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Interpretation ID: Merritt_letter

    Mr. J. Shayne Merritt
    Director, Automotive Safety Program
    Riley Hospital for Children
    575 West Drive, Room 004
    Indianapolis, IN 46202


    Dear Mr. Merritt:

    This responds to your letter asking for permission to use a Britax Two-Way Plus child restraint, a Swedish car seat that is sold in Europe, in the United States for a patient with unique healthcare needs.

    In your letter, you state that the patient is a 3-year-old who weighs over 35 pounds (lb), with a diagnosis of Pentalogy of Cantrell. You explain that this condition is a very rare disorder that is characterized by the absence of a sternum and accompanying ribs, resulting in the patients heart and lungs being completely unprotected. The medical staff at Riley Hospital has determined that she must continue to ride rear-facing until after her surgery next year.The child has reached the maximum weight of the rear-facing convertible seat she is currently using. You state that the child fits a Britax Two-Way Plus seat that will allow her to ride rear-facing until she reaches the design limits of the restraint.

    Please note that the use of child restraints, the specific subject of your letter, is governed by State law. Thus, your request for permission to use the Two-Way Plus for this patient should be addressed to state officials. However, the importation of child restraints into this country is governed by Federal law and is within the responsibility of this agency. This letter provides assistance in obtaining the child restraint for your patient.

    By way of background, we are authorized (46 U.S.C. 30101 et seq.)(the Safety Act) to issue Federal motor vehicle safety standards that establish performance requirements for new motor vehicles and items of motor vehicle equipment. We have used this authority to issue Federal Motor Vehicle Safety Standard (Standard) No. 213, Child Restraint Systems (49 CFR 571.213). Child restraint systems must conform to Standard No. 213 to be sold in this country. It is our understanding that the Two-Way Plus does not meet Standard No. 213 because, among other things, it cannot meet the standards performance requirements when attached to the vehicle seat with the seat belt alone. The restraint needs to lean against the vehicles dashboard when used with an older child (when installed at the front passenger seating position) or against the backs of the two front seats (when installed in a rear seating position). When a requirement is specified in a Federal safety standard, the Safety Act prohibits any person from manufacturing, selling, or importing a new product that does not comply with that requirement. The Safety Act does not explicitly provide for individual medical exemptions from that prohibition.

    However, we believe that flexibility is called for to accommodate the special medical condition of your patient. We will not institute enforcement proceedings against the person bringing a Two-Way Plus into this country for the child, subject to the following caveats.

    We understand that the instructions for the Two-Way Plus indicate that the restraint must always contact the dashboard when used rear-facing in the front seat. A rear-facing child restraint must not be used in a front passenger seat if there is a passenger-side air bag. A deploying air bag impacting the back of the child restraint could subject the child to severe or fatal head or neck injuries. Thus, if an air bag is present in the front position, it is imperative that the rear-facing restraint be used in a rear seat. The restraint must have a prominent warning, of the type required by S5.5.2(k)(4) of Standard No. 213, not to use the restraint rear-facing in the front seat with a passenger-side air bag. (If a vehicle does not have a rear seat or has a rear seat that is too small to accommodate the installation of a rear-facing child restraint system, the vehicle owner may apply for an on-off switch for the passenger air bag. Enclosed is a brochure that provides information about air bag on-off switches and a request form you can fax or mail to our agency to obtain permission for the installation of a switch.)

    In a rear designated seating position, the Two-Way Plus rests against the backs of the front seats, presumably for support against tumbling backwards (relative to the child) in a frontal crash. The manufacturer of the vehicle that the child will be riding in should be consulted to ensure that the vehicle seats would be strong enough to support the child restraint in a crash.

    We also ask that the Two-Way Plus be used only for your patient, and that it not be sold or given away when the child outgrows it. There should also be a label on the restraint that the restraint is not certified as meeting Standard No. 213.

    If we can be of further assistance, please do not hesitate to contact us.

    Sincerely,

    Stephen P. Wood
    Acting Chief Counsel

    Enclosure
    ref:213
    d.4/24/06