1. German model of clinical
engineering
Roland Redert, Dipl. Ing. (FH) Medizintechnik
TL Krankenhaus Agatharied / FKT- Medical Engineering: www.fkt.de

2. Content
1. Hospital organisation
2. Technical department
3. Internal vs. external service/engineering
4. Regulatory requirements?
5. Regulations by MDD
6. Education
7. Hospital engineer
8. Certification project
9. Further requirements
10. Responsible electrician
11. Operational safety
12. Authorised persons
13. IT-software
14. Incident reporting
15. Procurement in hospital
16. FKT
17. FKT project „technical hospital manager“
18. Further associations
Dipl. Ing. R. Redert, TL KH-Agatharied
FKT – Medical Engineering: www.fkt.de 2012, Sep., Folie 2

3. Hospital organisation
Hospital director
Directorate Pole
- Head of Medicals - Quality
- Head of Nurses - Marketing
- Head of Administration - Business Development
- Patient service
Personal and organisations
Technical Department Business Administration
Director
Dipl. Ing. R. Redert, TL KH-Agatharied
FKT – Medical Engineering: www.fkt.de 2012, Sep., Folie 3

4. hospital technical dep.
Head of Technical Dep.
Technical Engineer
IT mostly not part of / Secretary
Technical Dep.
Energy
Management / Operational
CAD / Projects Safety
IT Electrical Dep. Heating, Sanitary, Air Civil Engineering /
Medical Engineering
Condition., Mechanic. Caretaking
Master Craftsman / Master Craftsman Master Craftsman Civil Technician/
Medical Engineer
Engineer Engineer
Medical Engineer
Hotline / System Electrician Mechanic for Concierge 2
/ Technician
admin heating (e.g. Carpenter)
e.g. Electrician
Mechanic for air-
Electronic Concierge 3 with specific
System admin conditioning
technician (e.g. Painter) knowledge
Electronic Concierge 4
Hardware Plumber
technician
Support (e.g. Bricklayer)
Mechanic for bed
Software Support
Dipl. Ing. R. Redert, TL KH-Agatharied
2012, Sep., Folie 4
FKT – Medical Engineering: www.fkt.de

5. Internal vs. External
• Mostly technical departments with own people
– Degree of personal contribution may differ
 matter of cost efficiency / responsibility of work /
law (e.g. fire alarm system) / personnel capacity
– Contracts in particular for specific tasks or on a
regular base, e.g. for maintenance of high tech
equipment
• Outsourcing of technical department or parts of it
(e.g. head/manager) seldom
• Sometimes own private limited company
Dipl. Ing. R. Redert, TL KH-Agatharied
2012, Sep., Folie 5
FKT – Medical Engineering: www.fkt.de

6. Regulatory
requirements ?
• Head of technical department
– Any Engineer
• Section/Group leader
– Master craftsman
• Medical Group: „Servicing medical
equipment“
– Head of: Engineer / Technician
– Member: Assistant (e.g. Electrician)
Dipl. Ing. R. Redert, TL KH-Agatharied
2012, Sep., Folie 6
FKT – Medical Engineering: www.fkt.de

7. MDD 93/42 EWG
•  German law: MPG
„Medizinproduktegesetz“
•  Enactment for building up, running,
applying and servicing medical devices,
e.g. in hospitals: MPBetreibV
„MedizinprodukteBetreiberVerordnung“
Dipl. Ing. R. Redert, TL KH-Agatharied
2012, Sep., Folie 7
FKT – Medical Engineering: www.fkt.de

8. Regulation of servicing by MDD
MPBetreibV § 2, (1): Basic rules
Medical products may only be built up, run,
applied and serviced when is observed:
– assigned purpose by manufacturer
– general rules of technology
– rules for accident prevention
Dipl. Ing. R. Redert, TL KH-Agatharied
FKT – Medical Engineering: www.fkt.de 2012, Sep., Folie 8

