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 Printable version |
Evolution of medical examination gloves’ quality from 2001 to 2008: should laboratory tests be maintained? |
Journal de Pharmacie Clinique. Volume 28, Number 4, 189-92, octobre-novembre-décembre 2009, Article original
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 Résumé
Texte intégral
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Author(s) : M Guerrier, J Auchere, J Vernois, D Goeury, C Duhamel |
Summary : Examination gloves are an essential medical device in the hospital. Upon renewal of public contracts to the AP-HP, Hospital Tests Laboratory (LEH) carries out a systematic assessment (records, breakage, leakage, size measurements) to ensure compliance of the selected supplier. This study followed the evolution of examination gloves quality from 2001 to 2008. The standard NF EN 455 on medical gloves is used. The number of non-compliance has increased from 25% to 38% of the reference of gloves tested from 2001 to 2008. It is more important for examination latex gloves (75% of non-conformities in 2008). This study shows a significant decline in the quality of examination gloves, especially latex. The consequences of micro-holes can be of accidental exposure of personnel. This general decline in quality may be explained by more expensive raw materials (natural rubber latex) and transport (oil). To reduce costs, suppliers have changed the formularization which influences the technical characteristics. Users have several options. The first step seems to increase the quality monitoring either internally or through hospitals groups or supervision by an independent laboratory. Secondly, it seems important to educate users to report incidents during utilization. Finally, given the weakness of the CE class I why not take up the examination glove Class IIa as surgical glove which controlled under the same conditions, shows no non-compliance. In conclusion, this study has highlighted the importance of assessing the gloves technical properties. The examination glove is a commonplace DM, regarded as uncritical although a potential agent of transmission of infectious agent from its increasing use in care services. |
Keywords : examination gloves, quality control, medical device class I |
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