Commission staff working document accompanying the :#Communication from the Commission to the European Parliament and the Council on patient safety, including the prevention and control of healthcare-associated infections and the: # Proposal for a Council recommendation on patient safety, including the prevention and control of healthcare associated infections #Impact assessment {COM(2008) 836 fianl} {COM(2008) 837 final} {SEC(2008) 3005}
Date: 2008-12-15
Institutions: European Commission
Subjects: disease prevention, health care, health policy, organisation of health care

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EN 

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 15.12.2008 
SEC(2008) 3004 

COMMISSION STAFF WORKING DOCUMENT 

accompanying the 

COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN 
PARLIAMENT AND THE COUNCIL 

on patient safety, including the prevention and control of healthcare-associated 
infections 

and the 

Proposal for a 

COUNCIL RECOMMENDATION 

on patient safety, including the prevention and control of healthcare associated 
infections 

IMPACT ASSESSMENT 

{COM(2008) 836 fianl} 
{COM(2008) 837 final} 
{SEC(2008) 3005} 

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IMPACT ASSESSMENT1 

on a proposal for a Council Recommendation on patient safety and quality of health 
services, including the prevention and control of healthcare-associated infections 

1 

On the basis of the Impact Assessment Guidelines of 15 June 2005 (SEC(2005) 791) 

ii 

 
                                                 
TABLE OF CONTENTS 

Procedural issues and consultation of third parties ...................................................... 7 

Organisation and timing ............................................................................................... 7 

Consultation and expertise ........................................................................................... 7 

The Impact Assessment Board................................................................................... 11 

Terminology ............................................................................................................... 11 

The problem and its causes ........................................................................................ 12 

Adverse Events: The Size of the Problem.................................................................. 12 

The Public Perception of Adverse Events.................................................................. 16 

Current Member State Actions................................................................................... 16 

Current EU Actions.................................................................................................... 17 

Problems still to be addressed .................................................................................... 18 

The right of the Union to act – Subsidiarity test ........................................................ 22 

Objectives................................................................................................................... 25 

General objective........................................................................................................ 25 

Specific objectives...................................................................................................... 25 

Operational objectives................................................................................................ 25 

Policy options............................................................................................................. 26 

Analysis of impacts .................................................................................................... 29 

Policy option I: No additional EU action – status quo............................................... 31 

Policy option II: Strengthened cooperation with the Member States and other 
bodies, supported by technical guidance.................................................................... 36 

Policy option III: Strengthened cooperation with the Member States and other 
bodies, supported by soft law instruments, such as a Commission 
Communication and a Council Recommendation...................................................... 38 

Policy option IV: Strengthened cooperation with the Member States and other 
bodies, supported by a regulatory instrument, such as a Commission Decision ....... 39 

Comparing the options ............................................................................................... 40 

Advantages and disadvantages of the policy options identified in section 6 ............. 40 

Conclusions ................................................................................................................ 44 

Monitoring and evaluation ......................................................................................... 44 

1. 

1.1. 

1.2. 

1.3. 

2. 

3. 

3.1. 

3.2. 

3.3. 

3.4. 

3.5. 

4. 

5. 

5.1. 

5.2. 

5.3. 

6. 

7. 

7.1. 

7.2. 

7.3. 

7.4. 

8. 

8.1. 

8.2. 

9. 

9.1. 

Progress indicators and surveillance .......................................................................... 44 

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9.2. 

Evaluation................................................................................................................... 45 

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EXECUTIVE SUMMARY 

The  goal  of  this  paper  is  to  present  the  impact  assessment  on  a  proposal  for  a 
Communication  and  a  Council  Recommendation  on  patient  safety  and  quality  of 
health  services,  including  the  prevention  and  control  of  healthcare-associated 
infections. 

Patient safety is a growing issue across Europe. It is estimated that between 6.7 and 15 
million hospital admissions and over 37 million consultations in the primary care setting 
result in an adverse event for the patient as a result of receiving that healthcare. 

However,  Member  States  have  varying  levels  of  awareness  of  the  extent  and  type  of 
adverse events occurring in their health systems and dedicate varying levels of resources 
and expertise to counter the problem. Due to the varying levels of policy commitments it 
is  currently  not  possible  to  obtain  and  compare  incidence  rates  across  Europe,  as 
reporting does not yet take place everywhere and, where it does, not on the basis of the 
same criteria and definitions. That also implies that not enough information is available 
on  safety  levels  in  healthcare  systems  or  on  the  help  available  for  those  harmed  by 
healthcare. Current research findings, learning, experiences and expertise available in 
the  EU  are  not  sufficiently  benefiting  patients.  Not  enough  authoritative  guidance  is 
available to support patient safety efforts, such as agreed case definitions, guidance on 
best practice and requirements for infrastructure and processes. 

Although the problem of patient safety is primarily the responsibility of Member States, 
the European Union can support their efforts by taking actions where it has competence 
and - more broadly - in facilitating the exchange of good practice. Action by the EU is 
underpinned  by  the  need  to  address  the  consequences  of:  1.  cross-border  provision  of 
healthcare resulting from mobility of patients and professionals, 2. trans-border spread 
of infections, and 3. the lack of EU-wide data collection and monitoring.  

The general objective of the Recommendation is to prevent and reduce human illness 
and diseases and to obviate sources of danger to human health (as stipulated in Article 
152  of  the  Treaty),  through  1.  protecting  EU  citizens  from  preventable2  harm  in 
healthcare,  2.  supporting  the  Member  States  to  put  in  place  adequate  strategies  to 
prevent  and  control  adverse  events  in  healthcare,  including  healthcare-associated 
infections  and  3.  improving  EU  citizens'  confidence  that  they  have  sufficient  and 
comprehensible  information  on  levels  of  safety  and  available  redress  in  EU  health 
systems. 

Four  policy  options  were  identified  and  analysed  in  terms  of  their  possible  social, 
economic  and  environmental  impact:  I.  No  additional  EU  action  but  ongoing  research 
and  projects  continue  –  the  status  quo,  II.  Strengthened  cooperation  with  the  Member 
States and other bodies, supported by technical guidance, III. Strengthened cooperation 
with the Member States and other bodies, supported by soft law instruments, such as a 
Commission  Communication  and  Council  Recommendation,  and  IV.  Strengthened 
cooperation  with  the  Member  States  and  other  bodies,  supported  by  a  regulatory 
instrument, such as a Commission Decision. 

2 

"Preventable" was, in our scenarios defined as what is considered avoidable with current state of 
the art knowledge and policies, but it should be noted that preventability also evolves over time 
when more experience and knowledge about patient safety is being gathered. 

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Based  on  this  impact  assessment,  the  policy  option  of  a  proposal  for  a  Commission 
Communication  and  a  Council  Recommendation  on  patient  safety  and  quality  of 
health  services,  including  the  prevention  and  control  of  healthcare  associated 
infections,  is  preferred.  In  a  quantitative  simulation  -  that  used  as  a  base,  incidence 
rates reported in the literature and an evaluation of MS current policies against what is 
considered  best  practice  in  the  relevant  literature–  we  tried  to  give  an  idea  about  the 
potential  for  reduction  in  adverse  events.  It  was  estimated  that  a  reduction  of  750.000 
preventable3 adverse events across EU could be reaped with the preferred option – if all 
MS  established  a  patient  safety  policy  (above  all  reporting  and  learning  systems)  that 
performed as good as countries currently listed in the second best out of five categories 
(with a 10 % incidence rate).  

The cost savings and health benefits of patient safety policies would not come for free - 
as  healthcare  institutions  will  have  to  redeploy  personnel  form  healthcare  to  patient 
safety monitoring and reporting. To e g reap a 20% reduction in healthcare associated 
infections,  dedicated  infection  control  staff  will  be  needed.  Secondly,  also  government 
spending  for  patient  safety  will  be  necessary  to  allow  for  upfront  investment  and 
supporting action at national level. However there is solid evidence and agreement about 
the cost effectiveness of such policies in the long term with cost savings between 50.000 – 
1.5 million Euros for a 300 bed hospital. 

3 

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1.  PROCEDURAL ISSUES AND CONSULTATION OF THIRD PARTIES 

1.1. 

Organisation and timing 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

In  October  2004,  the  World  Health  Organization  (WHO)  launched  the  World 
Alliance for Patient Safety in response to a World Health Assembly Resolution 
(2002)  urging  countries  to  pay  the  closest  possible  attention  to  the  problem  of 
patient safety. 

A topic chosen by the European Commission for the first Global Patient Safety 
Challenge  covering  2005  and  2006  was  healthcare-associated  infections 
(HCAIs.) 

The  focus  on  HCAIs  followed  the  Commission's  report  to  the  Council  (COM 
(2005) 0684) on the implementation of Council Recommendation (2002/77/EC) 
on  the  prudent  use  of  antimicrobial  agents  in  human  medicine.  The  report 
outlined a variety of measures already taken by Member States in line with the 
Council  Recommendation;  it  also  highlighted  the  areas  of  the  Council 
Recommendation needing further attention, one of which was infection control 
to reduce the spread of resistant organisms. 

Not only emergence (under selective pressure of antimicrobials) but also spread 
is  an  important  driver  of  the  problem  of  resistance  and  therefore  the 
Commission  decided  to  take  an  initiative  in  the  area  of  infection  control  by 
developing recommendations on the prevention and control of HCAIs. 

More  generally,  on  patient  safety,  a  conference  organised  by  Luxembourg,  as 
Council  Presidency,  adopted  in  April  2005  the  Luxembourg  Declaration  on 
Patient Safety4. 

Following  this,  the  patient  safety  working  group  of  the  High  Level  Group  on 
Health Services and Medical Care was set up to identify areas where European 
collaboration and coordination of activities could bring added value. 

In 2007, the Working Group agreed on some recommended actions, which were 
subsequently endorsed by Member States, through the High Level Group  

Against this background, patient safety, including the prevention and control of 
HCAIs, was made a strategic item under the Commission's legislative and work 
programme 2008. The intention is to adopt a proposal in late 2008. 

1.2. 

Consultation and expertise 

1.2.1.  External consultation and expertise 

High Level Group on Health Services and Medical Care  

The  patient  safety  working  group  of  the  High  Level  Group  on  Health  Services  and 
Medical Care has met regularly since 2005. As well as representatives from the Members 
States,  it  includes  pan-European  organisations  representing  doctors,  nurses,  patients, 

4 

http://europa.eu.int/comm/health/ph_overview/Documents/ev_20050405_rd01_en.pdf 

7 

 
                                                 
hospitals,  pharmacists  and  dentists  as  well  as  the  Organisation  for  Economic  Co-
operation  and  Development  (OECD),  the  Council  of  Europe  (CoE)  and  WHO.  This 
working  group  has  played  a  key  role  in  defining  the  issues  described  in  this  impact 
assessment, as well as refining the options for action. 

Other  stakeholder  mechanisms  such  as  the  EU  Health  Policy  Forum,  the  European 
Consumers  Consultative  Group,  the  Health  Systems  Working  Party  and  the  EU  Social 
Dialogue Group on Hospitals have also had presentations on the issues. 

Network  on  communicable  diseases  and  the  European  Centre  for  Disease  Prevention 
and Control (ECDC) 

In the field of infection control, a document on 'Strategies for improving patient safety by 
prevention and control of healthcare-associated infections' was drafted with the help of a 
panel  of  experts.  This  incorporated  comments  from  the  surveillance  authorities  of  the 
Community network on communicable disease established by Decision No 2119/98/EC 
of  the  European  Parliament  and  the  Council5.  The  strategies  in  this  document  form  the 
basis for recommendations on the prevention and control of HCAIs. 

Expertise and data were also obtained from the ECDC.  

EC funded projects 

Projects  funded  by  the  Public  Health  Programme6  and  by  the  Research  Framework 
Programmes7  have  also  addressed  aspects  of  the  problem  of  patient  safety  and  HCAIs. 
Details of some of these are in section 3 and/or in Annex 1. 

Public consultation – preliminary results 

A web-based public consultation on actions on patient safety was launched on 25 March 
2008 and closed on 20 May 2008. 184 responses were received. 

The participants can be divided into eight categories, as in the table below. 

Table 1: Overview of the responses received 

Group 

NGO's 

Competent authorities total 

CA's at national level 

Number of responses 

36 

32 

17 
(CY; CZ; FI; IE; LV; SE; UK; MT, ES) 

CA's at regional level 

10 

5 

6 
7 

OJ  L  268/1  Decision  No  2119/98/EC  of  the  European  Parliament  and  of  the  Council  of  24 
September  1998  setting  up  a  network  for  the  epidemiological  surveillance  and  control  of 
communicable diseases in the Community 
http://ec.europa.eu/health/ph_projects/project_en.htm 
http://ec.europa.eu/research/index.cfm 

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CA's at local level 

Health professional associations 

Hospitals 

Patient and Consumer organisations

Industry 

Academia 

Anonymous responses and others 

Participants total 

5 

25 

21 

12 

8 

6 

44 

184 

As shown in the table above, the NGO's represented the biggest group with 19% of the 
total  responses,  followed  by  the  competent  authorities  with  17%,  health  professionals 
with 14%, hospitals with 11%, patient and consumer organisations with 6%, industry 4%, 
with and academia with  3%. Twenty-four percent of the responses were  anonymous  or 
could  not  be  categorised  in  any  of  the  groups  mentioned.  In  addition,  19  replies  were 
received outside of the on-line system. 

From a preliminary analysis, the responses indicated strong support for both national and 
Community action on patient safety, as illustrated in the chart below. 

Figure 1: 

Importance of a national or EU Patient Safety (PS) Strategy 

Importance of a National or EU PS-Strategy

4

171

14

163

100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

0%

National PS- Strategy

EU PS-Strategy

Very important/ important

not particularly important/ not important 

In  the  questionnaire,  the  Commission  put  forward  nine  possible  areas  of  action.  All  of 
these received strong support from an overwhelming majority of participants. The chart 
below  shows  how  the  areas  were  ranked.  In  fact,  political  leadership  and  financial 
support  (26%)  and  a  reporting  and  learning  system  (20%)  were  viewed  as  the  most 

EN 

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essential  components  followed  by  health  professional 
in  policy 
development (11%) and patient safety education for health professionals (11%) (Figure 
2). 

involvement 

Figure 2: 

Priority ranking of essential components of a patient safety strategy 

Priority ranking of Essential Components of a Patient Safety Strategy

4% 3%

7%

5%

8%

11%

11%

5%

26%

20%

political leadership and financial support
patient involvement in policy development
patient safety education for health professionals
patient safety indicators
a compensation system for those harmed by healthcare

a reporting and learning system
health professional involvement in policy development
standards and/ external assessment for patient safety
a dedicated patient safety research agenda and budget
other 

A summary report of the consultation containing a detailed analysis of the contributions 
received is being drafted and will be published shortly. 

On the specific topic of HCAIs, a separate consultation on the document 'Strategies for 
improving  patient  safety  by  prevention  and  control  of  healthcare-associated  infections' 
was held from 28 November 2005 to 20 January 2006. Contributions were received from 
national and regional health authorities, hospital and professional organisations, networks 
on  prevention  and  control  of  HCAIs,  research  institutes  and  patient  associations.  The 
Commission has evaluated the replies. The results of the consultation will be published in 
the near future. 

External expert support to the impact assessment 

The IA was supported by an external project to inform this impact assessment, with focus 
on  the  impact  (and  potential  impacts)  of  three  key  areas  of  possible  action  on  patient 
safety  –  the  introduction  of  reporting  and  learning  systems,  redress  mechanisms  and 
developing and using knowledge and evidence. The project included a thorough review 
of  peer-reviewed  and  grey  literature,  conducted  preliminary  data  extraction  and 
interviewed over thirty patient safety policy-makers and experts. 

The  ECDC  and  the  panel  of  experts  in  the  field  of  infection  control  also  provided 
scientific input to the impact assessment. 

On  4-5  June  2008,  the  Commission  met  hospital  managers  and  infection  control 
managers  from  EU  hospitals  and  with  a  representative  of  the  European  Federation  of 
Nurses  to  discuss  the  validity  of  the  various  assumptions  made  on  the  prevention  and 
control of HCAIs in this impact assessment. 

1.2.2. 

Internal consultation and expertise 

Other activities of the Commission or its agencies addressing specific aspects of patient 
safety  

EN 

10 

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There are a number of other ongoing or planned activities co-ordinated by the European 
Commission  or  its  agencies  aiming  to  address  specific  patient  safety  issues.  These  are 
described in more detail in section 3. 

Inter-service coordination 

An  inter-service  steering  group  was  established  in  autumn  2007.  DGs  EMPL,  ENTR, 
MARKT, RTD, SG, INFSO and EAC attended either or both of its two meetings on 14 
November 2007 and 2 June 2008. 

1.3. 

The Impact Assessment Board 

The draft Impact Assessment was submitted to the Board on 11 June 2008. The present 
version of the IA takes account of the recommendations given by the Board in its opinion 
of 14 July. The key amendments made to the impact assessment following the issuing of 
the Board opinion are: 

–  Clarification of the baseline scenario, including identification of existing policies and 
the problems of the current situation, as well as best practice in Member States, now 
included in the problem section (section 3).  

–  Clarification on the EU dimension of the identified problems and finally 

–  Clarification of the objectives at general, specific and operational level 

We therefore streamlined the 'problems still to be addressed' section and reduced issues 
from nine to seven and focussed in particular on those with a clear EU component such 
as the need for homogenous patient safety data to be able to compare safety levels across 
the  EU.  Also  the  objectives  were  streamlined  as  to  allow  for  a  more  transparent 
comparison of options. 

We  inserted  a  new  section  into  the  description  of  the  baseline  scenario  to  better  link  it 
with the projects listed in Annex I and described in more detail current best practice, as 
well as levels of meticillin-resistant Staphylococcus aureus (MRSA) as an example of the 
problem of HCAIs in the Member States. 

2. 

TERMINOLOGY  

Patient  safety  is  defined  as  freedom  for  a  patient  from  unnecessary  harm  or  potential 
harm  associated  with  healthcare.  A  patient  safety  incident  is  an  event  or  circumstance 
which  could  have  resulted,  or  did  result,  in  unnecessary  harm  to  a  patient.  An  adverse 
event  is  an  incident  which  results  in  harm  to  a  patient.  Harm  implies  impairment  of 
structure or function of the body and/or any deleterious effect arising there from. Harm 
includes disease, injury, suffering, disability and death and may thus be physical, social 
or psychological8. 

