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E-MANAGEMENT OF MEDICAL DEVICES IN ITALY


D. Bravar, G. Carlini, A. Cortese, T. dell’Aquila and N. Pangher

ITAL TBS S.p.A., Area Science Park, Trieste, Italy


Abstract: Italian Health sector has been experiencing, from
several years, a re-organization process, to improve the
efficiency of medical devices management by the introduction of
new instruments, included internet. In this setting, many
companies offer innovative products via web to the health
administration, especially for e-procurement. Ital TBS is an
Italian Clinical Engineering Services company, managing
different biomedical equipment. Moreover it has been managing
the Italian Observatory of Prices and Technologies, on behalf of
the Italian Ministry of Health and the Friuli Venezia Giulia
region. Actually, the national Data Bank consist in more than
70,000 models of medical devices. The know-how acquired by
this activity makes Ital TBS the ideal company to create and
manage a web portal for biomedical equipment. In order to
write a sensible plan of development, we have completed a
thorough analysis of the European and Italian Legislation,
market analysis and analysis of competitors. The result is that
the market does not demonstrate strong reasons to buy on-line,
but is heavily interested in finding all possible information on
technical specifications, possible configurations and efficient
comparison of prices and performances. The ItalTBS choice is
developing a web portal to offer high quality information about
biomedical devices.

I. INTRODUCTION

Internet is going to become a very powerful tool for
improving the quality of the services offered by a wide
typology of companies. Although the public debate has been
centred mainly on B2C solution (Business-to-Consumer) the
market behaviour shows that the B2B solution (Business-to-
Business) will have a wider role.

Italian Health Sector has been experiencing a deep re¬
organisation process at different levels: the purchase process
and management, the financing systems, together with
expenditure control and human resources have been re¬
organised in order to improve the quality of care and cost
containment. E-procurement and e-consulting services will
have an important role in such a process.

From legislative point of view new rules are necessary to
allow the WEB-based purchase processes for the public
administration: among the European countries, Italy
produced one of the greatest efforts.

The recent hype about e-commerce has driven many
companies to offer products for hospitals through the internet.
ITALTBS is setting-up a portal for procurement and
management of medical devices in order to move its “off¬
line’' services in an “on-line” context.

ITALTBS Spa has a long experience in providing a wide
typology of services to health structures. Through its clinical
engineering services, the company provides more than 70
hospitals with advanced tools for the biomedical equipment


management:

- Consultancy on the purchase of equipment and medical
devices

- Preventive maintenance

- Corrective maintenance

- Inspections of newly acquired equipment

- Periodical check of equipment safety according to
European Community rules.

- Performance testing

From the end of 1996, the Italian Ministry of Health
financed a 3-years project of the Regional Health Authority
of Friuli-Venezia Giulia named “National Observatory of
Prices and Technology” (OPT). The aim of this observatory
is increase the available instruments to all public health
structures providing technical and economic information for
a more efficient management of medical devices.

The OPT program, that has been operated by Ital TBS
CIVAB in the framework of an agreement between the
Regional Health Authority and the Area Science Park, has
developed the following products:

1. Technical bulletins on 36 different categories of
biomedical equipment available on the national market;

2. A national Data Bank and a national Coding System of
medical equipment and devices;

3. A monitoring system of medical equipment and devices
(diagnostic reagents, X-ray films, hemodialysis filters,
pacemakers, angiographic catheters, implantable devices)
purchase prices, based on data collected from the Italian
Regions;

4. Remote consultation (via Internet) of technical
information and purchase prices of medical devices in the
National Health System.

Within this project the company has managed the National
Data Bank of Biomedical Equipment whose archives contain
technical and commercial data on about 70,000 different
models of medical equipment and devices such as
pacemakers, prostheses and diagnostic reagents.

