Safety in biomedical engineering and hazard analysis, 4 Credits

Contents

To ensure high patient and user safety, medical equipment is surrounded by special legislation. This puts great demands on companies and engineers to have sufficient knowledge about managing risks in the development and management of such products and systems. Today's medical equipment are often connected to the hospitals' medical records, giving complex digitized systems that are demanding to overview and control.
 
This course gives you knowledge of how medical equipment and power supply should be designed to meet the safety requirements for patients and hospital staff. The course addresses risks and security aspects concerning medical devices in the areas of electrical, gas and radiation safety, and provides an insight into the security issues surrounding information data systems and software development within the area of medical technology. A practical introduction is given to the field of risk management. The course also includes one smaller project as well as laboratory work.

The course consists of two modules:
1. Theory, 3 ECTS
2. Project and laboratory work, 1 ECTS

Expected learning outcomes

The student must be able to:
Knowledge and understanding

• Give detailed descriptions of how medical equipment and electricity distribution should be designed to meet current safety requirements.
• Thoroughly describe the safety problems concerning equipment for gas as well as gas distribution within a hospital.
• Thoroughly describe important safety aspects when working with different types of radiation.
• In detail explain security issues concerning information data systems and software development in the area of biomedical engineering. 

Competence and skills

• Perform a risk analysis on a medical device or method.

Judgement and approach

• Reflect on patient and user safety when using technology in healthcare.
• Evaluate and analyze potential risks with medical equipment to ensure safe working methods.
• Evaluate and analyze risk-benefit ratios when developing safe medical devices.

Required Knowledge

Univ: Biomedical Engineering 10 ECTS or Biomedical Sensors and analyses 7.5 ECTS and an instroductory course in medicine 5 ECTS or equivalent. At least 90 credits completed of a three-year engineering degree, or at least 90 credits in one of the main fields of computer science, electronics, physics, chemistry, mathematics or mathematical statistics. Proficiency in English equivalent to Swedish upper Secondary course English A/6. Where the language of instruction is Swedish, applicants must prove proficiency in Swedish to the level required for basic eligibility for higher studies.

Form of instruction

The teaching is campusbased and is conducted in the form of lectures as well as project and laboratory work. Participation in the project and laboratory work is mandatory. Teaching can take place in English.
 

Examination modes

Module 1: Theory 3 ECTS
This module is examined with a written examination. The grade is assessed with Fail (U), Pass (G) or Pass with Distinction (VG).
 
Module 2: Laboratory and project work 1 ECTS.
This module is examined individuelly with written laboratory reports and oral presentation. The grade is assessed with Fail (U) or Pass (G).
 
On the whole course the grades Fail (U), Pass (G) or Pass with distinction (VG) are set. To pass the course it requires that all examinations and obligatory modules are approved. The grade is based on the grade received on module 1.

A student who has received a passing result on an exam may not take a new exam.

The examiner can decide on deviations from the examination form of the syllabus. Individual adaptation of the form of examination must be considered based on the student's needs. The form of the examination is adapted within the framework of the curriculum's expected study results. A student who needs an adapted examination, and who has received a decision on the right to support from the coordinator for students with disabilities at the Student Centre, must request adaptation from the department responsible for the course no later than 10 days before the examination. The examiner decides on an adapted examination, which is then notified to the student.

Other regulations

In the event that the course expires or major changes are introduced, the students are assured at least three occasions of examination (including regular examination) as prescribed in the syllabus to the course that the student originally registered in over a period of a maximum of two years from the previous syllabus expired.