HCAIs  are  defined  as  any  disease  or  pathology  (illness,  inflammation)  related  to  the 
presence  of  an  infectious  micro-organism  (bacteria,  fungi,  viruses,  parasites  and  other 

8 

The International classification for patient safety: Version 1.0 for use in field testing 2007 - 2008 
(ICPS). Geneva: WHO World Alliance for Patient Safety; 2007. 

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11 

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transmissible  agents)  or  its  products  as  a  result  of  exposure  to  healthcare  facilities  or 
healthcare procedures.  

3. 

THE PROBLEM AND ITS CAUSES 

3.1. 

Adverse Events: The Size of the Problem 

There is a limited but growing body of evidence concerning the prevalence and incidence 
of adverse events in health systems in EU Member States. National studies from the UK, 
Spain  and  France  provide  the  bulk  of  current  evidence  in  Europe  on  in-patient  adverse 
event  prevalence  and  its  implications.  From  these  studies  and  from  Key  Informant 
Interviews  conducted  for  an  external  project  informing  the  impact  assessment,  it  is 
estimated  that  in  EU  Member  States  between  8%  and  12%  of  patients  admitted  to 
hospitals suffer from adverse effects whilst receiving healthcare. 

In  the  UK,  a  National  Health  Service  (NHS)  report  in  2000,  An  Organisation  with  a 
Memory, revealed that poor patient safety was a major problem: data showed that at least 
400  patients  died  or  were  seriously  injured  in  adverse  events  involving  medical 
devices  in  1999  and  that  nearly  10,000  people  had  experienced  serious  adverse 
reactions  to  drugs.  According  to  the  2006  Spanish  National  Study  on  Hospitalisation-
Related  Adverse  Events  (ENEAS),  9.3%  of  hospital  patients  in  Spain  in  2005  suffered 
adverse  events  and  42.8%  of  these  were  deemed  preventable.  A  recent  French 
national survey of in-patient adverse events (Michel, 2007), found that in the course of 
the  7  days’  observation  per  unit  at  least  one  adverse  event  was  observed  in  55%  of 
surgical  units  and  40%  of  medical  units.  35.4%  of  the  adverse  events  were 
considered to have been preventable. More detail on these studies is in Annex 2. 

Data from OECD on the prevalence of adverse event mortality in the table below show 
that adverse events occurred in many Member States, but also indicate that there are large 
gaps in the data about patient safety. Comparability of incidence data is also limited as 
low prevalence rates might simply mean low reporting and apparently higher prevalence 
rates may indicate better data capture through more advanced reporting systems. 

Table 2: 

Prevalence and burden of adverse event mortality 

Adverse care events 

Adverse drug events 

Total 
deaths 

Deaths per 
100,000 

Years lost 
/100,000 

Total 
deaths 

Deaths per 
100,000 

Years lost 
/100,000 

EU-27 

Austria 

Czech Republic 

Denmark 

France 

Germany 

Greece 

Hungary 

Ireland 

Italy4 

Luxembourg 

99 

5 

6 

492 

635 

128 

30 

17 

347 

1 

1.0 

0.0 

0.1 

0.5 

0.5 

0.9 

0.2 

0.4 

0.4 

0.2 

16 

0 

1 

2 

5 

11 

4 

8 

4 

1 

12 

EN 

4 

3 

 - 

848 

72 

2 

4 

3 

11 

2 

0.0 

0.0 

 - 

0.9 

0.1 

0.0 

0.0 

0.1 

0.0 

0.4 

1 

0 

 - 

3 

1 

0 

1 

2 

0 

3 

   EN 

 
  
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Netherlands 

Poland 

Portugal 

Slovakia 

Spain 

Sweden 

UK 

17 

232 

23 

4 

255 

120 

413 

0.1 

0.5 

0.2 

0.1 

0.5 

0.6 

0.5 

0 

5 

1 

0 

5 

1 

3 

3 

22 

13 

1 

264 

9 

36 

0.0 

0.1 

0.1 

0.0 

0.4 

0.1 

0.0 

No data available for: Belgium, Bulgaria, Cyprus, Estonia, Finland, Latvia, Lithuania, Malta, Romania, 
Slovenia 

International 

USA 

Australia 

New Zealand 

Canada 

Japan 

2460 

176 

8 

197 

424 

0.7 

0.7 

0.2 

0.5 

0.2 

6 

2 

4 

4 

3 

317 

47 

5 

22 

76 

0.1 

0.2 

0.1 

0.1 

0.0 

0 

1 

1 

0 

2 

0 

1 

2 

2 

3 

0 

1 

Source: OECD Health Data 2007 

Despite  the  gaps  in  data,  what  is  available,  and  the  results  of  research  studies,  reveal 
similar  patterns,  and  suggest  substantial  health  costs  and  economic  costs  (and  hence 
substantial potential savings) due to adverse events. 

The  sources  of  adverse  events  and  harm  in  healthcare  settings  are  many.  The  Spanish 
ENEAS study indicates the main causes of adverse events in Spain. As shown in table 3, 
medication related adverse events account for 37% of the total, followed by nosocomial 
infection-related  (25%)  and  procedure-related  adverse  events  (25%).  A  complete 
overview  of  the  scale  of  the  patient  safety  problem  can  be  found  in  chapter  3.3  of  the 
external study supporting this impact assessment. 

Table 3: Type of adverse events 

Adverse events 

Related to the care provided 

Medication-related 

Nosocomial infection-related 

Procedure-related 

Diagnosis-related 

Others 

TOTAL 

AE's 

50 

245 

166 

164 

18 

12 

% 

7.63 

37.4 

25.34 

25.04 

2.75 

1.83 

655 

100.00 

The  results  of  the  public  consultation  on  patient  safety  confirmed  the  diversity  of 
experienced  adverse  events  (examples  cited  included  medication-related,  error  in 
diagnosis,  communication  problems,  surgery-related  events,  medical  device  or 
equipment related events and HCAIs). Medication-related events and errors in diagnosis 

Source: ENEAS 2006 

EN 

13 

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were the most frequently experienced in respondents' own country and in other Member 
States. 

HCAIs,  a  key  focus  of  the  current  initiative,  are  among  the  most  important  causes  of 
unintended  harm.  Incidence  figures  for  all  types  of  HCAIs  are  not  available  for  all  EU 
Member States. However, on the basis of recent national HCAI prevalence surveys and 
the  results  of  hospital-wide  surveillance  programmes  of  nosocomial  bacteraemia  in  EU 
Member States, it can be calculated that HCAIs affect 5% of hospital patients on average 
and  the  total  number  of  hospital  patients  acquiring  at  least  one  HCAI  in  the  EU  every 
year can be estimated at 4.1 million. Approximately 37,000 deaths are estimated to occur 
every year from these infections (see Annex 3). 

For  MRSA,  a  well-known  micro-organism  causing  HCAIs,  data  for  all  EU  Member 
States  are  available;  significant  differences  in  levels  of  MRSA  rates  can  be  seen  as 
illustrated in Figure 3. 

Figure  3:  Staphylococcus  aureus:  trends  of  meticillin-resistance  by  country  1999-
2006 (EARSS Annual Report 20069) 

9 

EN 

The European Antimicrobial Resistance Surveillance System (EARSS) is a project co-funded by 
the  Public  Health  Programme.  The 
at 
http://www.rivm.nl/earss/Images/EARSS%202006%20Def_tcm61-44176.pdf 

annual 

report 

found 

2006 

can 

be 

14 

   EN 

 
                                                 
Southern European countries, the United Kingdom and Ireland report the highest MRSA-
rates,  whereas  northern  European  countries  still  have  proportions  of  MRSA  in 
bacteraemia patients below 5%. 

HCAIs mostly occur during or after hospitalisation but can also develop in the context of 
ambulatory care. Patients who acquire HCAIs may be acutely ill and more likely suffer 
co-morbidities  and/or  chronic  disease.  Thus  elderly  people  are  often  concerned  -  an 
increasing  proportion  of  the  patient  population.  Individuals  receiving  antimicrobial 
chemotherapy  (changing  the  composition  of  the  host  flora),  patients  with  systemic  or 
local immune defects, or with devices such as intravenous lines and urinary catheters in 
places that by-pass their natural immune defences, are also at particular risk. 

Moreover,  the  infectious  micro-organisms  have  frequently  acquired  resistance  to 
antimicrobial agent(s), normally effective in the treatment of non-HCAIs. Consequently, 
infections and colonisations caused by these micro-organisms are often difficult to treat 
and  to  eradicate  from  the  healthcare  environment.  Owing  to  the  ability  of  infectious 
micro-organisms that can cause HCAIs to colonise patients for prolonged periods, these 

EN 

15 

   EN 

 
 
patients may  disseminate  the  micro-organisms both during and after their hospital stay. 
In this way the entire healthcare system, as well as the society as a whole, is carrying the 
burden  of  the  increasing  numbers  of  individuals  infected  or  colonised  with  healthcare-
associated pathogens. 

HCAIs thereby pose a considerable, and tangible, threat to public health. 

The  main  drivers  relating  to  the  incidence  of  HCAIs  are  depicted  in  the  flow  chart  in 
Annex 4. 

3.2. 

The Public Perception of Adverse Events 

The 2005 Eurobarometer survey on perception of medical errors  

Whilst estimating the extent of adverse events in our health systems is essential, it is also 
important  to  understand  patients'  perception  of  how  safe  they  think  EU  health  systems 
are.  The  challenge  is  not  only  to  ensure  the  safety  of  those  systems,  but  also  convince 
citizens  who  are  potential  patients,  or  the  friends  and  family  of  patients,  that  they  are 
safe. Patient confidence is crucial. Therefore, in 2005, the European Commission carried 
out a Eurobarometer survey on the perception of medical errors in the EU. The poll also 
covered  the  then  pre-accession  and  candidate  countries  and  the  Turkish  Cypriot 
Community. The Commission published the results in 200610. 

Almost  4  in  5  EU  citizens  (78%)  classified  medical  errors  as  an  important  problem  in 
their  country.  38%  ranked  the  issue  as  very  important  and  40%  saw  the  topic  as  fairly 
important. 23% said they or their family had been the victim of a medical error; 18% said 
this was in a hospital, while 11% said they had been prescribed the wrong  medication. 
Over  half  of  Europeans  believed  they  cannot  avoid  serious  medical  errors  in  hospitals. 
The perception of citizens, therefore, is that this is a significant problem. 

3.3. 

Current Member State Actions  

Best Practice 

Best practice in EU MS has been identified using as a reference the World Alliance for 
Patient  Safety's  definition  of  the  core  components  of  best  practice  in  patient  safety, 
especially  in  relation  to  the  existence  of  reporting  and  learning  systems,  and  MS  have 
then  be  classified  accordingly.  Characteristics  of  best  practice  in  MSs,  or  'exemplary' 
systems according to RAND's definitions, more details of which are included at Annex 5, 
include a well-developed, blame-free national reporting and learning system (in addition 
to local systems to support this), which covers all adverse events, an established redress 
system that includes alternatives to going to court (e.g. a 'no fault' liability system), the 
MS  being  active  in  initiatives  to  develop  and  use  knowledge  and  evidence  on  patient 
safety  and  an  established  national  institute  or  other  'competent  authority'  dedicated  to 
patient safety.  

RAND  found  that  four  MSs  –  Belgium,  Denmark,  the  Netherlands  and  the  UK  – 
currently  carry  out  best  practice  when  their  systems  were  evaluated  against  these 
characteristics,  categorising  them  as  having  ‘exemplary’  systems,  including  a  mature, 
blame-free reporting system and an institute dedicated to patient safety. Three countries 

10 

http://ec.europa.eu/health/ph_publication/eurobarometers_en.htm 

EN 

16 

   EN 

 
                                                 
(Germany, Czech Republic, Slovak Republic) were categorised as ‘very good’; they had 
well-established and functioning reporting systems but these were not fully blame-free. 
Eight  Member  States  (Sweden,  Republic  of  Ireland,  Spain,  Bulgaria,  France,  Finland, 
Portugal,  Austria)  were  classified  as  ‘good’  as  they  had  only  partial  reporting  systems 
which  did  not  cover  all  types  of  adverse  events.  Five  countries  (Hungary,  Lithuania, 
Latvia,  Poland,  Italy)  were  classified  as  ‘fair’  as  their  reporting  systems  were  not  at  a 
national  level.  Finally,  three  countries  (Slovenia,  Greece,  Cyprus)  were  considered  to 
have  ‘poor’  patient  safety  systems  in  that  they  had  no  patient  safety  reporting  and 
learning system.  

Of  course,  whilst  it  is  logical  to  assume  that  there  will  be  a  positive  direct  causal 
relationship between the preferable characteristics of a patient safety system in Member 
States,  as  defined  by  RAND,  and  patient  safety  outcomes,  the  immaturity  of  patient 
safety research and evaluation means that we can not prove this for sure at this point in 
time. Further research, monitoring and evaluation should make this link clearer in future.  

In  the  area  of  HCAIs,  strategies  to  prevent  and  control  HCAIs  have  been  developed  in 
different  Member  States  and  show  positive  results  where  a  strong  commitment  for 
effective  implementation  exists.  Best  practice  examples  include  entry  screening  of 
patients  for  colonisation  with  resistant  micro-organisms,  isolation  of  patients  colonised 
with  resistant  micro-organisms,  screening  of  healthcare  staff,  decolonisation  of  patients 
and  healthcare  staff,  strict  hygiene  practices,  surveillance  and  restrictive  antibiotic  use. 
For  example,  the  uncompromising  “search-and-destroy”  policy  (based  on  the  above-
mentioned best practices) in the Netherlands and in Nordic countries is thought to play an 
important role in the low prevalence of MRSA in these countries. 

Therefore,  for  patient  safety  efforts  in  general  and  specific  measures  to  prevent  and 
control  HCAIs,  there  is  clearly  much  to  be  gained  by  sharing  knowledge  and  best 
practice;  

3.4. 

Current EU Actions 

3.4.1.  European Commission Activities 

the  Commission 

Medication  errors  are  already  the  focus  of  current  EU  legislation  and  initiatives.  For 
the  areas  of 
example, 
pharmacovigilance,  which  it  is  in  the  process  of  revising.  The  European  Medicines 
Agency is currently developing new requirements for the naming of centrally-authorised 
medicines to try to reduce medication errors due to look-alike and sound-alike medicines. 

responsible 

legislation 

for 

in 

is 

The Commission has also recently revised its legislation on the safety of medical devices. 
Within the Open Method of Coordination, the Commission adopted in June 2006 a set of 
common indicators for the social protection and social inclusion process including health 
and long-term care. 

In  addition,  the  Commission  is  developing  e-health  systems  at  the  European  level  (e.g. 
through  the  lead  market  initiative).Using  new  technology  to  improve  patient  safety  in 
healthcare setting is one key element of this. Patient safety research is also included in 
the Commission’s  7th Framework  Programme, which  also covers eHealth patient safety 
solutions. 

EN 

17 

   EN 

 
the 

The  Commission  also  continues 
follow-up  of  Council  Recommendation 
(2002/77/EC) on the prudent use of antimicrobial agents in human medicine. Indeed, the 
growing levels of resistance in micro-organisms causing HCAIs due to inappropriate use 
of antibiotics is of concern. Therefore, the Commission is planning a second report to the 
Council on the implementation of Council Recommendation (2002/77/EC), outlining the 
progress made and the issues needing further attention. 

3.4.2.  Projects Co-Funded by the European Community 

A  number  of  European  Community  co-funded  projects  on  patient  safety,  including 
HCAIs, have either been completed or are currently still carrying out their work. A full 
list can be found at Annex 1 but two of the most important are described below. 

EUNetPaS (European Union Network for Patient Safety) was launched in February 2008. 
It  aims  to  establish  an  umbrella  network  of  Member  States  and  EU  stakeholders  to 
encourage  and  enhance  collaboration  in  the  field  of  Patient  Safety  by  evaluating, 
validating and diffusing new knowledge and good practices. 

The  IPSE  project  (Improving  Patient  Safety  in  Europe)  aims  to  reduce  the  burden  of 
HCAIs  and  their  related  threats  of  antimicrobial  resistance  (AMR)  by  providing 
evidence-based  guidance  and  educational  tools,  strengthening  the  status  of  infection 
control professionals, strengthening surveillance and developing indicators. 

3.5. 

Problems still to be addressed 

The Health Strategy White Paper11 adopted last year demonstrates how much has already 
been achieved in health policy at the EU level in a range of areas, based on different parts 
of the Treaty, for example in health and safety at work, pharmaceuticals, public health, 
food  safety,  research  and  environment.  Following  the  introduction  of  specific  public 
health provisions into the EU Treaties12, in the 1990s a large number of individual issues 
have  been  addressed  such  as  cancer,  communicable  diseases,  rare  diseases,  health 
promotion and most recently alcohol related harm and healthy diets. All these initiatives 
were  intended  to  co-ordinate  and  stimulate  a  wide  range  of  activities  in  the  specific 
health policy field.  

The  patient  safety  policy  area  is  no  different.  As  described  in  Section  1.1,  EU 
involvement in patient safety policy dates back to the World Health Assembly resolution 
of  2002  and  led  to  the  recommendations  by  the  High  Level  Group  on  Health  Services 
and  Medical  Care  in  2005.  Alongside  policy  discussions;  several  focused  initiatives 
developed, including the work of the Network on Communicable Diseases and of ECDC, 
as well as a number of EU-funded projects (see Annex 1) and initiatives in related areas 
of R&D and technological development.  

