Quality Assurance of Medical Devices and Cosmetics

Quality Assurance of Medical Devices and Cosmetics (FA221513/1sks)

• Course covers quality control of non-sterile medical devices and laboratory apparatus.
• Topics include: Introduction to 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).
• A group assignment (50% of the total grade) is required.
• The assignment involves preparing a protocol for QC analysis of medical devices (gloves, band-aids, micropipettes, analytical balances, or pH meters).
• Students must cite the literature used in their protocols.
• Deadlines for submission are: A (Nov 18), B (Nov 21), C (Nov 19), IUP (Nov 22), 5 pm (all times are local).

Medical Devices

• A medical device can be any instrument, apparatus, implement, appliance, implant, reagent for in vitro use, software, or material intended for medical use.
• Medical devices are classified by risk level (not sterility), including low-risk, low-moderate-risk, moderate-high-risk, and high-risk.
• Non-sterile devices, such as bandages, thermometers, stethoscopes, and balances, do not require a detailed level of sterility assurance.

Quality Control of Medical Devices

• Quality control involves assessing product quality from good manufacturing practices and materials with appropriate specifications.
• Good Medical Device Manufacturing Practice (CPAKB) and ISO 13485 are important aspects.
• ISO 13485 is designed for organizations involved in the design, production, installation, and servicing of medical devices and related services.

Product Information

• Product information must include an explanation of the device, description of features, intended use, indication for use, contraindications, warnings, adverse events, alternative therapies, materials, manufacturer information, and the production process.

Specification and Quality Assurance

• Requirements include functional characteristics, technical performance specification, design verification and validation, pre-clinical studies, software validation (if applicable), research on devices containing biological materials, clinical evidence, risk analysis (for class D devices), detailed material specifications, packaging specifications (for in vitro diagnostic devices), clinical evaluation (for in vitro diagnostic devices), and device safety information.

Physical Testing

• Physical testing ensures the device can withstand physiological stresses, undesirable conditions, and forces, and assesses possible failure modes (e.g., pressure test, elasticity test)
• This data is needed to understand long-term device performance.

Example QC of Medical Devices

• Different devices, like gauze, condoms, gloves, masks, safety glasses, thermometers, and band-aids, employ different testing methods. (See the provided table for specifics).

Laboratory Apparatus

• Laboratory apparatus includes tools, equipment, and instruments used for experiments and research in scientific laboratories.
• These apparatuses are crucial for accurate and reliable scientific data. They allow experiments to be duplicated and verified by other researchers.

Calibration of Laboratory Equipment

• Calibration is the process of adjusting a device or measuring instrument for accurate readings within designated tolerances.
• Calibration is typically achieved by comparing the instrument's readings to a known standard (e.g., master gauge).
• This ensures consistent and accurate data from the equipment.
• Calibration is applicable to instruments like pH meters, balances, scales, centrifuges, and pipettes.

pH Calibration

• pH calibration involves adjusting pH meters by measuring solutions of known pH levels.
• Single-point, two-point, and multi-point calibrations are different approaches to calibrate pH meters.
• The choice of method depends on the desired level of precision or expected range of pH samples.

pH Meter Calibration

• Single-point calibration focuses on consistent pH measurements.
• Two-point calibration uses a range of known pH samples to define the slope and offset errors of the pH electrode.

This quiz assesses knowledge on quality control processes for non-sterile medical devices and laboratory apparatus. It covers various topics including antioxidant activity analysis, peptide cosmetics development, and case-based study presentations. Prepare for multiple choice questions based on these themes and ensure you can cite relevant literature for your group assignment.