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BECCCBiomedical Equipment Calibration

and Consultation Center(BECCC)

Medical Device Quality Assurance

االكوع فضل دالعام المدير

الطبية الهندسة بقسم مساعد أستاذجامعة – الطبية األجهزة في دكتوراه

القاهرةhttp://

fadhl-alakwa.weebly.comfadlwork@gmail.com

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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:http://fadhl-alakwa.weebly.com/

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Laboratory work

infusion pump Electrical surgical unit Mechanical ventilator Electrical safety analyzer Spectrophotometer Defibrillator Patient safety Sphygmomanometer

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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.

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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.

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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.

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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

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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

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What we need?

We need medical equipment

management plan

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Medical device included in the management plan

equipment management (EM) number.

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Equipment function

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Physical risk associated with clinical application

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Maintenance requirements

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Equipment incident history

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Included devices

All devices with a total EM number of 12 or more will be included in the programme and scheduled for inspections and preventive maintenance.

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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.

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Equipment classification examples

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Equipment classification examples

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Responsibility

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Medical equipment Classifications

Deliver energy (ESU, Def , Pacemaker ) Control Fluid(IP, SP) Display ECG, SPO2, TEMP, CO, BP,HB(PM,

ECG)

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Medical equipment ClassificationsDeliver energy (ESU, Def , Pacemaker )

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Medical equipment ClassificationsControl Fluid(IP, SP)

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Medical equipment ClassificationsDisplay ECG, SPO2, TEMP, CO, BP,HB(PM, ECG)

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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)

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Calibration

Accuracy Precision Standards

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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

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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

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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

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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

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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

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Why Test & Calibration

What you cannot measure you cannot control

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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.

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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.

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Terminology

Quality Safety Incidents Risk Hazards Repair Calibration Maintenance Call medical equipment priority number Medical equipment management plan Inspection template JCI Metrology