Medical Device Quality Assurance د فضل الاكوع المدير العام أستاذ مساعد بقسم الهندسة الطبية دكتوراه في الأجهزة الطبية – جامعة القاهرة Please contact Dr Fadhl if you want to use this slides 1

Speaker Biography  Fadhl Alakwaa:  BECCC manger  BME assistant professor  Education:  PhD, CU,2009  MCS,CU,2007  BCS,CU,2003  Publication:  3 Books + 5 Journals + 12 Conference processing  Contact: Please contact Dr Fadhl if you want to use this slides 2

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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 4

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 5

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 6

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 7

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 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

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

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

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

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

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

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

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

Maintenance interval Please contact Dr Fadhl if you want to use this slides  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. 17

Equipment classification examples 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

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

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 21

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

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

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

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 25

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

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 27

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

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 30

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 31

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

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 33

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 for patient care – Downtime costs money Regulations, accreditation requirements and standards. Please contact Dr Fadhl if you want to use this slides 34

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 35