# C_2009228EN.01011301.xml

| 22.9.2009 | EN | Official Journal of the European Union | C 228/113 |
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22.9.2009

EN

Official Journal of the European Union

C 228/113

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Opinion of the European Economic and Social Committee on the Proposal for a Council Recommendation on patient safety, including the prevention and control of healthcare associated infections

COM(2008) 837 final/2 — 2009/0003 (CNS)

2009/C 228/22

On 21 January 2009, the Council decided to consult the European Economic and Social Committee, under Article 262 of the Treaty establishing the European Community, on the

‘Proposal for a Council Recommendation on patient safety, including the prevention and control of healthcare associated infections’

On 24 February 2009, the Bureau of the European Economic and Social Committee instructed the Section for Employment, Social Affairs and Citizenship to prepare the Committee’s work on the subject.

Given the urgent nature of the work, the European Economic and Social Committee appointed Mr BOUIS as rapporteur at its 452nd plenary session, held on 24 and 25 March 2009 (meeting of 25 March), and adopted the following opinion by 135 votes with four abstentions.

1.   Comments and recommendations

Comments and recommendations

| 1.1 | It is estimated that in EU Member States between 8 % and 12 % of patients admitted to hospital suffer from adverse events whilst receiving healthcare (1), being free of such infections on admission. |
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1.1

It is estimated that in EU Member States between 8 % and 12 % of patients admitted to hospital suffer from adverse events whilst receiving healthcare (1), being free of such infections on admission.

1

| 1.2 | Although few studies have been carried out in this area, it would seem that healthcare-associated infections (HCAI) increase the risk of death threefold, when a comparison is made of mortality rates of infected patients with the number of uninfected patients with the same pathology. |
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1.2

Although few studies have been carried out in this area, it would seem that healthcare-associated infections (HCAI) increase the risk of death threefold, when a comparison is made of mortality rates of infected patients with the number of uninfected patients with the same pathology.

| 1.3 | HCAI entail substantial additional costs, mainly due to prolonged hospitalisation, anti-infection treatments, laboratory tests and infection monitoring, management of after-effects, and even the compensation of families in the event of death. |
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1.3

HCAI entail substantial additional costs, mainly due to prolonged hospitalisation, anti-infection treatments, laboratory tests and infection monitoring, management of after-effects, and even the compensation of families in the event of death.

| 1.4 | A 10 % decrease in the number of HCAI would bring about a saving more than five times greater than the cost of possible preventative efforts in hospitals (2). |
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1.4

A 10 % decrease in the number of HCAI would bring about a saving more than five times greater than the cost of possible preventative efforts in hospitals (2).

2

| 1.5 | This proposal for a recommendation on patient safety, including the prevention and control of healthcare associated infections is therefore consistent with an ethical, social and economic approach. Controlling HCAI is of such importance that a proposal for a Directive would have been warranted. |
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1.5

This proposal for a recommendation on patient safety, including the prevention and control of healthcare associated infections is therefore consistent with an ethical, social and economic approach. Controlling HCAI is of such importance that a proposal for a Directive would have been warranted.

| 1.6 | This proposal is welcomed by the Committee; it is in line with Article 152, which provides for Community action to complement national policies on improving public health and preventing illness. |
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1.6

This proposal is welcomed by the Committee; it is in line with Article 152, which provides for Community action to complement national policies on improving public health and preventing illness.

| 1.7 | While endorsing the proposed supporting actions, the Committee would put forward a certain number of comments and proposals aimed at clarifying and increasing patient safety by preventing and controlling healthcare associated infections. |
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1.7

While endorsing the proposed supporting actions, the Committee would put forward a certain number of comments and proposals aimed at clarifying and increasing patient safety by preventing and controlling healthcare associated infections.

| 1.8 | The Committee feels that there is a particular need to develop analysis of the conditions of occurrence of HCAI and adverse events. In this regard – given the possibility of legal action – it would advocate clarifying the status of the data collected, with a view to upholding patient rights, whilst also encouraging analysis by risk-management professionals and structures. |
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1.8

