BME 436 Midterm Questions PDF

Which of the following devices releases medication to support its action but its NOT classified solely as a medical device? Identify a medical device that is not considered medical equipment: Which of the following is an example of a reagent as a medical device? Which of the following is an examp...

Which of the following devices releases medication to support its action but its NOT classified solely as a medical device? Identify a medical device that is not considered medical equipment: Which of the following is an example of a reagent as a medical device? Which of the following is an example of an appliance used as a medical device? Which of the following is an example of software used as a medical device? Which of the following is an example of an apparatus in medical devices? Which of the following is an example of a diagnostic medical device? Which of the following devices is intended for the prevention of disease? Which device is used as compensation for an injury? Which of the following devices is used for replacement of anatomy? Which device is used for modification of anatomy? Which of the following is an in vitro diagnostic (IVD) device used for compatibility purposes? Which of the following is an IVD device used for screening purposes? Which of the following is NOT included in health technology? Does Turkey have a health technology policy as part of its national health program? Does Turkey have an independent national health technology policy? The poorest 20% of the global population are roughly 10 times more likely to die before the age of 14 than the richest 20%. Which of the following is NOT a medical device-related political resolution aimed at overcoming this disparity, as agreed upon in the 2000 United Nations meeting? Which of these medical devices is used to reduce child mortality globally in poor populations? Which of the following devices is NOT used to reduce maternal mortality in poor populations? What is the measure that combines two other measures used in calculations of the global burden of disease? Which of the following describes a substandard medical device? Which of the following describes a falsely labeled medical device? Which of the following describes a counterfeit medical device? Which of the following examples illustrates poisoning in the context of compromised medical devices? Which of the following examples illustrates inadequate treatment? Which of the following examples illustrates contributions to drug resistance? Does Turkey have a National Legal Framework for Medical Devices? Does Turkey have a National Regulatory Authority for Medical Devices? Which of the following is an example of a regulation point in the medical device life span? Which of the following best describes the purpose of a medical device? What is the system that all medical devices are registered in Turkey is called? Which of the following medical devices can be advertised in Turkey according to the national directive? Which of the following classes of medical devices will need to be recertified according to the new system coming into action? Which of the following medical devices is classified as Class I? Which of the following medical devices is classified as Class II? Which of the following medical devices is classified as Class III? How are the risk classes named in in vitro diagnostic medical device regulations? Under Turkey's updated regulation, IVD devices without specific rules are classified as which risk group? Which of the following is an invasive medical device that is not implantable? Which one of the given medical devices is an inactive medical device? Which risk classes can softwares be classified in? Which one of the given medical devices can be sold in the EU and Turkey without certification from a Notified Body? Is a quality managemet system (QMS) is mandatory in Turkey for manufactorers of sterile surgical masks? If yes, what is it called? Which of the following is NOT a fundamental principle in a Quality Management System (QMS) for medical device manufacturers? Which entity is responsible for the assessment and certification of medical devices in the European Union, where you report your design reviews, design verification results, and quality management system compliance? Which of the following is one of the six essential elements of the EU Quality Management System (QMS) that ensures all employees are properly prepared and compliant? Is purchasing control a part of the QMS? How is a medical device identified uniquely and traced after putting into market in EU? How is it possible to improve the quality of medical devices by implementing a QMS? When a medical device manufacturer is certified for QMS, how long is it valid? Is there any necessary actions to be taken in this period? Nicotine Patch Disposable Syringe Blood Glucose Test Strips autoclave Radiology Image Processing Software Stethoscope ECG (Electrocardiogram) Machine Glove Soft Orthopedic Cast Pacemaker Orthodontic Braces blood compatability test kit HIV Test Kit Public Health Campaigns Yes, it’s called the Ulusal Sağlık Teknolojisi Değerlendirme Politikası No, Turkey integrates this within the national health program MDG 8: Promote Global Economic Growth All of them Glucose Meters Disability-Adjusted Life Year (DALY) Surgical gloves that fail quality standards A thermometer labeled with a CE mark but is actually not compliant with EU regulations Imitation