However, despite current best practice in MSs and the measures already being taken at 
the  EU  level  in  specific  patient  safety  areas  already  described,  there  is  still  a  need  for 
further  action  on  patient  safety  at  the  EU  level.  The  measures  currently  being  taken  in 
some MSs or at the EU level are not in themselves sufficient due to: (i) the absence of a 
clear  and  firm  political  commitment  to  action  on  patient  safety  from  all  MSs;  (ii)  the 

11 
12 

White Paper "Together for Health: A Strategic Approach for the EU 2008-2013", COM(2007) 630 
Initially in Article 129 of the Maastricht Treaty and then in a strengthened form in Article 152 of 
the Treaty of Amsterdam 

EN 

18 

   EN 

 
                                                 
limited  time-span  of  EU  co-funded  projects,  meaning  there  could  be  no  guaranteed 
longer-term action on patient safety at the EU level; (iii) failure of current initiatives to 
optimise the safety of cross-border patients.The current initiative is built on a number of 
diverse  actions  as  described,  and  is  intended  to  create  a  framework  to  stimulate  policy 
development  and  future  action  in,  and  between,  Member  States,  to  address  the  key 
remaining  patient  safety  issues  and  problems  confronting  the  EU,  which  are  set  out  in 
more detail below. 

1. 

Member  States  have  varying  levels  of  awareness  of  the  human  and 
economic costs of adverse events occurring in their health systems and we 
see, therefore, varying levels of political commitment to make patient safety 
a priority in national public health objectives. 

Evidence  suggests  that  EU  Member  States  are  at  different  levels  of  political 
awareness  and  priority-setting  and,  therefore,  at  different  stages  in  the 
development  and  implementation  of  effective,  comprehensive  patient  safety 
systems. 

The prevention and control of HCAIs is important for healthcare institutions as 
well  as  for  national  healthcare  budgets  and  society  at  large.  In  the  absence  of 
political  commitment,  healthcare  institutions  will  not  always  be  motivated  to 
invest adequately in the prevention and control of HCAIs. 

The variability of the existence of patient safety policies, systems, processes and 
cultures  among  EU  Member  States  was  identified  by  the  SIMPATIE  project. 
RAND  Europe  reviewed  its  findings  categorised  the  23  EU  Member  States 
involved  according  to  their  patient  safety  systems,  policies,  structures  and 
processes. Best practice has already been explained earlier. Currently only four 
EU MS meet that best practice. 

The EU could play a role in ensuring the communication of the core components 
of  'best  practice'  patient  safety  systems  to  all  MSs.  To  achieve  the  necessary 
political commitment at national level, a 'push' from the EU level  will support 
Member  States  to  make  patient  safety  a  priority  in  national  public  health 
objectives. 

2. 

No comparable data on incidence rates across EU and hence no possibility 
to compare patient safety levels and policies 

Closely linked to the fact that not all MS have patient safety policies in place is 
the uneven picture on adverse events incidence in all EU MS, as shown in table 
2. It is currently not possibly to obtain and compare data on patient safety levels 
for all EU MS. Therefore, comparable and aggregate data on the level of adverse 
events  in  healthcare  settings,  and  on  how  many  of  these  were  realistically 
preventable, should be collected.  

When there is not enough information available to MS authorities or the public 
on the extent and type of adverse events in healthcare systems it is difficult for 
those  authorities  to  decide  where  to  best  dedicate  scarce  resources  to  improve 
patient  safety  or  for  patients  to  make  an  informed  judgment.  An  additional 
consideration  is  that  the  cross-border  mobility  of  patients  means  that  some 
patients  may  face  a  choice  or  decision  to  access  healthcare  in  a  Member  State 

EN 

19 

   EN 

 
other  than  their  own.  Others  may  have  no  choice  but  to  do  so.  How  do  those 
patients know whether those health systems are as safe, safer or less safe than 
their  own  and  what  types  of  harm  are  they  at  particular  risk  from  if  accessing 
health systems at home or in another MS? 

Also, when a patient is harmed or even dies as a result of an adverse event, what 
support  can  that  patient  or  their  family  expect  from  the  healthcare  system  or 
authorities?  Patients  accessing  healthcare,  either  in  their  home  country  or 
another  Member  State,  need  to  know  how  to  make  a  formal  complaint,  what 
help,  support  and  redress  is  available  to  them  if  they  are  harmed  by  that 
healthcare  and  how  to  access  it.  There  is  clearly  a  case  to  have  data  in  all 
Member  States  which  will  help  people  to  make  informed  choices  or  decisions 
about  their  care  in  terms  of  safety,  support  and  possible  redress,  as  well  as  to 
inform the relevant authorities. 

Hence the need to develop a common 'language' or taxonomy' for patient safety 
within the EU - to make comparisons and learning easier and to be used to drive 
up  performance.  It  is  evident  that  such  a  common  taxonomy  can  only  be 
achieved jointly at the EU level. 

The  incidence  of  HCAIs  is  often  underestimated  because  of  inadequate 
surveillance.  Insufficient  data  on  the  incidence  of  HCAIs  in  healthcare 
institutions  makes  it  difficult  to  guide  and  evaluate  the  implementation  of 
infection  control  measures  and  to  compare  rates  between  institutions  as  a 
measure of performance. At national level, insufficient surveillance data make it 
difficult to compare healthcare institutions in terms of HCAI incidence rates and 
hamper  the  follow  up  of  the  epidemiology  of  HCAIs  in  order  to  detect  trends 
and  emerging  resistant  micro-organisms.  In  addition,  agreed  structure  and 
process  indicators  are  lacking  to  evaluate  the  performance  of  healthcare 
institutions in a comparable way. 

A  comprehensive  set  of  common  indicators  to  monitor  healthcare  safety  in 
Member States, including HCAI levels, is necessary. 

3. 

Current research findings, learning, experiences and expertise available in 
the EU do not sufficiently benefit patients because dissemination of effective 
patient  safety  interventions  and  solutions  is  not  coordinated  or  routinely 
carried out at the EU level. 

When  patients  access  healthcare  in  their  own  country,  or  in  another  Member 
State, they expect to receive the safest possible care – that is healthcare that has 
minimised  the  possibility  of  adverse  events  and  preventable  harm  occurring. 
Patients would benefit from those reporting and learning systems that do exist in 
MSs  being  mined,  and  research  findings  being  analysed,  to  inform  the 
development  of  effective  solutions  and  interventions  which  would  then  be 
shared throughout the EU. The EU can play a role in ensuring this dissemination 
of solutions and interventions. 

4. 

Senior  management  in  healthcare  institutions  does  not  have  enough 
commitment  towards  the  prevention  and  control  of  adverse  incidents, 
above  all  HCAIs.  Not  enough  research  on  the  cost-effectiveness  of 
prevention and control of HCAIs. 

EN 

20 

   EN 

 
Experience shows that, in most Member States, healthcare institutions approach 
HCAIs in a reactive instead of a proactive way. The prevention and control of 
HCAIs is often perceived by the senior management of healthcare institutions as 
a  net  cost  factor  and  often  measures  are  only  put  in  place  after  the  healthcare 
institution has been confronted with an outbreak of HCAIs. 

Although  evidence  is  available,  there  is  not  enough  research  on  the  cost-
effectiveness of prevention and control in healthcare institutions and at the level 
of national healthcare budgets and for society at large. In addition, there is not 
enough dissemination of best practices in healthcare institutions that have been 
shown to be cost-effective. 

This  part  of  the  action  to  improve  patient  safety  is  best  addressed  at  the 
local/regional level, but political ownership and stewardship at national and EU 
level is essential to support the cultural change necessary. In addition, tools such 
as  the  Public  Health  Programme  are  useful  to  stimulate  research  on  cost-
effectiveness  of  public  health  interventions  and  to  disseminate  these  results 
throughout the EU. 

5. 

Not  enough  awareness  among  healthcare  staff  on  the  issue  of  HCAIs  and 
insufficient  training  on  ways  to  prevent  and  control  HCAIs.  Not  enough 
authoritative guidance is available to support infection control staff, such as 
EU  agreed  case  definitions,  guidance  on  best  practice  and  minimum 
requirements for infrastructure. 

To bring about the necessary changes, a first step is that all staff in healthcare 
institutions  need  to  be  informed  about  the  problem  of  HCAIs.  In  addition, 
healthcare  staff  are  often  insufficiently  trained  on  ways  to  prevent  and  control 
HCAIs.  The  lack  of  awareness  and  training  results  for  example  in  poor 
compliance with hygiene practices which is an important driver in the incidence 
of  HCAIs.  This  is  a  fundamental  problem  in  the  majority  of  healthcare 
institutions throughout the EU. 

Although HCAIs are a multifaceted problem, ways to prevent and control it are 
well  understood.  Nevertheless,  the  information  is  rather  fragmented  and 
authoritative guidance pooling the best expertise available is lacking. 

At EU level, the ECDC can play an important role in pooling the best expertise 
to  develop  training  and  guidance,  and  assist  Member  States  in  implementing 
training and curricula for all healthcare staff and for infection control staff13. 

6. 

Antimicrobial resistance 

A  particularly  important  problem  is  that  of  the  growing  levels  of  resistance  in 
the  micro-organisms  involved  in  HCAI.  This  means  that  infections  and 
colonisations caused by them are often difficult to treat and difficult to eradicate 
from  the  healthcare  environment.  The  inappropriate  use  of  antibiotics  is  a  key 

13 

EN 

A  European  Core  curriculum  for  training  for  infection  control  staff  has  been  developed  by  the 
IPSE 
http://helics.univ-
be 
lyon1.fr/Working%20packages/WP1/Core%20Curriculum%20Report.pdf.  After  the  end  of  the 
IPSE project, many of the IPSE activities will be taken over by ECDC. 

project 

found 

and 

can 

at: 

21 

   EN 

 
                                                 
driver  in  the  problem  of  antimicrobial  resistance.  A  Council  Recommendation 
2002/77/EC, based also on the provisions of Article 152, dealt with the prudent 
use of antimicrobial agents in human medicine, and outlined clear-cut measures 
to be taken at national and EU level to reduce antimicrobial resistance. In 2005, 
the Commission issued a report to Council (COM (2005) 0684) on the measures 
taken and the areas needing further attention. The Commission is following up 
this important issue and plans a second report to Council in 2009. 

7. 

Spread of micro-organisms causing HCAIs 

Throughout the EU, there is an increased movement of patients and healthcare 
staff  within  healthcare  institutions.  There  is  also  an  increased  movement  of 
patients  and  healthcare  staff  between  healthcare  institutions  (nationally  and 
internationally)  These  increased  movements  contribute  to  the  spread  of  micro-
organisms  causing  HCAIs.  Budgetary  constraints  in  healthcare  institutions  can 
not only lead to high bed occupancy rates and poor staff to patient ratios but also 
to insufficient infrastructure (such as isolation facilities) to control the spread of 
micro-organisms. 

Although  there  is  no  evidence  available  at  this  time  to  suggest  that  the  cross-
border  movement  of  patients  in  itself  presents  a  specific  additional  risk  to 
patient safety, the fact that patients are increasingly making use of their rights to 
access healthcare in other MSs (as set out in the Directive on the Application of 
Patients' Rights in Cross-Border Healthcare), means that the problems described 
above  can  be  detrimental  to  citizens  of  other  MSs  too,  making  the  EU  a  valid 
participant  in  actions  to  attempt  to  solve  these  problems.  Surveillance  at  EU 
level, based on data gathered by the Member States, can detect emerging threats 
quickly  and  can  coordinate  a  quick  and  effective  response  to  these  micro-
organisms that are not constrained by national borders. 

4. 

THE RIGHT OF THE UNION TO ACT – SUBSIDIARITY TEST  

The  problem  of  patient  safety  is  primarily  the  responsibility  of  Member  States.  The 
European Union can support their efforts by taking actions where it has competence and - 
more broadly - in facilitating the exchange of good practices. As far as specific work on 
patient safety is concerned, the following areas of competence are relevant: 

•  Article 152 (public health) states that “Community action, which shall complement 
national policies, shall be directed towards [..] preventing human illness and diseases, 
and obviating sources of danger to human health. [..] The Community shall encourage 
cooperation between the Member States in the areas referred to in this Article and, if 
necessary, lend support to their action”. This supports work on systemic patient safety 
as well as that on HCAIs. 

•  Article 153 (consumer protection) provides an additional aspect especially linked to 
people's right to information. Both articles fall under shared Community and Member 
State competence. 

EN 

22 

   EN 

 
•  Besides  the  Treaty  basis,  Annex  I  of  Commission  Decision  2000/96/EC14  identifies 
nosocomial infections (or hospital acquired infections) as one of the health issues to 
be progressively covered by the Community network established under Decision No 
2119/98/EC. 

•  The High Level Group on Health Services and Medical Care has endorsed a number 
of  recommended  actions  in  the  area  of  patient  safety  where  European  level 
collaboration and coordination of activities could bring added value. 

In areas closely related to patient safety, Member  States  have  previously agreed on the 
right and the added value of the Union to act: 

•  Council Recommendation (2002/77/EC) of 15 November 2001 on the prudent use of 

antimicrobial agents in human medicine. 

•  Directive  2002/98/EC  of  the  European  Parliament  and  of  the  Council  of  27  January 
2003  setting  standards  of  quality  and  safety  for  the  collection,  testing,  processing, 
storage  and  distribution  of  human  blood  and  blood  components  and  amending 
Directive 2001/83/EC. 

•  Directive  2004/23/EC  of  the  European  Parliament  and  of  the  Council  of  31  March 
2004 on setting standards of quality and safety for the donation, procurement, testing, 
processing, preservation, storage and distribution of human tissues and cells 

The legal base exists to take action at EU level; this is however not enough to justify EU 
involvement.  The  subsidiarity  test  assesses  whether  EU  action  is  necessary,  in  other 
words whether action by a Member State or a group of Member States cannot sufficiently 
solve the problem. The test then evaluates whether action at EU-level adds value to the 
work done by Member States (the 'added-value test'), and it asks if the measures chosen 
are proportionate to the objectives (the 'boundary test'). This section looks at the first two 
elements of the test. 

Necessity Test 

The  arguments  justifying  the  necessity  of  EU  action  on  patient  safety  focus  on  3 
elements: 

•  Trans-boundary spread of infections 

•  Cross-border  provision  of  healthcare  resulting  from  mobility  of  patients  and 

professionals 

•  Need for EU-wide data collection and monitoring. 

Firstly, HCAIs can easily be transmitted from one Member State to another because of 
the mobility of patients. Micro-organisms are not constrained by national boundaries and 
can rapidly spread between countries as evidenced by the international spread of MRSA 
and Clostridium difficile PCR ribotype 027. In this area, it is therefore crucial that all MS 

14 

Commission  Decision  (2000/96/EC)  of  22  December  1999  on  the  communicable  diseases  to  be 
progressively  covered  by  the  Community  network  under  Decision  No  2119/98/EC  of  the 
European Parliament and of the Council. O.J. No L 28, 3.2.2000 

EN 

23 

   EN 

 
                                                 
are actively engaged and cooperation and coordination at EU will assist Member States 
in their actions. 

As regards the cross border movements of patients and healthcare professionals, they are 
currently still low, with only an estimated 1% of patients receiving treatment in another 
Member States in any year, but this is greater in border regions and is likely to increase 
with general population mobility.  

For  many,  concerns  about  the  safety  or  quality  of  healthcare  systems  in  other  Member 
States  are  the  main  factors  impeding  their  use  of  services  elsewhere.  In  addition,  some 
patients crossing borders to receive healthcare will also not be guaranteed the same level 
of  redress  (or  any  at  all)  that  they  would  be  entitled  to  in  their  own  health  system,  if 
something does go wrong.  

Finally, the European Commission as an international institution is well placed to collect 
comparable  data  from  the  EU-27.  Analysis  at  EU  level  allows  aggregation  of  data  and 
more  effective  analysis  of  trends  and  developments  as  well  as  identification  of  best 
practice  and  solutions.  This  is  all  the  more  important  as  there  is  little  co-operation 
between Member States to provide comparable data. Even though some Member States 
have well-developed data systems, these are not always compatible, and some Member 
States have very limited data.  

The other benefits of this activity will be discussed under the added-value test. 

Added-value test 

The  added-value  of  EU  activity  in  the  area  of  patient  safety  concentrates  around  three 
main factors: 

•  EU providing political weight and visibility, thus putting patient safety at the centre of 

MSs health priorities 

•  Economies  of  scale  –  benefits  of  community  wide  collection  of  data,  filling  in  the 

gaps in research. 

•  Effective knowledge sharing through exchange of best practice. 

Ensuring patient safety should be a very high priority – perhaps the highest priority – for 
Member  States'  healthcare  systems.  The  EU's  focus  on  this  issue  can  help  to  improve 
knowledge and awareness, to suggest cost-effective solutions and thus persuade Member 
States to make more efforts towards keeping patients safe. Current evidence suggests that 
EU Member States are at different levels of political awareness about the patient safety 
issue  and  therefore  also  as  regards  development  of  effective,  comprehensive  patient 
safety systems. 

On the other hand, available evidence from some MSs and non EU countries such as the 
US  and  New  Zealand  suggests  that  incidence  rates,  types  of  errors  and  potential 
effectiveness  gains  are  similar  in  all  health  systems.  At  the  moment,  however,  with 
reporting of adverse events not done everywhere, there are still significant data gaps as 
regards the patient safety levels and policies in the EU, which is why common definitions 
and  data  collection  at  EU  level  are  needed.  A  broad  list  of  indicators  on  patient  safety 
will be needed in light of the systemic nature of the patient safety issue, as well as the 

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multitude of causes. The Member States can thus also benefit from economies of scale 
linked to EU involvement. 

Finally, cooperation at European level using the best available evidence and expertise has 
great  potential  to  bring  added  value  both  to  individual  patients  and  to  health  systems 
overall.  By  tackling  common  problems  at  the  EU  level,  European  expertise  can  be 
pooled,  inequalities  stemming  from  unsafe  care  reduced,  and  duplication  of  effort  and 
resources  avoided.  One  aspect  where  EU  level  action  provides  added-value  is  the 
effective use of ICT systems for patient safety purposes where cross-border issues such 
as  inter-operability  arise.  Another  aspect  would  be  to  agree  upon  case  definitions  for 
HCAIs  and  common  indicators  to  measure  the  implementation  and  performance  of 
measures to prevent and control HCAIs. 

Similarly, Member States may implement – to different degrees – rules and incentives for 
the prevention and control of HCAIs, and professional groups and key stakeholders may 
continue  to  provide  non-statutory  guidance.  However,  in  most  Member  States,  these 
actions  have  so  far  not  achieved  the  necessary  organisational  and  behavioural  changes 
needed to bring down the incidence of HCAIs. 

5. 

OBJECTIVES 

5.1. 

