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TRANSCRIPT
10° Congreso Nacional SEEIC 2012
26 >28 September 2012, Barcelona - Spain
«European Models for Clinical Engineering Departments», 26 september 2012
Dott. Ing. Paola FREDA Director of Clinical Engineering Unit
A.O. Città della Salute e della Scienza di Torino (ex Molinette Hospital) - Italy
AIIC President
www.aiic.it
www.
Italian Association of Clinical Engineer
Found in Milan in 1993
Mission: Protect the profession of Clinical Engineering helping to spread the Clinical Engineering Services within health national system as an element for economic governance, safe and appropriate use of technological biomedical assets
Statute, Regulation and controlling body of AIIC
Controlling body of association
(cfr. Statute, Art. 4):
Meeting of Members
President
Executive board
Vice-president
Arbitration Council
Regional Contacts
Treasurer
Statute: gives
principles and basic
rules of association
Regulation:
practical
implementation
Categories of members
Main features N° %
MASTER DEGREE, JOINED AIIC AT LEAST 5 YEARS 30 4
MASTER DEGREE AND AT
LEAST 2 YEARS OF
EXPERIENCE IN CLINICAL ENGINEERING
265 31
MASTER DEGREE AND AT
LEST 1 YEAR OF
EXPERINCE IN CLINICAL ENGINEERING
107 13
TECHNICAL
PROFESSIONIST AND
MASTER DEGREE WITHOUT EXPERIENCE
126 15
STUDENTS 280 33
UNIVERSITY, COMPANY, NATIONAL ISTITUTIONS 36 4
Membership growth over time and geographical
distribution
49%
27%
24%
September 2012 Members Increase%
2000 96 0
2001 120 25
2002 162 35
2004 212 31
2005 223 5
2006 260 17
2007 318 43
2008 382 20
2009 521 36
2010 690 32
2011 738 7
2012 847 15
Agg. al 06-9-12
96 120 162 212 223 260
318 382
521
690 738
847
0
200
400
600
800
1000
2000 2001 2002 2004 2005 2006 2007 2008 2009 2010 2011 2012
mem
ber
s
year
Increasing number of members AIIC
Growth of supporting members
Supporting members AIIC
at the september 2012: 36
Supporting members
AIIC in the 2008: 4
Supporting members AIIC
in the 2010: 29
Main Partnership with national organisation and
scientific societies
Promotion of Clinical Engineers and AIIC
WEB SITE SCIENTIFIC MAGAZINES
WWW.AIIC.IT
NATIONAL CONGRESS
International link
• Affiliation to IFMBE • Attendance Clinical Engineering Directory (CED) • Link to USA colleagues of ACCE • Biomedical Advisory Council (BAC)
UPCOMING INTERNATIONAL
• X Congreso Nacional de la Sociedad Espanola de
Electromedicina e Ingegneria Clinica. Attendance
international session «European models for Clinical
and Engineering departements» , Barcellona 26
September 2012
• 1° Swiss Clinical Engineering Meeting, Basel 26
October 2012
• XIII Mediterrean Conference on Medical and
Biological Engineering and Computing MEDICON
2013, Sevilla
Organisation of National Health System
(SSN)
The regional health services are
•Aziende Sanitarie Locali (A.S.L.), Local Health Authority
•Aziende Ospedaliere (A.O.), Hospital
Organization
•Both provide services to population, the first with local district on territory
•Both have economical, administrative and organizational autonomy and authority
Governance
•General Director
•Administrative Director
•Sanitary Director
•Operative Units Complex and Simple (UOC and UOS): directors of different medical specialties with the task of co-ordination and organizing. There is always a UOC or UOS that has task of control of technical activities
ORGANISATION OF CLINICAL
ENGINEERING SERVICE IN ITALY
NAME
INTERNAL SERVICE
MIXED SERVICE
EXTERNAL SERVICE
ORGANISATION OF CLINICAL
ENGINEERING SERVICE IN ITALY
NAME MAIN FEATURES
INTERNAL SERVICE
It represents the first proposed
organizational model since the ‘80. It is
composed of Clinical Engineer and
Biomedical Technicians , all employed by
the National Health System. Usually the
Clinical Engineer is also director of UOC or UOS
ORGANISATION OF CLINICAL
ENGINEERING SERVICE IN ITALY
NAME MAIN FEATURES
MIXED SERVICE
This model is typical of ASL or AO that has only a
Clinical Engineer director in UOC or UOS. He is
involved in many activities, i.e. the planning of
purchase , HTA , risk management , test and
management of medical equipment , personnel
training ecc . Others like the maintenance and
safety check are performed by employees of a
specialized private company. Usually there is also a
Clinical Engineer , part of a private company, like is
always present a structure of expenditure control
by the National Health System.
