Client

A medical devices manufacturer.

Background

The company had identified a small number of metal contaminants in the silver sulphate component of a wound dressing that might (hypothetically) be leached from the dressing and transfer directly into the patients’ system (blood stream) following application to compromised skin. Specification limits were supplied for the most critical of these elements.

Project goals

Bibra was asked for an independent health risk assessment of the potential exposures at the specification limits.

Approach

Bibra estimated the potential exposures that would result from the supplied specification limits, and assessed whether these hypothetical exposures might pose any significant health risk to patients. Since the critical contaminants have well-studied toxicology profiles, their health risk assessment was based essentially on tolerable exposure values established by Expert Groups.

Bibra project team

Daniel Threlfall

Pete Watts

 

Medical devices

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