Lecture 3 Smart Medical Instrumentation System and Regulations PDF

UNIVERSITY INSTITUTE OF SCIENCES Academic Unit V Bachelor of Engineering (Computer Science & Engineering) Biology For Engineers 23SZT148 Smart Medical Instrumentation Systems DISCOVE...

UNIVERSITY INSTITUTE OF SCIENCES Academic Unit V Bachelor of Engineering (Computer Science & Engineering) Biology For Engineers 23SZT148 Smart Medical Instrumentation Systems DISCOVER. LEARN. EMPOWER  Course Outcome CO Title Level Number CO1 Identify the biological concepts from an knowledge engineering perspective. CO2 Development of artificial systems mimicking Understand human action. CO3 Explain the basic of genetics that helps to Analyze identify and formulate problems CO4 Apply knowledge of measurement system, Apply biomedical recording system and biosensors to excel in areas such as entrepreneurship, medicine, government, and education. Will be covered in this lecture CO5 Integrate biological principles for developing Create https://images.app.goo.gl/5obqqxo93P2UBmdU6 next generation technologies,  SYLLABUS Unit-2 Biosensors and measurement system Contact Hours: 15 Chapter 1 Medical Instrumentation: Sources of biomedical Signals, Basic medical Medical Instrumentation system, Performance requirements of medical Instrumentation Instrumentation System, Microprocessors in Medical instruments, PC base medical Instruments, General constraints in the design of medical Instrumentation system, Regulation of Medical Devices. Chapter 2 Measurement System: Specification of instruments, Statics & Dynamic Measurement characteristics of medical instruments, Classification of errors. Statistical analysis, Reliability, Accuracy, Fidelity, Speed of responses, Linearization of technique, and System Data Acquisition System. Biological sensors: Sensors/ receptors in the human body, basic organization of Chapter 3 the nervous system- neural mechanism, Chemoreceptor: hot and cold receptors, Biological sensors for smell, sound, vision, Ion exchange membrane electrodes, enzyme, glucose sensors, immunosensors, & biosensors & applications of biosensors. Sensor  Smart Medical Instrumentation Systems  Microprocessors in Medical instruments  PC base medical Instruments  General constraints in design of medical Instrumentation system  Regulation of Medical Devices  The application of Microprocessors in Medical Instrumentation  What is a Microprocessor? A microprocessor is a computer processor that incorporates the functions of a central processing unit (CPU) on a single integrated circuit (IC) or sometimes up to 8 integrated circuits. A microprocessor is programmable, multipurpose, clock-driven, register based electronic device that reads binary instructions from a storage device called memory, accepts binary data as input and processes data according to the instructions and then provides results as output. A digital computer with one microprocessor which  Application of Microprocessors in Medical Instrumentation Microprocessors have replaced conventional hard wired electronic systems that were initially used for processing data. This has resulted into a more reliable and faster data. Microprocessor system replaced programming devices as well as manual programming, making it possible for digital control of all the functions in medical instrumentation systems. The availability of more powerful microprocessors and large data storage capacities has made it Applications in Biomedical Instrumentation: Patient Monitoring Systems Microprocessors are used in devices like ECG (Electrocardiogram) machines, pulse oximeters, and blood pressure monitors to collect, process, and display patient data. Example: A microprocessor in an ECG machine collects electrical signals from electrodes on a patient's body, processes the signals to create a readable ECG waveform, and displays it on a screen. 8 Medical Imaging Systems: Microprocessors are employed in medical imaging equipment such as X-ray machines, CT (Computed Tomography) scanners, and MRI (Magnetic Resonance Imaging) scanners to control the imaging process and handle data acquisition. Example: In a CT scanner, a microprocessor coordinates the movement of the X-ray source and detectors, processes the collected data, and generates cross- sectional images of the patient's body. 9 Infusion Pumps: Infusion pumps used in hospitals and clinics to deliver precise doses of medication or fluids rely on microprocessors for accurate control. Example: A microprocessor in an infusion pump regulates the flow rate and ensures that the prescribed medication is administered safely. 10 Implantable Medical Devices: Microprocessors are used in implantable medical devices like pacemakers and insulin pumps to monitor physiological conditions and deliver therapy as needed. Example: A microprocessor in a pacemaker constantly monitors a patient's heart rate and delivers electrical pulses when necessary to regulate the heartbeat. 11 Laboratory Analyzers: Microprocessors are found in laboratory equipment, such as blood analyzers and DNA sequencers, to automate sample analysis and data processing. Example: A microprocessor in a blood analyzer processes blood samples, measures various parameters, and provides test results quickly and accurately. 12 Prosthetic Devices: Microprocessors are used in advanced prosthetic limbs to provide more natural and precise control over movements. Example: A microprocessor in a prosthetic hand can detect muscle signals from the wearer's residual limb and translate them into specific hand movements. 13 In biomedical instrumentation, microprocessors are crucial for ensuring accuracy, reliability, and real-time data processing. They enable healthcare professionals to diagnose, monitor, and treat patients more effectively, improving the overall quality of healthcare. 