The Practice of Medical Metrology

.: PREFACE
ÖN SÖZ
PREFACE
Prof. Dr. Albert GÜVENİŞ
Boğaziçi Üniversitesi Biyomedikal Mühendisliği Enstitüsü, İstanbul, Türkiye
Article Language: TR
Sağlık, hayatımız için en önemli konudur. Son yüzyılda bilimsel çalışmaların hızlanması ile, tıp, kanıta, kantitatif değerlere ve ölçüme dayalı bir sisteme doğru yönelmiştir. Tıp hizmetlerinin kalitesi, yapılan ölçümlerin doğruluğu ve hassasiyeti ile orantılıdır. Ölçümlerde hata ve belirsizlikler, yanlış tanı ve tedavilere neden olurlar. Bu nedenle, tıpta ölçüm cihazlarının ve ölçüm protokollerinin doğru yönetimi hayati bir rol oynamaktadır. Metroloji, ölçüm bilimine verilen addır. Tıbbi metroloji, kalibrasyon cihazları, bilgi, süreç ve standartlardan oluşan karmaşık bir sistemdir. Tıbbi metrolojinin uygulanması ile ilgili yayınlar azdır. Bu kitabın amacı, bu önemli konudaki boşluğu doldurmaya yöneliktir. Tıbbi metroloji alanında çalışan çok önemli bilim insanları bu projeye destek vermiştir. Hepsine tek tek teşekkür ediyorum. Ayrıca bu projeyi hayata geçiren Türkiye Kinikleri'ne sonsuz teşekkürlerimi sunarım.

Kitabın, sağlık alanında çalışan çok çeşitli uzman ve profesyonellere faydalı olmasını amaçladık. Sağlık hizmetleri yöneticilerinden hekimlere, hemşirelerden teknisyenlere, klinik mühendislerinden kalite uzmanlarına kadar geniş bir okuyucu kitlesinin bu kitaptan yararlanabileceğini umut ediyoruz.

Kitabın hazırlanmasında tıbbi metrolojinin farklı alanları ve uygulamaları için o alanlarda emek vermiş, uluslararası yayınlar yapmış bilim insanlarından yardım istendi. Kitap aşağıdaki bölümlerden oluşmaktadır:

İlk bölümün başlığı ''Tıbbi Metrolojinin Temel Prensipleri'' ve yazarı Doç. Dr. Mana Sezdi. Bu bölümde, uzman personel eğitimi, yetkilendirilmiş kuruluşlar, tıbbi cihaz türleri, test, kontrol ve kalibrasyon ölçümlerinin temelleri ve bu faaliyetleri kapsayan yönetmelikler ele alınmıştır

İkinci bölümün başlığı ''Tıbbi Metrolojide Fantomlar'' ve yazarları Dr. Tarık Karabey ve Prof. Dr. Mehmet Ertuğrul. Radyografik cihazların değerlendirme ve kalite kontrol testlerinin yapılabilmesi için uygun olarak tasarlanan ve gerçek dokunun yerini alan malzemelere fantom adı verilir. Bu bölümde dokuların iletkenlik ve geçirgenlikleri, dielektrik özellikleri, görüntüleme tekniklerinde ve radyoterapide fantomlar, fantomların sınıflandırılması ve fantomların tasarımı konuları ayrıntılı olarak anlatılmıştır.

Üçüncü bölümün başlığı ''Sağlık Personelinin Tıbbi Cihaz Kalibrasyonu ile İlgili Hassasiyetleri'' ve yazarları Dr. Hafize Özdemir Alkanat, Dr. Mehmet Alkanat ve Doç. Dr. Fadime Üstüner Top. Bu bölümde, sağlık personelinin kullandığı tıbbı cihazlara ilişkin kalibrasyon bilgilerinin ve uygulamalarının, bakım kalitesi ve sağlık hizmetleri verimliliği açısından önemi vurgulanmaktadır.

Dördüncü bölümün başlığı ''Hastane Akreditasyonunda Kalibrasyon Çalışmaları'' ve yazarı Prof. Dr. Yekta Ülgen. Bu bölümde hastane akreditasyonunda kalibrasyon çalışmalarının yeri ve genel gereklilikleri anlatılmaktadır. Bilgisayar destekli tıbbi cihaz yönetimi, yeni alınan cihazların seçimi ve satın alma karar mekanizmaları, tıbbi cihaz kabul muayeneleri, kullanıcı eğitimleri, koruyucu bakımları, periyodik bakımları, performans test ve ölçümleri, güvenlik test ve ölçümleri, tıbbi cihaz kalibrasyonları, akreditasyon çalışmaları çerçevesinde ele alınmaktadır.

Beşinci bölümün başlığı ''Medikal Ölçümler İçin Metroloji'' ve yazarı Doç. Dr. Baki Karaböce. Bu bölümde, medikal metroloji alanında TÜBİTAK UME'de medikal cihazların kalibrasyon izlenebilirliğinin ve ölçüm güvenliğinin sağlanmasına yönelik kalibratör, analizör, simülatör ve fantomların kalibrasyonlarının gerçekleştirilmesi için kurulan altyapı ayrıntılı şekilde anlatılmaktadır. Ayrıca izlenebilirlik şemaları verilmiştir.

Altıncı bölümün başlığı ''Tıbbi Laboratuvarlar İçin Kalite Yönetmelikleri ve Akreditasyon Standartları'' ve yazarı Prof. Dr. Fikriye Uras. Bu bölümde tıbbi laboratuvarların akreditasyonu, ISO 15189 standartları ve standardizasyon konusunda yapılan son çalışmalar ele alınmıştır.

