I have carefully reviewed the corrective action plan for Crib Cuddle which was jointly submitted to the Commission by Product Source, Inc. (which distributed the product from May 1982 to May 1983 under the brand name "Infacare") and Century Products, Inc. (which distributed the product from June 1983 until distribution of the original version of the product ceased in December 1984). In addition, I have reviewed other information provided by staff, including human factors analyses of the original and redesigned versions of the Crib Cuddle.
The Crib Cuddle came to the attention of the Commission almost a year ago (June 1984) when the staff learned of the death of a 5-week old infant in one of the products due to positional asphyxia. Subsequently, the Commission learned of two "near -misses" involving Crib Cuddles.
Following investigation of these incidents and analysis of the product, the staff preliminarily determined that Crib Cuddles (original design) present a substantial risk of injury to infants. Source, an agreement was reached that the firms would initiate a joint recall of the product and undertake a combined corrective action Program. (It should be noted that the firms have already, on their own initiative, begun implementation of certain activities outlined in the remedial program.) in addition; Century submitted two prototypes of new Crib Cuddle designs to the commission for evaluation.
The Crib Cuddle (original design) is a hammock-style device in Which an infant can be placed for sleeping. Its distributors recommend its use with infants from birth to three months of age. The hammock attaches to the side rails of a crib by six adjustable soaps, three on each side. The product also includes a plastic heart-shaped box containing a battery-operated! Mechanism which emits a pulsating sound and vibration. The heart-shaped box is inserted into a soft pad which is sewn on the hammock.
According to the instruction, when the Crib Cuddle is installed, the crib mattress should be raised to its highest position so that a flat base is created on which the baby can lie.
The staff has conducted a limited assessment of the new Crib Cuddle; however, at this time, they are unable to provide evidence which confirms the safety of the new design or its performance in actual use situations. Century Products has commissioned Brown University to conduct necessary safety tests. These tests are intended to provide more extensive information concerning infant-product interaction and will evaluate the performance of the product in more naturalistic circumstances.
While the corrective action plan proposed by Century Products and Product Source includes many elements, which I believe will provide adequate notice, admonitions, and guidance to the public concerning the risks associated with the original Crib Cuddle, I do not agree with the Commission staff's recommendation that the commission approve the corrective action plan and press release in the absence of data and other information which verifies that the hazards associated with the original Crib Cuddle are truly eliminated by there designed version. Because the corrective action plan will also effectuate a recall process which involves the replacement of the old version of the product with the redesigned version, approval of the plan in its present form, in my view, is tantamount to the approval of the redesigned Crib Cuddle, and, thereby, conveys to consumers the . mistaken impression that our (limited)'evaluation of the new Crib Cuddle has confirmed the product's safety.
Given the very unique nature of the product and the extreme vulnerability of the population at risk, I believe that the Commission should proceed with caution and take the necessary time and action to make reasonable determination, based on testing data now being developed, that the "new and improved" Crib Cuddle does not present a risk of injury to infants. In the absence of test results validating the efficacy and safety of the redesigned product, it is, in my view, premature at best to certify a plan which places in the hands of consumers a product which has not been fully tested and information which conveys the impression that the new Crib Cuddle is safe for infants. Therefore, in this context, I am voting not to approve the corrective action plan or press release for Crib Cuddle.