Medical Devices - Our Lady of Fatima University

OUR LADY OF FATIMA UNIVERSITY COLLEGE OF PHARMACY Valenzuela. Quezon City. Antipolo. Pampanga. Cabanatuan. Laguna PHARMACEUTICAL DOSAGE FORM AND DRUG DELIVERY SYSTEMS FINALS Name of Lecturer Instructor- College of...

OUR LADY OF FATIMA UNIVERSITY COLLEGE OF PHARMACY Valenzuela. Quezon City. Antipolo. Pampanga. Cabanatuan. Laguna PHARMACEUTICAL DOSAGE FORM AND DRUG DELIVERY SYSTEMS FINALS Name of Lecturer Instructor- College of Date COURSE FACILITATOR Pharmacy TIME TOPICS: Medical Devices OUTCOMES: At the end of the session the students will be able to: Demonstrate knowledge of the classes of medical devices Demonstrate understanding of the functions of medical devices Demonstrate competence in the use of medical devices Watch these Videos: Topic 9 ◉ https://www.youtube.com/watch?v=5uI8EA2cRDw (Parenterals) ◉ https://www.youtube.com/watch?v=cf9Y3xP2oTo (Sterile Compounding) Topic 10 ◉ https://www.youtube.com/watch?v=vUqwIL5lgS8 (Liposomal Technology) ◉ https://www.youtube.com/watch?v=KQA9YlhgTQc (Liposome: A Technological Marvel)  Watch these Videos: Topic 11 ◉ https://www.youtube.com/watch?v=33VO6olowQg&t=8s (Medical Devices Classification as per FDA) MEDICAL DEVICES Medical Devices A medical device is an instrument, apparatus, in vitro reagent , implant or other similar or related article , which is intended for use in the diagnosis of disease or other condition ,or in the cure , mitigation , treatment , or prevention of disease or intended to affect the structure or any function of the body and which does not achieve any of its primary intended purposes through its chemical action within or on the body.  Diagnosis, prevention, monitoring, treatment or alleviation of disease, (e.g.Urinary catheter) Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,(e.g.Bone cement) Investigation, replacement or modification of the anatomy or of a physiological process (e.g.Hip replacement) Control of conception (e.g.Condoms) And which does not achieve its principal intended action in or on the human body by Benefits of Medical Devices ▷ Enhances Diagnosis, Monitoring, Treatment  Monitors environmental, nutritional, and psychosocial factors  Aids in determining the patient’s condition  Giving the appropriate course of action or treatment  e.g. stethoscope, blood pressure monitors, and urinary catheters Benefits of Medical Devices ▷ Faster Recovery  Rehabilitation devices assist patients in regaining functionality and independence  e.g. Prosthetics or mobility aids Benefits of Medical Devices ▷ Control of conception ○ Medical devices can be used to assist in the achievement or management of a pregnancy. ○ e.g Birth Control, Condoms, Ultrasound Machines, ULTRASOUND MACHINE Benefits of Medical Devices ▷ Cost and time efficiency for diagnosis and treatment ○ It cost less money and take less time because the medical device can be used for that specific treatment. Benefits of Medical Devices ▷ Reduce risk of errors  Improving patient safety and quality of care by preventing medication errors, adverse drug events, and other harm caused by human or system errors  e.g. Blood infusion pump  Classification Medical Devices are classified as per their risk level and intended use MDD-Risk Based Classification o Class A (Class-I) – Devices involving low risk levels(Thermometer) o Class B (Class-II a) – Devices involving low to medium risk (Hypodermic Needle) o Class C (Class-II b) – Devices involving moderate to high risk (Lung ventilator) o Class D (Class-III) – Devices involving high risk. (Heart valve, implantable  Classification By USFDA o Class-I (Low Risk):Elastic bandages, Examination Glove,Adult Incontinence Pad o Class –II (Medium Risk): Catheter Cannula, Dialyzer , Piston syringe , Needle, Infusion Pumps, Bone fixation screw, Blood pressure kit o Class-III (High Risk): Pacemakers, Dental Lasers, Heart Valves. Registration of Medical Devices – United States FDA ‘APPROVAL PROCESS’ BY CLASS OF DEVICE Note: Approval of Class-3 Devices is complicated and involves clinical trials. Less than 10% of devices are considered Class-3 by the FDA.  Class I CLASS I Devices Classification Examples Risk  Electric toothbrush  Tongue depressor  Oxygen mask  Reusable surgical Class I scalpel Low to Moderate Risk  Bandages  Hospital beds  Non-electric wheelchair  Class II CLASS II Devices Classification Examples Risk  Catheters  Blood pressure cuffs  Pregnancy test kits Class II  Syringes Moderate to High Risk  Blood transfusion kits  Surgical gloves  Absorbable sutures  Class III CLASS III Devices Classification Examples Risk  Breast implants  Pacemakers  Defibrillators High Risk Class III  High-frequency ventilators  Cochlear implants  Implanted prosthetics References  Dhilawala, A. (2023, October 9). 5 key benefits of connected medical devices. Galen Data. https://galendata.com/the-key-benefits-of- connected- medical-devices/  Wyss, U. P. (2019, March 26). Improving the quality of life of patients with medical devices by a timely analysis of adverse events. PubMed Central (PMC). https:// www.ncbi.nlm.nih.gov/pmc/articles/PMC6443635/  Brazier, Y. (2018, February 26). What types of birth control are there? https:// www.medicalnewstoday.com/articles/162762  Medical devices. (2020, July 2). https:// www.who.int/health- topics/medical-devices#tab=tab_2 Thank you! Any questions? You can find me at: [email protected] #RisetotheT OP 21