26 3-2-redert

German model of clinical

engineering

Roland Redert, Dipl. Ing. (FH) Medizintechnik

TL Krankenhaus Agatharied / FKT- Medical Engineering: www.fkt.de

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

Hospital organisation

Hospital director

Business Administration Technical Department Personal and organisations

Director

Pole

- Quality

- Marketing

- Business Development

- Patient service

Directorate

- Head of Medicals

- Head of Nurses

- Head of Administration



Head of Technical Dep. Technical Engineer

/ Secretary

IT

Master Craftsman / Engineer

Hotline / System admin

System admin

Hardware Support

Software Support

Electrical Dep.

Master Craftsman

Electrician

Electronic technician

Electronic technician

Heating, Sanitary, Air Condition., Mechanic.

Master Craftsman

Mechanic for heating

Mechanic for air- conditioning

Plumber

Mechanic for bed

Civil Engineering / Caretaking

Civil Technician/ Engineer

Concierge 2 (e.g. Carpenter)

Concierge 3 (e.g. Painter)

Concierge 4

(e.g. Bricklayer)

Medical Engineering

Medical Engineer

Medical Engineer / Technician

e.g. Electrician with specific knowledge

Energy Management / CAD / Projects

Operational Safety

hospital technical dep.



IT mostly not part of

Technical Dep.

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



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)



MDD 93/42 EWG

• German law: MPG

„Medizinproduktegesetz“

• Enactment for building up, running,

applying and servicing medical devices,

e.g. in hospitals: MPBetreibV

„MedizinprodukteBetreiberVerordnung“



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




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




MPBetreibV § 4, (1): Maintenance

Requirements for correct maintenance of

medical products:

– Specific knowledge

– Principal qualification - requisite

– Required tools disposable



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



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


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.



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.



http://www.fbmt.de/

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)



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


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.



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

– ..





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

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)



Incident reporting

Formular has to be filled out (6 pages)



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



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



FKT

Collaboration of executive technicians

of german hospitals, aiming for

practical exchange of experience and

promotion of professional education.



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.



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.



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 !!





Documents

26 3-2-redert