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Interpretation Response #14-0080 ([Discovery Laboratories, Inc] [Ms. Louise J. Calabretta])

Below is the interpretation response detail and a list of regulations sections applicable to this response.

Interpretation Response Details

Response Publish Date:

Company Name: Discovery Laboratories, Inc

Individual Name: Ms. Louise J. Calabretta

Location State: PA Country: US

View the Interpretation Document

Response text:

September 23, 2014

Ms. Louise J. Calabretta
Director, Project Management
Discovery Laboratories, Inc.
2600 Kelly Road
Suite 100
Warrington, PA   18976-3622

Ref. No. 14-0080

Dear Ms. Calabretta:

This responds to your April 7, 2014 request for clarification on applicability of the Hazardous Materials Regulations (HMR; 49 CFR parts 171-180) for the transportation of used medical device heating units.   Specifically, you ask if shipments of used medical device heating units from a hospital or medical facility back to your laboratory would meet the definition of a “used health care product” under § 173.134(a)(8).

In your letter you indicate your company has developed a medical device heating unit, called a WARMING CRADLE®, to warm glass vials containing a drug used to prevent respiratory distress syndrome (RDS) in premature infants at high risk for developing RDS.  You indicate that the WARMING CRADLE® would most likely be stored in the Neonatal Intensive Care Unit of a hospital or medical facility and that, on occasion, the hospital or medical facility may wish to return used WARMING CRADLES®.  

You indicate that it is your understanding that the WARMING CRADLE® is classified as a Division 6.2, Category B material, and meets the definition of a “used health care product,” as you assume there is the potential, although minimal, that pathogens would be present on the device following the intended use.  You also noted in a follow-up communication with a member of my staff that: (1) you are not aware of contamination by any specific pathogen (whether Category A or B); and (2) you assume that hospitals and medical facilities are adhering to occupational Safety and Health Administration (OSHA) standard 29 CFR 1910.1030 to clean and disinfect surfaces after contact with blood or other potentially infectious materials

Section 173.22 states that it is the shipper’s responsibility to classify a hazardous material.  This office does not perform that function.  Based on your incoming letter, we would agree a used WARMING CANDLE® would be considered a used health care product as defined in
§ 173.134(a)(8) and be subject to the HMR.  However, based on your follow-up communication, if there is no pathogen present or if a hospital or medical facility is complying with 29 CFR 1910.1030, then the device is not regulated as an infectious substance

under the HMR.  Furthermore, if there is a pathogen present and/or there is no adherence to 29 CFR 1910.1030, then a used health care product may be excepted from the HMR as an infectious substance by complying with one of two options under § 173.134(b)(12): (1) comply with OSHA 29 CFR 1910.1030 (note this option does not apply to transport for disposal purposes); or (2) comply with the packaging requirements of § 173.134(b)(12)(ii) (note this option applies to used health care products returned to the manufacturer and does not apply to transport of a Category A substance).

I hope this answers your inquiry. If you need additional assistance, please contact this office at 202-366-8553.

Sincerely,

Robert Benedict
Chief, Standards Development Branch
Standards and Rulemaking Division

173.134(a)(8), 173.22, 173.134(a)(8), 173.134(b)(12): (1), 173.134(b)(12)(ii)

Regulation Sections

Section Subject
173.134 Class 6, Division 6.2-Definitions and exceptions
173.134 Class 6, Division 6.2-Definitions and exceptions
173.134 Class 6, Division 6.2-Definitions and exceptions
173.134 Class 6, Division 6.2-Definitions and exceptions
173.22 Shipper's responsibility