General objective 

The general objective is to prevent and reduce human illness and diseases and to obviate 
sources of danger to human health, as stipulated in Article 152 of the Treaty. 

5.2. 

Specific objectives 

1. 

2. 

3. 

4. 

to  protect  EU  citizens  from  preventable  harm  in  healthcare,  including  from 
HCAIs. 

to support the Member States to put in place the proper and adequate strategies 
to  prevent  and  control  adverse  events  in  healthcare,  including  HCAIs,  by 
pooling the best available evidence and expertise in the EU. 

to improve EU citizens' confidence that they have sufficient and comprehensible 
information  available  on  levels  of  safety  and  available  redress  in  EU  health 
systems,  including  healthcare  providers  in  their  own  country  and  in  other 
Member States. 

These objectives should result in fewer preventable deaths and illnesses and in a 
reduction in costs treating unnecessarily sick patients. 

5.3. 

Operational objectives 

1. 

2. 

Increase political awareness on the scale and size of the patient safety issue, as 
well  as  promoting  adequate  Member  States'  political  commitment  and 
acceptance. 

Gather  homogenous  and  comparable  data  and  information  on  patient  safety 
systems, initiatives and safety outcomes at EU level. 

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3. 

4. 

5. 

6. 

7. 

8. 

9. 

Share  best  practice  and  experience  of  MS  efforts  to  establish  efficient  and 
transparent  patient  safety  systems,  structures  and  policies,  including  reporting 
and  learning  systems,  education  and  training  developments,  use  of  indicators 
and/or standards and efforts to improve culture, on adverse events in healthcare. 
To share at the EU level, experiences of successful (as well as less successful) 
patient  safety  interventions  and  solutions  at  the  healthcare  setting  level,  for 
example  the  introduction  of  a  new  patient  identification  system  or  efforts  to 
reduce  mistakes  from  look-alike  medicines,  implemented  in  one  or  more 
Member State and evaluate the transferability of those solutions, and also share 
major patient safety alerts among all MSs. 

In  the  area  of  HCAIs,  foster  with  the  European  Centre  for  Disease  Prevention 
and  Control  (ECDC)  the  establishment  of  surveillance  methods,  indicators  to 
allow evaluation of the implementation and effectiveness of measures to prevent 
and  control  HCAIs,  guidance  on  best  practices  and  minimum  infrastructure 
requirements, as well as training curricula for healthcare staff. 

Develop common definitions and terminology for patient safety at the European 
Union level, including case definitions for HCAIs. 

Explore indicators for safety and quality of care. 

Consider other existing data sources, such as patient complaints, compensation 
systems,  clinical  databases,  monitoring  systems  and  other  adverse  incident 
reporting  systems  (such  as  those  in  the  areas  of  medical  device  vigilance  and 
pharmacovigilance) as complementary sources of information on patient safety. 
The compatibility of the data sources and the different reporting systems should 
be regularly reviewed. 

Develop and promote the research agenda on patient safety, at both MS and EU 
levels,  particularly  focusing  on  filling  the  current  research  gaps,  including 
further research on the cost-effectiveness of prevention and control of HCAIs.  

Promote the availability of information for patients and their families on how to 
complain,  and  what  redress  is  available  and  how  to  access  that  redress,  when 
patients are harmed by healthcare. 

10. 

Promote collaboration on patient safety issues between Member States, ECDC, 
EU  institutions  and  key  European  and  international  organizations  such  as  the 
WHO, OECD and CoE to ensure an integrated and consistent approach towards 
safer patient care. 

6. 

POLICY OPTIONS 

Option I:  No additional EU action –status quo 

The baseline scenario has been extensively described in section 3. 

Under this option, the Member States, stakeholders and international organisations would 
pursue  their  activities  on  patient  safety  without  any  further  co-ordination  or  incentives 
from the Commission. 

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26 

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Member  States'  representatives  would  come  together  with  stakeholders  on  a  voluntary 
basis  as  now  to  discuss  patient  safety  issues  and  possible  EU  activities  such  as  EU 
funded  projects.  Similarly,  Member  States  would  implement  –  to  different  degrees  – 
rules  and  incentives  to  increase  patient  safety  including  the  prevention  and  control  of 
HCAIs;  networks,  professional  groups  and  key  stakeholders  will  continue  to  provide 
guidance15. 

The Commission would continue co-funding projects on patient safety including HCAIs 
via  the  Public  Health  Programme  and  the  Framework  Programme  for  research  and 
technological  development.  Community  actions  trying  to  improve  specific  aspects  of 
patient safety such as pharmacovigilance or medical device safety would also be carried 
forward. 

The baseline scenario reflects the current situation and, therefore, includes the effects of 
the existing policies and projects as listed in section 3 and in Annex I. That means that 
this option also includes estimated effects of the EUNetPaS project that would continue 
to exist regardless of further action at EU level. 

Option II:  Strengthened  cooperation  with  the  Member  States  and  other  bodies, 
supported by technical guidance 

Under  this  option,  the  Commission  would  strengthen  cooperation  with  Member  States 
and  other  bodies  by  making  increased  use  of  the  instruments  described  under  option  I. 
For  example,  the  Commission  could  increase  the  focus  on  patient  safety  including 
HCAIs  in  the  Health  Programme  and  the  Framework  Programme  for  research  and 
technological development. The Commission could also step up its efforts in stimulating 
Member  States  to  cooperate  on  the  issue  of  HCAIs  and  to  develop  technical  guidance 
through the ECDC and the network of surveillance bodies. 

Article 5 of Regulation (EC) No 851/2004 of the European Parliament and of the Council 
establishing  a  European  centre  for  disease  prevention  and  control16  stipulates  that  "The 
Centre, through the operation of the dedicated surveillance networks and the provision 
of technical and scientific expertise to the Commission and Member States, shall support 
the  networking  activities  of  the  competent  bodies  recognised  by  the  Member  States." 
Member States have designated such bodies under Commission Decision 2003/542/EC17 
and ECDC could coordinate these bodies to: 

•  identify  main  problems  at  European  level  and  facilitate  mutual  information, 
consultation,  cooperation,  and  action  through  the  Community  network  (Decision  No 
2119/98/EC) 

•  establish  /  strengthen  EU-wide  surveillance  on  HCAIs  and  develop  a  strategy  for 

access to data from surveillance systems for HCAIs, risk factors and indicators 

•  establish  guidance  on  best  practice  on  the  prevention  and  control  of  HCAIs,  and 

minimum infrastructure requirements 

15 

16 

17 

e.g. guidance developed by ‘Improving Patient Safety in Europe (IPSE)’, a project funded by the 
Public Health Programme. 
Regulation  (EC)  No 851/2004 of  the  European Parliament  and  of  the Council  of 21 April  2004 
establishing a European centre for disease prevention and control. O.J. No L 142, 30.4.2004 
Commission  Decision  2003/542/EC  of  17  July  2003  amending  Decision  2000/96/EC  as  regards 
the operation of dedicated surveillance networks. O.J. No L 185, 24.7.2003 

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27 

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•  foster training and education initiatives 

•  A comparable structure within which guidance on general patient safety issues could 
be  developed  is  missing  –  with  the  exception  of  the  newly  established  network  for 
patient  safety,  EUNetPaS.  However,  as  previously  mentioned,  this  is  a  time-limited 
pilot  network  funded  under  the  Public  Health  Programme  which  will  work  only  in 
limited areas of patient safety. 

Option III:  Strengthened  cooperation  with  the  Member  States  and  other  bodies, 
supported  by  soft  law  instruments,  such  as  a  Commission  Communication  and  a 
Council Recommendation 

Under  this  option,  the  Commission  would  strengthen  cooperation  with  Member  States 
and other bodies by making increased use of the instruments described under option I. In 
addition,  the  Commission  would  develop  a  Communication  and  seek  a  political 
commitment  from  the  Member  States  via  a  Council  Recommendation  on  patient  safety 
and quality of health services, including the prevention and control of HCAIs. 

The  Communication would describe the  broader  context of patient safety, highlight the 
need  for  and  types  of  action  in  the  area  and  outline  the  Commission's  strategy  on 
improving patient safety. 

The Council Recommendation would include general recommendations on patient safety 
and  provide  specific  recommendations  on  the  prevention  and  control  of  HCAIs.  The 
recommendations in the proposed Council Recommendation would be complementary to 
Council Recommendation 2002/77/EC based on Article 152 of the Treaty and would be 
consistent with the findings of its implementation report. 

Option IV:  Strengthened  cooperation  with  the  Member  States  and  other  bodies, 
supported by a regulatory instrument, such as a Commission Decision 

This option would involve extension of Option II with a legislative proposal building on 
Decision  No  2119/98/EC  by  adopting  Commission  Decisions  covering  aspects  on  the 
prevention  and  control  of  HCAIs  in  accordance  with  Article  7  of  Decision  No 
2119/98/EC, i.e. by comitology. Decision No 2119/98/EC established a Network for the 
epidemiological  surveillance  and  control  of  communicable  diseases  in  the  Community, 
and Commission Decision 2000/96/EC already provided that nosocomial infections (i.e. 
HCAIs) are a special health issue to be progressively covered by the Community network 
under Decision No 2119/98/EC. 

For  example,  Article  3  c)  of  Decision  No  2119/98/EC  would  allow  the  Commission 
adoption  of  a  Decision  covering  case  definitions  for  HCAIs;  Article  3  d)  –  e)  would 
allow the adoption of a Commission Decision covering the nature and type of data and 
information  to  be  collected  and  transmitted  in  the  field  of  epidemiological  surveillance 
on HCAIs and the ways in which such data are to be made comparable and compatible, 
including epidemiological and microbiological surveillance methods.  

Under  this  option,  general  patient  safety  issues  could  not  be  addressed  in  the  Decision 
due  to  the  lack  of  an  appropriate  legal  basis  which  is  limited  to  infection  control  and 
prevention. 

Discarded options  

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28 

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Legislation,  including  a  Regulation  or  a  Directive  on  patient  safety  was  ruled  out  as  it 
would be extremely difficult to justify a specific and detailed legislative action covering 
all  the  aspects  of  the  proposal  on  the  grounds  of  subsidiarity  and  proportionality,  in 
particular as this is an area where primary responsibility lies with the Member States and 
there is no explicit legal basis for legislative action in this area in the Treaty. Owing to 
the  legal  unfeasibility  of  this  option,  no  screening  for  effectiveness,  efficiency  and 
consistency and no analysis of impacts is included. 

7. 

ANALYSIS OF IMPACTS 

In  order  to  assess  the  possible  health  and  economic  impacts  of  the  different  policy 
options, quantitative simulation scenarios have been developed to support the present IA. 
These scenarios use only data for hospital settings, not for outpatient care, as the former 
is much better documented than the latter and is also the main setting for HCAI. It has to 
be stated that the scenarios constitute only a rough approximation of the policy options at 
stake. It was not the intention to overstate the impacts, but rather to present a simulation 
of  effects  of  co-ordinated  and  comprehensive  policies  to  reduce  health  burden  due  to 
patient safety incidents with fairly accepted degree of plausibility. The scenario analysis 
is  meant  to  highlight  in  particular  the  extent  to  which  more  political  ownership  and 
leadership would improve patient safety outcomes.  

Our  scenario  for  general  patient  safety  policies  starts  from  the  assumption  that  patient 
safety  outcomes  in  various  MS  groups  differ  according  to  the  systems  in  place  and 
consequently  are  spread  along  the  range  of  prevalence  estimates  for  hospital-related 
incidents found in the literature range from 7 % to 16.6 % with a median of 10 %18.  

18 

To  note:  Prevalence  rates  in  outpatient  care  are  significantly  lower  than  in  hospital  settings  and 
are, according to national experience available from one country Spain in the range of less than 2 
% and mainly caused by mismedication.  

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Table 4: Alternative scenarios used in simulations 

Baseline 

Scenario 1 

Scenario 2 

Scenario 3 

Scenario 4 

prevalence 
adverse 
related 
hospitalisations 

of 
events 
to 

‘poor’ 
countries 
become ‘fair’ 

‘poor’ 
and 
‘fair’  countries 
become ‘good’ 

‘poor’, 
and 
countries 
become 
good’ 

‘fair’, 
‘good’ 

‘very 

countries 

All 
become 
‘exemplary’ 

Country Category 

‘exemplary’ 

‘very good’ 

‘good’ 

‘fair’ 

‘poor 

SOURCE: RAND Europe 

7 

10 

12 

14 

17 

7 

10 

12 

14 

14 

7 

10 

12 

12 

12 

7 

10 

10 

10 

10 

7 

7 

7 

7 

7 

Table 5: In-patient care: estimated number of adverse events 

Baseline 

Scenario 1 

Scenario 2 

Scenario 3 

Scenario 4 

Simulated 
outcome 

prevalence 
adverse 
related 
hospitalisations 

of 
events 
to 

‘poor’ countries 
become ‘fair’ 

‘poor’ 
and 
‘fair’  countries 
become ‘good’ 

‘poor’, 
and 
countries 
become 
good’ 

‘fair’, 
‘good’ 

‘very 

countries 

All 
become 
‘exemplary’ 

Adverse events 

10,274,289 

10,074,578 

9,577,161 

8,499,351 

6,311,945 

Permanent 
disability 

Death 

Preventable 
adverse events 

Preventable 
length-of-stay 
(person-years) 

SOURCE: RAND Europe 

1,562,411 

1,532,041 

1,456,399 

1,292,496 

959,857 

558,819 

547,956 

520,902 

462,280 

343,307 

4,397,396 

4,311,919 

4,099,025 

3,637,722 

2,701,512 

50,845 

49,857 

47,395 

42,061 

31,236 

Table 6: In-patient care: estimated potential health benefits relative to baseline 

Baseline 

Scenario 1 

Scenario 2 

Scenario 3 

Scenario 4 

Simulated 

prevalence 

of 

‘poor’ 

‘poor’ 

and 

‘poor’, 

‘fair’,  All 

countries 

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Outcome 

adverse 
related 
hospitalisations 

events 
to 

countries 
become ‘fair’ 

‘fair’  countries 
become ‘good’ 

‘good’ 

‘very 

and 
countries 
become 
good’ 

become 
‘exemplary’ 

Avoided Adverse 
events 

Avoided 
Permanent 
disability 

Avoided Death 

Avoided 
Preventable 
adverse events 

Avoided 
Preventable 
length-of-stay 
(person-years) 

SOURCE: RAND Europe 

0 

0 

0  

0 

0 

199,711 

497,417 

1,077,810 

2,187,406 

30,370 

10,863 

75,642 

163,903 

27,054 

58,622 

332,639 

118,973 

85,476 

298,371 

759,673 

1,695,883 

988 

3,450 

8,784 

19,609 

As of now, data gaps for the EU do not allow us to establish a direct causal relationship 
between  good  patient  safety  policies,  systems  and  structures,  and  patient  safety 
outcomes. Our estimates were therefore based on how close the MS patient safety system 
is to what is generally considered best practice in the literature. We took as a reference 
the World Alliance for Patient Safety's definition of best practice, especially in relation to 
the existence of reporting and learning systems and classified MS accordingly. 

The non-binding character of almost all of the options at stake limits the significance of 
this exercise, however the assumptions reflect experiences in the past with similar health 
policy initiatives where e.g. Council or Commission Recommendations - though legally 
non  binding  -  triggered  quite  substantial  improvements  due  to  quick  implementation  at 
MS level. (see example of cancer screening recommendation). We have assumed that for 
a  health  issue  as  dependent  on  leadership  as  patient  safety,  similar  effects  can  be 
envisaged. 

We  reviewed  the  above  mentioned  overall  scenario  by  developing,  with  the  help  of 
infection control experts from ECDC etc. also a separate potential reduction scenario for 
HCAI-related events only .The figures we obtained were even higher in that case, which 
is  because  the  overall  adverse  event  scenario  applies  an  average  rate  of  42% 
preventability. That reflects the fact that not every medical error will be easily avoidable, 
some  errors  e.g.  those  related  to  processes  and  communication  will  be  much  more 
difficult to rectify as they probably require considerable changes in the way medial staff 
communicate and coordinate. Nosocomial infection-related adverse events usually score 
much  better  on  preventability  (60%  and  higher)  so  that  their  reduction  potential  is 
underweighted in the overall reduction scenario.  

7.1. 

Policy option I: No additional EU action – status quo 

1. Economic impacts (direct and indirect costs of adverse events, costs of patient safety 
policies)  

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31 

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Current economic burden due to patient safety adverse events 

Preventable  medical  errors  prolong  the  suffering  of  patients,  increase  healthcare  costs 
and have other direct and indirect economic implications, such as loss of productivity and 
disability. With adverse events ranging from 7.5% to 16.6 % of all hospital admissions, 
and with as much as half of those being preventable events, (in particular infected-related 
events are very often preventable by appropriate measures and therefore also the focus of 
this initiative), the potential cost savings for health care systems in all MS are apparent.  

National experience from Spain suggests that adverse events resulted in a prolongation 
of  2.2  days  of  avoidable  stays  per  patient  -  a  high  number.  Furthermore,  there  are 
additional  costs  resulting  also  from  additional  procedures  and  treatments  which  are 
necessary after adverse events (this is the case in around two thirds of adverse events). In 
France it was observed that a longer hospitalisation period was associated with 40,5 % of 
all  adverse  events  and  the  French  study  furthermore  revealed  that  every  hospital, 
regardless of size is affected, and that in the course of a 7 day observation of each unit at 
least one adverse events was observed in 55 % of surgical and 40 % of medical units.  

The  cost  effectiveness  of  patient  safety  projects  is  furthermore  documented  by  the  fact 
that there are already today, e. g. in Germany, around 400 hospitals involved voluntarily 
in such projects – which they would probably not undertake if there was not a net benefit 
to be reaped. 

The economic impacts are particularly well documented in the specific case of HCAI: 

The UK National Audit Office estimated the cost of hospital-acquired infections to 
be  at  £1  billion  per  year  for  the  UK19  in  the  late  1990s  (equivalent  to  £1.6b  now). 
This  was  in  fact  an  under-estimate  in  that  it  did  not  include  infections  in  high-risk  or 
specialised  units  such  as  renal  dialysis  or  those  occurring  in  tertiary  referral  centres. 
Costs will be different for other countries and will change with time; however the relative 
magnitudes will be similar. 