ORGANISATION OF CLINICAL
ENGINEERING SERVICE IN ITALY
NAME MAIN FEATURES
EXTERNAL SERVICE
All activities are outsourced to external
service companies that could be also the
medical device producer or a group of several
producers. The Health National System
provides a fixed fee for all the period of
contract. This organizational model provides
especially the maintenance and the other activities could be not planned.
ORGANISATION OF CLINICAL
ENGINEERING SERVICE IN ITALY
• The existence of a Clinical Engineering Department is NOT required by law both for National Health System and private structure.
• Currently AIIC has proposed an amendment that should be introduced in Italian law of Clinical Governance in order to recognize the role of CED institutionally (“SIC”).
• The importance of CED is recognized, especially for the activity of maintenance, by the recommendation n° 9/2009 of Ministry of Labor of Public Health and Social Policy. The recommendation states that is necessary a structure with task of supervision, also with penal responsibility, of the maintenance and this is the CED where it exists.
• Following the indications of the recommendation n° 9 some Italian regions has institutionally established the role of CED in every local structure
ORGANISATION OF CLINICAL
ENGINEERING SERVICE IN ITALY
Report on Clinical Engineering Service by AIIC 2010
ORGANISATION OF CLINICAL
ENGINEERING SERVICE IN ITALY
Report on Clinical Engineering Service by AIIC 2010
ORGANISATION OF CLINICAL
ENGINEERING SERVICE IN ITALY
Report on Clinical Engineering Service by AIIC 2010
32%
24%18%
13%
13%
Clinical Engineering Service are in staff of:
TechicalManagement
AdministrativeDirection
Sanitary Direction
General Direction
Other
What about main activities?
Report on Clinical Engineering Service by AIIC 2010
The involvement in purchasing activity is not stated by law
What about main activities?
Report on Clinical Engineering Service by AIIC 2010
What about main activities?
Report on Clinical Engineering Service by AIIC 2010
What about main activities?
Report on Clinical Engineering Service by AIIC 2010
What about main activities?
Report on Clinical Engineering Service by AIIC 2010
What about the university education?
Report on Clinical Engineering Service by AIIC 2010
There are Biomedical Engineering courses in the most important Universities of Italy (Turin, Milan, Rome, Naples). A school of specialization in Clinical Engineering was founded 20 years ago in Trieste.
What about the university education?
Report on Clinical Engineering Service by AIIC 2010
Some data on Italian market of medical devices
Data by Assobiomedica (2010) Million of euro
Production in Italy 1448
Export 844 (58% of production)
Italian Production for Italian
market 644
Import 5757 (83% on Italian Market)
Italian market 6965
• For the report (2010) of the association of producers and suppliers of medical device (Assobiomedica) Italian market is the third in Europe behind Germany and France
• In the last assembly Assobiomedica has announced an estimate of 25-30% reduction in spending on the purchase of devices and services
The value of spending on maintenance
Report on Clinical Engineering Service by AIIC 2010
In the 44% of cases spending for maintenance is between 4,5% and 6% of the value of replacement
Regulatory requirements for servicing
• The decree-law 81/08 establishes the obligatoriness of regular servicing of devices and working environment for the safety of all workers. For the same decree the employer must ensure the right installation, the correct use and servicing of all devices.
• The Decree of the President of Republic 14 January 1997 states that in every health structure must be a complete plan for regular and extraordinary servicing of medical devices.
