Text proposed by the Commission

Amendment

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

(2) It is estimated that in EU Member States between 8% and 12% of patients admitted to hospitals suffer from adverse events whilst receiving healthcare; the numbers affected range from 6.7 million to 15 million hospital in-patients, along with more than 37 million primary care patients.

Justification

It is important to spell out, and understand the scale of, the problem and its public health implications.

Text proposed by the Commission

Amendment

(2a) It is estimated that, on average, healthcare-associated infections (HCAIs) occur in one patient in twenty, that is to say, 4.1 million patients a year in the EU, and that about 37 000 deaths are caused every year by the after-effects of such infections.

Justification

Healthcare-associated infections (HCAIs) are among the most frequent and destructive causes of unintended harm.

Text proposed by the Commission

Amendment

(3) 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 are preventable, both in the hospital sector and in primary care, with systemic factors appearing to account for a majority of them.

(3) 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, including those resulting from misdiagnosis and/or inappropriate treatment, are preventable, both in the hospital sector and in primary care, with limited financial resources and systemic factors appearing to account for a majority of them.

Justification

Unless there is a steady increase in resources for the health system, systemic factors and organisational solutions will not change anything.

The impact assessment (SEC(2008)3005) has shown that medical errors and misdiagnosis are one of the main causes of adverse events associated with healthcare.

Text proposed by the Commission

Amendment

(6a) Among the adverse events associated with healthcare, HCAIs are easily avoidable. Member States need to provide the means enabling the number of persons a year in the European Union affected by adverse events to be reduced by 20%.

Justification

Commission studies show that a 20% reduction in adverse events would be achievable, since infection control methods are well practised and quick to implement. Healthcare-associated infections cause about 37 000 deaths every year. That being the case, a reduction target should be set for Member States, which should be called upon to meet it by 2015.

Text proposed by the Commission

Amendment

(7) Evidence suggests that EU Member States are at different levels in the development and implementation of effective and comprehensive patient safety strategies. Therefore, this initiative 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.

(7) Evidence suggests that EU Member States are at different levels in the development and implementation of effective and comprehensive patient safety strategies. Therefore, this initiative 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, above all the responsibility of healthcare establishments and institutions for people's health. In accordance with Article 152 of the EC Treaty, however, there must be no encroachment upon Member States' competences.

Justification

Healthcare providers' responsibility towards patients needs to be stressed.

Support is given to avoiding the duplication of work. Close attention should be paid to WHO activities and the Council of Europe recommendations in the field of patient safety and any additional measures at Community level should be dovetailed to provide synergies. Detailed requirements and guidelines on patient safety issues at European level are, however, rejected with reference to Article 152.

Text proposed by the Commission

Amendment

(8) Patients should be informed and empowered by involving them in the patient safety process; they should be informed of levels of safety and on how they can find accessible and comprehensible information on complaints and redress systems.

(8) Patients should be informed and empowered by involving them in the patient safety process; they should be informed of levels of safety and on how they can find accessible and comprehensible information on complaints and redress systems. The individual Member State should, however, be competent for the type and method of compensation.

Justification

It is important that members of the public who have suffered as a result of healthcare failures receive sufficient compensation. The Rome I and Rome II Regulations already determine the applicable law for cross-border cases within the EU. There must be no encroachment upon Member States' competences.

Text proposed by the Commission

Amendment

(10) 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.

(10) 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. These data should only be used for the purposes of patient safety with respect to the control of HCAIs. 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.

Justification

Data protection rules must be followed when collecting these data. There should be no misuse.

Text proposed by the Commission

Amendment

(11) Information and communication technology tools, such as electronic health records or e-prescriptions, can contribute to improve patient safety, for instance by systematically screening for potential medicinal product interactions or allergies.

(11) 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, as has been recognised in Commission Recommendation 2008/594/EC of 2 July 2008 on cross-border interoperability of electronic health record systems1.

1 OJ L 190, 18.7.2008, p. 37.

Text proposed by the Commission

Amendment

(12a) Older people are more likely to succumb to infectious diseases whilst in hospital; therefore their needs as a specific group should be researched and steps taken to meet them so as to promote their rehabilitation and return to good health.

Justification

Older people are likely to have weaker immune systems and are more likely than younger people to pick up infectious diseases if they have hospital care. Research should be conducted into their unique needs because older patients should not receive a lower standard of healthcare than other citizens, and the aim should be to rehabilitate all citizens.

Text proposed by the Commission

Amendment

(15) Insufficient data on healthcare associated infections are 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 level.

(15) Insufficient data on healthcare associated infections are 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 level. Better information gathering at regional, national and European level should make it possible to determine more easily what direct correlations exist between the quality of the patient safety policies, systems and arrangements laid down and the results achieved in that field.

Justification

Surveillance systems need to be improved in order to obtain more complete data on HCAIs and determine what correlations exist between the policies, systems, and arrangements laid down and the results achieved. This will help to raise the standard of patient care and reduce hospital-acquired infections.

