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BECCC

Medical Device Quality Assurance د فضل الاكوع المدير العام أستاذ مساعد بقسم الهندسة الطبية دكتوراه في الأجهزة الطبية – جامعة القاهرة http:// fadhl-alakwa.weebly.com fadlwork@gmail.com. Biomedical Equipment Calibration and Consultation Center (BECCC). BECCC. Speaker Biography.

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BECCC

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  1. Medical Device Quality Assurance د فضل الاكوع المدير العام أستاذ مساعد بقسم الهندسة الطبية دكتوراه في الأجهزة الطبية – جامعة القاهرة http://fadhl-alakwa.weebly.com fadlwork@gmail.com Biomedical Equipment Calibration and Consultation Center (BECCC) BECCC Please contact DrFadhl if you want to use this slides

  2. Speaker Biography • FadhlAlakwaa: • BECCC manger • BME assistant professor • Education: • PhD, CU,2009 • MCS,CU,2007 • BCS,CU,2003 • Publication: • 3 Books + 5 Journals + 12 Conference processing • Contact:http://fadhl-alakwa.weebly.com/ Please contact Dr Fadhl if you want to use this slides

  3. Please contact Dr Fadhl if you want to use this slides

  4. Laboratory work • infusion pump • Electrical surgical unit • Mechanical ventilator • Electrical safety analyzer • Spectrophotometer • Defibrillator • Patient safety • Sphygmomanometer Please contact Dr Fadhl if you want to use this slides

  5. What we mean by Quality control? • Process which assure safety, maximum performance and expectation of failed. • Process which is certified by standards. • You have routine you follow. • You have written program. • You have a plan. Please contact Dr Fadhl if you want to use this slides

  6. Quality assurance Importance • Reduce downtime cost. • Improve performance. • Increase expected working life. • Mange your resources. • Reduce patient and operator incidents. • Increase patient safety. • Increase hospital reputation. • Optimize time usage. • Assure staff continuous improvement. • Reduce equipment risks and hazards. • Award accreditation. Please contact Dr Fadhl if you want to use this slides

  7. Why Developing countries need QA? • They do not have money to buy new equipment, so they have to care them. • They have low resources. • They import spare part from abroad so they have to wait until receiving them. • Staff have low education and experience, so they have to train them. Please contact Dr Fadhl if you want to use this slides

  8. Our situation • No periodic maintenance. • No periodic performance test. • No periodic calibration. • No staff training. • No improvement. • No Patient safety and satisfaction. • No system No clear plan Please contact Dr Fadhl if you want to use this slides

  9. Our situation • No periodic maintenance. • No periodic performance test. • No periodic calibration. • No staff training. • No improvement. • No Patient safety and satisfaction. • No system No clear plan Please contact Dr Fadhl if you want to use this slides

  10. What we need? • We need • medical equipment management plan Please contact Dr Fadhl if you want to use this slides

  11. Medical device included in the management plan • equipment management (EM) number. Please contact Dr Fadhl if you want to use this slides

  12. Equipment function Please contact Dr Fadhl if you want to use this slides

  13. Physical risk associated with clinical application Please contact Dr Fadhl if you want to use this slides

  14. Maintenance requirements Please contact Dr Fadhl if you want to use this slides

  15. Equipment incident history Please contact Dr Fadhl if you want to use this slides

  16. Included devices • All devices with a total EM number of 12 or more will be included in the programmeand scheduled for inspections and preventive maintenance. Please contact Dr Fadhl if you want to use this slides

  17. Maintenance interval • The maintenance requirement values are also used to determine the interval between each inspection and maintenance procedure for each device type. • Devices with an EM number of 19 or 20 will be given an inspection interval of four months. • Devices with an EM number of 15 or above will be scheduled for inspection at least every six months. • Devices with average or minimal requirements (values of 3, 2 or 1) are scheduled for preventive maintenance annually. • All devices classified as extensive (characteristic value of 4 or 5) are given a preventive maintenance interval of six months. Please contact Dr Fadhl if you want to use this slides

