Establishing tolerable limits for a potential wound dressing leachable, with subsequent risk assessment

Client

A medical technology company.

Background

It was established that a particular chemical may leach from a manufactured wound dressing to come into contact with the wound sites or intact skin of patients, and subsequently be absorbed.

Project Goals

The toxicologists at bibra were asked to identify or propose conservative safe/tolerable exposure limits for exposure to the chemical, and to assess the potential risks its release might pose to the health of patients.

Approach

Bibra used existing toxicity data and Expert Group assessments to derive health-precautionary values for tolerable exposure (acute and repeated dose, systemic and local toxicity). In addition, worst-case exposures were calculated for patients of different age groups, and were compared to these calculated tolerable exposure levels, and to industry derived no-effect levels (DNELs), to determine the potential risks of local or systemic toxic effects.

Project Outcome

Bibra successfully completed the report, concluding that the anticipated release of the compound from the dressing is not expected to result in significant systemic or local effects in patients.

Project Team

Beth O’Connell
Pete Watts

 

Medical devices

More recent work Info about us Meet our team