Biocompatibility skin irritation sensitisation two medical devices

Client

A medical device manufacturer.

Background

Two devices, intended to be used by children to self-administer a pharmaceutical, required a biocompatibility assessment in accordance with International Organization for Standardization (ISO) 10993 guidance.

Project goals

The toxicologists at bibra were asked to identify and summarise the available literature data on skin irritation and sensitisation potentials of the component materials of the two devices. The ultimate objective was to determine whether new in vivo studies on these endpoints could be waived.

Approach

Bibra performed literature searches on the materials and compounds of each identified component of the two devices to identify existing relevant toxicity data and Expert Group opinions. For some materials, compositional details were confidential but released to bibra under non-disclosure agreements, allowing bibra to independently assess irritation and sensitisation potentials without divulging confidential information. After considering the available data on each component, the toxicologists assessed the potential for the two whole devices to cause skin irritation and sensitisation reactions after the anticipated contact with patients’ skin.

Project outcome

Bibra performed literature searches on the materials and compounds of each identified component of the two devices to identify existing relevant toxicity data and Expert Group opinions. For some materials, compositional details were confidential but released to bibra under non-disclosure agreements, allowing bibra to independently assess irritation and sensitisation potentials without divulging confidential information. After considering the available data on each component, the toxicologists assessed the potential for the two whole devices to cause skin irritation and sensitisation reactions after the anticipated contact with patients’ skin.

Bibra project team

Charlie Johnson

Pete Watts

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