More Focus is Needed to Reduce Adverse Events for Diabetes Devices.

Area of Science:

• Medical device safety
• Diabetes technology
• Patient adverse events

Background:

• Diabetes device advancements have led to improvements in patient care.
• However, a significant increase in reported adverse events has been observed.
• The complexity of identifying and analyzing these events presents a considerable challenge.

Purpose of the Study:

• To highlight the escalating issue of adverse events associated with diabetes devices.
• To draw attention to the difficulties in accessing and interpreting FDA adverse event data.
• To encourage a greater focus on mitigating these safety concerns.

Main Methods:

• This commentary reviews trends in adverse event reporting for diabetes devices.
• It discusses the limitations of current data access tools, specifically the FDA website's query functionality.
• It considers potential contributing factors to the rise in adverse events, including user error.

Main Results:

• Adverse events related to diabetes devices nearly doubled between 2018 and 2019.
• The FDA's adverse event reporting system is difficult to navigate, impeding thorough examination.
• User error is identified as a common factor contributing to adverse events.

Conclusions:

• There is an urgent need to increase awareness and address the rising number of adverse events in diabetes devices.
• Improvements in data accessibility and user-centered design are crucial for effective safety monitoring.
• Further research and intervention strategies are required to reduce the incidence of these adverse events.