14 PC Base Medical Instruments Personal computer are popular in medical field and also software is largely commercially available and the users can purchase and use it. Computer are widely accepted in the medical field for data collection, manipulation, processing and a complete workstations for a variety of applications A personal computer becomes a workstation with the simple installation of one or more ‘instruments- on-a-board’ in its accessory slots. Basic elements in the system include sensors or transducers that convert physical phenomena into a measurable signal, a data acquisition system, an accquistion/analysis software package or programme and computing platform. System is highly flexible and can accommodate a variety of inputs, which can be connected to PC for analysis, graphics and control The systems works totally under the control of software PC medical instruments are gaining in popularity for several reasons including price, programmability and performance specifications Software development, rather than hardware development, increasingly dominates new product design cycles This includes operating systems, devices drivers, libraries, languages and debugging tools Microprocessors have been used to replace the complicated instructional procedures that are now required in some medical instruments. Microprocessors based instrumentation has enabled the ability to make intelligent judgement and provide diagnostic signals/warnings in case of potential error or even take appropriate corrections! Advantages of PC-based medical instruments 1.Cost-Effective: PC-based medical instruments are often more cost-effective than standalone devices with integrated displays and processing units. This is because they leverage the computing power of readily available PCs, reducing the need for specialized hardware. 2.Scalability: These instruments can be easily upgraded or customized by simply upgrading the PC's hardware or software. This scalability allows for the addition of new features or capabilities without replacing the entire instrument. 20 Processing Power: Modern PCs have substantial processing power, making them capable of handling complex data analysis, signal processing, and image processing tasks. This enables high-resolution data collection and sophisticated analysis techniques. User-Friendly Interface: PCs offer user-friendly interfaces with graphical displays, touchscreens, and interactive software. This makes it easier for healthcare professionals to operate and interpret the data from these instruments. 21 1.Data Storage and Management: PC-based instruments can store large volumes of patient data in electronic formats, making it easier to manage and retrieve patient records. They also enable connectivity to electronic health record (EHR) systems. 2.Remote Monitoring: Remote monitoring and telemedicine applications are facilitated by PC- based instruments. Healthcare providers can access patient data and perform diagnostics from remote locations 22 Applications 1.Medical Imaging: PC-based medical instruments are extensively used in medical imaging modalities such as ultrasound, MRI, CT scans, and digital radiography. The PC handles image acquisition, processing, and visualization. 2.Electrocardiography (ECG): PC-based ECG machines capture and analyze electrical signals from the heart, providing detailed ECG reports that can be printed or stored electronically. 3.Spirometry: Spirometers connected to PCs measure lung function and help diagnose respiratory conditions like asthma and chronic obstructive pulmonary disease 23 Electroencephalography (EEG): EEG systems connected to PCs record brainwave activity and are used in diagnosing neurological disorders and monitoring brain function. Laboratory Analyzers: PC-based systems are employed in clinical laboratories for automated analysis of blood, urine, and other biological samples, offering faster and more accurate results. Patient Monitoring: PC-based monitoring systems track vital signs such as heart rate, blood pressure, and oxygen saturation. They can provide real-time data and alarms in hospital settings. 24 Telemedicine: PC-based instruments support telemedicine applications, allowing healthcare providers to remotely diagnose and monitor patients, especially in remote or underserved areas. Research and Education: PC-based instruments are used in research laboratories and educational institutions for conducting experiments, simulations, and medical training. Rehabilitation and Assistive Devices: Devices like robotic exoskeletons and prosthetic limbs often rely on PC-based control systems for precise and adaptive movements. Dental Imaging: In dentistry, PC-based instruments are used for digital dental radiography and 3D imaging, improving diagnostic accuracy and patient car 25  General constraints in design of Medical Instrumentation System  The design of medical instrumentation systems is subject to various constraints and considerations to ensure their safety, accuracy, reliability, and effectiveness in healthcare applications. Here are some general constraints and considerations that designers must address: Patient Safety: Ensuring the safety of the patient is paramount. The system should not harm the patient through electrical, mechanical, or thermal means. Accuracy and Precision: Medical instruments must provide accurate and precise measurements or data. Errors in measurements can lead to incorrect diagnoses or treatments. 27 Reliability: Medical instruments must operate reliably without unexpected failures. They are often used in critical healthcare situations where any malfunction can have serious consequences. Regulatory Compliance: Medical instrumentation must adhere to various regulatory standards and certifications, such as FDA approval in the United States, CE marking in Europe, and ISO 13485 for quality management. 