Teleflex — Hazardous Materials Safety Interpretation

Page 1U.S. Department of Transportation Pipeline and Hazardous Materials Safety Administration 1200 New Jersey Avenue, SE Washington, DC 20590 MAR 3 0 2017 Jay White President and General Manager Teleflex 3015 Carrington Mill Boulevard Morrisville, NC 27560 Reference No. 16-0200 Dear Mr. White: This letter is in response to your December 11 , 2016, letter requesting clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to exceptions for passengers, crewmembers, and air operators. You describe in your letter a small lithium metal battery contained in both the EZ-IO Intraosseous Infusion system and the OnControl Driver system, further stating that the battery meets the requirements of each test in the United Nations (UN) Manual of Testing and Criteria Part III, Sub-section 38.3 and contains less than 2 grams of lithium metal. Specifically, you ask if Teleflex employees are permitted to transport this small lithium metal battery, as well as the devices in which it is contained, in carry-on baggage aboard a passenger aircraft for the purpose of demonstrations and promotional shows. The answer is yes, provided Teleflex employees follow the requirements in § 175.1O(a)(l8). The requirements of this section allow a passenger or crew member to carry a medical device containing dry cells or dry batteries (including lithium cells or batteries) in either checked or carry-on baggage. Spare lithium batteries must be individually protected to prevent short circuits (e.g., placing them in original retail packaging, insulating exposed terminals with tape, or placing each battery in a separate plastic bag or protective pouch) and must be placed in carry-on baggage only. I hope this information is helpful. Please contact us if we can be of further assistance. Chief, Standards Development Branch Standards and Rulemaking Division#

Page 2December 11 , 2016 )~)!l/{( ( 1.''_7) . /(J~.A .l k AC l {---' -\-- L ~ r \..,_ -> ® l l - · ~ :L ·)(~ lrelef lex 3015 Carrington Mill Blvd. Morrisville, NC 27560 USA Phone: 919-544-8000 www.teleflex .com U.S. Department of Transportation Pipeline and Hazardous Materials Safety Administration Attention: PHH-10 East Building 1200 New Jersey Avenue, SE Washington, DC 20590 Request for Interpretation Letter on 49 CFR § 175.1 O(a)(18) Dear Sir/Madam: I am writing to request a formal interpretation letter on the exceptions in the hazardous materials regulations (HMR) found at 49 CFR § 175.1 O(a)(18). This provision applies to passengers or crewmembers when they carry aboard the aircraft for personal use "portable electronic devices (e.g., watches, calculating machines, cameras, cellular phones, laptop and notebook computers, camcorders, medical devices etc.) containing dry cells or dry batteries (including lithium cells or batteries) and spare dry cells or batteries for these devices." (Emphasis added.) Teleflex is a manufacturer of two small, life-saving medical devices known as the EZ-10 lntraosseous Infusion system and the OnControl Driver system used in the delivery of fluids and medications to patients in the pre-hospital and hospital environments. These devices are powered by a small lithium metal battery that contains less than 2 grams of lithium metal content. The battery has been tested to meet the UN Manual of Tests and Criteria, Part Ill, Sub-section 38.3. Representatives from Teleflex intend to carry these devices aboard the aircraft for personal use when traveling to give demonstrations at medical facilities and promotional shows. The devices will be placed in customized carrying cases that will protect them from being damaged and inadvertent activation. We note that your office issued a letter to Arie Tillberg with Morpho Detection on March 3, 2016 (Ref. No. 15-0202) confirming that a small lithium ion battery may be carried aboard the aircraft by a Morpho Detection employee who is traveling to show the battery "for demonstrations and [at] promotional shows." The Teleflex situation is nearly identical to the one described in your March 3rct letter to Mr. Tillberg except that it addressed a lithium ion battery rather than a lithium metal battery-powered device. Therefore, we request confirmation that the EZ-10 lntraosseous Infusion system and the OnControl Driver system with a small lithium metal battery may be transported in carry-on baggage on passenger aircraft by Teleflex employees for the purpose of demonstrations and promotional shows. Thank you for your assistance. I can be reached 919.433.4806 if you have any questions regarding this issue. Sincerely, Jay White President and General Manager Vascular#

Page 3Dodd, Alice (PHMSA) From: Sent: To: Subject: Attachments: INFOCNTR (PHMSA) Monday, December 19, 2016 4:20 PM Hazmat Interps FW: Request for Interpretation Letter on 49 CFR § 175.10(a)(18) Jay White- Teleflex_Request_for_ DOT _Interp_ Letter 12 19 16-signed.pdf Hi Shante/ Alice, Please submit this as a letter of interpretation. Please let me know if you have any questions. Thanks, Jordan From: Howington, Kim [mailto:Kim.Howington@teleflex.com] Sent: Monday, December 19, 2016 10:01 AM To: PHMSA HM lnfoCenter <PHMSAHMlnfoCenter@dot.gov> Cc: gkerchner wileyrein .com <gkerchner@wileyrein.com>; Ball, Michael <Michael.Ball@teleflex.com>; White, Jay <jay.white@teleflex.com> Subject: Request for Interpretation Letter on 49 CFR § 175.10(a)(18) Dear Sir/Madam: Please see attached request for Interpretation Letter on 49 CFR § 175.10(a)(18}. Kindly confirm receipt, Kim Howington Executive Assistant to Jay White, President Vascular Division P: +1 .919.433.4818 ext. 68.4818 E: kim.howington@teleflex.com Teleflex 3015 Carrington Mill Blvd ., 6N, Morrisville, NC 27560 teleflex.com This e-mail message, including any attachment(s), is for the sole use of the intended recipient(s) and may contain confidential, proprietary and/or privileged information. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please notify the sender by reply e-mail and delete, and/or otherwise destroy, all copies of the original message, including any attachment(s).#