Welcome to your Medical Device In-Service A medical device is a product which is used for medical purposes in patients, in diagnosis, therapy or surgery. True False Which of the following is considered a medical device, select all that apply: Wheelchair Pacemaker Bandages Gloves Watch Smartphone Class I devices are subject to the most regulatory control and are used in supporting or sustaining life. True False Wheelchairs, Infusion pumps, and surgical drapes fall into which class? Class I Class II Class III Class IV A Scientific Review to ensure that safety and effectiveness of a medical device is called a %BLANK% Premarket Approval. Hypothesis Testing. Scientific Method. No review is needed. An example of a Class III medical device that requires a premarket approval is: Mechanical Ventilator Tracheostomy Inner Cannula Implantable Pacemaker All of the above What are the three things the SurgiChip tag is intended to minimize the likelihood of when the patient is undergoing surgery. Wrong Site Wrong Size Wrong Patient Wrong gender Wrong Doctor Wrong Procedure A type of medical device that can be used to access patient identification and health information is: Smartphone SurgiChip Tag VeriChip CIAA Chip Devices including many diagnostic instruments whose misuse, failure or absence with no replacement available would have a significant impact on patient care, but would not be likely to cause direct serious injury are classified as ______________-__________ Low-risk Medium-risk High-risk Great opportunity to sue for millions. Package testing needs to be conducted and documented to ensure packages meet regulations and all end-use requirements. True False Time is Up!