surgical mask without proper filtration, illegally branded with a trusted logo Mercury-containing thermometers causing toxicity upon breakage Wrongly given eyeglass prescriptions Improperly sterilized surgical instruments causing bacterial resistance Yes, under Decree Law 663, Ministry of Health Yes, it is called the Türkiye İlaç ve Tıbbi Cihaz Kurumu All of them To diagnose, monitor, treat, or prevent medical conditions in patients ÜTS Laser Epilation Device All of them Surgical gloves Blood transfusion kits Pacemaker Class A, Class B, Class C, Class D Class A Endoscope Surgical instruments All of them Masks No, it is not mandatory Monitor employee satisfaction Notified body By arranging training workshops and conferences for the personnel. Yes, it is absolutely essential. With unique device indentification (UDI) barcode. By creating a better tracking system. It is valid for 3 years with audits happening every 12 months. Inhalers for asthma MRI Scanner Defibrillator Stethoscope Orthodontic Braces Face Mask Prosthetic Limb Hip Joint Implant Stethoscope Hearing Aid Infusion Pump Hearing Aid Surgical Mask Procedures and Systems No, Turkey does not have this policy Yes, it is called the Independent Health Technology Assessment Strategy MDG 4: Reduce Child Mortality Safe Injection Devices Surgical Kits Years Lived with Disability (YLD) A blood pressure monitor that has been recalibrated according to manufacturer specifications A blood glucose meter that has accurate readings but is marketed as a non-calibrated device An insulin pump from a verified supplier with full documentation Inaccurate blood pressure monitors leading to incorrect hypertension management A surgical mask that fails to filter out pathogens Using the correct antibiotic based on culture and sensitivity results Yes, under the Ministry of Technology No, Turkey does not have a National Regulatory Authority Definition of a medical device (premarket phase) To provide a solution for technical issues in healthcare settings TMC Surgical Instruments Class I Devices Pacemaker Stethoscope Blood glucose meter Level 1, Level 2, Level 3 Class B Pacemaker Blood pressure monitor (tonometer) Class I MRI Scanner Yes, it is called GMP (Good Manufacturing Practices) Commit and start planning Management Review Meeting By relying solely on written manuals without interactive training. No, it is not necessary By assigning a random serial number By limiting employee training to save time. It is valid for 5 years with audits happening every 12 months. Drug-Eluting Stents X-ray Machine Insulin Pump Defibrillator Blood Glucose Meter Wheelchair Face Mask Prosthetic Limb Hip Joint Implant Infusion Pump Stethoscope Thermometer Pulse Oximeter Devices Yes, it’s called the Turkish National Health Technology Plan Yes, it is part of the EU health regulations MDG 5: Improve Maternal Health IV Lines Anti-Shock Garments Years of Life Lost (YLL) An infusion pump that operates within specified parameters A surgical mask that is correctly labeled for surgical use A genuine product from a well-known medical device company Improperly sterilized surgical instruments causing bacterial resistance A properly calibrated insulin pump A thermometer that provides accurate readings No, Turkey does not have a National Legal Framework Yes, it is part of the Ministry of Health Registration of establishments (placing on the market phase) To enhance the performance of healthcare professionals TST Dialysis Machines Class II Devices Hip joint implant Surgical gloves Surgical gloves Low Risk, Moderate Risk, High Risk Class C Hip joint implant Electric thermometer Class II ECG machine Yes, it is called CE Marking Analyze and document Regulatory Affairs Committee By expecting employees to self-study the QMS requirements without support. yes,but Only for high-risk devices By the manufacturer's name only By reducing the number of quality checks performed. It is valid for 2 years with audits happening every 6 months. Infusion Pumps Ultrasound Device Nebulizer Infusion Pump Surgical Instruments Hip Joint Implant Infusion Pump Blood Pressure Cuff Surgical Mask Artificial Eye Defibrillator Blood Glucose Meter Stethoscope Medicines Yes, it’s part of the General Health Program Yes, it is called the Health Technology Strategy MDG 6: Combat HIV/AIDS, Malaria, and Other Diseases Bandages Sphygmomanometers Quality-Adjusted Life Year (QALY) A stethoscope that has minor cosmetic damage but functions correctly A drug-eluting stent that has all the correct approvals A blood pressure cuff that meets all regulatory standards A stethoscope that is not functioning properly An autoclave that sterilizes instruments effectively A properly functioning nebulizer Yes, it is called the Turkish Medical Device Act Yes, it is called the National Health Authority Adverse event reporting (post-market phase) To serve as a substitute for medication in all cases ÜTM Blood Glucose Meter Class III Devices infusion pump Hip joint implant Stethoscope Type I, Type II, Type III Class D Dental implant Pacemaker Class III PCR kit Yes, it is called GMP (Good Manufacturing Practices) Train, implement, and monitor Quality Assurance Department By conducting random checks on employee knowledge without formal training. yes ,but Only for devices with CE marking By the product's packaging information By focusing solely on meeting minimum regulatory requirements. It is valid for 10 years with audits happening every 12 months.