The Global Harmonization Task Force’s (GHTF) has issued guidance establishing a uniform, global system for adverse event reporting during pre-market clinical investigations of medical devices.
The GHTF’s proposed model, devised by the organization’s Study Group 5 (SG 5), identifies types of adverse events stemming from clinical investigations that sponsors should report to National Competent Authorities. The SG 5 recommends that all participating countries should align their pre-market adverse event reporting requirements with the new GHTF model as they amend or develop their own regulatory systems.
Events that the GHTF guidance contends must be reported include all serious health threats, as well as device deficiencies that could cause serious adverse events. In questionable instances, sponsors should err on the side of caution and report to their appropriate authorities.
In terms of reporting timelines, the GHTF recommends that any adverse event posing a serious health threat be reported to a National Competent Authority within 48 hours. Within 10 days, sponsors should report unanticipated serious adverse device effects as well as serious adverse events resulting in death or serious injury. Finally, the GHTF recommends a 30-day deadline for reporting adverse events resulting in hospitalization or surgery, as well as device deficiencies that could have caused serious adverse events had they not been corrected or accounted for in time.
