Interpretation ID: nht91-1.24

DATE: January 15, 1991

FROM: Paul Jackson Rice -- Chief Counsel, NHTSA

TO: Michael L. Hayes

TITLE: None

ATTACHMT: Attached to letter dated 7-12-90 from Michael L. Hayes to General Curry, NHTSA; Also attached to letter dated 7-12-90 from Michael L. Hayes to James Gilkey (OCC 5046)

TEXT:

This responds to your letter to NHTSA's enforcement office and to your telephone conversations with Ms. Fujita of my staff, about the application of Safety Standard 213, Child Restraint Systems, to "transport incubators." Your letter and enclosures indicate that "transport incubator" refers to an incubator that is mounted on a collapsible stand with wheels. The incubator is typically used on an ambulance or helicopter to transfer a neonate from one medical facility to another, or between sites within a facility. The issue raised by your letter is whether Standard 213 applies to transport incubators.

We believe the answer is no, because a transport incubator is not an item of "motor vehicle equipment." Our agency has the authority under the National Traffic and Motor Vehicle Safety Act (copy enclosed) to regulate the manufacture and sale of new motor vehicles and items of motor vehicle equipment. Section 102(4) of the Safety Act defines, in relevant part, the term "motor vehicle equipment" as:

any system, part, or component of a motor vehicle as originally manufactured or any similar part or component manufactured or sold for replacement or improvement of such system, part, or component or as any accessory, or addition to the motor vehicle...

According to the manufacturer of the incubator, whom we contacted for information about the product, the incubator is sold to hospitals, and not to vehicle manufacturers for inclusion in new vehicles. Based on this information, a transport incubator is not a "system, part, or component of a motor vehicle as originally manufactured." Since there is no system, part or component similar to the incubator installed in or on a motor vehicle at the time of its delivery to the first purchaser and since there is no such system, part or component which is original equipment, the incubator is not sold as a replacement or improvement of original equipment.

The incubator also does not appear to be an "accessory . . . to the motor vehicle." In determining whether an item of equipment is considered an accessory, NHTSA applies two criteria. The first criterion is whether a substantial portion of the expected use of the item are related to the operation or maintenance of motor vehicles. We determine the expected use by considering product advertising, product labeling, and the type of store that retails the product, as well as available information about the actual use of the product. The second criterion is whether the product is intended to be used principally by ordinary users of motor vehicles. Items normally used by professional vehicle repair and maintenance

personnel would not meet this second criterion. If the product satisfies both criteria, the product is considered to be an "accessory" and thus is subject to the provisions of the Safety Act.

Applying these criteria to the incubator, we are uncertain whether a substantial portion of the exBpected use of the incubator is related to motor vehicle (ambulance) operation. We are unsure because we lack information about the extent of the non-motor vehicle uses of the incubator. However, regardless of our conclusion about the first criterion, we conclude that the incubator does not satisfy the second one (which is directed to the nature of the likely users of the product). The incubator would not be used by ordinary vehicle owners. Instead, the incubator is intended for use by professional medical personnel only. Since at least one of the criteria is not satisfied, the transport incubator is not an accessory.

The Food and Drug Administration has the authority to regulate medical "devices." We suggest that you address your concerns about transport incubators to that agency.

I hope this information is helpful.