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Summaries of EU Legislation

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Patient safety and the prevention of healthcare associated infections

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Patient safety and the prevention of healthcare associated infections

Every year, 8 to 12 % of patients admitted to hospital suffer from complications related to care which they have received in hospitals in the European Union (EU). These complications, often related to systemic factors, lead to distress for patients and their families, as well as high healthcare costs. In order to minimise these dysfunctions, the European Commission recommends better framing of patient security.


Council Recommendation 2009/C 151/01 of 9 June 2009 on patient safety, including the prevention and control of healthcare associated infections.


Patient safety during treatment constitutes a major public health problem and generates considerable cost. This Recommendation advises the introduction of a framework aimed at improving patient safety and preventing adverse events, in particular the healthcare associated infections * which may be contracted in healthcare institutions.

Patient safety

The establishment and development of national policies and programmes on patient safety

A competent authority responsible for patient safety on their territory should be designated. This measure would contribute, inter alia, to embedding patient safety as a priority issue in health policies and programmes at national as well as regional and local levels.

In order to improve patient safety, more efficient systems, processes and tools in the area of healthcare safety should be developed. Safety standards and practices applying to healthcare should be reviewed regularly.

Health professional organisations should also be encouraged to have a more active role in patient safety.

An approach should be introduced to promote safe practices so as to prevent the most commonly occurring adverse events such as medication-related events, healthcare associated infections and complications related to surgical intervention.

Making patients part of the process

Patients should be involved, through the associations representing them, in the definition of patient safety policies. They should, moreover, receive information on safety standards which are in place as well as complaints procedures and available remedies or redress. It would also be opportune to enable patients to acquire a basic knowledge of patient safety.

Improving information and introducing reporting systems

The introduction or improvement of existing reporting systems should enable information to be provided on the extent, types and causes of incidents related to patient care. Such systems should be designed to encourage healthcare workers to report any adverse event *. They would also allow patients and their families to share their experiences.

These systems would also enable other risk management systems in the field of health safety to be supplemented, such as those concerning pharmacovigilance.

Education and training of healthcare workers

Healthcare workers have an important role to play in improving patient safety. It is therefore essential that they have multidisciplinary training and education in this field. Undergraduate and postgraduate programmes, continuing professional development and on-the-job training for healthcare workers should therefore include the issue of patient safety.

All healthcare workers should be duly informed of existing risks and safety measures.

Sharing knowledge, experience and best practice at Community level

It would be relevant to develop a system to classify and assess patient safety at European level. This approach requires the preparation of common definitions and terminology as well as comparable indicators which would allow Member States to make mutual use of information and experience acquired at national level. This exchange of knowledge and best practice would also enable patient safety policies to be improved and to better target research in this field.

Prevention of healthcare associated infections

A strategy to prevent and control healthcare associated infections should be established in order to:

  • implement prevention and control measures at national or regional level;
  • improve the prevention and control of infection in healthcare institutions;
  • establish active surveillance systems;
  • foster education and training of healthcare workers;
  • facilitate access to information for patients.


On average, healthcare associated infections occur in one hospitalised patient in 20, that is to say 4.1 million patients a year in the European Union, and cause 37 000 deaths. Many of these deaths could be avoided. This Recommendation builds upon the work of the World Health Organization (WHO) in order to propose a framework for patient safety.

Key terms of the Act

  • Healthcare associated infections: means diseases or pathologies related to the presence of an infectious agent or its products in association with exposure to healthcare facilities or healthcare procedures or treatments;
  • Adverse event: means an incident which results in harm to a patient;
  • Patient safety: means freedom, for a patient, from unnecessary harm or potential harm associated with healthcare.

Last updated: 27.08.2009