Medical Device Risk Assessments
Today more than ever parenteral therapeutics are 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 interact with the device.
- FMEA Assessments – appropriately characterizing the severity rating associated with the failure mode.
- Residual Risk Assessment – The totality of the potential 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.
Assessing and mitigating device-related risks early in development is critical to facilitate successful clinical application.