Biocompatibility and toxicological risk assessment of a “permanent” medical device

Background

The client, who markets a wound dressing with existing EU approval for ‘prolonged’ use (24 hours – 30 days), wished to extend the approval to cover >30 days use. According to ISO 10993-1 guidelines, the wound dressing would then be classified as a ‘surface device’ in contact with ‘breached or compromised skin’ for a ‘permanent duration’.

Client

An international manufacturer of wound care products.

Project goals

Bibra was asked to assess the biocompatibility of the dressing for ‘permanent’ use, following the recently updated ISO 10993-1 guidelines. This involved an assessment of endpoints including cytotoxicity, skin irritation, skin sensitisation, acute systemic toxicity, material-mediated pyrogenicity, subacute/subchronic systemic toxicity, genotoxicity, carcinogenicity and implantation effects.

Approach

An assessment of the dressing’s biocompatibility was carried out according to ISO 10993, Council Directive 93/42/EEC and US FDA guidelines utilising data generated by the client. In addition, a toxicological health risk assessment was carried out in compliance with ISO 10993-17 on the key identified organic and elemental extractables from the dressing. Tolerable exposures to key extractables were calculated from existing toxicity data (typically using NOAELs from key studies) for men, women, children and neonates and were compared against a worst-case exposure scenario.

Project outcome

The wound dressing showed excellent biocompatibility, and the toxicological risk assessment determined there were reassuring margins between the tolerable exposures (or other reliable health benchmarks) and the estimated extractable exposures.

Bibra project team

Pete Watts

James Hopkins

Charlie Johnson

 

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