www.hhs.gov U.S. Department of Health and Human Services
Activity Outline
FDA Grand Rounds: Electrical Safety in CTP Regulated Products
April 8, 2021
Virtual
Activity Coordinator:
Rokhsareh Shahidzadeh (rokhsareh.shahidzadeh@fda.hhs.gov),  Sharron Watson (Sharron.Watson@fda.hhs.gov)
 
Series Description

The FDA Grand Rounds is webcast every other month to highlight cutting-edge research underway across the agency and its impact on protecting and advancing public health. Each session features an FDA scientist presenting on a key public health challenge and how FDA is applying science to its regulatory activities.


Lecture Description
Battery-related injury and damage reports associated with electronic nicotine delivery systems (ENDS; e.g., e-cigarettes) increased nearly 100-fold from 2009-2017 despite the likelihood that the voluntary, primarily self-reported incidents were under-reported.1, 2, 3 ENDS battery overheating, fires and explosions (OFE) have resulted in serious, disfiguring or disabling injuries.2, 4 FDA-CTP continues to receive reports of battery-related adverse experiences, including one death.

In response, FDA-CTP conducted public education and outreach, developed an infographic on avoiding tobacco product related OFE, and convened a public workshop and opened a public docket to gather information regarding battery-operated tobacco products electrical safety concerns and risk mitigation.5 That information informed guidances and a proposed rule.6, 7, 8 One guidance provides manufacturers with battery testing (ANSI/CAN/UL 8139 [UL 8139])9 information that could address OFE hazards.6 FDA encourages and supports tobacco products changes to become UL 8139 compliant. FDA provided industry with information that could be included in premarket tobacco product applications that addresses battery-related concerns.7, 8 FDA continues to examine the science to provide support and guidance to tobacco product manufacturers to remove those products that demonstrate high risks, and for manufacturers to develop products that reduce OFE risks to tobacco products consumers.
References
  • SM Trigger, B Coleman. Social media mentions of electronic nicotine delivery systems (ENDS) battery-related overheating, fires, and explosions: Findings from a pilot study. Int J Environ Res Public Health (2019) 16(8):1308
  • CJ Corey, JL Chang, BL Rostron; Electronic nicotine delivery system (ENDS) battery-related burns presenting to US emergency departments,2016; Injury Epidemiology (2018) 5:4.
  • Battery Safety Concerns in Electronic Nicotine Delivery Systems; Public Workshop; Establishment of a Public Docket; Request for Comments. Docket No. FDA-2016-N-4232 published January 4, 2017 https://beta.regulations.gov/docket/FDA-2016-N-4232
  • SF Rudy, EL Durmowicz; Electronic nicotine delivery systems: overheating fires and explosions; Tob Control (2017) 26:10–18.
  • Electronic Cigarette Fires and Explosions in the United States 2009 – 2016; USFA FEMA; July 2017.
Series Objectives
  • Discuss the research conducted at the FDA
  • Explain how FDA science impacts public health
Learning Objectives After completion of this activity, the participant will be able to:
  • Describe the key electrical risks and hazards associated with battery-operated tobacco products: proximity to body, limited protections and controls, interchangeable cells, high current draw
  • Describe how manufacturer compliance with industry standards may reduce electrical risks and hazards
  • Explain things users can do to reduce electrical risks and hazards
Target Audience
This activity is intended for physicians, pharmacists, nurses, and other scientists within the agency external scientific communities.
Agenda

Lecture 1 April 8, 2021
Time Topic Speaker
12:00 - 1:00 PM Electrical Safety in CTP Regulated Products Selena Russell, PhD
Karen Coyne, PhD
Continuing Education Accreditation
Jointly Accredited Provider
In support of improving patient care, FDA Center for Drug Evaluation and Research is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.
ICPE Credit
This activity was planned by and for the healthcare team, and learners will receive 1 Interprofessional Continuing Education (IPCE) credit(s) for learning and change.
CME
FDA Center for Drug Evaluation and Research designates this live activity for a maximum of 1.00 AMA PRA Category 1 Credit(s). Physicians should claim only the credit commensurate with the extent of their participation in the activity.
CPE
This knowledge-based activity has been assigned ACPE Universal Activity Number JA0002895-0000-21-016-L04-P for 1.00 contact hour(s).
CNE
FDA Center for Drug Evaluation and Research designates this activity for 1.00 contact hour(s).
Requirements for Receiving CE Credit

Physicians, pharmacists, nurses, and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation via the CE Portal (ceportal.fda.gov). For multi-day activities, participants must attest to their attendance and complete the faculty evaluation each day. Final activity evaluations must be completed within two weeks after the activity - no exceptions.

Attention Pharmacists and Pharmacy Techs: Failure to provide your correct NABP AND Date of Birth information, in the required format, may result in the loss of credit for this activity. NABP profile number should be the 6-7 digit profile number assigned by the CPE Monitor and your birth date should be in the MMDD format (e.g. 0721) Do not provide your pharmacy license number. Please click the "My Account" tab and then navigate to "Edit Contact Information" to verify that your information is correct.

Important Note regarding completion of evaluations and receiving credit
Attendees have 14 days from the last day of the activity to log in, complete the required evaluation(s) and attest to your attendance to claim credit.Physicians and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 8 weeks after the last session of the activity to obtain their CE credit.
Disclosure

Faculty
  • Coyne, Karen, PhD, Associate Director, FDA Center for Tobacco Products nothing to disclose
  • Russell, Selena, PhD, Senior Chemist, FDA Center for Tobacco Products nothing to disclose

Planning Committee
  • Dinatale, Miriam, Team Leader, Food and Drug Administration nothing to disclose
  • Pfundt, Tiffany, PharmD, Pharmacist, FDA nothing to disclose
  • Wheelock, Leslie, RN, MS, RN, Director, OSPD, FDA, OC, OCS, OSPD nothing to disclose

CE Consultation and Accreditation Team
  • Bryant, Traci, M.A.T., CE Consultant, FDA/CDER/OEP/DLOD - nothing to disclose
  • Zawalick, Karen, CE Team Leader, FDA/CDER/OEP/DLOD - nothing to disclose
Registration Fee and Refunds
Registration is complimentary, therefore refunds are not applicable.
ACCME Joint Accreditation
  • This warning banner provides privacy and security notices consistent with applicable federal laws, directives, and other federal guidance for accessing this Government system, which includes (1) this computer network, (2) all computers connected to this network, and (3) all devices and storage media attached to this network or to a computer on this network.
  • This system is provided for Government-authorized use only.
  • Unauthorized or improper use of this system is prohibited and may result in disciplinary action and/or civil and criminal penalties.
  • Personal use of social media and networking sites on this system is limited as to not interfere with official work duties and is subject to monitoring.
  • By using this system, you understand and consent to the following:
    • The Government may monitor, record, and audit your system usage, including usage of personal devices and email systems for official duties or to conduct HHS business. Therefore, you have no reasonable expectation of privacy regarding any communication or data transiting or stored on this system. At any time, and for any lawful Government purpose, the government may monitor, intercept, and search and seize any communication or data transiting or stored on this system.
    • Any communication or data transiting or stored on this system may be disclosed or used for any lawful Government purpose.