Mandatory Medical Device Act Reporting Training Mandatory Medical Device Act Reporting TrainingClick here to download the Training document. After reading the document, please begin the test below:Staff Name* First Last Staff Email* Mandatory Medical Device Act Reporting Training Test1. What year was the final medical device reporting rule published?a. 1989b. 1990c. 1995d. 20102. The US Food and Drug Administration (FDA) is responsible for:a. Protecting public safetyb. Security of human and veterinary drugsc. Helping the public receive accurate, timely science-based health informationd. All the above3. The FDA monitors:a. Driver’s speedb. Medical device reportingc. Furnitured. Insects4. Adverse medical device events can be the result of:a. User errorb. Lack of cost controlc. Poor planningd. Weather conditions5. The most important fact that led to the development of the Medical Device Reporting Act was:a. The under reporting of medical device problemsb. Understaffingc. There were too many devices July 2016d. The FDA wanted to create a new department6. A death from a medical device must be reported within 10 working days to:a. Only the manufacturerb. Only to the FDAc. Both the FDA and manufacturerd. The local authorities7. A serious injury from a medical device is required to be reported within 10 working days to:a. Only the manufacturer unless unknown, then to the FDAb. Only to the FDAc. The Department of Stated. All of the above8. Clients may expect their client records are always be treated as confidential.a. Selling the product overseasb. Criminal and civil penaltiesc. Prohibiting sale of the productd. Changing the design9. It is ok to speak about my client to a friend if I whisper and no one else is around.a. Malnutritionb. Correct labelingc. Too many activitiesd. User error10. Clients do not have to be made aware of changes in their Service Plan.a. There are more medical devices used in the home than ever beforeb. Home healthcare professionals can identify problem medical devices used in the homec. Home healthcare workers have policies and procedures for MDR reporting and can follow-up on reporting requirementsd. All of the above
