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ILAPHAR | Revista de la OFIL

ILAPHAR | Revista de la OFIL

Revista de la Organización de Farmacéuticos | Ibero-latinoamericanos | Ibero Latin American Journal of Health System Pharmacy

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Is it necessary for medical devices to include latex content in their labeling?

Rev. OFIL 2017, 27;4:353-373

Fecha de recepción: 10/03/2017  –  Fecha de aceptación: 01/08/2017

Zamora-Gimeno MJ, Merenciano-Villodre C, Belenguer-Cebrian MP

Servicio de Farmacia. Hospital Virgen del Consuelo. Valencia (España)

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Correspondencia:

Mª Jesús Zamora Gimeno

Hospital NISA Virgen del Consuelo

C/Callosa d’En Sarrià, 12

46007 Valencia

Correo electrónico: mariajesus.zamora.gimeno@hospitales.nisa.es

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SUMMARY

Objective: To analyze the latex content of medical devices (MD) that are adquired through the Pharmacy Service and to classify them according to the presence or absence of latex under its composition.

Material and methods: A data collection sheet was elaborated with the following items: MD’s description and reference, supplier, latex content, and presence information on the labeling. There was reviewed the packaging of all MD included in the Pharmacy Department, and it was requested to every supplier, by phone or by e-mail, written information (“free-latex” certificated or failing that, the data sheet) about the content in latex of its MD if the information was not present on the labeling.

Results: There were reviewed 1,101 references of MD provided by 150 suppliers. 4.45% (49) of the reviewed references contained latex in their composition and only 20% (220) of the total of products indicated the presence or absence of latex in their labeling.

Conclusions: The knowledge of the latex content of MD by the multidisciplinary team that attends the patient has contributed to increase the safety of the patient and the health personnel. In addition, the present study has revealed the scarce information on the latex content specified in the labeling of MD, which implies the need for more stringent regulation by the Health Authorities at the time of authorization and placing on the market of the MD in order to avoid errors in patients allergic to it.

Key Words: Latex allergy, medical devices, latex, hypersensitivity, health personnel, patient.

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Download PDF:  ¿Es necesario que los productos sanitarios incluyan en su etiquetado el contenido en látex?

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ISSN Edición impresa: 1131-9429
ISSN Edición electrónica: 1699-714X

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