Concept for the Development of a Course of Lectures at Higher Education Level for Training Students of Medical Engineering
Theme of Course: “Safety in Medical Engineering”
Script 2010 19 Pages
- Safety in Medical Engineering
- Aims of the Course
- Legal Regulations
- Tasks of a Medical Engineer
- Mechanical Safety
- Electrical Safety
- Current, Voltage, Resistance
- Resistances in the Human Body
- Effects of Electricity on the Human Body
- Electrical Safety Precautions
- Power Supply Systems
- IEC Protection Classes
- Classification of Locations Used for Medical Purposes
- Currents and Leakage Currents in Medical Engineering
- Electrical Safety Measurements
- Safety-Related Controls
- List of References
This concept is intended to help develop a course of lectures specially aimed at training medical engineering students within the scope of Engineering or Bachelor studies at an institute of higher education.
It should contain and illustrate basic aspects regarding the content of a course of lectures with its emphasis on “Safety in Medical Engineering”. This instructional concept should also provide information and procedural instructions on drafting a lecture or lecture manuscript.
Safety in Medical Engineering
The term “safety” in medical engineering encompasses numerous, closely linked specialist fields. Safety in medical engineering includes electrical safety, mechanical safety and also chemical and hygienic safety, as well as the safety of medical devices and equipment themselves. This concept is particularly concerned with the electrical safety of medical devices and medical equipment. The aspect of mechanical safety can be addressed and elaborated on in other lecture courses such as “Materials” or “The use of plastics in medicine”.
The subject of chemical and hygienic safety can be addressed and elaborated on in lecture courses related to “Microbiology” and “Chemistry”. The aspect of safety within medical engineering is a component part of studies for students of medical engineering and, therefore, should be provided in a series of lectures which have been specifically organized, in didactic terms, for the topic. Parallel to the lectures, laboratory schedules should be drawn up during which the theory conveyed in lectures can be underlined by practical, in-depth experience using real medical devices.
Aims of the Course
The lecture course concerning “Safety in Medical Engineering” should have the following objectives and convey them. The course should explain to students of medical engineering how to handle and use medical devices and equipment in a responsible way. When doing so, it is important to include subjects involving the special requirements defined for the development and construction of medical apparatus. Medical engineering students must be made aware of the particular risks which specific medical devices represent and how to prevent these risks by being provided with practical examples. Medical engineering students must be taught how to apply basic legal requirements, specific directives and standards and have the various explanations linked to case studies and real incidents.
After having successfully completed the “Safety in Medical Engineering” lecture course, the students should be capable of assessing practice-related examples with and on medical apparatus. Students should also be able to develop and implement approaches to solutions to prevent safety-related sources of errors.
Main Legal Regulations
Since the safety of medical devices encompasses many bordering fields of expertise, only the basic legal regulations, directives and standards should (and can) be addressed during the course of lectures. The most important legal regulations applicable to everyday contact with medical devices are the following:
- Medical Devices Act (German MPG) Current version dated 24th July 2010 (BGBl. I S. 983). The purpose of this act is to regulate the trafficking of medical devices and, as a result, to ensure the safety, suitability and performance of medical device as well as to ensure the health of patients, users and third-parties is maintained and provide them with the necessary protection.1
- Medical Devices Operator Ordinance (German MPBetreibV) Current version dated 29th July 2009 (BGBl. I S. 2326). This directive applies to the installation, operation, usage and maintenance of medical products in accordance with § 3 of the Medical Devices Act with the exception of medical products for clinical tests or performance evaluation tests.2
- DIN EN 60601-1-2; VDE 0750-1-2:2010-05 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (IEC 60601-1- 2:2007, modified); German version EN 60601-1-2:2010.3
- DIN EN 62353; VDE 0751-1:2008-08 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment (IEC 62353:2007); German version EN 62353:2005 Edition: 2008-08 4
- DIN VDE 0701-0702; VDE 0701-0702:2008-06 Inspection after repair, modification of electrical appliances - Periodic inspection of electrical appliances General requirements for electrical safety Edition: 2008-06, Standard5
- DIN VDE 0100-710;2004-06
Erection of low-voltage installations - Requirements for special installations or locations - Part 710: Medical locations - Information sheet for the use of (IEC 60364-7-710:2002, modified) Edition: 2004-06.
- BGV A3 Accident prevention regulations Electrical installations and equipment Edition: 2005-01 Procedural instructions Electrical installations and equipment Edition: 2005-01.
This list of the most important basic legal texts, documents and standards does not claim to be complete.
However, it does represent a minimal requirement within the development of a concept for a course of lectures concerning “Safety in Medical Engineering”.
Tasks of a Medical Engineer
To begin the course, the students should be introduced to a detailed description of the occupational tasks for which a medical engineer is responsible. Three professional fields must be presented, accompanied by practical examples:
- Medical engineers involved in development
- Medical engineers involved in sales
- Medical engineers involved in service.
1 Gesetz über Medizinprodukte (Medizinproduktegesetz-MPG) Medizinproduktegesetz in der Fassung der Bekanntmachung vom 7. August 2002 (BGBl. I S. 3146), zuletzt geändert am 24.07.2010 (BGBl. I S.983)
2 Verordnung über das Errichten, Betreiben und Anwenden von in der Fassung der Bekanntmachung vom 21. August 2002 (BGBl. I s:3396), zuletzt geändert am 29.07.2009 (BGBl. I S. 2326)
3 DIN EN 60601-1-2; VDE 0750-1-2:2010-05 Medizinische elektrische Geräte - Teil 1-2: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale -Ergänzungsnorm: Elektromagnetische Verträglichkeit - Anforderungen und Prüfungen (IEC 60601-1-2:2007, modifiziert); DIN Deutsches Institut für Normung e.V. und VDE Verband der Elektrotechnik Elektronik Informationstechnik e.V. Berlin
4 DIN EN 62353; VDE 0751-1:2008-08 Medizinische elektrische Geräte - Wiederholungsprüfung und Prüfung nach der Instandsetzung von medizinischen elektrischen Geräten (IE 62A/504/CDV:2005); DIN Deutsches Institut für Normung e.V. undVDE Verband der Elektrotechnik Elektronik Informationstechnik e.V.Berlin
5 DIN VDE 0701-0702; VDE 0701-0702:2008-06 Prüfung nach Instandsetzung, Änderung elektrischer Geräte - Wiederholungsprüfung elektrischer Geräte - Allgemeine Anforderungen für die elektrische Sicherheit. DIN Deutsches Institutfür Normung e.V. und VDE Verband der Elektrotechnik Elektronik Informationstechnik e.V. Berlin