NIOSH NPPTL Webinar, May 7, 2020
Updated May 12, 2020
Factors to Consider when Planning to Purchase Respirators from Another Country, Including KN95 Respirators from China
Date/Time: Thursday, May 7, 2020, 1:00 p.m. EDT
When there is a shortage of NIOSH-approved filtering facepiece respirators (FFRs), as we are experiencing during the coronavirus disease 2019 (COVID-19) pandemic, other reliable options must be found. The Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) have determined that respirators that meet the regulatory requirements of the countries listed in the FDA’s Emergency Use Authorization (EUA) may be appropriate to protect workers during the pandemic. However, due to the current demand, buyers should be aware that there are an unprecedented number of products on the market that do not perform as advertised.
This webinar will discuss the common pitfalls of purchasing respirators internationally to assist buyers to make informed procurement decisions to keep their workers safe. The considerations presented in this webinar will help to maximize the likelihood of obtaining safe and effective products.
View recording of webinar.
View the Factors to Consider When Planning to Purchase Respirators from Another Country document on the CDC COVID-19 webpage.
Links mentioned in the webinar:
- Understanding the Use of Imported Non-NIOSH-Approved Respirators (NIOSH Science Blog)
- NIOSH Certified Equipment List
- NPPTL Respirator Assessments to Support the COVID-19 Response
(Included in the FDA Presentation)
- EUA: https://www.fda.gov/media/136664/download
- APPENDIX A
- Dear hEALTHcare provider letter: https://www.fda.gov/medical-devices/medical-device-safety/letters-health-care-providers
- Frequently asked questions: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/non-niosh-approved-respirator-eua-faq
FDA Emergency Use Authorization
- March 28 FDA EUA on imported non-NIOSH approved FFRs
- Exhibit 1 to FDA’s March 28 EUA – list of authorized respirators
- April 3 FDA EUA on non-NIOSH approved respirators manufactured in China
- Appendix A to FDA’s April 3 EUA – list of authorized respirators manufactured in China
Additional Related Information for Purchasers of Respiratory Protection Equipment
Christina Baxter, Ph.D., is the CEO of Emergency Response TIPS, LLC which provides practical, evidence-based solutions for emergency response through the development of next generation tools for enhanced situational awareness and responder safety and instructional design materials for instructor-led and web-based programs in the areas of CBRNE, hazardous materials, and clandestine laboratory response. Prior to forming Emergency Response TIPS, LLC, Dr. Baxter was the program manager over the CBRNE program at the Department of Defense’s Combating Terrorism Technical Support Office where she was responsible for managing domestic and international CBRNE research and development programs to combat terrorism on behalf of the U.S. Government, as well as overseeing the international CBRNE agreements with Australia, Canada, Israel, Singapore, and the United Kingdom. Dr. Baxter is the chairperson for the National Fire Protection Association standards for CBRNE personal protective equipment. She is also a committee member for several other standards in the protection and hazardous materials operations arenas. She has greater than 20 years experience in the CBRNE/hazardous materials emergency response community.
Luke Bosso is the Senior Vice President and Chief of Staff for the Indiana Economic Development Corporation (IEDC). Mr. Bosso has served as senior operations director for the Office of Governor Eric J. Holcomb prior to joining the IEDC. Prior to that, he was the Deputy Chief of Staff for the Department of Child Services where he helped lead the organization and manage a $1 billion budget. He also served as the Regulatory and Permitting Ombudsman for Develop Indy. In this role, he worked with businesses to help navigate local permitting and zoning requirements. Mr. Bosso is actively involved with several nonprofits including the Indianapolis Zoo and USA Boxing. He received his bachelor’s degree from Franklin College.
Danny Chan is the Managing Director of Iconic Private Equity Partners. Mr. Chan has spent the past ten years investing, consulting and advising Greater China companies. He has over fourteen years of experience in the finance industry. While attending university as an undergraduate he was featured in Money Magazine for his performance in trading stocks.
Mr. Chan has appeared on Fox Business Network, Yahoo Finance, CBS News, Market Watch, Chicago Tribune, Chicago Sun Times and various other media outlets. He is fluent in Mandarin and English and earned a bachelor’s degree in finance from Indiana University.
Maryann D’Alessandro, Ph.D., has served as the Director of the National Institute for Occupational Safety and Health (NIOSH) National Personal Protective Technology Laboratory (NPPTL) since March 2012, and was previously the Associate Director for Science for NPPTL. Dr. D’Alessandro provides leadership to the NIOSH PPT Core and Specialty Program where she serves as the Manager leading the effort to align PPT initiatives with user needs across all workplace industry sectors. Within the Personal Protective Technology (PPT) Program, Dr. D’Alessandro has served as the catalyst for aligning surveillance, research, standards, certification, outreach and intervention activities to improve workplace safety and health. Prior to joining NIOSH in 2003, she had a short academic career at the University of Pennsylvania’s Department of Bioengineering, and also served 15 years with the U.S. Army in biomedical sensors, communications, and intelligence systems research and development. Dr. D’Alessandro holds Electrical Engineering degrees from the Florida Institute of Technology (B.S.), Fairleigh Dickinson University (M.S.), and Georgia Institute of Technology (Ph.D.).
Suzanne Schwartz, MD, MBA is FDA’s Deputy Director (& Acting Office Director) Office of Strategic Partnerships & Technology Innovation (OST), Center for Devices & Radiological Health, US Food & Drug Administration.
Suzanne began her career at FDA in 2010 as a Commissioner’s Fellow and joined CDRH the following year as a Medical Officer in the former Office of Device Evaluation, Division of Surgery, Orthopedics and Restorative Devices. Soon after, Suzanne became CDRH’s Director of Medical Countermeasures and Emergency Preparedness/Operations (EMCM) in the Office of the Center Director. In this role, she provided leadership in the strategic planning and implementation of CDRH’s medical countermeasures, counter-terrorism, and public health emergency preparedness/operations initiatives involving medical devices. Suzanne began spearheading CDRH’s medical device cybersecurity strategic initiative while in her role as Director of EMCM in 2013, chairing the CDRH Cybersecurity Working Group which is tasked with formulating policy on medical device cybersecurity on behalf of the Agency.
In 2015, Suzanne assumed the position of CDRH’s Associate Director for Science and Strategic Partnerships, where she provided leadership and strategic direction for additional Center programs such as Partnering with Patients, External Expertise and Partnerships, the Standards Management Program, as well as initiatives to advance the health of women, children, and special populations.
Suzanne earned an MD from Albert Einstein College of Medicine of Yeshiva University in New York in 1988, trained in General Surgery and Burn Trauma at the New York Presbyterian Hospital – Weill Cornell Medical Center; an executive MBA from NYU Stern School of Business in 2012, and completed Cohort X of the National Preparedness Leadership Initiative – Harvard School of Public Health & Harvard Kennedy School of Government executive education in June 2013. Most recently, Suzanne earned a certificate of mastery for all requirements set forth in the Leadership for a Democratic Society, conferred by the Federal Executive Institute, US Office of Personnel Management.
John Powers is a Supervisory General Engineer and has served as the Branch Chief of the Evaluation and Testing Branch, NIOSH National Personal Protective Technology Laboratory, in Morgantown, West Virginia, since July 2016. Mr. Powers began his career with NIOSH in February 1997. Prior to NIOSH, Mr. Powers worked 9 years for the Department of Defense. He received a B.S. in electrical engineering from The Pennsylvania State University in 1988. Mr. Powers has several publications related to the development of engineering controls to protect workers. His current interests are on the development of real-time sensor technology for respiratory protection as well as the development of conformity assessment programs for personal protective equipment.