Evaluation of a Novel Medical Device by Simulating Strangulation Hazards

Abstract

There are reports in the literature of children dying in hospital by strangulation or asphyxia via tubing and monitor wires. The population at risk has been identified as infants from the age of 6 months to 36 months and children who are cognitively or developmentally impaired.

BC Children’s Hospital (BCCH) engaged BCIT to develop a solution to this problem. Working with BCCH nurses, BCIT developed the Infant Safety Vest (Vest) an anti-entanglement device and built sufficient number of prototypes for testing in the Living Lab.

This project aimed to test the effectiveness and safety of the Vest via human factors testing in a simulated hospital environment prior to initiating the evaluation in actual hospital settings. The Vest was to be evaluated by a representative sample of infant children and users to establish its effectiveness and safety in a laboratory environment which was set up to simulate a hospital room and a play area.

The primary design objective had been to develop a product that reduces the risk of strangulation. The study shows that the frequency of all entanglement around all parts of the body was reduced by 66% when the Vest was used. The frequency of neck and above-arm entanglement (which leads to risk of strangulation) was reduced by 71% when the Vest was used. In the crib setting, the frequency of neck and above arm entanglement was reduced by 88% when the Vest was used. It is not known whether similar results would be obtained in the clinical setting.

The study findings with respect to key design requirements will be presented.