Overall  in  the  European  Union,  it  has  been  estimated  that  there  are  around  4.1  million 
hospital patients suffering from at least one HCAI in the EU per year and that, based on 
an  average  excess  hospital  stay  of  4  days20,  HCAIs  generate  approximately  16.4 
million extra hospital days per year. Assuming an average EU hospital cost of 334 € 
(not  including  post-hospital  costs21),  the  resulting  healthcare  cost  for  the  EU27  can  be 
estimated conservatively at € 5.48 billion. 

In addition, it has been estimated that patients that acquired a HCAI take  on average 6 
more days to return to work22. If we assume that 1/3 of the patients acquiring an HCAI 

19 

20 

21 

22 

Action on healthcare associated infections (HCAI) in England: Regulatory Impact Assessment. Department 
of 
UK 
Health, 
(http://www.dh.gov.uk/prod_consum_dh/idcplg?IdcService=GET_FILE&dID=246&Rendition=Web) 
Emori  TG,  Gaynes  RP.  An  overview  of  nosocomial  infections,  including  the  role  of  the  microbiology 
laboratory. Clin Microbiol Rev 1993; 6(4):428-442. 
Hospitals in Europe Link for Infection Control through Surveillance. C. Suetens. ESQH Workshop, Brussels, 
30 November 2001 
Plowman  R,  Graves  N,  Griffin  M,  Roberts  JA,  Swan  A,  Cookson  B,  et  al.  The  socio-economic  burden  of 
hospital  acquired  infection.  London:  PHLS,  2000  and  Plowman  R,  Graves  N,  Griffin  MAS,  Roberts  JA, 
Swan  AV,  Cookson  B,  Taylor  T.  The  rate  and  cost  of  hospital-acquired  infections  occurring  in  patients 
admitted to selected specialties of a district general hospital in England and the national burden imposed. J 
Hosp Infect 2001; 47:198-209. 

EN 

32 

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are productive, this represents a total loss of 8.2 million working days in the EU per year, 
resulting in a productivity loss of €1.37 billion (at an averag e EU labour productivity of 
€167.20/day 23 (see Annex 6)). This figure does not yet take into account the productivity 
loss  due  to  people  staying  away  from  work  to  take  care  of  relatives  having  acquired  a 
HCAI.  The  costs  of  37,000  attributable  deaths  annually  have  also  not  been  taken  into 
account. 

Investment costs for a general framework for patient safety 

Most administrative and compliance costs are related to the setting up and maintenance 
of a reporting and learning system which is at the core of any patient safety system and 
policy. Such systems already (at least partially or locally) exist in 20 MS. A new system 
would have to be set up in seven MS and adaptations and extensions of coverage would 
need to be made in up to 16 MS. There are costs to be expected at both the national and 
healthcare setting levels, and moreover the costs of setting up the systems will basically 
occur in the short term while the cost savings will come only in the longer-term.  

Healthcare  institutions  will  have  to  respond  to  additional  reporting  and  surveillance 
duties  in  cases  were  more  efforts  are  needed.  In  our  scenarios  for  the  different  policy 
options, we made the following assumptions on investments in human resources: a 5-10 
% reduction of HCAI across the EU with a staffing level of one infection control nurse 
per 600 beds;  a  20-30  %  reduction  for one infection control nurse per 250 beds24.  One 
can assume an EU average annual cost of €42,000/infection control nurse 25 and a total of 
2.88 million beds (see Annex 7) and a current staffing level of one infection control nurse 
per 1000 beds which would mean employing an additional 1,920 nurses in scenario one, 
8640 in scenario two for the EU. Costs for other surveillance and improved infrastructure 
could not be obtained. 

Government-spending will also increase in most cases. As a general indication, the per 
capita spending on patient safety investments in the UK and the US, both with advanced 
patient safety systems, can be used: 0,86 £ per capita in UK ; 0,22 US $ per capita in US.  

Cost-effectiveness of patient safety (including HCAI policies)  

Although  the  upgrading  of  organisational  structures  for  patient  safety  will  result  in 
additional  costs  in  some  MS,  recent  literature  and  national  experience  on  the  issue 
suggests  that  benefits  from  system-level  patient  safety  improving  strategies  can  well 
exceed costs, leading to net financial gains and reduce prevalence of adverse events.  

23 
24 

25 

The figure of €167.20 per day is based on  an average EU GDP output of €20.9/hour  
Recommended levels of infection control nurses of 1 per 100 – 250 beds have been cited in the 
literature (see section 7.3.2) 
The  breakdown  is  as  follows:  gross  salary:  €30,000;  benefits  (15%):  €4,500.00;  computer  and 
equipment: €3,500.00; training: €4,000.00 

EN 

33 

   EN 

 
                                                 
SOURCE: Wendin (2008) 

Figure 4: Key financial impacts of adverse events 

trauma,  bedsores,  surgical  site 

A  cost  benefit  analysis  in  the  US  on  interventions  addressing  adverse  events  with 
infections,  catheter-related  bloodstream 
obstetric 
infections, MRSA and drugs suggests that the implementation of patient safety strategies 
can lead to between 50% and 96% reduction in medical error rates and net savings 
from  50  thousand  to  1.5  million  €  for  a  300-bed  hospital .  For  HCAI  in  particular,  a 
UK study from 2000 indicated that a 10% reduction in the number of hospital acquired 
infections in the UK could result in a saving of £93 million per year26. 

2. Health impacts (mortality and morbidity)  

Health gains from better prevention in healthcare settings will also be significant.  

The supporting study for this IA suggests that under the 'no policy change' option, i.e. no 
increased  action  on  patient  safety  at  the  EU  level,  the  EU  is  likely  to  see  around  10 
million  adverse  events  related  to  hospitalisations  (including  those  infection-related)  of 
which  almost  4.4  million  would  be  preventable27,  resulting  in  more  than  50.000 
preventable  person-years  additional  hospitalisation  time.  The  US  Institute  of  Medicine 
estimated that preventable adverse patient events, including hospital-acquired infections, 
are  responsible  for  44,000-98,000  deaths  annually  in  the  US  at  a  cost  of  $17-$29 
billion28. 

26 

27 

28 

Plowman  R,  Graves N,  Griffin  M,  Roberts  JA,  Swan A,  Cookson  B,  et  al.  The  socio-economic 
burden of hospital acquired infection. London: PHLS, 2000. 
This reflects the share of preventability in all adverse events used in the Spanish ENAS study of 
2005. This is only an average, in some cases e.g. for infections preventability will be much higher, 
in others, e.g. process related medial errors lower. 
To  Err  Is  Human:  Building  a  Safer  Health  System  (2000).  Institute  of  medicine.  Committee  on 
quality of health care in America. National academy press. Washington, D.C. 

EN 

34 

   EN 

 
 
                                                 
For  HCAI  in  particular,  on  the  basis  of  recent  national  HCAI  prevalence  surveys  in 
Europe  and  the  results  of  hospital-wide  surveillance  programmes  of  nosocomial 
bacteraemia  in  different  Member  States,  it  can  be  calculated  that  HCAIs  affect  an 
estimated  5%  of  hospital  patients  on  average  and  the  total  number  of  hospital  patients 
acquiring at least one HCAI in the EU every year can be estimated at 4.1 million (with a 
total  incidence  of  4.5  million  HCAIs  per  year).  Approximately  37,000  deaths  are 
estimated to occur every year as a consequence of infection (see Annex 3). 

The most frequent infections are urinary tract infections (UTIs, on average 28% (i.e. 1.26 
million  UTIs  in  the  E27  per  year)  in  the  national  prevalence  surveys),  followed  by 
respiratory tract infections (25%, i.e. 1.13 million respiratory infections in the EU27 per 
year),  surgical  site  infections  (SSIs;  17%,  i.e.  765,000  SSIs  in  the  EU27  per  year), 
bacteraemia  (10%,  i.e.  450,000  cases  of  bacteraemia  in  the  EU27  per  year)  and  others 
(including diarrhoea, with increasing importance due to Clostridium difficile (especially 
ribotype 027)). MRSA is isolated in approximately 5% of all HCAIs. 

to 

intubation),  3.1%  developed  blood  stream 

Based on surveillance data (period 2004-2005) on patients staying more than 2 days  in 
intensive  care  units  (ICUs)  in  European  hospitals,  7.2%  developed  pneumonia  (mainly 
due 
infections  (mainly  catheter-
associated)29. Similar ICU surveillance data for the period 2000-2003 showed that 4.9% 
developed  urinary  tract  infections30.  The  EPIC  (European  Prevalence  of  Infection  in 
Intensive Care) 1-day-prevalence study in 1992 found an ICU related infection in 20.6% 
of intensive care patients31. 

Health equity 

Patient safety events and in particular HCAI affect in particular vulnerable citizens such 
as the elderly, acutely ill people, people with impaired immune systems (e.g. transplant 
patients  receiving  immunosuppressive  therapy,  cancer  patients  receiving  chemo-  or 
radiotherapy, HIV positive people), who represent an important and growing share of the 
EU  population:  The  elderly  (65y  or  older)  represent  16.5%  (80  million)  of  the  EU 
population32. Around 4.5 million people in the EU suffer from cancer33 and the there are 
estimated to be about 700,000people with HIV in the EU at34. 

For  policy  option  I,  the  baseline,  we  would  assume  that  some  progress  in  avoiding 
adverse events will be made in MS where patient safety is already on the political agenda 
and  efforts  would  continue  even  without  an  additional  EU  initiative  to  frame  patient-
safety efforts.  

We assume this because there are some EU projects ongoing (see Annex 1) that address 
some aspects of patient safety, but these projects are also time-limited and will therefore 

29 

30 
31 

32 
33 

34 

The  IPSE  (Improving  Patient  Safety  in  Europe)  Annual  Report  2006  (http://helics.univ-
lyon1.fr/Documents/IPSE_Annual_Report_2006.pdf) 
HELICS Implementation Phase II, final report March 2005 
The prevalence of nosocomial infection in intensive care units in Europe. Results of the European 
Prevalence of Infection in Intensive Care (EPIC) Study. EPIC International Advisory Committee. 
Vincent JL et al. JAMA. (1996) 275(5):362 
Europe in figures — Eurostat yearbook 2006-07 
Research in the behavioural and social sciences to improve cancer control and care: a strategy for 
development. Eur. J. Cancer 40 (2004) 316-325 
The 
European  Communicable  Disease 
(http://www.ecdc.eu.int/pdf/Epi_report_2007.pdf) 

Epidemiological  Report 

ECDC 

2007, 

EN 

35 

   EN 

 
                                                 
not  always  deliver  continued  decreases  in  adverse  events.  However,  there  would  be  a 
substantial number of MS without a general patient safety policy in place at all - which 
implies  that  patients  and/or  healthcare  practitioners  will  still  not  able  to  report  adverse 
events and near misses in their countries. Without systematic reporting there will be no 
solid  basis  for  monitoring  or  launching  a  national  patient  safety  policy.  In  some  MS 
patients also do not have the possibility to seek redress after medical errors.  

We  assume  that  the  gaps  between  advanced  MS  with  a  developed  policy  agenda  for 
patient safety and those that have not would continue to exist under the baseline scenario. 
–  given  the  importance  of  political  commitment  and  senior  staff  stewardship.  Hence 
substantial differences in the disease burden due to patient safety will continue to exist 
between Member States, which is discriminatory and affects equal access to high quality 
healthcare services.  

Given the root causes of HCAI, the figures are not expected to decline either, despite the 
efforts of some Member States and funding through the Public Health and the Research 
Programmes.  Moreover,  in  regard  to  HCAI  it  is  not  only  patients,  but  also  health 
professionals  who  are  at  risk:  Their  job  quality  and  safety  is  affected  if  the  necessary 
measures  are  not  in  place  to  protect  them.  This  is  in  conflict  with  Article  13  of  the 
Charter of Fundamental Rights of the European Union35. 

7.2. 

Policy  option  II:  Strengthened  cooperation  with  the  Member  States  and 
other bodies, supported by technical guidance 

As  regards  general  policy  frameworks  for  patient  safety,  we  can  assume  under  this 
option,  which  would  require  a  strengthened  cooperation  of  MS  and  other  bodies,  that 
increased  knowledge  sharing  will  help  MS  improve  their  patient  safety  systems  and 
hence their performance in prevention of medical errors. It is not yet clear whether this 
policy  option  could  also  include  some  technical  guidance  for  general  patient  safety 
issues,  but  this  could  certainly  be  done  for  HCAI  based  on  the  Commission  Decision. 
Establishing  common  indicators  and  monitoring  could  be  developed  under  this  option, 
too,  but  only  in  technical  subgroup  the  High  Level  Group  that  does  not  have  political 
weight or a formal basis for its work. 

1. Health and economic impacts 

For  this  policy  option,  we  assumed  more  progress  would  occur,  in  particular  through 
knowledge sharing - so that in our simulation scenario all EU MS with ‘poor’ and ‘fair’ 
patient  safety  reporting  and  learning  systems  would  be  able  to  advance  and  experience 
similar adverse event rates as countries classified as having already ‘good’ patient safety 
reporting and learning systems. That would mean that instead of having an average of 14 
%  adverse  events  in  hospital  admissions,  those  countries  would  come  closer  to  the 
performance of average countries which is in our scenario given with 12 %. In concrete 
terms  that  would  mean  that  adverse  preventable  events  would  be  reduced  by  298.371 
cases as compared to the baseline scenario resulting also in a reduction of 3450 prevented 
personal years of hospitalisation. However, the differences in Member States with their 
varying levels of political commitment to make patient safety a priority in national public 
health objectives will only be partly remedied under this option.  

35 

Charter  of  Fundamental  Rights  of  the  European  Union  (2000/C  364/01).  O.J.  No  C  364, 
18.12.2000 

EN 

36 

   EN 

 
                                                 
In  our  specific  scenario  on  nosocomial  infections  we  assume  that  strengthened 
cooperation  with  the  Member  States  and  other  bodies,  supported  by  technical  guidance 
would reap an overall 5% decrease of HCAI, a quarter of the potential for reduction in 
infection-related  incidents  reported  in  the  literature.  In  the  absence  of  a  political 
commitment to bring about the needed organisational and behavioural changes, reaching 
the  achievable  20-30%  decrease  of  HCAIs36,37  (requiring  an  intensive  prevention  and 
control  programme  including  surveillance  and  training  of  healthcare  staff)  is  unlikely. 
We  assume  HIA  reduction  successes  are  applicable  across  the  board,  given  that  some 
infection-related safety policies are in place in all EU 27..  

A  projected  5%  decrease  would  in  our  HCAI-scenario  result  in  225,000  HCAIs  fewer 
every year. As explained above, the higher numbers are due to the fact that HCAI cases 
are the easiest and quickest to prevent. 225.000 cases imply a considerable  decrease of 
the HCAI morbidity and mortality burden. A 5% decrease would also save €274 million 
in health expenditure and represent a gain of €68.5 million in productivity. A UK study 
from 2000 indicated that a 10% reduction in the number of hospital acquired infections in 
the UK could result in a saving of £93 million per year38. 

Considering  the  above,  it  becomes  clear  that prevention and control of  HCAIs, even at 
suboptimal levels of 5%, is already highly cost-effective. 

2. Employment effects 

In all options (exception status quo) slightly positive employment effects can be expected 
due  to  the  need  for  more  resources  for  reporting  and  surveillance  as  well  as  infection 
control in health-care institutions.  

Projected  on  the  EU27  situation  with  a  total  of  2.88  million  beds  (see  Annex  7), 
employing  one  infection  control  nurse  per  600  beds39  and  assuming  a  current  staffing 
level of one infection control nurse per 1000 beds would mean employing an additional 
1,920 nurses. Assuming an EU average annual cost of €42,000/infection control nurse 40, 
this would mean an additional annual expenditure of about €80 million for policy option 
II. Costs for surveillance and improved infrastructure have not been obtained. 

3. Environmental Impacts 

Environmental impacts seem to be confined to the specific area of healthcare-associated 
infections,  to  a  lesser  extent  be  linked  of  other  causes  of  medical  errors.  Under  policy 
option  II,  minor  environmental  impacts  are  likely  to  occur  due  to  an  increased  use  of 
disposable medical products and disinfectant chemicals, but it is very difficult to estimate 
those.  

36 

37 

38 

39 

40 

Harbarth S, et al. The preventable proportion of nosocomial infections: an overview of published 
reports. J Hosp Infect 2003; 54:258-266 
Haley  RW,  Culver  DH,  White  JW,  et  al.  The  efficacy  of  infection  surveillance  and  control 
programs in preventing nosocomial infections in U.S. hospitals. Am J Epidemiol 1985;121:182-
205. 
Plowman  R,  Graves N,  Griffin  M,  Roberts  JA,  Swan A,  Cookson  B,  et  al.  The  socio-economic 
burden of hospital acquired infection. London: PHLS, 2000. 
Recommended levels of infection control nurses of 1 per 100 – 250 beds have been cited in the 
literature (see section 7.3.2) 
The  breakdown  is  as  follows:  gross  salary:  €30,000;  benefits  (15%):  €4,500.00;  computer  and 
equipment: €3,500.00; training: €4,000.00 

EN 

37 

   EN 

 
                                                 
7.3. 

Policy  option  III:  Strengthened  cooperation  with  the  Member  States  and 
other  bodies,  supported  by  soft  law  instruments,  such  as  a  Commission 
Communication and a Council Recommendation 

The option would not only bring together various fragmented and specific patient safety 
initiatives  at  EU  level  (e  g  in  the  area  of  research,  innovation  policy  and 
pharmacovigilance)  under  one  framework,  but  would  above  all  provide  a  high  level 
political  commitment  from  MS  to  take  action  on  patient  safety.  It  could  address  the 
overall  cultural  leadership  systemic  communication  and  process  barriers  and  could 
integrate HCAI as  part  of an overall patient safety policy. As explained above, success 
for  patient  safety  depends  on  leadership  and  cultural  change  which  is  why  we  assume 
substantial  benefits  for  this  option,  where  MS's  ownership  is  greatest.  In  particular  we 
assume that some MS that have no patient safety reporting system would start developing 
such  systems  and  launch  development  of  general  patient  safety  policies.  The  more 
advanced  MS  would  benefit  from  increased  knowledge  sharing  and  data  gathering, 
including technical guidance for both systemic and infection-related issues. We therefore 
assumed in our general scenario a larger impact of EU-level action under policy option 3, 
with  the  result  of  all  EU  countries  advancing  to  the  relatively  better  levels  of  adverse 
events  reported  by  the  literature.  That  means  that  we  assume  the  exemplary  countries 
remain  as  efficient  as  they  are  and  all  other  MS  move  towards  the  reported  average  of 
10% adverse events (‘very good’). This is still a conservative estimate (given the average 
preventability rate) but even so we could avoid more than 750.000 preventable adverse 
events and reduce by more than 8000 additional person-years of hospitalisation. 

