Biomedical engineering, patient safety and standards
When electronics must work every time — because a human life might depend on it
Most electronic devices breaking down is annoying. If medical technology breaks down at the wrong time, the consequence can be far more serious. Therefore medical engineering is one of the specializations at the course level 3 that requires extra — not just technical skill but systematicity, documentation and understanding that the patient is always what it is all about.
§What is medical technology?
The biomedical engineer works with the electronic equipment used to monitor, examine and treat patients — from measuring vital parameters and heart rhythms to imaging systems, ventilators and equipment for surgery and anaesthesia. The education's objectives specifically state that you should be able to ensure patient safety in biomedical work, including performing safety tests according to applicable safety standards and clinical testing of equipment — and that you should have basic knowledge of anatomy, physiology and hospital hygiene, because the technical work here is never separated from the patient it ultimately affects.
§IEC 60601-1 — the standard for safe medical electrical equipment
The central international standard for electrical medical equipment is IEC 60601-1, which sets out the general requirements for basic safety and essential performance. It covers, among other things, protection against electric shock, fire and other electrical hazards, as well as requirements for electromagnetic compatibility, software safety and the equipment's robustness under both normal and foreseeable abnormal use. In practice, the standard means that equipment in direct or close contact with patients must be designed and tested significantly more rigorously than consumer electronics — because a failure here not only costs a device, but can cost a person's health.
§The EU's regulation of medical devices
Beyond the technical safety standard, medical devices in the EU are covered by the Medical Device Regulation (MDR) which sets requirements for how equipment is classified by risk, documented, marked and monitored throughout its lifetime — also after it is put into use. The higher the risk class of the equipment, the more comprehensive the requirements for documentation, testing and follow-up. For you as a technician, this means that every intervention, every repair and every calibration must be documented so the equipment's history can always be traced.
§Why hygiene and anatomy are part of the technical trade
It may seem surprising that an electronics education includes knowledge of anatomy, physiology and hospital hygiene — but it makes good sense when you remember where the equipment is used. A medical technician who doesn't understand how an apparatus relates to the body may overlook why a particular error margin is dangerous in that specific context. And equipment that moves between departments and patients must be handled so it doesn't itself become a source of infection — hospital hygiene is therefore just as much the technician's responsibility as the clinic's.
- 01Safety testing according to applicable standards before and after service
- 02Calibration so the equipment's measurements can still be trusted
- 03Documentation of every repair, test and calibration
- 04Hygienic handling of equipment moving between patients
- 05Clinical testing where relevant before equipment is used again
§Clinical informatics and further dissemination
The education's goals also point to the medical technician having knowledge of clinical informatics—that is, how information technology is used in the healthcare system—and being able to participate in training other staff groups in medical technical equipment. This reflects that the subject is not only about repairing a box, but about being the person who can explain to clinical staff how the equipment works and what they should be aware of in their daily work.
“In medical device technology, a well-written service report is just as important as a well-functioning apparatus — both protect the patient.”
— Professional view on medical technology.