Health risk assessment of extractables – an epidural catheter

Client

The manufacturer of an epidural catheter.

Background

The company had commissioned extractables and headspace analyses on a medical device designed to administer anaesthetic to the epidural space.

Project Goals

Bibra toxicologists were asked to assess whether the extractables might pose any significant health risks to patients.

Approach

Bibra estimated exposures that might result from use of the device, and assessed whether these hypothetical exposures might pose any significant health risk to patients – assuming that the extractables might represent genuine leachables. Appropriate toxicity data was used in the assessment, taking into account the acute nature of the use and the specific exposure route.

Project Outcome

The client was provided with a health risk assessment report that reached a confident conclusion that the extractables would not pose any significant health risks, even if they were to be actual leachables. The report was submitted to the US FDA.

Project Leader

Pete Watts

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• Health risk assessment of extractables – a vial used to store an ocular pharmaceutical