For our HCAI–only reduction scenario we came up with even better successes given that 
for infections, the ways to control them are well understood, and quick to implement, and 
above all they are highly preventable. 

1. Health and economic impacts 

According to the literature, a 20% (Harbarth et al.41) to 32% (Haley et al.42) reduction in 
hospital acquired infections can be achieved using an intensive infection prevention and 
control programme including surveillance. Indeed, the SENIC (Study on the Efficiency 
of Nosocomial Infection Control) study, performed by Haley et al. in US hospitals from 
1970-1976,  found  that  an  intensive  infection  prevention  and  control  programme 
including surveillance reduced hospitals' infection rates by 32%43.  

Essential components of such programs included conducting organized surveillance and 
control activities and having a trained, effectual infection control physician, an infection 
control  nurse  per  250  beds,  and  a  system  for  reporting  infection  rates  to  practicing 
surgeons. The same study estimated that the cost of infection control teams was only 7% 
of  the  infection  costs.  Therefore,  if  infection  control  programmes  were  effective  in 
preventing only 7% of HCAIs, the costs of the programmes would already be covered. 

41 

42 

43 

Harbarth S, et al. The preventable proportion of nosocomial infections: an overview of published 
reports. J Hosp Infect 2003; 54:258-266 
Haley  RW,  Culver  DH,  White  JW,  et  al.  The  efficacy  of  infection  surveillance  and  control 
programs in preventing nosocomial infections in U.S. hospitals. Am J Epidemiol 1985;121:182-
205. 
Haley  RW,  Culver  DH,  White  JW,  et  al.  The  efficacy  of  infection  surveillance  and  control 
programs in preventing nosocomial infections in U.S. hospitals. Am J Epidemiol 1985;121:182-
205. 

EN 

38 

   EN 

 
                                                 
We assume now that under this policy option all EU MS would implement most of that 
so  that  the  estimated  reduction  could  actually  reap  the  possible  20%  decrease.  A  20% 
decrease would mean up to 900.000 HCAIs less every year, resulting in a major decrease 
of  the  HCAI  morbidity  and  mortality  burden  which  would  save  €1.10  billion  in  public 
health expenditure and represent a gain of €274 milli on in productivity. 

2. Employment effects 

In  all  options  (except  the  status  quo)  slightly  positive  employment  effects  can  be 
expected as more resources are needed for reporting and surveillance as well as infection 
control in healthcare institutions. Haley et al.44 mentions the need for 1 infection control 
nurse per 250 beds as part of an intensive infection prevention and control programme. 
The Aucoin report45 proposes 1 infection control nurse per 100 specialised care beds, 1 
infection  control  nurse  per 133  normal  care  beds  and  1  infection  control  nurse  per  250 
long-term care beds. The EU has a total of 2.88 million beds. Employing one infection 
control nurse per 250 beds and assuming a current staffing level of one infection control 
nurse per 1000 beds would mean employing an additional 8,640 nurses. Assuming an EU 
average  annual  cost  of  €42,000  per  nurse,  th is  would  mean  an  additional  annual 
expenditure  of  about  €363  million  for  polic y  option  III.  Costs  for  surveillance  and 
improved infrastructure have not been obtained. 

Considering the above, it becomes clear that successful prevention and control strategies 
are highly cost-effective. 

3. Environmental Impacts 

Environmental impacts seem to be mainly confined to the specific area of HCAIs. Under 
option III, minor environmental impacts are likely to occur because of increased use of 
disposable medical products and disinfectant chemicals, but it is very difficult to estimate 
those.  

7.4. 

Policy  option  IV:  Strengthened  cooperation  with  the  Member  States  and 
other bodies, supported by a regulatory instrument, such as a Commission 
Decision 

As stated, a Commission Decision could only address infection-related, and not general 
and  systemic  patient  safety  issues  given  the  lack  of  a  legal  base  for  this.  That  would 
mean  that  this  policy  option  would  only  reap  benefits  comparable  to  those  of  policy 
option  III  if  it  is  accompanied  by  a  Recommendation.  If  not,  we  assume  the  general 
patient safety benefits to be in the range of those identified under policy option II.  

As regards HCAI, we do not assume, however, that the benefits would be much bigger 
than  those  identified  in  policy  option  III.  That  is  because  Article  3  of  Decision  No 
2119/98/EC does not provide a legal basis to address all the operational objectives of the 
proposal, and therefore essential parts (e.g. creation  of infection prevention  and  control 

44 

45 

Haley  RW,  Culver  DH,  White  JW,  et  al.  The  efficacy  of  infection  surveillance  and  control 
programs in preventing nosocomial infections in U.S. hospitals. Am J Epidemiol 1985;121:182-
205. 
Aucoin  et  al.  'D’abord,  ne  pas  nuire…Les  infections  nosocomiales  au  Québec,  un  problème 
majeur  de  santé,  une  priorité.  Rapport  du  Comité  d'examen  sur  la  prévention  et  le  contrôle  des 
infections  nosocomiales.'  La  Direction  des  communications  du  ministère  de  la  Santé  et  des 
Services sociaux, Quebec, Canada (2005). 

EN 

39 

   EN 

 
                                                 
programmes  in  hospitals  or  developing  specific  training)  of  the  integrated  strategy  to 
combat  HCAIs  would  have  to  be  left  out.  Whereas  it  would  be  feasible  to  use 
Commission Decisions to reinforce certain aspects of the integrated strategy after it has 
been  put  in  place  via  e.g.  a  Council  Recommendation,  it  is  expected  that  this  option 
without  an  integrated  strategy  will  not  perform  much  better  than  the  option  of 
strengthened  cooperation  with  the  Member  States.  In  particular,  there  would  be  no 
additional push resulting from an overarching patient safety policy.  

A synoptic overview of the different policy options and the extent to which they could 
achieve the identified specific objectives is presented in Table 7. Figures were rounded. 

Policy option I 

Policy option II 

Policy option III  

Policy option IV 

Specific 
objective 1 

Protect  EU 
citizens  from 
harm  

progress, 
Little 
which  would  occur 
in 
basically 
countries 
where 
patient  safety  is  a 
political priority 

of 
Reduction 
300.000  preventable 
adverse  events 
in 
total 

of 

Reduction 
750.000 
preventable  adverse 
events in total 

O with slight 
improvements 

+ 

++ 

+ to ++ 

Specific 
objective 2 

No additional EU 
level support 

Some  additional  EU 
support 
level 
through 
technical 
guidance on HCAI 

Political  ownership 
and 
leadership  of 
all MS, exchange of 
best practice 

Quick 
implementation 
possible 

Political ownership 
if accompanied by a 
Recommendation, 
Decision addresses 
some aspects of 
HCAI which would 
be legally binding. 

O 

O 

+ 

+ 

++ 

+ to ++ 

++ 

+ to ++ 

Support  MS 
to  put 
in 
place  patient 
safety 
strategies 

Specific 
objective 3  

Improve  EU 
citizens 
confidence  

8. 

COMPARING THE OPTIONS 

8.1. 

Advantages and disadvantages of the policy options identified in section 6 

Option I 

No EU action – the status quo 

Advantages 

Disadvantages 

The  patient  safety  working  group  of  the  high  level 
working  group  on  healthcare  is  the  main  platform 
for  patient  safety  information-sharing  and  learning 
at  the  European  level,  bringing  together  Member 
States, stakeholders and international organisations. 
The  involvement  of  the  key  players  has  helped  to 
ensure that synergies are developed and that overlap 
of efforts can be avoided. 

a 

technical 

The  patient  safety  working  group  is,  as  the  name 
another 
suggests, 
Committee  and  does  not  have  political  weight.  It 
will not necessarily continue to exist as there is no 
formal basis of its work. 

subgroup  of 

While organisations like the WHO's World Alliance 
for patient safety have launched some patient safety 

EN 

40 

   EN 

 
 
 
 
 
Projects  funded  by  the  Commission  have  proved  a 
valuable 
towards  a  better 
understanding of the problems and finding possible 
solutions. 

to  progress 

tool 

These  initiatives  involve  the  professionals  in  the 
field and offer flexibility for Member States to tailor 
the results to their national situations. 

programmes and campaigns on particular aspects of 
patient  safety  such  as  clean  hand  policy,  there  has 
been  no  attempt  to  approach  the  patient  safety 
problem comprehensively, addressing all the factors 
that could improve patient safety outcomes. 

It is clear that there are still big gaps in the data in 
most EU Member States on the extent and causes of 
adverse  events.  Without  increased  action  at  EU 
level  these  gaps  are  likely  to  continue  to  exist  in 
many Member States. 

Coordination  of  these  projects  under  different 
Community programmes is quite difficult. 

The  projects  do  not  always  include  all  Member 
States. In many instances those involved in the best 
systems are leading the projects and the results are 
not likely to benefit the whole EU. 

The projects have a limited time frame and limited 
resources so that there is a risk of losing continuity 
once  the  project  is  finished.  The  projects  do  not 
always  have  the  financial  capacity  to  transfer  their 
results  to  the  political  level  in  order  to  make  them 
more widely operatives. 

Community  initiatives  aimed  at  improving  patient 
safety  in  areas  such  as  pharmacovigilance  and 
medical device safety and technology already exist. 

These actions do not fully meet the demands of the 
current  situation  or  the  needs  of  patients  or 
governments  to  tackle  this  major  public  health 
concern. 

These  initiatives  only  focus  on  specific  patient 
safety  concerns,  such  as  in  the  area  of  product 
safety,  and  do  not  seek  to  address  the  overall 
cultural,  leadership,  systemic,  communication  and 
process barriers to improved safety. 

The OMC for healthcare and long-term care may be 
useful  in  the  future  to  monitor  and  compare 
Member  States'  performance  in  the  area  of  patient 
safety  against  a  number  of  indicators  that  could  be 
developed. 

Poor  performance  against  such 
in 
individual countries may prompt Member States to 
try  to  improve  their  performance  in  patient  safety 
but  would  not  provide  adequate  guidance  on  what 
actions could work best in their settings. 

indicators 

No  extra  resources  needed  for  the  prevention  and 
control of HCAIs 

The  EUNetPaS  project  would  continue 
September 2010. 

to 

As  such,  the  OMC  initiative  could  complement  a 
proposal  on  patient  safety,  but  would  not  be 
sufficient to address this important issue in itself. 

The  non-statutory  guidance  on  the  prevention  and 
control  of  HCAIs  has  up  till  now  not  been  able  to 
address  the  problems  related  to  HCAIs  as  listed  in 
section 3. 

This  option  fails  to  profit  from  Community  added 
value by  pooling  the best  expertise  and  identifying 
best practices on HCAIs as described in section 4. 

The  EUNetPaS  project  is  largely  an  operational 
mechanism  and  does  not  bring  with  it  the  full 
political  commitment  to  improving  patient  safety 
from  MS  governments  which  we  are  seeking. 

EN 

41 

   EN 

 
co-funded  under 

EUNetPaS  is  also  a  time-limited  project,  (30 
months  running  from  February  2008  to  August 
the  Public  Health 
2010) 
Programme, there will be doubts as to its long-term 
sustainability once its funding runs out. The project 
will  not  fully  address 
the 
the  objectives  of 
Commission's initiative, even in the short-term.  

For example, the project is not seeking to establish 
and  implement  a  common  taxonomy  and  EU-wide 
patient  safety  indicators.  The  sharing  of  effective 
patient safety interventions is limited to medication 
safety  whereas  the  Commission's  initiative  aims  to 
share  best  practice  and  effective  solutions  in  all 
areas of harm. EUNetPaS will be, in the short-term 
at least, a useful operational tool for Member States 
to add EU value on patient safety. However, it is a 
time-limited,  specific  project  and  should  not  be 
regarded as having either the same purpose or effect 
as a broad- ranging political initiative. 

Option II) 
supported by technical guidance 

Strengthened  cooperation  with  the  Member  States  and  other  bodies, 

Advantages 

Disadvantages 

The  advantages  listed  under  option  I  would  be 
further underlined by a more active involvement of 
the Commission in current activities. 

Guidelines  are  not  legally  binding  on  Member 
States  so  this  option  presents  a  real  risk  that 
Member States could ignore them. 

between  Member  States 

Coordination 
has 
sometimes  proved  to  be  ineffective  l  without  any 
legal instrument supporting the actions. 

Mechanisms to fund projects addressing HCAIs are 
in  place  (under  the  Public  Health  and  Research 
Framework  Programmes)  and  the  focus  on  patient 
safety and HCAIs could be increased. 

increase 
time-limited  projects  can 
Although 
understanding  of  problems,  they  cannot  overcome 
structural  differences  among  Member  States  nor 
assure political commitment. 

ECDC  could  provide  added  value  in  coordinating 
the  Member  States'  activities  and  providing 
guidance on the prevention and control of HCAIs. 

Coordination  between  MS  by  itself  may  not  be 
sufficient  to  control  HCAIs  since  many  Member 
States  have  varying  levels  of  political  commitment 
strengthened 
action.  Therefore, 
to 
coordination  supported  by  technical  guidance  may 
not  be  sufficient 
the  needed 
organisational and behavioural changes. 

to  bring  about 

taking 

Option III)  Strengthened  cooperation  with  the  Member  States  and  other  bodies, 
supported  by  soft  law  instruments,  such  as  a  Commission  Communication  and 
Council Recommendation 

Advantages 

Disadvantages 

A  Communication  would  provide  an  overarching 
structure for the Community's diverse initiatives on 

Neither  a  Commission  Communication  nor  a 
Council Recommendation is legally binding. 

EN 

42 

   EN 

 
 
 
 
This  option  would  require  detailed  negotiations  in 
the Council in order to achieve consensus. 

Investments are necessary to bring about the needed 
organisational and behavioural changes. 

patient safety. 

It  could  address  the  overall  cultural,  leadership, 
systemic,  communication  and  process  barriers  to 
improved patient safety. In consequence, morbidity 
and  mortality  due  to  patient  safety  issues  could 
decrease substantially. 

It  would  present  findings  and  good  practice 
principles on patient safety to be applied in the EU 
and highlight the need for actions. 

A  Council  Recommendation 
include 
recommendations  on  patient  safety  and  specific 
recommendations  on  the  prevention  and  control  of 
HCAIs. 

could 

A  Council  Recommendation  would  represent  a 
strong  political  commitment  to  address  patient 
safety and HCAIs. 

The literature and this impact assessment show that 
improved  prevention  and  control  of  HCAIs  is 
highly cost-effective. 

A  Council  Recommendation  allows  for  monitoring 
and evaluation of the recommended measures. 

This option corresponds to what is indicated in the 
Commission's Legislative and Work programme as 
a strategic initiative for 2008. 

Option IV)  Strengthened  cooperation  with  the  Member  States  and  other  bodies, 
supported by a regulatory instrument, such as a Commission Decision 

Advantages 

Disadvantages 

The  legal  basis  exists  to  put  in  place  via  a 
Commission Decision some of the elements needed 
to improve the prevention and control of HCAIs. 

With  a  Decision  only  some  of  the  elements  to 
improve  prevention  and  control  of  HCAIs  can  be 
put  in  place,  but  not  all.  Moreover,  general  patient 
safety issues, could not be addressed. 

A  Commission  Decision  is  a  legally  binding 
instrument  which  would  promote  a  strong  political 
commitment to address the issues covered. 

Essential  parts  of  the  integrated  strategy  to  combat 
HCAIs  (e.g.  creation  of  infection  prevention  and 
control  programmes  in  hospitals  or  developing 
specific training on HCAIs prevention and control ) 
would have to be left out. 

It would be feasible to use Commission Decisions to 
reinforce certain aspects of an integrated strategy on 
HCAIs  after  it  has  been  put  in  place  via  e.g.  a 
Council  Recommendation.  However  it  is  expected 
that  this  option  without  an  integrated  strategy  will 
not  perform  much  better 
the  option  of 
strengthened cooperation with the Member States. 

than 

EN 

43 

   EN 

 
 
 
8.2. 

Conclusions 

Based on the above, the policy option of a proposal for a Commission Communication 
and  a  Council  Recommendation  on  patient  safety  and  quality  of  health  services, 
including the prevention and control of HCAIs is preferred. 

9. 

MONITORING AND EVALUATION 

9.1. 

Progress indicators and surveillance 

Problem definition 

Issues to be monitored 

Indicators 

Source of info 

How  often  data  gathered 
and analysed?  

Level  of  awareness  of  extent  and 
type  of  adverse  events  among 
Member States 

Quality 
harmonization 
the 
awareness of MS  

level 

and 
of 
of 

the 

Once a year from 2010 

Data  from 
EUNetPaS 
project 

information 

Availability  of 
for 
patients  on  safety  levels  and  help 
available 
in 
different healthcare systems  

in  case  of  harm 

Patients'  awareness 
in 
of  differences 
safety 
levels  and 
overall satisfaction  

Reporting 
and 
learning  system 
within 
the 
EUNetPaS 
project 

Once a year from 2010 

Objectives 

Creation  of  homogenous 
and 
comparable data and information on 
patient  safety  systems,  initiatives 
and safety outcomes at EU level. 

Access  and  level  of 
use  of  up-to-date 
and  comprehensive 
information system. 

Competent 
authorities 

Yearly report 

Develop  common  definitions  and 
terminology for patient safety at the 
EU level 

Unified 
terminology in use. 