9. Regulation of servicing by MDD
MPBetreibV § 2, (2) / §4 (3): Personal
qualification
Medical products may only be built up, run,
applied and serviced by persons with
appropiate
– Education
– Specific knowledge for maintenance on
medical products
– Experience
Dipl. Ing. R. Redert, TL KH-Agatharied
2012, Sep., Folie 9
FKT – Medical Engineering: www.fkt.de

10. Regulation of servicing by MDD
MPBetreibV § 4, (1): Maintenance
Requirements for correct maintenance of
medical products:
– Specific knowledge
– Principal qualification - requisite
– Required tools disposable
Dipl. Ing. R. Redert, TL KH-Agatharied
FKT – Medical Engineering: www.fkt.de 2012, Sep., Folie 10

11. Requirements for testing
medical devices
• Electrical measurement: DIN VDE 0751
(not DIN VDE 0702 !)
•  People with appropiate
– Education (also profound knowledge of MDD-MPG,
MPBetreibV, ..)
– Specific knowledge for maintenance on
medical products, practical experience
– Knowledge of guidelines of manufacturer
– Ability to verificate the faultless condition of a
medical product
– Appropriate measurement tools
Dipl. Ing. R. Redert, TL KH-Agatharied
FKT – Medical Engineering: www.fkt.de 2012, Sep., Folie 11

12. Education in medical
engineering
• Polytechnical institutes for medical
technicians (2 years)
• Bachelor (7 semester)
• Master (10 semester)
– Approx. 40 universities offer courses in
medical technology in Germany
– Diversifications:
• Biomechanics
• Medical electronics
• Design and building of machines …
Dipl. Ing. R. Redert, TL KH-Agatharied
2012, Sep., Folie 12
FKT – Medical Engineering: www.fkt.de

13. Hospital engineer
• There is just 1 university offering clinical
technology (focused on technical facility
management, specificly for hospitals)
• Additional courses at universities
There is principle no recognized
professional/working profile for a clinical
engineer.
Dipl. Ing. R. Redert, TL KH-Agatharied
2012, Sep., Folie 13
FKT – Medical Engineering: www.fkt.de

14. Certification project
Fbmt (association of biomedical
engineering: www.fbmt.de)
• Offers + promotes certification of
technicians working on medical devices.
• Trying to establish standard for
technicians without specific high school
degree.
• Refreshment on a regular basis desired.
Dipl. Ing. R. Redert, TL KH-Agatharied
2012, Sep., Folie 14
FKT – Medical Engineering: www.fkt.de

15. Further Requirements
• Some manufacturer require certifications
to work on their equipment (minimisation
of risk ..), especially on hygiene related
products as medical desinfectors or
sterilisators.
• Technical standards (DIN, ISO, ..) may
define requisits (e.g. for any alarm
equipment)
Dipl. Ing. R. Redert, TL KH-Agatharied
2012, Sep., Folie 15
FKT – Medical Engineering: www.fkt.de

16. Responsable
Electrician
DIN VDE 1000-10
• Formal denomination required in any
entity-hospital!
– (Master craftsman or engineer)
• Responsable for electrical security
• Freedom of functional direction and
guidance
• Actual knowledge  Ought to attend
courses
Dipl. Ing. R. Redert, TL KH-Agatharied
2012, Sep., Folie 16
FKT – Medical Engineering: www.fkt.de

17. Operational safety
Technical Rule for operational safety
TRBS 1203
Definition of actual technical standard,
occupational health and -hygiene and consolidated
findings for providing and use of means for work
as well as supervision requiring systems.
 Employer has to entrust ‚Authorised persons‘
for testing.
Dipl. Ing. R. Redert, TL KH-Agatharied
FKT – Medical Engineering: www.fkt.de 2012, Sep., Folie 17