The Committee feels that there is a particular need to develop analysis of the conditions of occurrence of HCAI and adverse events. In this regard – given the possibility of legal action – it would advocate clarifying the status of the data collected, with a view to upholding patient rights, whilst also encouraging analysis by risk-management professionals and structures.

| 1.9 | The Committee would stress the need for national policies and programmes to be established and developed, for public and patient information, for the coordination of reporting systems, and for staff training at State and healthcare institution levels. |
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1.9

The Committee would stress the need for national policies and programmes to be established and developed, for public and patient information, for the coordination of reporting systems, and for staff training at State and healthcare institution levels.

| 1.10 | Pointing out that HCAI affect both hospitalised patients and outpatients, the Committee calls for the same monitoring efforts to be applied to medical treatment and the control of adverse events in all types of healthcare facility. |
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1.10

Pointing out that HCAI affect both hospitalised patients and outpatients, the Committee calls for the same monitoring efforts to be applied to medical treatment and the control of adverse events in all types of healthcare facility.

2.   Gist of the Commission recommendation

Gist of the Commission recommendation

2.1   Background

Background

| 2.1.1 | Article 152 of the Treaty provides that Community action, which is to complement national policies, is to be directed towards improving public health, preventing human illness and diseases, and obviating sources of danger to human health. |
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2.1.1

Article 152 of the Treaty provides that Community action, which is to complement national policies, is to be directed towards improving public health, preventing human illness and diseases, and obviating sources of danger to human health.

| 2.1.2 | It is estimated that in EU Member States about 10 % of patients admitted to hospital suffer from adverse events whilst receiving healthcare (3). |
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2.1.2

It is estimated that in EU Member States about 10 % of patients admitted to hospital suffer from adverse events whilst receiving healthcare (3).

3

| 2.1.3 | EU Member States are at different levels in the development and implementation of effective and comprehensive patient safety strategies. |
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2.1.3

EU Member States are at different levels in the development and implementation of effective and comprehensive patient safety strategies.

2.2   The Recommendation approach

The Recommendation approach

| 2.2.1 | Member States should set up or improve comprehensive reporting and learning systems so that the extent and causes of adverse events can be captured in order to develop efficient solutions and interventions. |
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2.2.1

Member States should set up or improve comprehensive reporting and learning systems so that the extent and causes of adverse events can be captured in order to develop efficient solutions and interventions.

| 2.2.2 | Comparable and aggregate data should be collected at Community level and best practices should be disseminated among the Member States. |
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2.2.2

Comparable and aggregate data should be collected at Community level and best practices should be disseminated among the Member States.

| 2.2.3 | The prevention and control of HCAI should be a long-term priority for healthcare institutions; all hierarchical levels and functions should cooperate in this. |
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2.2.3

The prevention and control of HCAI should be a long-term priority for healthcare institutions; all hierarchical levels and functions should cooperate in this.

| 2.2.4 | Patients should be informed and empowered by involving them in the patient safety process. |
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2.2.4

Patients should be informed and empowered by involving them in the patient safety process.

3.   General comments

General comments

3.1   The Committee points out that a HCAI is an infection contracted in a healthcare institution by a patient who was free of such infection on admission; such infections can either be linked to the treatment received, or can simply arise during hospitalisation irrespective of any medical intervention.

3.1.1   The Committee wishes to emphasise that higher hygiene standards for health professionals can only be guaranteed if the necessary conditions are met, in particular the working conditions concerning periods of contact with patients, ongoing training and employees’ satisfaction with their working conditions. The Committee thus calls on the authorities responsible for the health sector to make the requisite resources available.

3.2   The Committee notes that HCAI can be transmitted either endogenously or exogenously – i.e. from one patient to another via the hands of a healthcare provider or via medical or paramedical equipment; infections can also arise from a contaminated environment (water, air, materials or equipment, food, etc.).

