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Legislation and Medical Technology Management

* Exchange students do not have to consider this information when selecting suitable courses for an exchange stay.

Course Unit Code450-2066/01
Number of ECTS Credits Allocated2 ECTS credits
Type of Course Unit *Compulsory
Level of Course Unit *First Cycle
Year of Study *Third Year
Semester when the Course Unit is deliveredSummer Semester
Mode of DeliveryFace-to-face
Language of InstructionCzech
Prerequisites and Co-Requisites Course succeeds to compulsory courses of previous semester
Name of Lecturer(s)Personal IDName
PET497Ing. Lukáš Peter, Ph.D.
CIH07RNDr. Josef Čihák
Summary
The subject "Legislation and management of medical technology" will provide basic and information on the use of medical devices in terms of valid legislation. The course focuses on the internal structure and function of the healthcare facility, on technical development and investment activities, on medical devices - ZP - their division according to a number of views, compilation of investment plans with acquisition of ZP, cooperation of technicians ensuring and guaranteeing correct and safe use of ZP in providing health care, the entire administration and records of the PA. The subject acquaints with the laws applicable to the use and management of the ZP, with the technical standards for ZP instrumentation, with the standards for construction of ZP, the metrology law, the quality management system from the point of view of the medical device, as well as from the point of view of the manufacturers of medical technology.
Learning Outcomes of the Course Unit
The aim of the course is to prepare students to work with the necessary legislation for medical devices both from the point of view of hospital facilities and from the point of view of manufacturers of medical technology.
Upon completion of this course the student will be acquainted with the basic concepts in the field of management of medical technology both from the point of view of the manufacturer and from the point of view of the users of medical technology. The student will know how to work with European regulations, standards and recommended documents for medical devices. This subject focuses mainly on the necessary legislation in the field of management and management of medical devices.
Course Contents
1.First hour
• Introduction to the management of medical devices

2. Basic terms
• ISO, MDR, MDD, CSN EN, MEDDEV

3.Management of medical devices from the point of view of the hospital
• Organizational Structure and Management of Health Facilities, Medical Environment, Place, Role and Administration of Medical Devices, Legislation and Medical Devices, SÚKL, VZP, Notified Body, Notification, Accreditation

4. Health rules
• Health Safety, Adverse Events and Risks, Multidisciplinary Team, Interfaces to Healthcare Activities and Competencies

5. Biomedical technician / hospital engineer
• Position of technician / engineer, Legislation in performance of his work, Safety of medical device, Definition of other important concepts.

6.Equipment of individual workplaces
• Legislation for procurement, operation and maintenance of medical devices, Management of the assets of individual workplaces, Protection from individual sources of radiation, Patient environment, Medical device - waste

7.Metrology of medical devices
• Verification and Calibration of Meters, Units for Health, Safety Tests

8 - 9. Service support
• Legislation, Safety inspections, Disposable use of medical devices, In vitro and implantable medical devices

10 - 11.Management of quality system for manufacturers
• ČSN EN ISO 13485: 2016, Structure, Applications, Certification, Registration, Declaration of Conformity

12 - 14.Technical component
• Structure, Requirements, Content, Marking of medical devices, Usability of medical devices, Validation and verification of medical software, Clinical trials, Clinical trials, Clinical trials, Biological evaluation, Risk analysis
Recommended or Required Reading
Required Reading:
Presentation of lectures
MDR 2017/745.The EU Medical Devices Regulation, 2017, 175 p.
LEPAKHIN, K. V. Medical Device Regulations–Global Overview and Guiding Principles. WHO, Geneva, 2003.
Prezentace z přednášek
MDR 2017/745. NAŘÍZENÍ EVROPSKÉHO PARLAMENTU A RADY (EU) 2017/745, 2017, 175 p.
LEPAKHIN, K. V. Medical Device Regulations–Global Overview and Guiding Principles. WHO, Geneva, 2003.
VEJROSTA, Vladimír. Konstrukce zdravotnických elektrických přístrojů: aplikace požadavků mezinárodních a evropských norem. Česká společnost pro zdravotnickou techniku, 2001.
Recommended Reading:
ISO 13485:2016. Medical devices -- Quality management systems -- Requirements for regulatory purposes. International Organization for Standardization, 2016. 36 p.
ISO 14971:2007. Medical devices -- Application of risk management to medical devices. International Organization for Standardization, 2007. 82 p.
COUNCIL DIRECTIVE 93/42/EEC concerning medical devices, 1993, 58 p.
Another regulatory documents
ČSN EN ISO 13485 ed. 2. Zdravotnické prostředky - Systémy managementu kvality - Požadavky pro účely předpisů. Praha: Český normalizační institut, 2016. 56 p.
ČSN EN 14971. Zdravotnické prostředky - Aplikace řízení rizika na zdravotnické prostředky. Praha: Český normalizační institut, 2012. 80 p.
MDD 93/42/EHS. SMĚRNICE RADY 93/42/EHS o zdravotnických prostředcích, 1993, 58 p.
Další platné předpisy a normy
Planned learning activities and teaching methods
Lectures, Individual consultations
Assesment methods and criteria
Task TitleTask TypeMaximum Number of Points
(Act. for Subtasks)
Minimum Number of Points for Task Passing
Credit and ExaminationCredit and Examination100 (100)51
        CreditCredit40 20
        ExaminationExamination60 31