Yedinci bölümün başlığı ''Yeni Teknolojilerin ve Kalibrasyon Çalışmalarının Hasta Güvenliğine Etkisi'' ve yazarı Prof. Dr. Albert Güveniş. Bu bölümde tıp uygulamalarına son zamanlarda dahil edilen yapay zekâ, teletıp gibi yeni teknolojiler kalite kontrol ve hasta güvenliği açısından ele alınmaktadır

Son bölümün başlığı ''Tıbbi Laboratuvarlarda Ölçüm Belirsizliği ve Tanı-Tedavi Sonuçlarına Etkisi'' ve yazarları İbrahim Türk, Ayla Yıldız, Berrin Berçik İnal. Bu bölümde tıbbi metrolojide kullanılan terimler, hata ve belirsizlik modelleri, ölçüm belirsizliğini hesaplama yöntemleri ve mukayeseleri, kullanılan rehberler, tanı ve tedavideki uygulamalar ve ölçme belirsizliği raporlama şekilleri detaylı olarak anlatılmaktadır.

Kitabın tüm sağlık çalışanlarına yararlı olmasını temenni ediyorum.

Prof. Dr. Albert GÜVENİŞ
Editör
Health is the most important issue for our life. With the acceleration of scientific studies in the last century, medicine has moved towards a system based on evidence, quantitative values and measurement. The quality of medical services is strongly related to the accuracy and precision of the measurements. Errors and uncertainties in measurements cause misdiagnosis and wrong treatments. Therefore, the correct management of measuring devices and measurement protocols plays a vital role in medicine. Metrology is the name given to the science of measurement. Medical metrology is a complex system consisting of calibration devices, information, processes and standards. Publications on the application of medical metrology are scarce. The aim of this book is to fill this gap. Very important scientists and academicians working in this field have supported this project. I thank each and every one of them. I would also like to express my infinite gratitude to ''Türkiye Klinikleri'' which brought this project to life.

We aimed to make the book useful to a wide range of experts and professionals working in the field of health. We hope that a wide range of readers, from health care managers to physicians, from nurses to technicians, from clinical engineers to quality specialists, will benefit from this book.

In the preparation of the book, help was sought from academics and scientists who have worked in different fields and applications of medical metrology and have made international publications in those fields. The book consists of the following sections:

The title of the first chapter is ''Basic Principles of Medical Metrology'' and its author is Assoc. Dr. Mana Sezgi. In this section, expert personnel training, authorized organizations, types of medical devices, basics of testing, control and calibration measurements and regulations covering these activities are discussed.

The title of the second chapter is ''Phantoms in Medical Metrology'' and its authors are Dr. Tarik Karabey and Prof. Dr. Mehmet Ertuğrul. Materials that are designed appropriately for the evaluation and quality control tests of radiographic devices and replace real tissue are called phantoms. In this section, conductivity and permeability of tissues, dielectric properties, phantoms in imaging techniques and radiotherapy, classification of phantoms and design of phantoms are explained in detail.

The title of the third chapter is ''Healthcare Personnel's Sensitivity to Medical Device Calibration'' and its authors are Dr. Hafize Özdemir Alkanat, Dr. Mehmet Alkanat and Assoc. Prof. Dr. Fadime Üstüner Top. In this section, the importance of calibration information and applications for medical devices used by healthcare personnel in terms of quality of care and efficiency of healthcare services is emphasized.

The title of the fourth chapter is ''Calibration Studies in Hospital Accreditation'' and its author is Prof. Dr. Yekta Ülgen. In this section, the place and general requirements of calibration studies in hospital accreditation are explained. Computer-aided medical device management, selection of newly purchased devices and purchasing decision mechanisms, medical device acceptance examinations, user trainings, preventive maintenance, periodic maintenance, performance tests and measurements, safety tests and measurements, medical device calibrations, accreditation studies are handled.

The title of the fifth chapter is ''Metrology for Medical Measurements'' and its author is Assoc. Professor Dr. Baki Karaböce. In this section, the infrastructure established at TUBITAK UME for the calibration of calibrators, analyzers, simulators and phantoms in order to ensure the calibration traceability and measurement safety of medical devices in the field of medical metrology is explained in detail. In addition, traceability schemes are given.

The title of the sixth chapter is ''Quality Regulations and Accreditation Standards for Medical Laboratories'' and its author is Prof. Dr. Fikriye Uras. In this section, the accreditation of medical laboratories, ISO 15189 standards and recent studies on standardization are discussed.

The title of the seventh chapter is ''The Effect of New Technologies and Calibration Studies on Patient Safety'' and its author is Prof. Dr. Albert Güveniş. In this section, new technologies such as artificial intelligence and telemedicine, which have recently been included in medical applications, are discussed in terms of quality control and patient safety.

The title of the last chapter is ''Measurement Uncertainty in Medical Laboratories and Its Effect on Diagnosis-Treatment Results'' and its authors are İbrahim Türk, Ayla Yıldız, Berrin Berçik İnal. In this section, terms used in medical metrology, error and uncertainty models, measurement uncertainty calculation methods and their comparison, guidelines, applications in diagnosis and treatment, and measurement uncertainty reporting methods are explained in detail.

I hope the book will be useful to all healthcare professionals.

Prof. Dr. Albert GÜVENİŞ
Editor

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