Medical Device Reporting Training Medical Device Reporting TrainingClick here to download the Training document. After reading the document, please begin the test below:Staff Name* First Last Staff Email* Medical Device Reporting Training Test1. What year was the final medical device reporting rule published?19891990199520102. The US Food and Drug Administration (FDA) is responsible for:Protecting public safetySecurity of human and veterinary drugsHelping the public receive accurate, timely science-based health informationAll the above3. The FDA monitors:Driver’s speedMedical device reportingFurnitureInsects4. Adverse medical device events can be the result of:User errorLack of cost controlPoor planningWeather conditions5. The most important fact that led to the development of the Medical Device Reporting Act was:The under reporting of medical device problemsUnderstaffingThere were too many devicesThe FDA wanted to create a new department6. A death from a medical device must be reported within 10 working days to:Only the manufacturerOnly to the FDABoth the FDA and manufacturerThe local authorities7. A serious injury from a medical device is required to be reported within 10 working days to:Only the manufacturer unless unknown, then to the FDAOnly to the FDAThe Department of StateAll of the above8.Lack of MDR compliance by the user or manufacturer can lead to:Selling the product overseasCriminal and civil penaltiesProhibiting sale of the productChanging the design9. A device may contribute to a patient/client’s death or serious injury because of:MalnutritionCorrect labelingToo many activitiesUser error10. Home healthcare employees have an important role in the MDR Act because:There are more medical devices used in the home than ever beforeHome healthcare professionals can identify problem medical devices used in the homeHome healthcare workers have policies and procedures for MDR reporting and can follow-up on reporting requirementsAll of the above
