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Abstract

The tools of risk assessment are now applied in the regulation of most classes of commercially produced chemicals, and there appear to be good reasons to apply the technique to potentially hazardous chemical constituents of medical devices. If it is to be applied, several sets of issues and data requirements almost unique to device constituents risk assessment need to be explored. Most important of these are the issues of inter-route extrapolation and assessment of human exposure to device constituents. An example of the latter problem, involving residues of the device sterilant ethylene oxide, is provided to reveal the types of data needed to assess human exposure to device constituents. It also reveals the type of device usage database that has been developed to assist exposure assessment. Several suggestions for dealing with data gaps in all types of device risk assessment are provided.

References

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Data Requirements for Assessment of Device Risks

Abstract

References