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Measurement & calibration of medical equipments


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Measurement & calibration of medical equipments

  1. 1. • Definitions • Purposes • Metrology Basics • Role of BMET • Role CE • Documentation • Conclusion
  2. 2. Definitions Measurement is the process or the result of determining the ratio of a physical quantity, such as a length or a mass, to a unit of measurement, such as the meter or the kilogram. The science of measurement is called Metrology. Instrumentation is defined as the art and science of measurement and control. An instrument is a device that measures and/or regulates process variables such as flow, temperature, level, or pressure. Calibration is a comparison between measurements, one is set (standard) value and the other measured (practical) value that leads to process of corrective actions when results are out of limits. The accuracy of a measurement system is the degree of closeness of measurements of a quantity to that quantity's true value.
  3. 3. Definitions The precision of a measurement system , also called reproducibility or repeatability , is the degree to which repeated measurements under unchanged conditions show the same results. High Accuracy Low Precision Low Accuracy High Precision A measurement system is designated valid if it is both accurate and precise
  4. 4. Example NIBP measurement supposed to be within tolerance of 5 mmHg, therefore: ± 1 mmHg ± 2 mmHg ± 3 mmHg ± 4 mmHg ± 5 mmHg
  5. 5. By performing the test 3 times: (a) (b) (c) We notice all the readings within the tolerance but the following points are reasonable: • Figure (a): with low accuracy and precision is not acceptable and requires calibration • Figure (b): High Accuracy & precision , Calibration not required • Figure (c): High precision and low accuracy close to the limit, Calibration is recommended
  6. 6. Purpose of Measurement The purpose of measurement is to provide information about a quantity of interest - a measurand. For example, the measurand might be the flowrate, potential difference, or energy .. Etc. No measurement is exact. When a quantity is measured, the outcome depends on: • The measuring system, • The measurement procedure, • The skill of the operator, • The environment, and other effects.
  7. 7. Metrology Basics • Metrology includes all theoretical and practical aspects of measurement • A core concept in metrology is (metrological) traceability, defined as "the property of the result of a measurement or the value of a standard whereby it can be related to stated references, usually national or international standards, through an unbroken chain of comparisons, all having stated uncertainties.“ • Traceability is most often obtained by calibration, establishing the relation between the indication of a measuring instrument and the value of a measurement standard. • Mistakes can make measurements and counts incorrect. Even if there are no mistakes, nearly all measurements are still inexact.
  8. 8. BMET Role  The basic program for BMET was established to prepare him/her for conducting complete performance assurance and electrical safety testing. Performs preventive/scheduled maintenance on medical devices as required. Performs repairs and calibrations with the highest degree of complexity or requiring expert diagnostic and repair skills, among other responsibilities.  With the advancement of medical technology field, the sophistication of medical equipments is incremental every year, which requires highly skilled BMET of well-established academic program. Although, certain categories of medical equipments regulations required certified BMET or certified service engineer to work with the equipment.  Therefore, many original equipment manufacturers (OEM) have emphasized that no one allowed to dismantle or service their products such as life support equipments, sophisticated technology, and surgical equipments unless OEM-certified technicians/engineers.
  9. 9. Clinical Engineer Role  Biomedical engineers, by definition, apply the concepts, knowledge, and techniques of virtually all engineering disciplines to solve specific problems in the biosphere. When biomedical engineers work within a hospital or clinic, they are more properly called clinical engineers.  American College of Clinical Engineering has defined the Clinical Engineer as a professional who supports and advances patient care by applying engineering and managerial skills to healthcare technology.  Cost-effective management of a medical equipment calibration and repair service  Supervision of the safety and performance testing of medical equipment performed by BMETs  Training of medical personnel in the safe and effective use of medical devices and systems  Development and implementation of documentation protocols required by external accreditation and licensing agencies  Establish quality control (QC) & quality assurance (QA) program for medical technology and maintains CMMS data secured and updated.
  10. 10. Documentation BME Program of documentation was established to document and maintain the important data according to the following procedure: I. Documentation of New Equipment: I. Equipment Details (Description, Manufacturer, Model, S/N, Control No, ECRI code, Vendor .. etc.) II. PO Details (PO#, Date, Cost, Warranty type & period, Contract#, Install Date, Acceptance Date .. Etc.) II. PPM Documentation: (Equipment details, Test Equipment, Qualitative Check, Quantitative Measurement, Electrical Safety, Calibration Data .. Etc.) III. W.O. Documentation: (W.O.#, Equipment Details, Incident/Defect Details, Repair Details, Utilized Spare Parts, Vendor Service Report as applicable, .. Etc.) IV. All Original Service Reports to be filed by companies and copies only attached to W.O. & PPM. V. Quality Assurance Documentation by Clinical Engineers: Random samples of PPMs & W.O. to be tested and documented for variety of equipments from different disciplines.
  11. 11. Conclusion  In light of the above, and by reviewing equivalent organizations practice for medical equipment that obviously confirm the inarguable truth that measurement and calibration is just a daily function of BMET as the medical equipments are highly specialized, risky (involving life-support and surgical equipments) and advanced technology that all demanding the personnel –BMET- who is responsible about the service, troubleshooting, and calibration to have specialized body-of-knowledge and certified training from OEM, plus field experience in many equipments is required.  The Aim of this tutorial and future sessions is to keep an open communication channel through interactive discussion of all departmental emerging issues and to encourage the teamwork spirit by sharing the ideas and knowledge of interest. In addition, the training sessions also, will be documented and accounted for the benefits of attendees.