MDD Quiz 1 - First two lectures PDF

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Questions based on Medical Device Industry, Life Cycle and Biocompatibility and Clinical Trials and Evidence of Medical Devices
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Medical Devices and Diagnostics Quiz Medical Device Industry, Life Cycle and Biocompatibility Clinical Trials and Evidence of Medical Devices Questions 1. At the age of 65, Aussies can expect to live, on average, X of their remaining years with some level of disability. Please select correct answer for X a. ¼ b. ½ c. all d. none e. 2/3 2. What is the reason for the aging population phenomenon in Australia a. People live longer due to better life style b. People have better health care c. Reduced fertility rates d. Reduced infant mortality e. All of the above 3. What is the main principle for medical device classification according to TGA a. Device size b. Device working principle c. Risk level to patient d. Device application location e. Material of device 4. An investigator for a clinical trial must be a. Employed by the sponsor company to conduct the clinical trial for them b. Suitably qualified and experienced in the indication, eg. Cardiologist, physiotherapist, dentist etc c. A member of the human research ethics committee d. a scientist working on a medical device development from the beginning e. all of the above 5. Medical devices in Australia are regulated by: a. EMEA b. TGA c. FDA d. HRECs e. NHMRC 6. A biocompatible material is: a. A biomaterial that exists within a physiological environment without significant adverse effects on biomaterial itself. b. A biodegradable material constructed from organic origins c. A biomaterial that does not produce any significant adverse effects on the body d. A biochemically inert material

e. A biomaterial that exists within a physiological environment without any significant effects on the material and on the body. 7. A haemolysis assay is a type of in vitro test that measures: a. Cell toxicity to implantable devices and materials b. The damage to red blood cells when these are exposed to biomaterials or material extracts c. Blood coagulation time d. Sensitivity of tissues to biomaterial extracts e. Change in blood adsorption and fluorescence properties 8. The first type of trial usually conducted for medical devices is: a. Pilot b. Post marketing c. Pivotal d. Feasibility e. In Vitro testing 9. What percentage of medical devices are produced within Australia? a. 85% b. 50% c. 20% d. 70% e. 5% 10. COVID-19 effects on Australian and global medical device industry can be summarised by several main trends. Choose the statement that you believe is NOT TRUE: a. Medical devices require a personalised approach that is based on data collected and analysed for each patient individually b. Analog based devices are simple and inexpensive, getting more relevance in the post-COVID world of a compromised economy. c. New health therapies and diagnostics need to be built into the existing health system to minimise disruption and further economic costs. d. Cyber security and protection of personal data is the key trend in modern medical device industry as devices become more personalised and based on data-driven algorithms. e. Medical device industry needs to adopt solutions that are scalable and highly adaptive for the changing health situation around the world. 11. Unapproved medical devices in Australia (not on the ARTG) can only be supplied to patients legally via: a. Personal importation b. The Special Access Scheme (SAS) c. The Clinical Trial Exemption (CTX) Scheme d. The Clinical Trial Notification (CTN) Scheme e. All of the above 12. Clinical data for medical devices in Australia can include a. Both clinical trial data and literature review data b. Advertising brochures c. Clinical investigation (clinical trial) data d. Literature review data

e. Letters from key opinion leaders

Medical Device Industry, Life Cycle and Biocompatibility Clinical Trials and Evidence of Medical Devices Answers 1. b. ½ 2. e. all of the above 3. c. risk level to patient 4. b. Suitably qualified and experienced in the indication, eg. Cardiologist, physiotherapist, dentist etc 5. b. TGA 6. e. A biomaterial that exists within a physiological environment without any significant effects on the material and on the body. 7. b. The damage to red blood cells when these are exposed to biomaterials or material extracts 8. a. pilot 9. c. 20% 10. b. Analog based devices are simple and inexpensive, getting more relevance in the post-COVID world of a compromised economy. 11.

e. all of the above

12.

a. both clinical trial data and literature review data...