MEDICAL DEVICES Bou MUL; oy | Pror. AWAD AL-ZABEN BIOMEDICAL SYSTEMS AND MEDICAL INFORMATICS DEPARTMENT Hyyaw1 FACULTY FOR ENGINEERING TECHNOLOGY YARMOUK UNIVERSITYDAT INEM CONN ers m ©D Bioengineering: The application of engineering to the development of health care devices, analysis of biological systems, and manufacturing of products based on advances in the technology => (Biomedical eng. & Biochemical eng.) = © Biotechnology: The study of microbiology process technology => Agriculture, and food and drug production). m * Biomedical Engineering: An engineering discipline concerned with the application of science and technology to biology and medicine. = © Medical electronics: A division of biomedical engineering concerned with electronic devices and methods in medicine.MepIcAL DEVICE Medical Device: One definition Medical device means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purpose and necessary for its proper application, intended by the manufacturer to be used for human beings. LTTtae Wa mele OATS Lite NT aCe Restriction to human beings refers to market approval only, technical requirements refer to all patients human or animal.MepIcAL DEVICE = Hospital information system intended for patient data management is NOT considered medical device. m Software to process x-ray images or ECG Classifications are considered medical devices. Applications of Medical Device m Diseases (diagnosis, prevention, monitoring, treatment or alleviation); = Handicap or injury (diagnosis, monitoring, treatment, alleviation, compensation); a Anatomy (investigation, replacement, modification); m Physiological processes (investigation, replacement, modification); = Control of conception (contraception or fertilization).No unacceptable isks Performs as intended Figure 1: Medical DeviceMEDICAL TECHNOLOGY MANAGEME| © Biomedical engineer has full responsibility and authority on all matters of medical technology management (MTM). elite) = © Medical equipment maintenance program that provides: us Inspection, preventive maintenance, and repair. m © Selection and acquisition of appropriate technologies. = > Maximize the safety and effectiveness of medical devices in use. © Including electrical and radiation safety. = Achieve compliance with regulatory requirements «=r We need to have our own medical instrumentation regulations. m © Provide consultation to the medical staff on capabilities & limitations of medical instrumentations. Can you now see the difference between Biomedical engineer and any other engineeringRisks of Medical Devices Risk : Means probability of occurrence. Specifics risks includ m Electric hazards, if the patient is a direct part of the electric circuit; m Physical hazards due to insufficient solidity and/or stability (e. g. patient lifter) or noise, mechanical movement, pressure, overheating, fire, explosion or excessive radiation m Biologic hazards due to overdosage of highly effective drugs (e. g. infusion pump) or unintended release of adverse agents contained in material directly contacting intact skin, wounds or blood circulation; m Hygienic hazards by transmitting pathogenic germs when touching contaminated parts (e. g. insufficiently sterilized endoscopes, catheters); = Functional hazards through inaccuracies, malfunction and/or breakdown of life mon- itoring, supporting or sustaining devices (e. g. patient monitor, infusion pump, lung ventilator, pacemaker).SAFETY OF MEDICAL DEVICES Evia Means that the device must not cause any unacceptable risk during the intended use of the device under normal conditions or single fault condition. Single fault condition Condition in which a single means for protection against a SAFETY HAZARD in equipment is defective or a single external abnormal condition is present Safety Factors Applied on 222? think about it 2222 think about itSE VCova a Ca cele that the device is free from unacceptable risk directly caused by hazards under normal condition and single fault condition that when absent or degraded, may generate unacceptable risks Applied on patients users environment ecologyhy Patien Because of the probability that the patient : being in direct contact to the electric circuit or even being a part of it. (@) has missing protection from the skin (3) missing reflexes to reduce or avoid adverse effects due to the patient’s condition @ survival depending on a medical device’s function and reliability (3) impact of imperceptible emissions ©) increased infection hazards due to introduction of foreign bodies @ increased risk of interference and hazardous coupling among devices due to the simultaneous use of several electromedical devices increased health risks due to released hazardous substances from applied parts @) long-term contact with applied parts exposure to high energies, temperatures, pressure increased risk of user errors because of emergency situations, stress or tirednessAye Because users are exposed to specific risks such as © physical factors (e. g. high energies, dangerous invisible radiation, temperatures) dangerous substances (e. g. exhaled anaesthetic gases, leakages of hazardous laser media) @) pathogens (e. g. direct contamination, inhalation or vaporated tissue) combination of risk factors (e. g. RF surgery sparks and mixtures of explosive gases with air or oxygen)Why environment?? Because environment is exposed to risks such as : disturbance of mains network by powerful electromedical devices emission of radiation and fields emission of dangerous substances spilled liquids Why ecology?? exposed to adverse and dangerous substances released into ground, water and/or air with potential bioaccumulationREQUIREMENTS Essential Requirements of Medical Devices Medical devices must exhibit an acceptable risk/benefit ratio when used under conditions. Medical devices must be designed and constructed in conformity with generally acknowledged state of the art of science and technology and following the principles of integrated safety Medical devices must achieve the medical performance intended by the design. Medical devices must meet requirements 1-3 during their whole expected lifetime Medical devices must fulfill their intended characteristics and performance also after storage and transport. Medical devices must not have unintended side-effects constituting unacceptable risks. Medical devices must be accompanied by all information required for safe use during the intended lifetime. Medical devices must meet several particular essential requirements concerning design, construction and performance