Text proposed by the Commission

Amendment

(15a) Member States have to be in a position to reduce the number of persons affected by HCAIs. As regards the possible means to that end, it is essential to recruit more nurses specialising in infection control.

Justification

Commission studies show that approximately 8700 nurses specialising in infection control need to be recruited if healthcare-associated infections are to be reduced rapidly and effectively. The optimum ratio is one specialist HCAI nurse for every 250 hospital beds.

Text proposed by the Commission

Amendment

(15b) Furthermore, Member States and their healthcare institutions should consider the use of link staff to support specialist nurses at clinical level in acute and community facilities.

Text proposed by the Commission

Amendment

(15c) In order to reduce adverse events resulting from healthcare, Member States should be encouraged to set local and national targets for recruitment of health professionals specialising in infection control, taking into account the recommended target ratio of one nurse for every 250 hospital beds by 2015.

Justification

An increased number of healthcare professionals specialising in infection control is needed to improve patient safety standards. However, the specific number of staff required will depend on the type of treatment being carried out at the hospital and so targets should be set at the local and national level.

Text proposed by the Commission

Amendment

(16a) The Commission should bring forward proposals to prevent the circulation of counterfeit drugs and harm to patients and health workers from needlestick injuries.

Text proposed by the Commission

Amendment

REDUCTION TARGETS

Text proposed by the Commission

Amendment

(1) Member States should provide the means necessary to bring about a 20% reduction in the number of persons in the European Union affected annually by adverse events resulting from healthcare, the target thus being to reduce such events by 900 000 cases a year by 2015.

Justification

Commission studies show that adverse events could be reduced by 900 000 cases a year, since infection control methods are well practised and quick to implement. Healthcare-associated infections cause some 37 000 deaths a year. It is therefore important to set a reduction target for Member States to meet by 2015.

Text proposed by the Commission

Amendment

(a) Designating the competent authority or authorities responsible for patient safety on their territory;

(a) Designating the competent authorities at the various levels of state and local government administration responsible for patient safety and supervision and coordination of measures to improve public health on their territory;

Justification

Bodies responsible for coordinating public health measures at regional level do not exist in all the Member States (e.g. Poland).

Text proposed by the Commission

Amendment

(c) Supporting the development of safer systems, processes and tools, including the use of information and communication technology.

(c) Supporting the development of safer, user-friendly systems, processes and tools, including the use of information and communication technology.

Justification

The development of systems, processes, and tools should allow for the needs and abilities of their users.

Text proposed by the Commission

Amendment

(ba) Informing patients about treatment risks and introducing legal mechanisms to facilitate the lodging of claims for damage to health, including against pharmaceutical companies.

Justification

In the new Member States, many people are unaware of their rights and of the remedies they can obtain and from whom. Moreover, they do not know to whom they should turn in order to assert their rights.

Text proposed by the Commission

Amendment

(a) Provide adequate information on the extent, types and causes of errors, adverse events and near misses;

(a) Provide adequate information on the extent, types and causes of errors, adverse events and near misses and identify those responsible;

Justification

Patients must know exactly who is responsible for what.

Text proposed by the Commission

Amendment

(ba) Provide for confidential sharing of information between health authorities in different Member States on health professionals who have been found guilty of negligence or malpractice.

Text proposed by the Commission

Amendment

(ba) Providing adequate education and training for all healthcare workers so that they use medical technology appropriately in accordance with the function and specifications outlined in the instruction manuals in order to prevent health risks and adverse effects, including those arising from unintended reuse of devices.

Justification

Healthcare workers need to have the best possible knowledge about the proper functioning and use of the products they use in treatments. Only this knowledge enables them to minimise the risks for patients and themselves which could arise from wrong application of medical devices, for example by reusing devices which are designed and manufactured for one use on one patient only.

Text proposed by the Commission

Amendment

(c) To gather and share comparable data and information on patient safety outcomes in terms of type and number at EU level to facilitate mutual learning and inform priority setting.

(c) To gather and share comparable data and information on patient safety outcomes in terms of type and number at EU level to facilitate mutual learning and inform priority setting. The scale and cost of the data collection, and use of the data collected, should not be disproportionate to the expected benefits. The data should only be collected in order to achieve the objective of reducing HCAIs through common learning.

Justification

The cooperation sought between Member States and the Commission with respect to classification, codification and data collection should not result in the Commission obtaining the right to draw conclusions from the data collected.

Text proposed by the Commission

Amendment

(ba) Promoting opportunities for cooperation and exchange of experience and best practice between hospital managers, clinical teams and patient groups across the European Union on patient safety initiatives at the local level.

Text proposed by the Commission

Amendment

(-a) Provide effective risk assessment mechanisms, including pre-admission diagnostic screening of patients, in order to rapidly identify conditions requiring additional precautionary measures.

Justification

It is vitally important that patients are assessed prior to admission, and that those carrying infections, such as MRSA, are quickly diagnosed and treated, to safeguard their health and to prevent them passing infections on to other patients and to healthcare staff.