• The decree-law 46/97 establishes that all medical devices can work just with an appropriate servicing and appropriate installation and correct use. Moreover for the same decree the instruction for correct use must specify also all information about the frequency of the maintenance and calibration operations.
• Many technical standards by CEI and UNI determine how to make the operations of maintenance and calibration in “workmanlike” manner.
Software medical devices
• Due to the 2007/47/EC (software regarded as a medical devices) also software is included in servicing operation by the Italian Law ( decree-law 37/2010 and subsequent amendments on servicing). So all the next operations are necessary also for software: testing, validation, servicing (regular and extraordinary), dismissing.
• But there is NO OFFICIAL regulation about the responsibility on software medical devices. Of course every hospital has a structure responsible for it.
• Where is present, the CED has the responsibility also on software. The other responsible is the ICT Department
• The most frequent condition is: ICT Department is responsible for computer network infrastructure (also networking of new medical devices), while CED is responsible for medical software. Sometimes there is the difference between network for medical device (under CED responsibility) and other network (ICT responsibility
• Biomedical and Clinical Engineer has all the necessary skills to manage the proper integration between medical devices and computer network
Ing. Paola Freda
Az. Osp. Città della Salute e della Scienza, Turin
• Electronic engineer – bioengineering, Politecnico of
Torino, Italy
• I have worked for 12 years (1987 – 1999) by WABCO
Westinghouse of American Standard Group (now an
Ansaldo - Faiveley Company) in development of RFID
system for toll, intermodal and rail transport
• In 1999 I won a public competition as Engineer
Director of Technological Unit in Hospital S. Giovanni
Battista of Turin (Molinette), and on May 2004 I
became the Director of new Clinical Engineering
• Coordinator of HTA Nucleo Tecnico in Aress Piemonte
• In the main board of AIIC since 2005
• President of AIIC since 2010
Ing. Paola Freda
San Giovanni Battista Hospital
• Nowadays the hospital is part of
the largest A.O. of Europe, Città
della Salute e della scienza di
Torino (12.000 employees)
• 1175 beds in San Giovanni
Battista (The third one in Italy)
• More than 40 medical
specializations
• 5735 employees
• 983 Doctors and 1988 nurses
• More than 20.000 equipments
• 9 TC + 1 TC for radioteraphy,
• 5 RMN
• 5 Gamma Camera
• 7 LINAC
• 8 Angiography
• 1 Da Vinci Robot
• More than 30 surgery rooms
• University center
Ing. Paola Freda
San Giovanni Battista Hospital
Maintenance activity
• Internal Technicians &
vendor assistance (CT,
NMR , Digital X-Ray, US
Hi tech, lithotripsy,
LINAC, nuclear medicine,
endoscopy, dialisys,
diagnostics laboratories
and blood analysis)
• Amount : > = 14.800 €
million/year (leasing
excluded)
Employees
• 1 Clinical Engineer
(Director)
• 8 office workers
• 1 Technician
Responsible
• 5 Technicians
• 2 Biomedical Engineer
(tecnical support
contract)
Ing. Paola Freda
San Giovanni Battista Hospital
Employees
• 1 Technician Responsible
• 2 Senior Technicians
Purchase support
• Technical activity from
HTA up to technology
validation after put in
service (collaudo).
• Preparation of technical
doc for bid, participation
in technical bid
commission, performing
of putting into service
(collaudo) of all the
biomedical equipment.
Biomedical ICT
(may 2012)
• 1 ICT Responsible
• 1 senior Technician
UPCOMING NATIONAL
XIII Convegno Nazionale AIIC
Stazione Marittima – Napoli
11 – 13 aprile 2013
LA CONVERGENZA FRA
MEDICAL DEVICE AND
INFORMATION TECHNOLOGY
Ing. Claudio Cecchini
Az. Osp. Valtellina Valchiavenna
Thank you very much for your
attention
Dott. Ing. Paola FREDA
Director of Clinical Engineering Unit S. Giovanni Battista
A.O. Città della Salute e della Scienza di Torino
(ex Molinette Hospital) - Italy
AIIC President
www.aiic.it