An 
evaluation. 

external 

Within 
future 
a 
evaluation  of  proposed 
SANCO  health  related 
initiatives  

Develop 
HCAIs, 
Decision 2119/98/EC 

case 
in 

definitions 

for 
accordance  with 

Commission 
Decision  covering 
case  definitions  for 
HCAIs 

ECDC,  external 
expertise 

Continuous follow-up 

Creation of European reference data 
for  comparisons  between  countries 
and hospitals 

Existence 
functional 
surveillance 
systems 

Within 
future 
a 
evaluation  of  proposed 
SANCO  health  related 
initiatives 

of 

An 
evaluation. 

external 

Existing 
European 
surveillance 
systems,  ECDC 
(for 
communicable 
diseases). 

with 

ECDC 

the 
Foster 
surveillance 
of 
establishment 
methods  and  indicators  to  allow 
evaluation  of  the  implementation 

ECDC 

Continuous follow-up. 

of 

Availability 
surveillance 
methods, indicators, 
guidance  on  best 

44 

   EN 

EN 

 
and 

practices 
minimum 
infrastructure 
requirements, 
well 
as 
curricula 
healthcare 
agreed at EU level. 

as 
training 
for 
staff 

Process 
(e.g. 
standard  operating 
procedures  on  hand 
hygiene) 
and 
structure 
(number 
of  infection  control 
personnel) 
be 
indicators 
developed 
by 
ECDC,  building  on 
the 
the  work  of 
IPSE project. 

to 

Prevalence 
and 
incidence of HCAIs 
in Member States. 

ECDC 

In  reports  to  the  Council 
at  the  interval  specified 
in 
Council 
the 
Recommendation. 

National 
competent 
authorities, 
ECDC 

annual 

The 
ECDC 
epidemiological report on 
communicable  diseases 
in Europe. 

Number of accepted 
on 
applications 
patient safety. 

Public  Health 
Programme 

Yearly statistics 

DG RTD 

and 

and  effectiveness  of  measures  to 
prevent 
control  HCAIs, 
guidance  on  best  practices  and 
minimum 
infrastructure 
requirements,  as  well  as  training 
curricula for healthcare staff. 

Monitor  the  implementation  and 
the 
effectiveness 
recommendations on the prevention 
and control of HCAIs. 

of 

Decrease  of  level  of  HCAIs  in 
Member States. 

information 

Develop  and  promote  the  research 
agenda  on  patient  safety,  including 
the  use  of 
and 
communication  technology  (ICT), 
the  diagnosis, 
new 
tools 
treatment  of 
prophylaxis 
HCAIs,  as  well  as  further  research 
on 
of 
prevention and control of HCAIs.  

cost-effectiveness 

for 
and 

the 

9.2. 

Evaluation 

It is envisaged to evaluate the overall patient safety initiative, including implementation 
of the Recommendation, using external experts to assess its relevance, effectiveness and 
efficiency.  This  evaluation  could  be  part  of  a  comprehensive  evaluation  project  for 
different health related initiatives. In relation to HCAI, Member States will also submit 
reports on implementation of the Recommendation. The proposed indicators and data to 
be  collected  in  the  future  should  enable  the  measurement  of  the  economic  and  social 
impact of initiative. 

EN 

45 

   EN 

 
 
ANNEX 1: 

EU-FUNDED PATIENT SAFETY / HCAIS PROJECTS 

The  MARQuIS  research  project  ("Methods  of  Assessing  Response  to  Quality 
Improvement  Strategies")  was  designed  to  help  assess  the  value  of  different  quality 
strategies and to provide information for countries contracting care for patients moving 
across  borders  and  for  individual  hospitals  reviewing  the  design  of  their  quality 
strategies.  The  results  also  provided  evidence-based  advice  for  developing  quality 
approaches at EU level for healthcare institutions. 

The  SIMPATIE  project  ("Safety  Improvement  for  Patients  in  Europe")  aimed  to 
facilitate  free  movement  of  people  and  services  by  developing  EU-wide  commonality 
and transparency in methodology on patient safety in healthcare institutions. The project 
used Europe-wide networks to establish a common set of vocabulary, indicators, internal 
and external instruments for improvement in safety in healthcare.  

The,  EUNetPaS  ("European  Union  Network  for  Patient  Safety")  was  launched  in 
February  2008.  It  aims  to  establish  an  umbrella  network  of  Member  States  and  EU 
stakeholders  to  encourage  and  enhance  collaboration  in  the  field  of  Patient  Safety  by 
evaluating, validating and diffusing new knowledge and good practices.  

The HELICS implementation phase I project (Hospital in Europe Link for Infection 
Control  through  Surveillance)  aimed  to  lay  the  practical  foundations  for  a  European 
Network  on  hospital  acquired  infections  by  the  creation  and  analysis  of  two  databases 
(on  surgical  and  intensive  care  unit  (ICU)  infections);  developing  consensus  for 
prevalence  surveys  and  surveillance  of  emerging  infections  in  immuno-compromised 
patients; validating a European methodology to create evidence-based scientific advice, 
recommendations or standards; and setting up an inventory of training and fellowships on 
infection control. 

The  HELICS  implementation  phase  II  project  (Hospital  in  Europe  Link  for 
Infection  Control  through  Surveillance)  aimed  to  create  a  robust  and  validated 
surveillance  system  and  establish  reference  data  sets  for  surveillance  of  Surgical  Site 
Infections  (SSIs)  and  infections  in  ICUs.  Data  on  SSIs  and  infections  in  ICUs  were 
collected on a pilot basis and a database was established to collect regular data on these 
infections. 

The IPSE project ("Improving Patient Safety in Europe") aims to reduce the burden 
of  HCAIs  and  their  related  threats  of  antimicrobial  resistance  (AMR)  by  providing 
evidence-based  guidance  and  educational  tools,  strengthening  the  status  of  infection 
control professionals, strengthening surveillance and developing indicators. 

PSIP (Patient safety through intelligent procedures in medication) is an ICT project 
under  the  7th  Framework  Programme  aiming  at  producing  systematic  epidemiological 
knowledge  on  adverse  drug  events  and  improving  the  medical  cycle  in  a  hospital 
environment  through  innovative  data  mining  and  semantic  mining  techniques  using 
available hospital data. 

46 

 
ANNEX 2: 

EVIDENCE OF THE SCALE OF THE PATIENT SAFETY PROBLEM  

Studies from the UK, Spain and France provide the bulk of current evidence in Europe 
on in-patient adverse event prevalence and its implications. The UK studies demonstrate 
the scope and universal nature of the problem, the costs of compensation claims and most 
common  incident  types.  Spain’s  study  also  covers  the  scope  of  the  problem,  the 
proportion  of  incident  types  by  severity,  the  root  causes  and  consequences  in  extended 
hospital  stays.  The  French  study  also  shows  the  universality  of  the  problem  of  patient 
safety and the root causes. 

The  UK,  a  National  Health  Service  (NHS)  report  in  2000,  An  Organisation  with  a 
Memory, revealed a big  problem  of poor patient safety: existing data  (admittedly poor) 
showed  that  at  least  400  patients  died  or  were  seriously  injured  in  adverse  events 
involving medical devices in 1999 and that nearly 10,000 people had experienced serious 
adverse reactions to drugs.  

Compared to the UK, there is a slightly lower nation-wide incidence of adverse events in 
Spain.  According  to  the  2006  Spanish  National  Study  on  Hospitalisation-Related 
Adverse  Events  (ENEAS)46,  adverse  events  among  all  hospital  patients  in  Spain  in 
2005 was 9.3% 47and 42.8% of these were deemed preventable. More specifically, the 
incidence of patients with adverse events directly related to their hospital care (excluding 
primary  care,  out-patient  treatment  and  those  caused  at  another  hospital)  was  8.4% 
(473/5,624). A total of 17.7% of these patients had more than one adverse event related 
to their hospital care. 

The Spanish study found that adverse events not only result in an extended hospital stay 
(31.4%), but also in re-admission to a hospital (24.4%), with some patients having more 
than  one  adverse  event  which  caused  their  re-admission.  Adverse  events  extended 
hospital stays by an average of 4 days and by 7 days where re-admission was needed. A 
total of 3,200 additional days (6.1 per patient) were caused by adverse events, 1,157 of 
which were avoidable. 

The  third  European  national  study  is  a  recent  French  national  survey  of  in-patient 
adverse events (Michel, 2007) .This, prospectively assessed with ward staff, found that in 
the course of the 7 days’ observation per unit at least one adverse event was observed 
in 55% of surgical units and in 40% of medical units.48 The investigators and the ward 
staff  considered  35.4%  of  the  adverse  events  to  have  been  preventable  (39.6%  in 
medicine and 32.1% in surgery). This result indicated that every type of hospital and unit 
is  affected  by  adverse  events,  and  hence  substantiates  the  classification  of  in-patient 

46 

47 

48 

ENEAS  was  a  retrospective  cohort  study.  A  sample  of  24  hospitals  was  random  layered  by 
hospital size, in which the hospitals to take part in the study were chosen at random according to 
the  sample  size  required  to  compiling  all  of  the  discharges  for  the  study  period  which  met  the 
criteria  for  inclusion.  6  small-sized  (under  200  beds),  13  medium-sized  (200-499  beds)  and  5 
large-sized (500 beds or more) were included, with a total of 5,624 case records. 
A total of 1,755 (32%) of the 5,624 patients were screened as possible AE's, 3,869 of whom were 
ruled  out  due  to  their  not  meeting  the  requirements  of  any  of  the  screening  guide  alerts.  On 
reviewing  the  patients  screened  as  positive,  501  false  positives  and 191  patients  showing  solely 
incidents were found. A total of 1,063 patients with AE's during hospitalisation were detected, the 
incidence of patients with healthcare-related AS's being 9.3% (525/5,624).  
Excluding obstetric wards, but including public, private and teaching hospitals. Total participation 
rate was 40%. The 8754 patients included in the study were followed up on average over 4 days, 
giving a total of 35 234 days of observation (17 105 in medicine and 18 129 in surgery). 

EN 

47 

   EN 

 
                                                 
adverse  events  as  a  public  health  problem.  A  longer  period  of  hospitalisation  was 
associated with 40.5% of all adverse events. 

EN 

48 

   EN 

 
ANNEX 3: 
ESTIMATE FROM MULTICENTRE PREVALENCE SURVEYS OF NOSOCOMIAL INFECTIONS

THE BURDEN OF HEALTHCARE-ASSOCIATED INFECTIONS  IN EUROPE:  AN 
49 

Hospital-wide incidence  figures for all types of nosocomial infections  are not  available 
from European countries. The type of surveillance generating these figures, hospital-wide 
surveillance  of  all  nosocomial  infection  types,  was  abandoned  worldwide  in  the  early 
nineties  because  of  poor  cost-effectiveness  in  terms  of  prevention  of  nosocomial 
infections(1). 

Given  this  lack  of  hospital-wide  figures,  the  total  annual  number  of  nosocomial 
infections occurring on a yearly basis in the EU can be estimated by converting the mean 
prevalence of national or multicentre prevalence surveys to incidence figures according 
to the method described by Freeman et al. (2) and applied by Gastmeier et al. (3). 

A review of recent prevalence surveys in industrialized countries showed that the mean 
prevalence  of  nosocomial  infections  in  acute  care  hospitals  is  approximately  7.1%, 
ranging from 3.5% to 10.5% (table 1). 

Table  1.  Overview  of  recent  prevalence  surveys  of  nosocomial 
industrialised countries 

infections 

in 

Spain, 96-99 

UK, 1996 

NI 
Prevalence

N 
hospitals

N 
patients 

Ref

8.9%

(4;5)

233

210985 

9.0%

(6;7)

157

37111 

Germany, 1997 

3.5%

(8)

72

14996 

France, 2001 (1996) 

6.6% (9;10)

1533

162220 

Norway, 2003 

Suisse, 2002 

Italy, INF-NOS, 2002 

Greece, 2000 

Italy, Lombardy, 2000 

Slovenia, 2001 

Canada, 2002 

UK & IE, 2006 

France, 2006 

Scotland, 2007 

5.1% (11;12)

8.1% (13;14)

7.5%

9.3%

4.9%

4.6%

10.5%

(15)

(16)

(17)

(18)

(19)

71

60

15

14

88

19

25

12257 

7540 

2165 

3925 

18667 

6695 

5750 

7.6% (20;21)

273

75763 

5.0%

9.5%

(22)

(23)

2337

358353 

45

11608 

49 

Calculation by ECDC, unpublished results 

EN 

49 

   EN 

 
  
                                                 
The Netherlands, 2007 

6.9%

(24)

30

8424 

Total, mean 

7.1%

Assuming an overall average length of hospital stay of 10 days (LA), a mean length of 
stay  of  22  days  in  patients  who  acquire  one  or  more  nosocomial  infections  (LN)  and  a 
mean  interval  between  admission  to  onset  of  first  infection  (INT)  of  8  days  (figures 
corroborated by ref.(3)), this prevalence figure of 7.1% converts to an incidence figure of 
approximately 5.1% according to the formula I=P*LA/(LN-INT) with a 95% confidence 
interval ranging from 4.3% to 5.9%. The figure of 5% compares relatively well to best 
nationwide figure of 5.7 per 100 admissions yet available from the US (25).  

According  to  Eurostat  figures,  in  the  EU  (2005  figures  completed  by  earlier  years  if 
missing,  ref.  http://epp.eurostat.ec.europa.eu/  and  Health  in  Europe  2005  pocketbook 
edition),  the  number  of  hospital  admissions  is  approximately  81  million  per  year  (on 
average 16247 admissions/100 000 inhabitants/year). The yearly number of patients with 
at least one nosocomial infection in the EU can thus be estimated at 4,131,000 patients 
(95%  CI  3483000-4779000).  Since  several  patients  acquire  more  than  one  infection 
during the same hospitalisation (average from the national prevalence surveys review 1.1 
infections  per  infected  patient)  the  yearly  number  of  nosocomial  infections  can  be 
estimated at 4,544,100 (95% CI 3831300-5256900). 

The  impact  of  nosocomial  infections  on  the  excess  length  of  stay  in  the  hospital  and 
mortality (attributable morbidity and mortality) depends on the type of infection (highest 
for pneumonia and bloodstream infections) and estimates vary considerably in scientific 
literature.  Based  on  overall  estimates  of  attributable  mortality  in  nosocomial  infections 
by the CDC (26;27), approximately 37,179 deaths (0.9%; 95%CI 31347-43011) directly 
caused by nosocomial infections occur every year in the EU and an additional 111,537 
(95%CI  94041-129033)  deaths  occur  to  which  infections  contributed.  Nosocomial 
infections  also  generate  approximately  16  million  extra  days  of  hospital  stay  per  year 
(average of 4 days per infection (26)). 

Reference List 

(1) 

(2) 

(3) 

(4) 

Haley  RW.  Surveillance  by  objective:  a  new  priority-directed  approach  to  the 
control of nosocomial infections. The National Foundation for Infectious Diseases 
lecture. Am J Infect Control 1985; 13(2):78-89. 

Freeman  J,  Hutchison  GB.  Prevalence, incidence  and duration.  Am J Epidemiol 
1980; 112(5):707-723. 

Gastmeier  P,  Brauer  H,  Sohr  D,  Geffers  C,  Forster  DH,  Daschner  F  et  al. 
Converting incidence and prevalence data of nosocomial infections: results from 
eight hospitals. Infect Control Hosp Epidemiol 2001; 22(1): 31-34. 

Vaque  J,  Rossello  J,  Trilla  A,  Monge  V,  Garcia-Caballero  J,  Arribas  JL  et  al. 
Nosocomial  infections  in  Spain:  results  of  five  nationwide  serial  prevalence 
surveys (EPINE Project, 1990 to 1994). Nosocomial Infections Prevalence Study 
in Spain. Infect Control Hosp Epidemiol 1996; 17(5):293-297. 

EN 

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(5) 

(6) 

(7) 

(8) 

(9) 

Vaque J, Rossello J, Grupo de Trabajo EPINE. Evolución de la Prevalencia de las 
infecciones nosocomiales en los hospitales Españoles, Proyecto EPINE 10 años, 
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Emmerson  AM,  Enstone  JE,  Griffin  M,  Kelsey  MC,  Smyth  ET.  The  Second 
National Prevalence Survey of infection in hospitals - overview of the results. J 
Hosp Infect 1996; 32(3):175-190. 

Plowman R, Graves N, Griffin MA, Roberts JA, Swan AV, Cookson B et al. The 
rate  and  cost  of  hospital-acquired  infections  occurring  in  patients  admitted  to 
selected  specialties  of  a  district  general  hospital  in  England  and  the  national 
burden imposed. J Hosp Infect 47[3], 198-209. 2001. 

Gastmeier P, Kampf G, Wischnewski N, Hauer T, Schulgen G, Schumacher M et 
al.  Prevalence  of  nosocomial  infections  in  representative  German  hospitals.  J 
Hosp Infect 1998; 38(1):37-49. 

Réseau  d'alerte,  d'investigations  et  de  surveillance  des  infections  nosocomiales 
(RAISIN). Enquête de prévalence nationale 2001 - Résultats. 2001. 

(10)  Prevalence of nosocomial infections in France: results of the nationwide survey in 
1996.  The  French  Prevalence  Survey  Study  Group.  J  Hosp  Infect  2000; 
46(3):186-193. 

(11)  Eriksen  HM,  Iversen  BG,  Aavitsland  P.  Prevalence  of  nosocomial  infections  in 

hospitals in Norway, 2002 and 2003. J Hosp Infect 60[1], 40-45. 2005.  

(12)  Bruun T, Loewer HL. Prevalence surveillance system of nosocomial infections in 

Norway. Euro Surveill 2007; 12(8):E070830. 

(13)  Sax  H,  Ruef  C,  Pittet  D.  Résultats  de  l'enquête  nationale  de  prévalence  des 

infections nosocomiales de 2003 (snip03). Swiss-Noso 11, 1-5. 2004. 

(14)  Sax  H,  Pittet  D.  Surveillance  des 

infections  nosocomiales  en  Suisse: 
méthodologie  et  résultats  des  enquêtes  de  prévalence  1999  et  2002.  Swiss-Noso 
10, 1-5. 2003.  

(15)  Nicastri  E,  Petrosillo  N,  Martini  L,  Larosa  M,  Gesu  GPIG.  INF-NOS  Study 
Group.  Prevalence  of  nosocomial  infections  in  15  Italian  hospitals:  first  point 
prevalance study for the INF-NOS project. Infection 31[Suppl 2], 10-15. 2003. 