  18. Equipment classification examples Please contact Dr Fadhl if you want to use this slides

  19. Equipment classification examples Please contact Dr Fadhl if you want to use this slides

  20. Responsibility Please contact Dr Fadhl if you want to use this slides

  21. Medical equipment Classifications • Deliver energy (ESU, Def , Pacemaker ) • Control Fluid(IP, SP) • Display ECG, SPO2, TEMP, CO, BP,HB(PM, ECG) Please contact Dr Fadhl if you want to use this slides

  22. Medical equipment ClassificationsDeliver energy (ESU, Def , Pacemaker ) Please contact Dr Fadhl if you want to use this slides

  23. Medical equipment ClassificationsControl Fluid(IP, SP) Please contact Dr Fadhl if you want to use this slides

  24. Medical equipment ClassificationsDisplay ECG, SPO2, TEMP, CO, BP,HB(PM, ECG) Please contact Dr Fadhl if you want to use this slides

  25. Medical equipment Classifications • Deliver energy (ESU, Def , Pacemaker ) Measure the output and test the feedback • Control Fluid(IP, SP) Measure the deliverable over time and test the alarm • Display ECG, SPO2, TEMP, CO, BP,HB(PM, ECG) Display real and accurate signals(use simulator) Please contact Dr Fadhl if you want to use this slides

  26. Calibration • Accuracy • Precision • Standards Please contact Dr Fadhl if you want to use this slides

  27. Accuracy & Precision • The quantity we want to measure has a “true” value • We use a measuring instrument and obtain a reading • If the measured value is close to the true value, the measuring system has high accuracy • If we measure a quantity multiple times with the same system under the same conditions, we will get different values • If the spread of the values is small, the measuring system has high precision Please contact Dr Fadhl if you want to use this slides

  28. Accuracy & Precision The “true” value is 2.5. Our instrument shows 2.60±0.02. We take multiple readings: The mean is 2.60. The readings fall between 2.58 and 2.62 Please contact Dr Fadhl if you want to use this slides

  29. Accuracy & Precision The “true” value is 2.5. Our instrument shows 2.60±0.02. We take multiple readings: The mean is 2.60. The readings fall between 2.58 and 2.62 • Accuracy limits • Precision limits Please contact Dr Fadhl if you want to use this slides

  30. Calibration • Calibration: process of comparing an unknown against a reference standard within defined limits, accuracies and Uncertainties. • ANSI, AAMI, IEC 60601, UL, NFPA, ISO 13485, IEEE • The FDA’s Quality System Regulation. • Manufacture Please contact Dr Fadhl if you want to use this slides

  31. Requirements of Test & Calibration service – Written Program – Routine calibration or verification at suitable intervals – Control of inspection, measuring and test equipment. – Calibration procedures including specific directions and limits for accuracy and precision – Deviation or discrepancies should be investigated – Traceable Calibration Standards – Calibration records – Visible Calibration status Please contact Dr Fadhl if you want to use this slides

  32. Why Test & Calibration • What you cannot measure you cannot control Please contact Dr Fadhl if you want to use this slides

  33. When to test • On newly acquired equipment prior to being accepted for use • During routine planned preventative maintenance. • After repairs have been carried out on equipment. Please contact Dr Fadhl if you want to use this slides

  34. Need for Medical Equipment Testing • • Medical device incidents resulting in patient injury and death• Ensure that the equipment is performing to the expected standards of accuracy, reliability, free of hysteresis and linear (as designed).• Safe and effective devices need to be available forpatient care– Downtime costs money• Regulations, accreditation requirements and standards. Please contact Dr Fadhl if you want to use this slides

  35. Terminology • Quality • Safety • Incidents • Risk • Hazards • Repair • Calibration • Maintenance • Call • medical equipment priority number • Medical equipment management plan • Inspection template • JCI • Metrology Please contact Dr Fadhl if you want to use this slides

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