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Interpretation Response #00-0068 ([Guidant Corporation] [Sam H. Lott, Ph.D.])

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

Interpretation Response Details

Response Publish Date:

Company Name: Guidant Corporation

Individual Name: Sam H. Lott, Ph.D.

Location State: TX Country: US

View the Interpretation Document

Response text:

April 18, 2000

Sam H. Lott, Ph.D.                Ref. No. 00-0068
Radiation Safety Officer
Guidant Corporation
8934 Kirby Drive
Houston, Texas 77054

Dear Dr. Lott:

This is in response to your March 1, 2000, letter requesting clarification on the return shipment of a radiotherapy cartridge containing phosphorus-32 encapsulated in a nitinol (nickel-titaniurn) wire under the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180).  Specifically, you ask whether the shipment of the returned cartridge containing the used wire (approximately 35 mCi) qualifies for transport by passenger-carrying aircraft under provisions in §173.448(f) of the HMR.

According to your letter, the radiotherapy containing phosphorus-32 encapsulated in nickel-titanium wire is used in intravascular radiotherapy for prevention of restenosis following interventional procedures such as balloon angioplasty or stenting.  The wire is contained and shielded in a replaceable cartridge that is inserted at the customer site in an afterloader for use.  The system is used for 3-4 wee in patient treatment and then the cartridge containing the used wire is exchanged for another cartridge containing a fresh wire.

Section 173.448(f) provides for the transportation of Class 7 (radioactive) materials by passenger­carrying aircraft if the material is intended for use in, or incident to, research, medical diagnosis or treatment.  It is the opinion of this Office that the return shipment of the cartridge containing the used wire qualifies as material intended for use incident to medical diagnosis or treatment, and may be transported by passenger-carrying aircraft.

I hope this answers your inquiry.

Sincerely,

Delmer F. Billings
Chief, Standards Development
Office of Hazardous Materials Standards

173.448

Regulation Sections

Section Subject
173.448 General transportation requirements