(16)  Gikas A, Pediaditis J, Papadakis JA, Starakis J, Levidiotou S, Nikolaides P et al. 
Greek  Infection  Control  Network.  Prevalence  study  of  hospital-acquired 
infections  in  14  Greek  hospitals:  planning  from  the  local  to  the  national 
surveillance level. J Hosp Infect 50[4], 269-275. 2002.  

(17)  Lizioli A, Privitera G, Alliata E, Antonietta Banfi EM, Boselli L, Panceri ML et 
al. Prevalence of nosocomial infections in Italy: result from the Lombardy survey 
in 2000. J Hosp Infect 54[2], 141-148. 2003. 

(18)  Klavs  I,  Bufon  LT,  Skerl  M,  Grgic-Vitek  M,  Lejko  ZT,  Dolinsek  M  et  al. 
Prevalance of and risk factors for hospital-acquired infections in Slovenia-results 
of the first national survey, 2001. J Hosp Infect 2003; 54(2):149-157. 

EN 

51 

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(19)  Gravel  D,  Taylor  G,  Ofner  M,  Johnston  L,  Loeb  M,  Roth  VR  et  al.  Point 
prevalence  survey  for  healthcare-associated  infections  within  Canadian  adult 
acute-care hospitals. J Hosp Infect 2007; 66(3):243-248. 

(20)  Hospital  Infection  Society,  Infection  Control  Nurses  Association.  The  Third 
Prevalence  Survey  of  Healthcare-associated  Infections  in  Acute  Hospitals  2006. 
England. 
Results. 
of 
http://www.his.org.uk/_db/_documents/Summary_of_preliminary_results_for_En
gland.pdf, 1-7. 2007. 

Preliminary 

Summary 

(21)  Hospital Infection Society. The Third Prevalence Survey of Healthcare-associated 
release. 

Infections 
http://www.his.org.uk/_db/_documents/Press_information.doc. 2006. 

Hospitals. 

Acute 

Press 

in 

(22)  Réseau  d'alerte,d'investigations  et  de  surveillance  des  infections  nosocomiales 
(RAISIN).  Enquête  nationale  de  prévalence  des  infections  nosocomiales,  juin 
2007. 
préliminaires, 
2006. 
http://www.invs.sante.fr/publications/2007/enp2006_resultats_preliminaires/enp_
2006_resultats_preliminaires.pdf. 2007.  

Résultats 

janvier 

(23)  Reilly  J,  Stewart  S,  Allardice  G,  Noone  A,  Robertson  C,  Walker  A  et  al.  NHS 
Scotland National HAI Prevalence Survey. Final Report 2007. Health Protection 
Scotland.  http://www.documents.hps.scot.nhs.uk/hai/sshaip/publications/national-
prevalence-study/report/full-report.pdf, 1-240. 2007.  

(24)  PREZIES.  PREZIES 

surveillance  netwerk  ziekenhuisinfecties. 
Resultaten  prevalentiestudie  maart  2007.  http://www.prezies.nl/prev/index.html. 
20-12-2007. 

landelijk 

(25)  Haley  RW,  Culver  DH,  White  JW,  Morgan  WM,  Emori  TG.  The  nationwide 
nosocomial infection rate. A new need for vital statistics. Am J Epidemio 1985; 
121(2):159-167. 

(26)  Emori TG, Gaynes RP. An overview of nosocomial infections, including the role 

of the microbiology laboratory. Clin Microbiol Rev 1993; 6(4):428-442. 

(27)  Martone WJ, Jarvis WR, Culver DH, Haley RW. Incidence and nature of endemic 
and  epidemic  nosocomial  infections.  In:  Bennett  JV,  Brachman  PS,  editors. 
Hospital Infections, 3rd ed. Little, Brown and co. , Boston, 1992: 577-596. 

EN 

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ANNEX 4: 

THE MAIN DRIVERS RELATING TO THE INCIDENCE OF HCAIS 

EN 

53 

EN 

 
  
 
ANNEX 5: PATIENT SAFETY SYTEM CATEGORIZATION BY RAND 

A. ‘Exemplary’ category 

Among the twenty three countries studied, four Member States can be grouped as ‘exemplary’ 
countries in relation to patient safety. 

Criteria: 
The  country  in  this  rank  has  a  ‘mature’  system  for  patient  safety  reporting  and  learning  at 
national and local levels. But, the system may or may not include patient reporting; 
The country has an established redress mechanism (e.g. a no-fault liability system, Tribunals of 
Inquiry and Compensation and/or litigation); 
The  country  is  very  active  in  participating  and/or  leading  EU-level  and  international-level 
initiatives  to  develop  and  use  knowledge  and  evidence  on  patient  safety  (e.g.  OECD  patient 
safety  indicator  study,  World  Alliance  on  Patient  Safety,  High  Level  Working  Group, 
SIMPATIE project, EU NetPaS); 
The country has an institute dedicated to patient safety; 
Some of these countries are reviewing and evaluating their Patient Safety systems for further 
improvements; 
Some countries have already conducted their own country-specific studies of the extent of the 
problem of patient safety; and, 
Nomination  by  other  expert-respondents  from  other  countries  who  confirm  the  exemplary 
nature of the countries in the Top Rank. 

B. ‘Very good’ category 

Three  countries  were  categorised  as  ‘very  good’,  This  group  was  a  distinct  category  because 
the reporting and learning systems included patient reporting. 

Criteria: 
The country has a well-established and functioning reporting and  learning system  at  national 
level  for  patient  safety  exists  in  the  country  AND  patients  can  report  to  the  system.  But,  the 
system may not be fully blame-free; 
There is a redress mechanism; 
The country may have a (new) institute dedicated to patient safety; 
The  country  may  be  evaluating  and/or  implementing  changes  to  the  existing  Patient  Safety 
systems; 
The country may have conducted its own study on the extent of the problem; and, 
The  country  is  actively  participating  in  EU-level  and/or  international-level  initiatives  to 
develop and use knowledge and evidence on patient safety (e.g. OECD patient safety indicator 
study, World Alliance on Patient Safety, High Level Working Group, SIMPATIE project, EU 
NetPaS). 

C. ‘Good’ category 

The ‘good’ grouping was the largest one with 8 EU Member States included.  

Criteria: 
The country has a well-established and functioning reporting and  learning system  at  national 
and local levels for patient safety exists in the country, but the system may not be fully blame-
free and/or may be limited to some adverse events; 

EN 

54 

   EN 

 
There is a redress mechanism; 
The country may have a (new) institute dedicated to patient safety; 
The  country  may  be  evaluating  and/or  implementing  changes  to  the  existing  Patient  Safety 
systems; 
The country may have conducted its own study on the extent of the problem; and, 
The  country  is  actively  participating  in  EU-level  and/or  international-level  initiatives  to 
develop and use knowledge and evidence on patient safety (e.g. OECD patient safety indicator 
study, World Alliance on Patient Safety, High Level Working Group, SIMPATIE project, EU 
NetPaS). 

D. ‘Fair’ category 

The ‘fair’ group included 5 countries 

Criteria: 
A reporting and learning system for patient safety exists in the country but may not be at the 
national  level,  or  may  not  be  fully  developed  at  national  level  because  it  lacks  the  learning 
dimension or is not yet electronic (user-friendly); 
There  may  or  may  not  be  a  redress  mechanism  in  place  and  what  is  in  place,  is  only  court-
based compensation; 
The country may have an institute for healthcare quality and safety but may not be dedicated 
only to patient safety; and, 
The  country  is  actively  participating  in  EU-level  and/or  international-level  initiatives  to 
develop and use knowledge and evidence on patient safety (e.g. OECD patient safety indicator 
study, World Alliance on Patient Safety, High Level Working Group, SIMPATIE project, EU 
NetPaS). 

E. ‘Poor’ category 

Three countries belonged to the ‘poor’ group  

Criteria: 
There is currently no national patient safety reporting and learning mechanism in the country, 
but there may be partial systems at local level; 
There is no redress mechanism that is fair to both patients and professionals in the country; 
As a minimum, the country is a member of the High Level Working Group and may also be 
active in developing and using knowledge and evidence at EU level through participation in, 
for example, World Alliance, OECD, SIMPATIE, IPSE, EU NetPaS etc; 
The country may have an institute for quality and safety in healthcare, but it is not dedicated to 
patient safety; and, 
Nomination  by  peers  or  self  as  being  an  example  of  a  country  having  poor  patient  safety 
activities. 

These criteria are summarised in the table below. 

EN 

55 

   EN 

 
Taxonomy of selected EU countries working on Patient Safety Improvement Strategies 

Star category 

‘Objective’ criteria for country taxonomy 

exemplary 

very good

good 

fair 

poor 

The country has a well-developed national reporting and learning system (RLS) 
in addition to local systems 

The country’s RLS is blame-free 

The country’s RLS includes both reporting and learning components 

The country’s RLS is not restricted to specific adverse events (i.e. includes the 
full range of incidents) 

Patients  can  participate  in  reporting  to  the  country’s  reporting  and  learning 
system 

The country has an established (de jure) redress system that includes more than 
going  to  court  (e.g.  a  no-fault  liability  system,  Tribunals  of  Inquiry  and 
Compensation and/or litigation/tort-based) 

The country is active in initiatives to develop and use knowledge and evidence 
on patient safety. Examples include, but are not limited to: OECD patient safety 
indicator study, World Alliance on Patient Safety, High Level Working Group, 
SIMPATIE project, EU NetPaS 

The  country  is  active  in  leading  initiatives  to  develop  and  use  knowledge  and 
evidence at either EU or international levels 

The country has an established national institute, or other Competent Authority 
and it is dedicated to patient safety 

There is currently, or there has been, an evaluation of the existing patient safety 
system(s) of the country in question for further improvements 

The  scope  of  the  national  problem  of  patient  safety  has  been,  or  is  currently 
being, empirically investigated to some degree (either at national or local level) 
in the country in question 

† 

EN 

56 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SOURCE: RAND Europe 

LEGEND: 

(full fulfilment of criteria); 

 (partial fulfilment, at least in progress or planned); 

 (not fulfilled).  

NOTE: † One country in this 4-star category did not fulfil this criteria at all (i.e. has only a de facto tort-based redress 
mechanism), but it was included among the other countries in this category because it fulfilled all other criteria and was 
therefore not deemed to warrant being placed in the lower category. 

EN 

57 

EN 

 
  
 
 
 
 
 
ANNEX 6: CALCULATION OF LABOUR PRODUCTIVITY

50 

Population
(million)

Male
(million)

Female
(million)

Employed men
(million)

Employed women
(million)

Hours worked by 
men (million)

Hours worked by 
women (million)

GDP
(€ million)

GDP per hour 
worked (€)

Austria
Belgium
Bulgaria
Cyprus
Czech Rep
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Ireland
Italy
Latvia
Lithuania
Luxembourg
Malta
Netherlands
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
UK
EU27

8,2
10,4
7,8
0,7
10,2
5,4
1,3
5,2
60,6
82,5
11,1
10,1
4,1
58,5
2,3
3,4
0,5
0,4
16,3
38,2
10,5
21,7
5,4
2,0
43,0
9,0
60,0
488,8

4,0
5,1
3,8
0,3
5,0
2,7
0,6
2,5
29,4
40,4
5,5
4,8
2,0
28,4
1,1
1,6
0,2
0,2
8,1
18,5
5,1
10,6
2,6
1,0
21,2
4,5
29,4
238,6

4,2
5,3
4,0
0,4
5,2
2,7
0,7
2,7
31,2
42,1
5,6
5,3
2,1
30,1
1,2
1,8
0,3
0,2
8,2
19,7
5,4
11,1
2,8
1,0
21,8
4,5
30,6
250,2

3,0
3,5
2,3
0,2
3,7
2,2
0,4
1,8
20,2
28,8
4,1
3,0
1,5
19,9
0,7
1,1
0,1
0,1
6,5
10,9
3,7
6,8
1,7
0,7
15,9
3,3
22,8
168,9

2,6
2,9
2,1
0,2
2,9
1,9
0,4
1,8
18,0
25,1
2,6
2,7
1,2
13,6
0,7
1,1
0,2
0,1
5,4
9,2
3,3
5,7
1,4
0,6
11,2
3,2
20,2
140,3

245.000
298.000
21.000
13.000
98.000
208.000
11.000
155.000
1.710.000
2.247.000
181.000
88.000
160.000
1.417.000
13.000
21.000
29.000
4.000
502.000
243.000
147.000
79.000
38.000
27.000
904.000
288.000
1.791.000
10.938.000

306.418,4

217.605,3

50 

EN 

Eurostat (2005 data). Hours worked based on Eurostat data with: an EU average of 93% and 66% of employed men and women respectively working full-time, with an 
EU average of 40 and 20 hours respectively for a full-time job and a part-time job; an EU average of 5 weeks of holidays. Days off sick from work have not been taken 
into account. 

58 

20,9

EN 

 
  
                                                 
ANNEX 7: CALCULATION OF INPATIENT DAY COST

51 

Austria
Belgium
Bulgaria
Cyprus
Czech Rep
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Ireland
Italy
Latvia
Lithuania
Luxembourg
Malta
Netherlands
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
UK
EU27

1998
723,9
787,5
838,1
412,5
876,0
449,5
722,8
776,3
847,7
929,3
508,0
831,1
654,2
548,7
922,2
961,5
1055,1
562,8
512,3
744,0
387,6
749,7
804,4
559,1
380,9
380,4
424,7
679,8

1999
878,4
782,3
747,7
408,8
860,2
434,4
716,5
759,7
832,6
920,2
496,6
836,8
639,7
486,8
885,2
938,0
712,5
547,1
505,7
735,1
385,8
749,6
796,3
554,0
376,0
373,8
415,7
661,9

Beds per 100,000 inhabitants
2000
698,7
777,8
739,3
416,9
867,5
425,1
682,9
753,4
817,1
912,2
495,2
839,1
628,9
470,9
855,1
923,2
657,1
544,2
492,1
718,7
381,6
762,7
785,5
540,6
372,7
358,5
413,1
652,6

2002
845,8
759,2
646,6
438,2
872,5
412,8
605,9
735,9
783,5
887,8
472,1
783,8
593,0
444,6
773,4
892,8
644,3
745,8
459,1
709,9
365,1
747,1
755,5
508,9
356,7
338,1
405,3
628,6

2001
853,6
767,4
699,2
404,2
867,0
417,7
681,8
745,2
794,3
901,9
478,2
784,8
606,0
461,4
809,5
869,4
651,7
759,8
464,7
717,5
374,9
769,2
765,4
516,9
362,5
349,0
408,5
640,9

2003
835,7
752,3
626,7
431,1
868,0
398,0
591,2
723,6
768,4
874,4
470,3
782,5
581,6
417,9
779,3 :
866,1
638,2
750,3
440,5
644,7 :
366,2
657,4
722,5
496,0
347,8
327,1
404,6
607,5

2004
776,5
749,1
611,6
421,0
859,3
389,8
581,0
705,6
749,6
857,6
469,8
782,0
574,4
400,6

840,8
631,8
755,2
438,2

365,1
658,3
689,0
480,1
344,5
316,2
398,3
595,9

2005
770,9
744,8
593,3
380,0
850,3
380,0
548,4
704,2
734,8
846,4
473,8
786,2
559,6
400,9
766,4
814,7
625,4
743,7
437,2
652,2
365,5
661,8
677,1
483,9
339,0
305,2
388,7
590,4

inhabitants 
(million)

#beds

8,20
10,40
7,80
0,70
10,20
5,40
1,30
5,20
60,60
82,50
11,10
10,10
4,10
58,50
2,30
3,40
0,50
0,40
16,30
38,20
10,50
21,70
5,40
2,00
43,00
9,00
60,00
488,80

63.213,80
77.459,20
46.277,40
2.660,00
86.730,60
20.517,30
7.129,20
36.618,40
445.288,80
698.280,00
52.591,80
79.406,20
22.943,60
234.526,50
17.627,20
27.699,80
3.127,17
2.974,80
71.263,60
249.140,40
38.374,00
143.610,60
36.563,40
9.678,00
145.770,00
27.468,00
233.220,00
2.880.159,77

cost/bed
/day
319,00
501,00
38,00
255,00
110,00
773,00
73,00
267,00
524,00
625,00
389,00
41,00
349,00
541,00
51,00
42,00
761,00
217,00
400,00
91,00
296,00
40,00
66,00
240,00
321,00
610,00
830,00

cost/bed/ 
day corr
319,00
350,70
54,29
255,00
157,14
541,10
104,29
267,00
366,80
437,50
389,00
58,57
349,00
378,70
72,86
60,00
532,70
217,00
400,00
130,00
296,00
57,14
94,29
240,00
321,00
427,00
581,00
334,02

cost/day

20.165.202,20
27.164.941,44
2.512.201,71
678.300,00
13.629.094,29
11.101.911,03
743.473,71
9.777.112,80
163.331.931,84
305.497.500,00
20.458.210,20
4.650.934,57
8.007.316,40
88.815.185,55
1.284.267,43
1.661.988,00
1.665.841,68
645.531,60
28.505.440,00
32.388.252,00
11.358.704,00
8.206.320,00
3.447.406,29
2.322.720,00
46.792.170,00
11.728.836,00
135.500.820,00
962.041.612,74

51 

EN 

Hospital beds: Eurostat (2005 data); shaded cells for number of beds were calculated by linear regression. Cost/bed/day: based on healthcare unit cost for inpatient day for patients with 
cardiovascular disease (J. Leal et al. Eur. Hearth J. (2006) 27, 1610-1619); shaded cells for cost/bed/day are estimates extrapolated from healthcare unit costs in countries with similar 
comparative price levels (comparative price levels: Eurostat 2005 data).The estimates on cost/bed/day for the individual Member States are debatable as they were collected for treating 
cardiovascular disease (usually very expensive treatment) and not HCAIs for which figures for all Member States are not available; in addition, these costs may not reflect the situation for 
2008. When checking these figures with hospital representatives from different Member States, it was felt that the figures for the 'old' Member States represented an overestimation and the 
figures for the new Member States represented an underestimation. Therefore, the following correction factors were applied: figures in bracket 0-200 euro were divided by 0.70; figures in 
200-400 bracket were not adapted; figures in excess of 400 euros were multiplied by 0.70. 

59 

EN