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

Rapid innovation makes some devices available for patient implantation prior to extensive preclinical trials. This article reviews information that risk managers can utilize to help patient-subjects and clinician-researchers make informed decisions about new device implantation in the absence of preclinical trial data. Novel devices should be regarded by risk managers as sources of unknowns with potential for procedural complications and other harms. Risk-benefit analyses during informed consent should include patient-subjects' preferences, experience of the implanting surgical team, disclosure of conflicts of interest, and postprocedure follow-up planning. Checklists can help risk managers facilitate critical conversations and decision making about whether to implant devices with no extant risk profile.