3.2.1   Regardless of the means of transmission, the incidence of infection can be increased by the condition of the patient in respect of:

| — | age and pathology; |
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age and pathology;

| — | certain treatments (particularly excessive use of antibiotics); and |
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certain treatments (particularly excessive use of antibiotics); and

| — | certain medical intervention required by the treatment. |
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certain medical intervention required by the treatment.

3.3   Furthermore, given that medical progress is enabling increasingly frail patients to be treated, thus multiplying the risk factors, the quality of healthcare as well as the safety of all medical treatment and the environment of the facility must all be subject to a highly organised system of defined and monitored procedures, increased vigilance, and information and training measures.

3.4   Reducing the avoidable element of HCAI, such as nosocomial illnesses, is crucial to patient safety, given that hospitalisation already entails other risks such as falls, side-effects of medication, etc. Infection prevention should therefore form part of a broader approach covering all adverse events.

3.5   For these reasons, the Committee welcomes the draft recommendation presented by the Commission.

4.   Specific comments

Specific comments

4.1   General patient safety issues

General patient safety issues

| 4.1.1 | The Committee would particularly stress the need for each Member State to set up a HCAI control committee – to work in conjunction with hygiene task forces – charged with drawing up a national strategic programme, subject to regular assessment, which could be applied at regional and healthcare institution levels. |
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4.1.1

The Committee would particularly stress the need for each Member State to set up a HCAI control committee – to work in conjunction with hygiene task forces – charged with drawing up a national strategic programme, subject to regular assessment, which could be applied at regional and healthcare institution levels.

| 4.1.2 | The Committee feels that bolstering anti-HCAI structures and encouraging healthcare institutions to adopt an infection prevention and control policy is of utmost urgency. The same attention should be given to outpatient care. |
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4.1.2

The Committee feels that bolstering anti-HCAI structures and encouraging healthcare institutions to adopt an infection prevention and control policy is of utmost urgency. The same attention should be given to outpatient care.

| 4.1.3 | The Committee welcomes the willingness of patient organisations and representative bodies to be involved in framing patient safety policies and programmes at all levels; this requires effective transparency in on-site monitoring and publication of the relevant information. |
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4.1.3

The Committee welcomes the willingness of patient organisations and representative bodies to be involved in framing patient safety policies and programmes at all levels; this requires effective transparency in on-site monitoring and publication of the relevant information.

| 4.1.4 | The Committee thinks that the legal status of qualitative and quantitative data on HCAI and other adverse effects should be ascertained, given that certain data can be used in court in the case of legal action. A balance needs to be struck between upholding patient rights and encouraging in-depth analysis of adverse events by risk-management professionals and structures. |
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4.1.4

The Committee thinks that the legal status of qualitative and quantitative data on HCAI and other adverse effects should be ascertained, given that certain data can be used in court in the case of legal action. A balance needs to be struck between upholding patient rights and encouraging in-depth analysis of adverse events by risk-management professionals and structures.

| 4.1.5 | The Committee, conscious of evaluation procedures in a climate of confidence, would emphasise that any reporting system should be distinct from disciplinary systems and procedures applicable to medical, paramedical, administrative or service staff. |
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4.1.5

The Committee, conscious of evaluation procedures in a climate of confidence, would emphasise that any reporting system should be distinct from disciplinary systems and procedures applicable to medical, paramedical, administrative or service staff.

| 4.1.6 | Mindful of the need for patients to be properly informed on risk and safety levels, the Committee would call for welcome booklets to be produced, highlighting recommendations on good hygiene practice and the measures taken. |
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4.1.6

Mindful of the need for patients to be properly informed on risk and safety levels, the Committee would call for welcome booklets to be produced, highlighting recommendations on good hygiene practice and the measures taken.

| 4.1.7 | Given that the cornerstone of any prevention strategy is fostering the education and training of staff involved in patient safety, the Committee thinks that the training of staff specialised in the field of hygiene would be consolidated by better defining the content of the training received by doctors, nurses and all other hospital staff. |
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4.1.7

Given that the cornerstone of any prevention strategy is fostering the education and training of staff involved in patient safety, the Committee thinks that the training of staff specialised in the field of hygiene would be consolidated by better defining the content of the training received by doctors, nurses and all other hospital staff.

| 4.1.8 | The Committee would stress the need for health professionals to be receptive to comments by patients and/or their relatives in respect of their failure to comply with hygiene procedures. In tandem with raising patient awareness of hospital hygiene rules, health professionals should also be made aware of the need to listen to and take on board the comments and wishes of patients and their relatives. |
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4.1.8

The Committee would stress the need for health professionals to be receptive to comments by patients and/or their relatives in respect of their failure to comply with hygiene procedures. In tandem with raising patient awareness of hospital hygiene rules, health professionals should also be made aware of the need to listen to and take on board the comments and wishes of patients and their relatives.

4.2   Prevention and control of HCAI

Prevention and control of HCAI

| 4.2.1 | The Committee believes that curbing HCAI also requires:






  — | environment monitoring by a bio-hygienist technician, focused on air treatment, water monitoring, disinfecting materials and the microbiological aspect of surfaces; |
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4.2.1

The Committee believes that curbing HCAI also requires:

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environment monitoring by a bio-hygienist technician, focused on air treatment, water monitoring, disinfecting materials and the microbiological aspect of surfaces;

| — | strict compliance with the hand-hygiene procedures by healthcare providers, patients and their visitors; |
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strict compliance with the hand-hygiene procedures by healthcare providers, patients and their visitors;

| — | monitoring of the catering aspect of healthcare facilities, with microbiological tests to check the conformity of supplies and prepared products, cold and hot chains, food processing and disposal systems, and the hygiene practices of kitchen and food service staff; |
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monitoring of the catering aspect of healthcare facilities, with microbiological tests to check the conformity of supplies and prepared products, cold and hot chains, food processing and disposal systems, and the hygiene practices of kitchen and food service staff;

| — | close monitoring of cleanliness of hospital, surgery and treatment premises which may require a regular change of cleaning products; |
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close monitoring of cleanliness of hospital, surgery and treatment premises which may require a regular change of cleaning products;

| — | very close monitoring of hot and cold water supplies and water that has been treated for medical use. |
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very close monitoring of hot and cold water supplies and water that has been treated for medical use.

| 4.2.2 | The Committee regrets that the Commission recommendation does not make sufficient reference to the obligation to analyse adverse events. A certain number of systems, such as the morbidity-mortality review, could improve healthcare safety if implemented regularly. |
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4.2.2

The Committee regrets that the Commission recommendation does not make sufficient reference to the obligation to analyse adverse events. A certain number of systems, such as the morbidity-mortality review, could improve healthcare safety if implemented regularly.

| 4.2.3 | The Committee deems the exchange of information – based on observations and good practice implemented in the framework of Commission-Member State coordination – a suitable means of classifying, codifying or even standardising certain practices; moreover, this could help establish benchmarks that could be extremely useful in the construction or renovation of healthcare facilities. |
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4.2.3

The Committee deems the exchange of information – based on observations and good practice implemented in the framework of Commission-Member State coordination – a suitable means of classifying, codifying or even standardising certain practices; moreover, this could help establish benchmarks that could be extremely useful in the construction or renovation of healthcare facilities.

| 4.2.4 | The Committee notes that the Commission has called on the Member States to establish an inter-sectoral mechanism within one year of the adoption of the recommendation, and will check to see if this is carried out. |
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4.2.4

The Committee notes that the Commission has called on the Member States to establish an inter-sectoral mechanism within one year of the adoption of the recommendation, and will check to see if this is carried out.

Brussels, 25 March 2009.

The President of the European Economic and Social Committee

Mario SEPI

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(1)  Technical report on Improving Patient Safety in the EU prepared for the European Commission, published in 2008 by the RAND Cooperation.

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Improving Patient Safety in the EU

(2)  Report on La politique de lutte contre les infections nosocomiales by the French parliamentary office for health policy assessment (2006).

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La politique de lutte contre les infections nosocomiales

(3)  Idem footnote 1

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