What are the causes of adverse events in medical devices?

Release time:

2024-08-30

The causes of adverse events in medical devices are very complex

What are the causes of adverse events in medical devices?

The causes of adverse events in medical devices are very complex, including design defects inherent in product risks, device performance and functional failures or damages, errors in product user manuals, limitations in pre-market research and development, etc. Among them, adverse events caused by design defects account for about 14% of the incidence of device adverse events. Due to various factors, some design flaws in medical devices can only be discovered after being used clinically and undergoing long-term validation.