How Should Risk Managers Respond to Cases for Which No Risk Profile Exists?

Area of Science:

• Medical Device Innovation
• Risk Management in Healthcare
• Patient Safety

Background:

• Medical devices are increasingly available for implantation before comprehensive preclinical trials.
• This gap necessitates robust risk management strategies for novel devices.

Purpose of the Study:

• To provide risk managers with information for informed decision-making regarding new device implantation.
• To guide patient-subjects and clinician-researchers in the absence of extensive preclinical data.

Main Methods:

• Review of existing information relevant to risk management for novel medical devices.
• Emphasis on incorporating patient preferences, surgical team experience, and conflict of interest disclosure.
• Utilization of checklists to facilitate critical conversations and decision-making processes.

Main Results:

• Novel devices present unknowns and potential risks, including procedural complications.
• Informed consent processes must be enhanced to include patient-specific factors and post-procedure planning.
• Risk managers play a crucial role in navigating decisions for devices lacking a risk profile.

Conclusions:

• Risk managers should treat novel devices as sources of uncertainty.
• Comprehensive risk-benefit analyses and informed consent are vital for patient safety.
• Checklists can support structured decision-making for implanting new medical devices.