Which of the following incidents should be reported under SMDA?

Reporting requirements under the Safe Medical Devices Act (SMDA) emphasize the need to ensure patient safety and device reliability. Serious injuries or illnesses caused by medical devices are critical incidents that fall under mandatory reporting due to the potential implications for patient health and safety. This includes any event that results in significant negative health effects, hospitalization, or increased risk of death, highlighting the regulatory focus on serious consequences stemming from medical device use.

The rationale behind prioritizing these types of incidents for reporting is that they can indicate device defects or failures that may affect many patients. By collecting and analyzing data on serious incidents, regulators can initiate investigations, implement corrective actions, and promote improvements in device design and manufacturing processes. This proactive approach contributes to the overall enhancement of medical device safety and efficacy in healthcare settings.

While other incidents, such as minor injuries, loss of property, or malfunctions without injury, may be important for tracking and monitoring device performance, they do not carry the same level of urgency or risk related to patient safety. Hence, they are typically not mandated for reporting under SMDA.