Quality Assurance of Medical Devices (FA221513/1sks) PDF

Quality Assurance of Medical Devices and Cosmetics (FA221513/1sks) d quality control of non-sterile medical devices & laboratory apparatus Siti Nurul Hidayah | Department of Pharmaceutical Chemistry...

Quality Assurance of Medical Devices and Cosmetics (FA221513/1sks) d quality control of non-sterile medical devices & laboratory apparatus Siti Nurul Hidayah | Department of Pharmaceutical Chemistry Faculty of Pharmacy, Universitas Gadjah Mada  Course material Introduction of quality control of medical devices and laboratory apparatus Analysis of antioxidant activity of raw material and cosmetics Development of peptide and protein-based cosmetics Student presentation for case-based study Exam (15 multiple choice questions) 2  Group assignment (50% of total grade) Grouping: same as your group for laboratory practice. Assignment: prepare a protocol for QC analysis of one of these medical devices: Group 1: Laboratory glove Group 2: Band-Aid Group 3: Micropipette (calibration) Group 4: Analytical balance (calibration) Example: QC analysis for Gauze (kain kasa) or pH meter calibration in your laboratory practice. Note: please attached the literature used for making the protocol. Submit via eLOK: max A (18 Nov), B (21 Nov), C (19 Nov), IUP (22 Nov) 5 pm! 3  What is medical devices? 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. 4  Non-sterile medical devices Medical devices are not classified as sterile and non-sterile devices, but classified based on the risk level Asian medical Device Directive Non-sterile medical devices: do not need a detail level of sterility assurance! These products are usually diagnostic or non-invasive, such as: stethoscope, bandages, thermometers, balance, etc. 5  Quality control of medical devices Quality means a measure of product quality assessed from good manufacturing practices and use of materials with appropriate specifications and meet the specified requirements. Good Medical Device Manufacturing Practice (CPAKB) ISO13485 6  Product information explanation of medical devices description and features of medical devices intended use indication instruction for use contraindication warning (if any) adverse event alternative therapy material manufacturer information production process 7  Specification and quality assurance functional characteristics technical performance specification of the medical device summary of design verification and validation document pre-clinical studies test result of software validation (if applicable) result of the research on any device containing biological material clinical evidence risk analysis and result of risk analysis (for class D) specification and/or requirement of raw material specification of packaging (for in vitro diagnostic medical devices) data of analysis result and/or clinical evaluation(for in vitro diagnostic medical devices) clinical evaluation report and device safety 8  Physical testing Physical testing shall be conducted to predict the adequacy of medical device response to physiological stresses, undesirable conditions and forces, long- term use and all known and possible failure modes. Pressure test (uji tekanan) Elasticity test (uji tarik) 9  Example of QC of medical devices Devices Testing Gauze, absorbent cotton, adult - Absorbency test diaper, sanitary napkins, etc. - Fluorescence test Condom - Durability test - Leaking test Laboratory glove - Pressure test - Elasticity test Safety mask - Filter test - Bacterial filtration efficiency Safety glasses and goggles - Impact resistance - Chemical splashes test Thermometer - Calibration Band-aid - Adhesive strength 10  What is laboratory apparatus? Laboratory apparatus refers to the various tools, equipment, and instruments used in scientific laboratories to carry out experiments and research. These apparatuses play a vital role in the accuracy and reliability of scientific data, ensuring that experiments can be replicated and verified by other scientists. 11 Should we calibrate these? 12 Calibration of laboratory equipment Calibration is the process of adjusting a device or measuring instrument so that its readings are correct within a specified tolerance The purpose of calibration is to ensure that the results of measurements made with a particular instrument are accurate and consistent. 13 Calibration can be performed on a variety of instruments, including pH meters, balances, scales, centrifuges, pipettes, etc. 14 Calibration is usually done by comparing the readings of the instrument to those of a known standard, such as a master gauge, calibrated against another standard of known accuracy. 15  pH calibration A pH calibration is the process of adjusting your pH meter by measuring solutions of a known pH value. 16  pH meter calibration single point calibration two-point calibration multi-point calibration single point calibration: looking to measure a consistent pH value with little variation two-point calibration: have a range of pH samples. The buffer solutions should bracket your expected pH sample. In this process, the pH meter determines the slope and offset error for the actual pH electrode in use. 17 Question? 18