3.7.2009   

EN

Official Journal of the European Union

C 151/1

(1)

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

(2)

It is estimated that in Member States between 8 % and 12 % of patients admitted to hospital suffer from adverse events whilst receiving healthcare (4).

(3)

The European Centre for Disease Prevention and Control (ECDC) has estimated that, on average, healthcare associated infections occur in one hospitalised patient in 20, that is to say 4,1 million patients a year in the EU, and that 37 000 deaths are caused every year as a result of such infections.

(4)

Poor patient safety represents both a severe public health problem and a high economic burden on limited health resources. A large proportion of adverse events, both in the hospital sector and in primary care, are preventable with systemic factors appearing to account for a majority of them.

(5)

This recommendation builds upon, and complements, work on patient safety carried out by the World Health Organisation (WHO) through its World Alliance for Patient Safety, the Council of Europe and the Organisation for Economic Cooperation and Development (OECD).

(6)

The Community, through the seventh framework programme for research and development (5), supports research in health systems, in particular in the quality of healthcare provision under the Health Theme, including a focus on patient safety. The latter is also given particular attention under the Information and Communication Technology Theme.

(7)

The Commission, in its White Paper ‘Together for Health: A Strategic Approach for the EU 2008-2013’ of 23 October 2007, identifies patient safety as an area for action.

(8)

Evidence suggests that Member States are at different levels in the development and implementation of effective and comprehensive patient safety strategies (6). Therefore, this recommendation intends to create a framework to stimulate policy development and future action in and between Member States to address the key patient safety issues confronting the EU.

(9)

Patients should be informed and empowered by involving them in the patient safety process. They should be informed of patient safety standards, best practices and/or safety measures in place and on how they can find accessible and comprehensible information on complaints and redress systems.

(10)

Member States should set up, maintain 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. Patient safety should be embedded in the education and training of healthcare workers, as the providers of care.

(11)

Comparable and aggregate data should be collected at Community level to establish efficient and transparent patient safety programmes, structures and policies, and best practices should be disseminated among the Member States. To facilitate mutual learning, a common terminology for patient safety and common indicators need to be developed through cooperation between Member States and the European Commission, taking into account the work of relevant international organisations.

(12)

Information and communication technology tools, such as electronic health records or e-prescriptions, can contribute to improving patient safety, for instance by systematically screening for potential medicinal product interactions or allergies. Information and communication technology tools should also aim to improve the understanding of users of the medical products.

(13)

A national strategy, complementary to strategies targeted towards the prudent use of antimicrobial agents (7), should be developed incorporating prevention and control of healthcare associated infections into national public health objectives and aiming to reduce the risk of healthcare associated infections within healthcare institutions. It is essential that the necessary resources for implementing the components of the national strategy are allocated as part of the core funding for healthcare delivery.

(14)

The prevention and control of healthcare associated infections should be a long-term strategic priority for healthcare institutions. All hierarchical levels and functions should cooperate to achieve result-oriented behaviour and organisational change, by defining responsibilities at all levels, organising support facilities and local technical resources and setting up evaluation procedures.

(15)

Sufficient data on healthcare associated infections are not always available to allow meaningful comparisons between institutions by surveillance networks, to monitor the epidemiology of healthcare associated pathogens and to evaluate and guide policies on the prevention and control of healthcare associated infections. Therefore, surveillance systems should be established or strengthened at the level of healthcare institutions and at regional and national levels.

(16)

Member States should aim to reduce the number of people affected by healthcare associated infections. In order to achieve a reduction in healthcare associated infections, recruitment of health professionals specialising in infection control should be encouraged. Furthermore, Member States and their healthcare institutions should consider the use of link staff to support specialist infection control staff at the clinical level.

(17)

Member States should work closely with the health technology industry to encourage better design for patient safety in order to reduce the occurrence of adverse events in healthcare.

(18)

To achieve the patient safety objectives mentioned above, including the prevention and control of healthcare associated infections, Member States should ensure a fully comprehensive approach while considering the most appropriate elements having a real impact on the prevalence and burden of adverse events.

(19)

Community action in the field of public health should fully respect the responsibilities of the Member States for the organisation and delivery of health services and medical care,

‘Adverse event’ means an incident which results in harm to a patient;

‘Harm’ implies impairment of the structure or function of the body and/or any deleterious effect arising therefrom;

‘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;

‘Patient safety’ means freedom, for a patient, from unnecessary harm or potential harm associated with healthcare;

‘Process indicator’ means an indicator referring to the compliance with agreed activities such as hand hygiene, surveillance, standard operating procedures;

‘Structure indicator’ means an indicator referring to any resource, such as staff, an infrastructure or a committee;

1.

Support the establishment and development of national policies and programmes on patient safety by:

2.

Empower and inform citizens and patients by:

3.

Support the establishment or strengthen blame-free reporting and learning systems on adverse events that:

4.

Promote, at the appropriate level, education and training of healthcare workers on patient safety by:

5.

Classify and measure patient safety at Community level, by working with each other and with the Commission:

6.

Share knowledge, experience and best practice by working with each other and with the Commission and relevant European and international bodies on:

7.

Develop and promote research on patient safety.

8.

Adopt and implement a strategy at the appropriate level for the prevention and control of healthcare associated infections, pursuing the following objectives:

9.

Consider, for the coordinated implementation of the strategy referred to in (8) as well as for the purposes of information exchange and coordination with the Commission, the ECDC, the European Medicines Agency and the other Member States, the establishment, if possible by 9 June 2011, of an inter-sectoral mechanism or equivalent systems corresponding to the infrastructure in each Member State, collaborating with, or integrated into, the existing inter-sectoral mechanism as set up in accordance with Council Recommendation No 2002/77/EC of 15 November 2001 on the prudent use of antimicrobial agents in human medicine (9).

10.

Disseminate the content of this recommendation to healthcare organisations, professional bodies and educational institutions and encourage them to follow the approaches suggested therein so that its key elements can be put into everyday practice.

11.

Report to the Commission on the progress of the implementation of this recommendation by 9 June 2011 and subsequently on request by the Commission with a view to contributing to the follow-up of this recommendation at Community level,