production oversight procedures are in place? How are mislabeling or other false assertions of certification addressed? • What are the incentives or barriers to assessing and asserting conformity? • What are the challenges regarding innovation, interfaces among PPT components, etc.? What needs to be done to improve the conformity assessment process? What value is added by having a conformity assessment/certification process in place? Are data available on how certification of firefighter ensembles impacts firefighter safety and health? 9:30 a.m. Session 2: Current Conformity Assessment Efforts: Other Products Facilitator: Melissa A. McDiarmid 9:30–9:45 Body Armor Safety Initiative Lance Miller, National Law Enforcement and Corrections Technology Center 9:45–10:00 EPA Noise Reduction Rating Program Ken E. Feith, Environmental Protection Agency 10:00–10:15 Consumer Product Safety J. Gibson Mullan, U.S. Consumer Product Safety Commission 10:15–10:30 CBRN Ensembles for Law Enforcement Debra Stoe, National Institute of Justice 10:30–11:00 Discussion with the Committee

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131 APPENDIX A Questions: • Overview of the certification/conformity assessment processes: Who sets standards? Who tests? Who accredits? Who provides the certification? What value is added by having a conformity assessment/certification process in place? • What is the role of government in the process? How were decisions made regarding the role of government? • What is the typical fee structure? • What is the duration of validity of the certification? What production oversight procedures are in place? What post-marketing surveillance activities are conducted? How are mislabeling or other errors in assertions of conformity assessment addressed? • What are the challenges regarding innovation? What are the incentives or barriers to assessing and asserting conformity? What needs to be done to improve the conformity assessment process? Are data available on how certification impacts worker or consumer safety? 11:00 a.m. Session 3: Measuring the Impact of Certification on Worker Safety and Health Facilitator: Barbara J. Burgel 11:00–11:15 Patricia A. Gleason, Safety Equipment Institute 11:15–11:30 Preston Anderson, Sperian Fall Protection, Inc. 11:30–11:45 Discussion with the Committee Questions: • How do standards and conformity assessment/certification impact worker safety? What data are available?

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132 CERTIFYING PERSONAL PROTECTIVE TECHNOLOGIES • What value is added by having a certification/conformity assessment process in place? 11:45 a.m. Lunch 12:30 p.m. Session 4: Incentives and Barriers to Conformity Assessment and Certification Facilitator: James S. Johnson 12:30–12:45 Ginny Fitzner, Directorate of Standards and Guidance, OSHA Kevin Robinson, Nationally Recognized Testing Laboratories Program, OSHA 12:45–12:55 Louise Kuhny, Joint Commission (via phone) 12:55–1:05 Robin T. Scott, Sport Dimension, Inc. 1:05–1:15 Daniel K. Shipp, International Safety Equipment Association 1:15–1:45 Discussion with the Committee Questions: • What drives the need for conformity assessment/certification? For government? For manufacturers? For consumers? How is the balance determined between being overly prescriptive and not prescriptive enough? • What issues do regulatory or accrediting organizations consider in stipulating the need for products to meet specific standards or certification requirements? • What is the value of certification in terms of patient safety and worker safety? Does the Joint Commission provide feedback or incentive to healthcare facilities that choose to purchase certified equipment? Does the Joint Commission have any PPT standards related to healthcare worker safety?

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133 APPENDIX A • What are the relative costs of various certification mechanisms to the final product and what are the differences in manufacturing to meet different certification requirements globally? • How does a manufacturer decide if it is worth investing in third-party testing or certification or if a new product is worth bringing to market if certification is required? 1:45 p.m. Session 5: Risk-Based Approaches to Conformity Assessment Facilitator: Anugrah Shaw 1:45–2:00 Gordon Gillerman, National Institute of Standards and Technology 2:00–2:15 Markham C. Luke, Center for Devices and Radiological Health, FDA 2:15–2:45 Discussion with the Committee Questions: • What risk-based approaches have been used to develop current conformity assessment processes? • Should the development of a conformity assessment process take into account the effectiveness of recalls in the product category or consider the likelihood that the user can effectively determine the quality and suitability of the product for the intended use? • What current process is used at the FDA to assess the level of risk of a medical device and make determinations about the device class and whether the 510(k) process is required? Are medical device determinations predominantly based on risk to the patient or the healthcare worker or both? What are the current post- marketing surveillance efforts for device safety? Are any medical devices required to go through third-party testing prior to FDA clearance? How

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134 CERTIFYING PERSONAL PROTECTIVE TECHNOLOGIES are devices (e.g., gowns) regulated that are sold without having gone through the FDA medical device clearance process? 2:45 p.m. Session 6: Case Study: Healthcare Worker Gloves Facilitator: Alexander Isakov 2:45–3:00 Terrell Cunningham, Food and Drug Administration 3:00–3:15 Michael S. Zedalis, Ansell Healthcare, LLC 3:15–3:30 David Hermann, Aspen Healthcare Metrics 3:30–3:45 Sharon Welbel, Cook County Health and Hospitals System 3:45–4:15 Discussion with the Committee Questions: • What is the current FDA process and what standards are required to be met for FDA 510(k) clearance? • Should a more in-depth conformity assessment process be implemented for gloves used in health care? If so, what type of process? If not, why? • Are there adequate performance standards in place to test various types of gloves to see if they would meet certification requirements? If not, what is needed? • What are the reasons why third-party testing and certification efforts have not been developed to date? • What incentives and barriers would there be for implementing a more in-depth certification/conformity assessment process? • What risk-based approaches could be used to determine the type of conformity assessment processes needed for the various types of gloves?

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135 APPENDIX A • What factors go into the decision to purchase? Would a third-party certification process make a difference in purchasing decisions? 4:15 p.m. Public Comment—Registered Speakers Moderator: Howard J. Cohen 5:00 p.m. Adjourn

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