28 Data Security and Privacy: Protecting patient data is crucial. Systems must comply with data security and privacy regulations, such as HIPAA (Health Insurance Portability and Accountability Act) in the United States. Compatibility: Medical instruments should be compatible with existing healthcare infrastructure and systems, including electronic health records (EHRs) and hospital information systems (HIS). 29 Ease of Use: User interfaces should be designed with healthcare professionals in mind, ensuring ease of use and minimizing the risk of errors. Maintenance and Serviceability: Instruments should be designed for easy maintenance and service to minimize downtime and reduce the cost of ownership. 30 Power Efficiency: Many medical instruments are portable or used in environments where power availability may be limited. Designers must consider power efficiency to prolong battery life or reduce power consumption. Size and Portability: Depending on the application, medical instruments may need to be compact and portable for use in different clinical settings. 31 Environmental Conditions: Some medical instruments may be used in extreme environmental conditions, such as high humidity, temperature variations, or sterile environments. Designers must consider these conditions. Cost Constraints: Medical instruments should be cost- effective to make them accessible to a wider range of healthcare facilities and patients. 32 Regulation of Medical Devices The medical instrumentation industry in general and hospitals in particular are required to be most regulated industries This is because when instruments are made on human beings and by the human beings, the equipment should not only be safe to operate but must give intended performance so that the patients could be properly diagnosed and treated To minimize the problems various countries have introduced a large numbers of codes, standards and regulations for different types of equipment and facilities It is therefore, essential that engineers understand their significance and be aware of the issues that are brought about by technological and economical realities  Regulation s: 1 A regulation is an organization’s way of specifying that some particular standard must be adhered to these are rules normally promulgate by the government Codes: 2 A systems of principles or regulations or a systematized body of law or an accumulation of a system of regulations and standards. In general, a code is compilation of standards relating to providing health care to the state population Specificatio n: 3 Documents used to control the procurement of equipment by laying down the performance and other associated criteria. These documents usually cover design criteria, system performance, materials and technical data  A standard is a multi-party agreement for Standards: establishment of an arbitrary criterion for reference Alternatively standard is prescribed set of: Rules Conditions or classification of components Delineation of procedures Specification of materials Performance Design or operations Measurements of quality and quality in describing materials, products, systems, services or practice Standards exist that address systems (protection of the electrical power distribution systems from faults), individuals (measure to reduce potential electric shock hazards) and protection of the environment (disposal of medical waste)  Medical devices were classified into Class I Class II Class III It was based on the principle that devices that pose greater potential hazards should be subject to more regulatory requirements  Class I General Controls: Manufacturers are required to perform registration, premarketing notification, record keeping, labeling, reporting of adverse experiences, and good manufacturing practices, these controls apply to all three classes. Class II Performance Standards: Apply to devices for reasonable assurance of safety and efficacy, and for which existing information is sufficient to establish a performance standard. However, until performance standards are developed by regulation, only general control apply. Class III Premarketing Approval: Such approval is required for devices used in supporting or sustaining human life and preventing impairment of human health The FDA has extensively regulated these devices by requiring manufactures to prove their safety and effectiveness prior to market release.  REFERENCES o C. R. Balamurugan and D. Periazhaagar Basics of Biomedical Instrumentation. Magnus Publications, Chennai ISBN: 978-81-939626-7-1 o Gupta, P.K.. Cytology, Genetics and Molecular Biology, Rastogi Publishers, Meerut, 1993. o Roit I.M., Brostoff J. and Male D. Mosby.Immunology (6 th Edition) by, An imprint of Elsevier Sci Ltd., 2002. o G. Webster , Medical Instrumentation: Application And Design, 3rd edition ,Wiley Publishers o D Reddy, Biomedical Signal Processing, Tata Mcgraw Hill Publications. o Sergio Cerutti Advanced Methods of Biomedical Signal Processing, Oxford Publications. o B. Jacobson, J.G. Webster, Medical and Clinical Engineering, Prentice Hall, International. o Cromwell, Biomedical Instrumentation and Measurements, Prentice Hall, International. o R.S. Khandupur, Handbook of Biomedical Instrumentation, - Tata McGraw Hill o Leslie Cromwell, Fred J. Weibell, Erich A. Pfeiffer, "Biomedical Instrumentation and Measurements", Pearson Education. o https://nptel.ac.in/courses/121/106/121106008/ o https://www.utoledo.edu/engineering/bioengineering/undergrad/prospective/whatisbioe.html#:~:text=Bioen gineering%20is%20the%20application%20of,health%20care%20and%20other%20fields o https://i.pinimg.com/originals/68/c9/30/68c930e95113ceb2e3dfc9de2f164680.png o https://youtu.be/FBUpnG1G4yQ THANK YOU