II. METHODOLOGY

To create a model for an “Electronic Office for Medical
Devices management and procurement”, the Italian
Healthcare system must be analized. The Italian Healthcare
system is managed by public administration, based on a
strong discipline on purchase practices. A lot of European,
national and regional regulations bind to make tenders in
order to purchase medical devices. There are different rules
depending on the value of the items: over 200.000 Euro an
European tender must be performed, while usually under this
value it’s possible to make national tenders.



Report Documentation Page


Report Date Report Type Dates Covered (from... to)

25 Oct 2001 N/A

Title and Subtitle Contract Number

E-Management of Medical Devices in Italy

Grant Number
Program Element Number

Author(s) Project Number

Task Number
Work Unit Number

Performing Organization Name(s) and Address(es) Performing Organization Report Number

ITAL TBS S.p.A Area Science Park Trieste, Italy

Sponsoring/Monitoring Agency Name(s) and Address(es) Sponsor/Monitor’s Acronym(s)

US Army Research, Development & Standardization Group -

(UK) PSC 803 Box 15 FPO AE 09499-1500 Sponsor/Monitor’s Report Number(s)

Distribution/Availability Statement

Approved for public release, distribution unlimited

Supplementary Notes

Papers from 23rd Annual International Conference of the IEEE Engineering in Medicine and Biology Society, October
25-28, 2001, held in Istanbul, Turkey. See also ADM001351 for entire conference on cd-rom.. The original document
contains color images.

Abstract


Subject Terms



Number of Pages

3






Moreover depending on the particular region in Italy,
below a certain limit (ranging from 5000 to 25000 Euro)
“private bargaining rules” are performed, which allow an
administrator to buy a particular device after having received
offers from different suppliers (almost three offers).

Public commissions, composed by administrators, medical
doctors and technical consultants (typically clinical engineers
or healthcare consultants), judge the technical performances
and the economic conditions offered by the suppliers. The
technical performances are based on the clinical needs of the
physicians, on the amount of activity for the particular
equipment/device and on the funding available to the
hospital. The technical consultants can define a minimum set
of technical specifications which have to be satisfied and
result in a “go - no go” answer: the cheapest bid would then
win the tender. Another possibility is to define a complete set
of technical specifications with a related weight parameter,
which could be used to assign a score to the technical offer:
the combination of technical score and cost would then serve
as the parameter determining the winning bid.

During last years one of the core activities of ITALTBS has
been to deliver the consulting services for the purchase
commissions and this create the starting point to create a
model of the “Electronic Office for Medical Devices
Management”. An internet solution could offer to the
administrations a new, rapid and practical method of
publishing the technical specifications together with the
economic conditions and calling for bids available to all
interested suppliers.

Actually the average time needed to organize and conclude
a procurement process range from 10 to 18 weeks: the first 2
to 4 weeks are spent in defining the technical and economic
specifications for the devices to be purchased, while the
following period is used to receive the bids and analyse
results. Supplier provision offices always receive technical
specifications just in time to prepare an offer and often they
work in a little time.

In this terms also suppliers would be facilitated because
they could read immediately on line technical specifications,
download all documentation and send offers in digital format,
facilitating also the analysis of documentation.

The whole process time could be reduced by as much as
50% with a substantial impact on the costs of the procedure.

At the end, thank to the new rules, it would be possible that
hospital administrations can purchase medical devices as a
private administration. Web portal is designed to offers an e-
rnarket place in which it would be possible the organization
of inverse auctions, where the technical specifications could
serve as a pre-qualification and the bidders could make their
economic offers on-line, lowering the price in order to win
the bids. There will be a transact section to submit the
proposal, publish auction and create procurement groups.

Many new players have entered the market of e-commerce
in the healthcare sector, and normally only little information
is available about the results of the initiatives. About 15
competitors were identified in Europe: most of them are
directed to a national market, while about three are targeting
an European audience. An important target of the analysis


was to find financial information: are companies, offering e-
commerce solutions for the purchase of biomedical
equipment, successful? Data and comments are available
only about companies listed on stock exchanges.

