Management of Health Care Technology

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Code Completion Credits Range Language
F7ABBESP Z,ZK 2 1P+1C English
Garant předmětu:
Jiří Hozman
Jiří Hozman
Iva Batíková, Václav Bláha
Department of Biomedical Technology

There is necessary and mandatory attendance for all exercises. Apology is possible in case of one case only (only serious reasons). The course ends with assessment and exam. As regards assessment, there are required 3 mandatory presentations, i.e. presentation (PPT, PPTX or PDF file) of the topic „organizational chart of the typical hospital in my country“ (including www links), presentation (PPT, PPTX or PDF file) of the topic „legislation of the medical device in my country“ (including www links) and presentation (PPT, PPTX or PDF file) of the typical technical standard (norm) for medical devices in my country (including www links). As regards exam test, i.e. 20 questions with three possible answers, only one is always correct - multiple choices) evaluated with respect to the grading scale ECTS. Max. number of points is 100, i.e. for one right answer 5 points and for wrong answer 0 point. The minimum number of points is 50 pts for this exam test.

Syllabus of lectures:

1. Introduction to the subject of medical technology management, the aim of the course. Introduction of new software and technologies in healthcare facilities. Technical standards for the use and application of PPE. Harmonised standards. Declaration of conformity, care of PPE, quotation.

2.Interpretation of basic concepts. Scheme of regulation of production, distribution and use of medical devices by legal and technical regulations, technical standards, Law 22/1997Sb., infusion technology.

3.Law on medical devices, selection of its essential and important provisions.

4.Air conditioning in health care, three-stage air conditioning. Risk classes of PPE, rules for its determination according to n.v. 54/2015 Coll. Ionizing radiation. Protection against its adverse effects. Legal regulation of the use of sources of ionizing radiation, Act 263/2016 Coll. (Atomic Act), Decree of the SUJB.

5.Pressure vessels in health care. Medical gases, water, steam. Revision. Electrical distribution systems. Types of sterilization, steam sterilization system, feed water, application of different types of sterilization, hollow instruments.

6.Metrological provision of medical instruments. Law 505/1990 Coll. on metrology, Decree 345/2002 Coll. on specified measuring instruments, marks of metrological bodies certifying their law. Uncertainty of measurement, selection of measuring instruments, symptom analysis, carrying out technical checks at the hospital workplace by own forces.

7.Public Procurement Act: award of contracts by open procedure, auction. Documents for purchase contracts, works contracts, service contracts.

Syllabus of tutorials:

1. Conditions for credit. Thematic division of exercises. Assignment of basic concepts. Design of software content for a specific clinic. Demonstration of real hospital system software. Recording of medical devices.

2.Working with class IIb and III medical devices. What devices belong to this category. How to handle these products. Familiarity with testers. Management of instrumented medical devices. Routine technical inspection.

3.Working with Class IIb and III medical devices. What devices belong to this category. How to handle these products. Uncertainty of measurement. Performance of BTK on ECG or tonometer (verification) or defibrillator or medical thermometer (verification).

4.Creating a maintenance plan with a division between internal and external maintenance. Work with the operating manual. Determining the risk class of different types of medical devices. Performing BTK on an infusion pump or linear dispenser or vital signs monitor.

5.Preparing tender documents for a medical device. Tender conditions.

6.Tendering procedure. Preparation of the tender.

7.Determination of set and working gauges. Metrological rules. Calibration, verification, validation. Preparation of accompanying documentation for the selected medical device. Preparation of the purchase or work contract for the subject of the successful tender. Service contract.

8.Presentation of independent works - practical demonstration of measurements

Study Objective:

The aim of the course is to introduce students to all requirements in terms of ensuring the operability and functionality of medical technologies, explain the application of legislation and describe the basic requirements of operation. Special attention is paid to cleanliness of the premises, washing of medical devices and sterilization.

Study materials:

Mandatory literature:

[1] WILLSON, Keith. Medical equipment management. Boca Raton: Taylor & Francis, 2014. ISBN 9781420099591.

[2] Managing medical devices within a regulatory framework. Waltham, MA: Elsevier, 2016. ISBN 9780128041796.

[3] MINIATI, Roberto, Ernesto IADANZA a Fabrizio DORI. Clinical engineering: from devices to systems. Amsterdam:

Elsevier, 2016. ISBN 978-0-12-803767-6.

[4] Clinical engineering: a handbook for clinical and biomedical engineers. Editor Azzam F. G. TAKTAK, editor Paul

GANNEY, editor Dave LONG, editor Paul WHITE. Amsterdam: Elsevier, 2014. ISBN 978-0-12-396961-3.

Recommended literature:

[1] Medical Devices: Regulations, Standards and Practices. Elsevier Science, 2015. ISBN 9780081002919.

[2] WANG, Binseng. Medical equipment maintenance: management and oversight. San Rafael: Morgan & Claypool,

2012. Synthesis lectures on biomedical engineering. ISBN 978-1-62705-056-2.

[3] IEC 62353 International standard - Medical electrical equipment - Recurrent test and test after repair of medical

electrical equipment: Norme internationale - Appareils électromédicaux - Essai récurrent et essai aprés réparation d'un

appareil électromédical. Geneva: International electrotechnical commision, 2014.

[4] Clinical engineering handbook. Editor Joseph F. DYRO. Amsterdam: Elsevier Science & Technology, 2004. Academic Press series in biomedical engineering. ISBN 9780080476575.

Time-table for winter semester 2023/2024:
Time-table is not available yet
Time-table for summer semester 2023/2024:
Kotenová I.
Bláha V.


(lecture parallel1
parallel nr.1)

Kladno FBMI
Lab. nemoc. infor. systémů
Kotenová I.
Bláha V.


(lecture parallel1
parallel nr.1)

Kladno FBMI
Počítačová učebna
Hozman J.

(lecture parallel1)
Kladno FBMI
Demo. lab. LPT, ZS a VP
The course is a part of the following study plans:
Data valid to 2023-11-30
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