AMEK 2013 SCIENTIFIC CONFERENCE & EXHIBITION THEME: EMPOWERING FACILITY MANAGEMENT AND HEALTHCARE TECHNOLOGY IN KENYA

CHALLENGES OF CALIBRATION of MEDICAL EQUIPMENT and calibration AT THE MOI TEACHING And REFERRAL HOSPITAL

PRESENTED BY FELIX T. KARBOLO Tel: 0722-911 215 olelarbolo@gmail.com fkarbolo@yahoo.com

WELCOME

Introduction Calibration in Moi Teaching and Referral Hospital (MTRH) begun as one of vision 2030 flagship project associated with ISO 9000 certification requirement. Several audits ensued after the hospital was certified and calibration became a major cause of non conformance, this lead to the establishment of a comprehensive plan to correct the non-conformity. The corrective action was to come up with a calibration laboratory where all calibration of medical instruments and equipment will be carried out.

Introduction cont’n

Objectives To know what is calibration. To be able to differentiate between calibration and measurement. Determine the need/purpose of doing calibration in a hospital set up. Empower the public on technological advancement in healthcare (calibration, validation & verification). Get to know some challenges facing calibration.

OBJECTIVES OF CALIBRATION

ISO Definition of Quality Degree to which a set of inherent characteristics fulfills requirements. Characteristic – distinguishing feature (i.e. physical, sensory, temporal or functional etc. Requirement – need or expectation that is stated or implied or obligatory i.e. custom or common practice for you!

What is ISO QMS? What is QMS (Quality Management System)? QMS=MS (Management System) + QM (quality management) Where:- MS=System for establishing policy and objectives and how to achieve the objectives (Top management). QM=coordinated activities for achieving the quality objectives (operational level)

ISO 9000 & Calibration -Calibration is as a result of ISO 9000 conformance to requirement. ….in MTRH it basically came about as a corrective action to non-conformance of medical equipment & instruments to their measurement requirement. TRACEABILITY-Traceability is the unbroken chain of calibration/verification from a primary standard to the device in question -ISO is not our subject in these case.

What is calibration? -Set of operations that establish, under specified conditions, the relationship between values of quantities indicated by a measuring instrument or measuring system, or values represented by a material measure or a reference material, and the corresponding values realized by standards. -The natural process of transition that is used to measure accuracy and comparison of a measuring instrument that has standard to determine the possible errors in a specific scale.

What is Measurement? -The process of determining the value of some quantity in terms of a standard unit. -Set of operation having the object of determining a value of a quantity. What is metrology? ….it is the science of measurement.

Why Do We Calibrate? Uncertainty of Measurement? Uncertainty? To determine the uncertainty of measurement Uncertainty of Measurement? ….is a parameter associated with the result of a measurement, that characterizes the dispersion of the values that could reasonably be attributed to the measurand. Uncertainty? The degree of doubt about a measurement.

What is Accuracy? Precision. The closeness of the experimental mean value to the true value. High accuracy = Small systematic error. Precision. The degree of scatter in the results. High precision = Small random error

Parameters we calibrate Temperature. Pressure both positive and negative. Mass. Speed (tachometry). Conductivity AC/DC.

Conditions to check during calibration Temperature. Humidity. Vibration. Air flow. Poor handling of equipment. Noise level. Accessibility. Lighting. Cleanliness.

CALIBRATION REQUIREMENTS -The list of items required to undertake calibrations generally includes: A suitable environment. An appropriate standard. A set of pressure connection. A method of generating and regulating the pressure. A system of recording measurements. A method for calculating results. A procedure. Trained staff.

NEED/PURPOSE OF CALIBRATION To ensure readings from an instrument are consistent with other measurements and instruments. To determine the accuracy of the instruments readings. To establish the reliability of the instrument i.e. that it can be trusted. To maximize the safety of the patients and staff.

Factors that influence the result of measurement during calibration Means Methods Material Results and errors Man power Milieu/ surrounding

This is the 5 M diagram normally used in measurement to ascertain some factors that influence the end result of a measurement. Means. Method. Material. Milieu/Surrounding. Manpower.

Challenges of calibration in MTRH & MOH Lack of total support from top management. Lack of awareness from the other staff who are our customers. Lack of proper measurement standards. High expectation from top management and other stake holders. An under trained human resource. It’s expensive.

Challenges of calibration in Kenya It’s expensive. Lack of trained human resource. Lack of awareness about ISO standards (ISO 9000 & 17025). Public as stake holders are also not aware of this requirement.

The role of biomeds in calibration It’s the duty of biomeds to provide know how(CPD’s) in handling and use of measurement instruments and equipment. Calibrate parameters they are trained in. Prepare calibration schedules. Prepare standard operating procedures (SOP’s) for calibration.

RECOMENDATIONS There is a need for establishment of Regional Calibration Centre's (RCCs) by the MOH. At least 2 biomeds from each regional centre should be trained in calibration. For purposes of quality, it is imperative for the government to outsource this service to accredited calibration laboratories.

WHATEVER YOU DO, REMEMBER WHATEVER YOU DO, REMEMBER. ONE ACCURATE MEASUREMENT IS WORTH A THOUSAND EXPERTS OPINIONS & WE MEASURE FOR SAFETY

THANK YOU!! GOD BLESS BIOMEDS

QUESTIONS??