18. Authorised persons
Responsibility of employer to entrust ‚authorised persons‘
for plenty of tasks with relevance of security, e.g.:
– Waste
– Occupational health-doctor
– Occupational safety-at-work expert
– Fire safety engineer
– Data protection official
– Risk prevention officer
– Hygiene safety medical, ..
– Authorised persons for medical devices
– Radiation protection officer
– Environmental officer
– ..
Dipl. Ing. R. Redert, TL KH-Agatharied
FKT – Medical Engineering: www.fkt.de 2012, Sep., Folie 18

19. IT-Software
Borderline between IT-department and
medical-engineering/technical group for
software is not generally defined
– needs hospital specific regulation
– in certain cases singular responsibility
(e.g. Webserver of medical monitoring, ..)
 DIN EN 80001: Risk management for
medical devices in medical networks
Dipl. Ing. R. Redert, TL KH-Agatharied
2012, Sep., Folie 19
FKT – Medical Engineering: www.fkt.de

20. Incident reporting
MDD MPG MPBetreibV §3
Any incident with a medical device has to be
reported to “Bundesinstitut for pharma and
medical devices” (Public body for vigilation,
evaluation and measurements)
Responsibility in hospital matter of internal
regulation (departmental note)
Dipl. Ing. R. Redert, TL KH-Agatharied
2012, Sep., Folie 20
FKT – Medical Engineering: www.fkt.de

21. Incident reporting
 Formular has to be filled out (6 pages)
Dipl. Ing. R. Redert, TL KH-Agatharied
2012, Sep., Folie 21
FKT – Medical Engineering: www.fkt.de

22. Procurement in
hospital
• No official regulation
• Mostly procurement department in general
–  Public procurement rules!
• For medical devices
– Prealignment between doctors, medical
technichians and procurement important!
– High end devices: Planning by medical
engineering department / external engineering
office
Dipl. Ing. R. Redert, TL KH-Agatharied
2012, Sep., Folie 22
FKT – Medical Engineering: www.fkt.de

23. FKT
Fachvereinigung Krankenhaustechnik e.V.
Association of engineers working in hospital
• General hospital maintenance
• Members mostly heads of technical
departments
• President: Horst Träger
• Spokesman for Medical engineering:
Roland Redert
Dipl. Ing. R. Redert, TL KH-Agatharied
2012, Sep., Folie 23
FKT – Medical Engineering: www.fkt.de

24. FKT
Collaboration of executive technicians
of german hospitals, aiming for
practical exchange of experience and
promotion of professional education.
Dipl. Ing. R. Redert, TL KH-Agatharied
2012, Sep., Folie 24
FKT – Medical Engineering: www.fkt.de

25. FKT
Main aspects
•Contact person for all hospital related technical matters
•Optimizing maintenance on building and medical devices
•Assuring availability of devices
•Economic operation
•Promoting operational safety
•Expertise of technicial employees for reconstruction work and
procurement
•Participation in design of new technical rules and laws
•Supporting education.
Dipl. Ing. R. Redert, TL KH-Agatharied
2012, Sep., Folie 25
FKT – Medical Engineering: www.fkt.de

26. FKT-project „hospital
engineer“
Workgroup for definition of job description
„hospital engineer“
 technical hospital manager
– general tasks
– necessary skills
– required education
Coordination with Austria and Switzerland in
cooperation with high schools planned.
Dipl. Ing. R. Redert, TL KH-Agatharied
FKT – Medical Engineering: www.fkt.de 2012, Sep., Folie 26

27. Further Assoc.
• WGKT www.wgkt.de
– Mainly universitary and research aspects
• VDE-DGBMT www.vde.com/de/fg/DGBMT
– German society biomedical engineering
• Fbmt www.fbmt.de
– Primarily medical technology engineering
• DKG e.V. www.dkgev.de
– German society of hospital institutions
• … and more !!
Dipl. Ing. R. Redert, TL KH-Agatharied
2012, Sep., Folie 27
FKT – Medical Engineering: www.fkt.de

28. Dipl. Ing. R. Redert, TL KH-Agatharied
2012, Sep., Folie 28
FKT – Medical Engineering: www.fkt.de