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F7ABBESP - Management of Health Care Technology

Code Completion Credits Range Language
F7ABBESP Z,ZK 2 1P+1C English
Jiří Hozman (guarantor)
Václav Bláha, Kristýna Koldová, Iva Kotenová, Petr Kudrna
Department of Biomedical Technology

Absolutní podmínka: docházka min. 70 % na cvičeních, zvládnutí testu, který bude na začátku tří cvičení, nad 50 % úspěšnosti, v případě nižší úspěšnosti studentovi není započítána docházka na cvičení.

Podmínky zkoušky:

5 otázek v testu, každá hodnocena 10 body, ústní zkouška 2 otázky, každá hodnocena 25 body. Celkové hodnocení stupnicí ECTS ve SZŘ.

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:
The course is a part of the following study plans: