Certified Healthcare Safety Professional (CHSP) Practice Exam

What does the Safe Medical Devices Act require?

1. Annual inspections of medical devices

2. Reporting of injuries and deaths caused by medical devices

3. Certification of medical device manufacturers

4. Prohibition of certain medical devices

The correct answer is: Reporting of injuries and deaths caused by medical devices

The Safe Medical Devices Act requires the reporting of injuries and deaths caused by medical devices. This legislation aims to enhance the safety and effectiveness of medical devices by implementing a system where healthcare facilities and manufacturers are mandated to report adverse events associated with their use. Through this requirement, the act facilitates the identification of potential risks and the monitoring of device performance in real-world settings, fostering greater accountability in the healthcare industry. By emphasizing the importance of tracking these incidents, the legislation helps protect patient safety and informs necessary regulatory actions or recalls when devices are found to compromise health outcomes. The other options pertain to aspects of medical device regulation but do not align specifically with the core requirements outlined in the Safe Medical Devices Act. Annual inspections and certification processes are generally handled under different regulatory frameworks, while prohibitions on devices relate to broader safety and efficacy evaluations rather than injury reporting specifically.