Biomedical Engineering Design I Lecture ONE PDF

BIOMEDICAL ENGINEERING DESIGN I BME 251 (Lecture ONE) Dr. Daniel Akwei Addo 1 Casely Hayford Building (BME lab [office 1]) [email protected]  Outline of Presentation Biomedic...

BIOMEDICAL ENGINEERING DESIGN I BME 251 (Lecture ONE) Dr. Daniel Akwei Addo 1 Casely Hayford Building (BME lab [office 1]) [email protected]  Outline of Presentation Biomedical Engineering Design Medical Device Determination Medical Device Classification 2  Learning Objectives 1) Students should be able to identify elements considered in deciding whether a product qualifies as a medical device or not. 2) Students should be able to classify medical devices. 3) Students should be able to describe how the stage-gate model, engineering design process and the spiral model influence medical device design decisions. 3  What is Biomedical Engineering Design? Systematic approach used by biomedical engineers to develop solutions that address healthcare challenges. It involves the application of engineering principles, biological and medical knowledge, and creativity to design devices, systems, or processes that improve patient care, diagnosis, and treatment. In short, it is the Systematic approach used by biomedical engineers to develop MEDICAL DEVICES. 4 Is My Product a Medical Device? Medical Devices Are Diverse Simple Complex 5  Is My Product a Medical Device? What is a Medical Device? According to WHO A medical device can be any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination for a medical purpose. 6  Is My Product a Medical Device? The FDA defines a medical device as: "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes." 7  Is My Product a Medical Device? Knowing Your Product What is the intended use of your product? How does your product function? What claims do you intend to make? 8  Is My Product a Medical Device? Defining Your Intended Use is Key! Clearly state the general purpose or its function Further describe the disease or condition the product will diagnose, cure, mitigate, treat or prevent The intended patient population 9  Is My Product a Medical Device? Defining Your Intended Use is Key! Product General purpose Disease or condition being Intended patient/ addressed user population Personal protective Protection from the spread of Adult equipment micro-organism Increase mobility of Leg amputation Outpatient care users 10 Is My Product a Medical Device? Special Considerations ALL SOME ALL NONE 11 Is My Product a Medical Device? Special Considerations 12 Is My Product a Medical Device? Special Considerations 13 Is My Product a Medical Device? Special Considerations 14 Is My Product a Medical Device? Special Considerations 15 Is My Product a Medical Device? Special Considerations 16  Is My Product a Medical Device? Special Considerations Section 520(o)(1)(B) of the FD&C Act, states that software that is intended "for maintaining or encouraging a healthy lifestyle and is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition" is not a device under section 201(h) of the FD&C Act. This category includes fitness trackers, apps that track fitness and/or diet, exercise equipment and video games. 17 Is My Product a Medical Device? Medical Device Determination & Medical Device Classification 18 Is My Product a Medical Device? 19 Is My Product a Medical Device? 20 Is My Product a Medical Device? 21 Is My Product a Medical Device? 22 Is My Product a Medical Device? 23 Is My Product a Medical Device? 24 Is There An Existing Classification For My Medical Device? 25  Is There An Existing Classification For My Medical Device? Kindly google “accessdata.fda.gov” 26 Is There An Existing Classification For My Medical Device? 27 Is There An Existing Classification For My Medical Device? 28 Is There An Existing Classification For My Medical Device? 29 Is There An Existing Classification For My Medical Device? 30 Is There An Existing Classification For My Medical Device? 31 Is There An Existing Classification For My Medical Device? 32 Is There An Existing Classification For My Medical Device? 33 Is There An Existing Classification For My Medical Device? 34 Is There An Existing Classification For My Medical Device? 35  Medical Device Classification Medical devices classified based on risks. The higher the risk associated with the use of the device the higher the class number. 36  Medical Device Classification Class I Involves low risk of illness or injury. Require General Controls [with or without 510(k)]. Almost all Class are 510(k) exempt. Not intended to help support or sustain life or be substantially important in preventing impairment to human health. Examples of Class I devices include Stethoscopes. Bandages. Bedpans. Tongue depressors. Latex gloves. Surgical masks. Irrigating dental syringes. 37  Medical Device Classification Class II These devices are deemed to be higher risk than Class 1. Require both General and Special control (510k). Exemptions from 510(k) can also be applied for. Examples: Catheters, Pregnancy tests, Blood Pressure Cuffs, Blood transfusion appliances, Surgical Gloves, Contact lenses, Syringes, Absorbable Sutures. 38  Medical Device Classification Class III Highest level of risk to patients. Require both General Control and Pre-Market Approval (PMA). No exemptions from control requirements. Entirely novel devices. Support or sustain human life. Includes Pacemakers, Breast implants, Defibrillators, Ventilators, Foetal blood sampling monitors, Implanted 39 prosthetics.  Medical Device Classification General Controls include the provisions of the Act pertaining to: Adulteration Notification and repair, replacement, and refund Misbranding Records and reports Device registration and listing Restricted devices Banned devices Good Manufacturing Practices.  Medical Device Classification Special Controls (510k) include the provisions of the Act pertaining to:  Medical Device Classification Pre-Market Approval (PMA) include the provisions of the Act pertaining to: Device description Clinical studies Bench testing Manufacturing processes and validations Animal studies Labeling Biocompatibility tests sterilization validations Shelf life studies software validations  Medical Device Classification Medical Device Regulation Act (1976) ❖ New medical device not already captured in the FDA medical device database (1976) placed under Class 3. What if the new device does not pose significant risk? De-Novo Classification (1997) ❖ The de-novo classification allows for new medical devices that do not present significant amount of risk to be placed under Class 1 or 2. ❖ Requires General and Special Controls.  Medical Device Classification Determine the device class, submission type, regulation number, GMP and recognised consensus standards (if applicable) of the following. Oxygen Mask Crutch Scalpel General purpose reagent Hospital Bed HIV test kit Stair climbing wheelchair Bulbous stent Wheelchair elevator Cane (safety walk) 44