According to Drs @paull_douglas, MS, & Paul N. Uhlig, MPA, checklists can help risk managers facilitate critical conversations and decision-making about whether to implant devices with no extant risk profile: https://t.co/eKIJi3CTPt
Risk managers have critical roles in helping address decisions that patients and care teams must make about whether, when, and how to implant novel, untested devices: https://t.co/6U7CRKZMtK
"A clinical team & organization have an ethical obligation to discuss arranging for postimplantation surveillance to capture safety issues that become apparent through patient-subjects’ living with the device." Drs @paull_douglas, MS, & Paul N. Uhl
Devices deemed “substantially equivalent” to existing approved devices can be brought to market without clinical trials prior to first human use if approved through the FDA’s 510k exemption process, despite being supported by only a limited amount of data: