22.9.2009   

EN

Official Journal of the European Union

C 228/113

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.

1.2

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.

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).

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.

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.

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.

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).

2.1.3

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

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.

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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age and pathology;

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certain treatments (particularly excessive use of antibiotics); and

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certain medical intervention required by the treatment.

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.

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.

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.

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.

4.2.1

The Committee believes that curbing HCAI also requires:

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.

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.