Certification Board for Sterile Processing and Distribution (CBSPD) Sterile Processing Technician Practice Exam

The Medical Device Reporting regulation mandates what requirement from healthcare facilities?

1. Report on device cost effectiveness

2. Report deaths or serious injuries from medical devices

3. Report device usage statistics

4. Report staff training effectiveness

The correct answer is: Report deaths or serious injuries from medical devices

The Medical Device Reporting regulation specifically requires healthcare facilities to report any deaths or serious injuries that occur as a result of medical devices. This regulation is in place to ensure that any potential safety issues or adverse events associated with medical devices are documented and communicated to the appropriate regulatory bodies. The objective is to monitor the safety and effectiveness of medical devices and take necessary actions to protect patient health. In the context of this regulation, options that focus on cost-effectiveness, usage statistics, or training effectiveness do not fall under the requirements mandated by the Medical Device Reporting regulation. These aspects, while important in their own right, do not relate directly to the reporting of serious incidents that can have implications for patient safety or device performance.