Patients: Pre-Clinical Testing

Smith+Nephew is required by law to test its new medical device products to demonstrate that they are safe and effective before they are used with patients.

Whenever possible, Smith+Nephew gains assurance of safety and efficacy from non-animal evaluation methods only. We also prioritise the use of known safe ingredients and materials that require no further testing. However, in certain instances, Government regulations require in-vivo testing to be conducted as part of the product approval process.

Smith+Nephew has for many years adopted a strong ethical policy on in-vivo testing. We follow the internationally recognised principles of the 3Rs (Replacement, Reduction and Refinement) to minimise the use of in-vivo tests. Tests are only performed once all appropriate alternative evaluation methods have demonstrated sufficient confidence in the products to be evaluated.

Smith+Nephew works with academic partners and contract research organisations that have earned Association for Assessment and Accreditation of Laboratory Animal Care (“AAALAC”) accreditation, demonstrating their commitment to responsible animal care and use. We audit suppliers to ensure they comply with applicable laws and regulations. We follow Good Laboratory Practice for Nonclinical Laboratory Studies (GLP) Regulations published by the US Food and Drug Administration (“FDA”) as well as the OECD Principles on GLP.

Smith+Nephew also supports external groups dedicated to identifying alternative non-animal methods of testing including the Fund for the Replacement of Animals in Medical Experiments (“FRAME”).