III. RESULTS

The model of the “Electronic Office for Medical Devices
Management and Procurement ” is based on the transfer of
the off-line core competencies of ITALTBS in an on-line
context: the customer will be able to obtain the technical
specifications of the equipment, after answering a set of
questions about his clinical needs and more generally about
his activity.

In particularly, the available services (fig.l) are listed
below:

• Free access information

• On line consulting

• Auction on line

At the first level, principle of operation for the most
important medical equipment, the most interesting news from
the healthcare field, discussion forums on topics of great
interest in this field, workshop and congress, news (product
and actions) from manufacturers are available.

To access the second level, the customer needs to be
registered as a client. In this level he finds detailed technical
features and data for each product and informative sheets on
biomedical equipment.

In this level, the customer is guided to the definition of
technical specification of the device needed, by a guided list
of questions. The portal shows all the commercial products
and the medium price for this configuration, and list the
minimum technical specifications requirement.

On demand, the specifications can be included into a
specific document necessary for a tender of public
administration.

The third level is the organization of inverse auctions,
where the technical specifications could serve as a pre¬
qualification and the bidders could make their economic
offers on-line, lowering the price in order to win the bids.

The complete model of the web portal for the “Electronic
Office for Medical Devices Management and Procurement”
is described in Fig. 2.

IV. DISCUSSION

The Procurement Officers have expressed doubts about
concluding all the acquisition procedures on-line, through
auctions. For the moment, in the acquisition of biomedical
equipment and devices, particularly if characterized by high
technology content and important clinical effects, a
commission where also medical and technical experts are
present, is viewed as necessary. Only the commission can
sanction which equipment fits best the clinical, technical and
economic conditions set by the hospitals. Besides, some
critical points have been found, mainly due to the
organization complexity and the heterogeneity of the



Publish


Content


Transact


I Phase



^News on biomedical
technologies
^Information by suppliers
and Events

^Principle of operation of
Medical equipment
^Standards and guidelines
'''Links

^Health Yellow pages
^Scientific and technologic
advice


s Product technical
chart

v' Different equipment
configuration
s Auction archive
s On line support
s Map of installed
medical equipment
'''Price list



Workflow e Document


1 Management 1

*1 ---»J— _______ _►

! II Phase ! Ill Phase


: - v


Manufacturers, suppliers etc....



s Consult call for bids
s Send bids
v' Recive information on
auction results
s Auction News
s Specific Standards
s Standard’s updates
s Products statistical
data and issues





Figure 2: Description of “Electronic Office for Medical Devices Management and Procurement”.


purchase processes of health structures.

On the other side the legislation allows free movement to
the hospitals below the threshold of 200.000 Euro: this could
lead to the possibility of closing agreements with the single
hospitals to set up particular acquisition procedures. The
legal framework is therefore not completely clear, also
because e-commerce practices are still in their infancy. There
is room though for what are called experimentation: special
procedures that hospitals or regional health authorities can
follow in order to test new procedures.

v. Conclusion

Although the market does not demonstrate strong reasons
to buy on-line, it seems heavily interested in finding all
possible information on technical specifications, possible
configurations and efficient comparison of prices and
performances. To offer on-line services to the hospital
administration, the best choice may be starting from make
available via web high quality information about biomedical
devices in Italy and in Europe. Only in a second moment,
depending on the development of the market conditions, will
be possible the creation of a full e-marketplace with a on-line
auction activity.


References

[1] Inchingolo P., Fioravanti F. (1993): ‘Development of an
Italian data base of medical devices’, Proc. of IFMBE-CED
Workshop, Trieste, 1993, pp. 147-154

[2] delTAquila T., Bravar D., Buffolini F., Cortese A.,
Giuricin C., Pangher N., Trampus M. (1999): ‘The Italian
Observatory Of Medical Equipment And Devices’, Proc. of
EMBEC’99, Vienna, 1999, pp. 624-625

[3] Bowen D. (2000), ‘What happened to e-marketplace in
2000?’, article on www.devicelink.com











































































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