Biological risk assessment of a new size of medical device

Client

An international manufacturer of wound care products.

Background

The client, who markets a wound dressing with existing EU and US FDA approval for long-term (>30 days), has since manufactured a larger-sized, but otherwise identical, variant of this product.

Project goals

According to ISO 10993-1 guidelines, any change to the medical device warrants a revaluation of the biocompatibility of the device. Bibra was therefore asked to assess the biocompatibility of this larger dressing in accordance with ISO 10993-1:2018.

Approach

An initial assessment of the dressing’s biocompatibility was carried out utilising data generated by the client on the smaller dressings, or their extracts. Critically, an ISO 10993-17 toxicological health risk assessment was carried using the chemical characterisation data of the smaller dressings. By considering a worst-case patient treatment scenario, and by extrapolating these data to account for the larger dressing size, exposures to these chemical components were estimated. For each constituent, health risks were discussed with respect to the estimated patient exposures.

Project outcome

The wound dressing showed excellent biocompatibility, and the toxicological risk assessment demonstrated that treatment with the new larger dressing was highly unlikely to result in any significant adverse health effects.

Bibra project team

Charles Johnson
Pete Watts

 

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