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Public Health
Expert opinion

Safety of the use of bisphenol A in medical devices

Final Opinion

Description

WG BPA in medical devices
SCENIHR members: Emanuela Testai, Philippe Hartemann, Eduardo Rodriguez-Farré
SCCS member: Suresh Chandra Rastogi
External experts: Wim De Jong, Juana Bustos, Laurence Castle, Ursula Gundert-Remy, Arne Hensten, Hilde Molvig Kopperud, Nicolás Olea, Aldert Piersma
Contact:SANCO-C2-SCENIHR@ec.europa.eu
On request from: European Commission
Doi: 10.2772/75546
Adopted on: 18 February 2015

Content of the opinion:

This opinion assesses whether the use of bisphenol A in medical devices such as implants, catheters, and dental devices could give reasons for safety concerns, to provide indications on limit values for BPA release from medical devices and to identify any patient group, e.g. infants, pregnant and breastfeeding women who would be particularly at risk.

Several exposure scenarios have been evaluated taking into account the material used, information related to BPA leaching, the duration of a single treatment and the frequency of treatments, giving rise to toxicologically relevant acute, short and long term exposure.

The SCENIHR concludes that risk for adverse effects of BPA may exist when the BPA is directly available for systemic exposure after non-oral exposure routes, especially for neonates in intensive care units, infants undergoing prolonged medical procedures and for dialysis patients. Although the benefit of medical devices has also to be considered, the SCENIHR recommends that, where practicable, medical devices that do not leach BPA should be used. The possibility of replacing BPA in these products should be considered against their efficiency in the treatment, as well as the toxicological profile of the alternative materials.

However, better data on exposure would be beneficial for the refinement of the present risk assessment, to be carried out when new data on exposure via medical devices will be available.

Keywords:

Bisphenol A, risk assessment, safety, medical devices, SCENIHR

Opinion to be cited as:

SCENIHR (Scientific Committee on Emerging and Newly Identified Health Risks), Safety of the use of bisphenol A in medical devices, 18 February 2015.

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