26 3-1-freda

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.

http://www.aiic.it/

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

http://www.ord-ing-bo.it/home.htm

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)

http://www.accenet.org/default.asp

http://www.dea.uniroma3.it/biolab/images/htai.gif

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



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



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.



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.



• 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



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?


The involvement in purchasing activity is not stated by law









What about the university education?


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?


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


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


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


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

[email protected]

http://www.aiic.it/

mailto:[email protected]

Documents

26 3-1-freda