Medical Device Risk Assessments

Today's parenteral therapeutics are often self-administered utilizing an associated medical device. It is imperative that the clinical benefit-risk assessment incorporate the drug product and the delivery system as an integrated entity:

• Human Factors Considerations – Understanding how the patient or Health Care Provider interacts with the device for safe and effective delivery.

• Failure Mode Assessments – Appropriately characterizing the severity rating associated with the failure mode.

• Residual Risk Assessment – The totality of the potential integrated device risk to patient safety should inform the penultimate Benefit-Risk evaluation.

• Ultimate Benefit-Risk Assessment – Considering the implications of a device failure with the drug product’s pharmacology and the intended patient population.

• Small Parts Safety and Device Safety Labeling – Identifying special hazards associated with device use or storage.