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Mechanical safety of pacifiers sold in Portuguese pharmacies and childcare stores

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Mechanical safety of pacifiers sold in Portuguese pharmacies and childcare stores

Juliana Carneiro

1

, Ana I. Oliveira

1,2

, Cláudia Pinho

1,2

, Cristina Couto

1,3

, Rita F. Oliveira

1,2

, Fernando Moreira

1,4

1 Escola Superior de Tecnologia da Saúde do Porto, Instituto Politécnico do Porto, Vila Nova de Gaia, 4400-330 Vila Nova de Gaia, Portugal;

2 Centro de Investigação em Saúde e Ambiente, Instituto Politécnico do Porto, Vila Nova de Gaia, 4400-330 Vila Nova de Gaia, Portugal;

3 Serviços farmacêuticos, Hospital Pedro Hispano, Unidade Local de Saúde de Matosinhos, EPE, 4454 509 Senhora da Hora, Portugal;

4 Department of Legal Medicine and Forensic Sciences, Faculty of Medicine, University of Porto, 4200-319 Porto, Portugal & Pharmaceutical Services, Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE, Vila Nova de Gaia, 4400-129 Vila Nova de Gaia, Portugal

Correspondence: Fernando Moreira (ffm@estsp.ipp.pt) – Department of Legal Medicine and Forensic Sciences, Faculty of Medicine, University of Porto, 4200-319 Porto, Portugal &

Pharmaceutical Services, Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE, Vila Nova de Gaia, 4400-129 Vila Nova de Gaia, Portugal

Potential dangers that arise from the use of pacifiers by children have been reported for the past few decades. The repeated cases of injuries and even fatalities possibly due to poorly designed pacifiers justified the elaboration of guidelines that ensured the mechanical safety of those devices in United States of America, Brazil and European Union.

This experimental study is the first one to describe the submission of a group of pacifiers sold in a European country to a group of tests and determinations that enable the evaluation of its mechanical safety, after EN1400 came into force. Adopted methods included determinations of nipple resistance, total size of the device, presence and size of ventilation holes, performance of a swallowing risk test and label analysis.

All 13 samples were bought in pharmacies and childcare stores in the north of Portugal and

belonged to five different brands. The obtained results revealed that all analysed samples

presented the minimum required ventilation holes with adequate sizes and correct

placement. Also all samples proved to have nipples with adequate resistance to stretch and

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never exceeded the maximum permitted size. None of the samples went by the polytetrafluoroethylene (PTFE) device that mimicked the mouth of a child. It is quite clear that pacifiers sold in Portuguese pharmacies and childcare stores present high standards of mechanical security, probably owing to the implementation of EN1400. However, it would be important to perform similar tests on pacifiers sold in internet websites.

Keywords Toddlers, EN1400, asphyxiation prevention

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