Text proposed by the Commission

Amendment

(-aa) Provide adequate protection for healthcare staff, through vaccination, post-exposure prophylaxis, routine diagnostic screening, provision of personal protective equipment and the use of medical technology that reduces exposure to blood-borne infections;

Justification

Healthcare staff risk potentially fatal infections every day and can spread infections amongst patients and out into the community.

Text proposed by the Commission

Amendment

(-ab) Provide effective infection prevention and control in long-term nursing and rehabilitation facilities.

Justification

It is important that long-term nursing homes are not overlooked. Close living proximity, building design, multiple medications, pressure sores and catheter usage all make nursing homes ideal for breeding and spreading MRSA and other infections.

Text proposed by the Commission

Amendment

(b) Enhance infection prevention and control at the level of the healthcare institutions;

(b) Enhance infection prevention and control at the level of the healthcare institutions and ensure the highest standards of cleanliness, hygiene, and, where necessary, asepsis:

(i) as regards supplies used at the time of admission of patients or during their stay;

(ii) as regards medical and paramedical equipment, electro-medical devices used for patients, and dispensing of medicines;

(iii) as regards patient care facilities;

Justification

To prevent nosocomial infections, all equipment with which patients come into contact has to meet the highest possible standards of cleanliness, hygiene, and, where necessary, asepsis.

Text proposed by the Commission

Amendment

-  promote hand hygiene among health professionals;

Justification

Infection is usually spread on the hands of healthcare staff and other people who come into contact with infected patients or with environmental surfaces.

Text proposed by the Commission

Amendment

- Enhance prevention and control of the spread of diseases among, and their transmission by, medical and paramedical personnel, to that end implementing the requisite prevention-oriented policies, including the necessary staff vaccination campaigns;

Justification

Medical and paramedical personnel are not just exposed to the danger of catching diseases and healthcare-associated infections, but are also potential carriers. Member States should therefore seek to guarantee the safety of staff as well as patients. As regards the ways of reducing the incidence of healthcare-associated infections, it would be useful to organise specifically targeted staff vaccination campaigns.

Text proposed by the Commission

Amendment

(d) Foster education and training of healthcare workers at Member State level and at the level of healthcare institutions;

(d) Foster education and training of healthcare and paramedical workers at Member State level and at the level of healthcare institutions, focusing in particular on nosocomial infections and viral antibiotic resistance;

Justification

The fact that viruses are resistant to antibiotics is one of the main reasons for nosocomial infections and should feature prominently in the training provided to healthcare personnel at every level. To enable nosocomial infections to be reduced, all staff working in healthcare facilities need to be given thorough training on a continuing basis.

Text proposed by the Commission

Amendment

(e) Improve the information given to patients;

(e) Improve the information given to patients, using the social and health network as well as by means of information campaigns conducted from time to time in the press and on the radio, television and the Internet;

Justification

Patients need to be fully informed about risks, degrees of safety, and the measures applied to avert errors and nosocomial infections. Information campaigns should consequently be organised at regular intervals, using the various types of media.

Text proposed by the Commission

Amendment

(f) Support research.

(f) Support research, for instance into potential medical applications of nanotechnologies and nanomaterials.

Justification

Nanotechnologies have many applications, those in the health field being among the most promising. For example, altering surface nanostructures of hospital building materials so as to make surfaces clean or sterile could be a helpful way to control healthcare-associated infections.

Text proposed by the Commission

Amendment

(fa) Report every healthcare-associated infection outbreak affecting a significant number of patients to the European Centre for Disease Prevention and Control.

Text proposed by the Commission

Amendment

(fb) Conduct awareness campaigns for the public and for healthcare workers with the aim of reducing practices which lead to antimicrobial resistance.

Text proposed by the Commission

Amendment

PART II: REPORT BY THE COMMISSION

PART II: ACTIONS BY THE COMMISSION

Justification

Nanotechnologies have many applications, those in the health field being among the most promising. For example, altering surface nanostructures of hospital building materials so as to make surfaces clean or sterile could be a helpful way to control healthcare-associated infections.

Text proposed by the Commission

Amendment

(1a) The Commission should consider where existing Community legislation could be strengthened to improve patient safety, for example by ensuring that, when healthcare professionals cross borders within Europe, the professional regulators share information about any disciplinary procedures concluded or pending against individuals, and not just their initial qualifications.

Text proposed by the Commission

Amendment

(1b) Using the practical guide drawn up by the World Health Organisation in 2002, entitled ‘Prevention of hospital-acquired infections’1, the Commission is invited to produce a document aimed at patients on the prevention of nosocomial infections.

1 WHO, ‘Prevention of hospital-acquired infections. A practical guide’, first edition, December 2002 (second edition published in 2008).

Justification

The WHO practical guidelines on infection control at points of care, drawn up in 2003, have proved to be very useful. They are, however, intended specifically for healthcare personnel. A European document aimed specially at patients might prove valuable from the point of view of nosocomial infection control, as well as enabling patients to gain a basic understanding of patient safety.

Text proposed by the Commission

Amendment

Incident which results in harm to a patient. Harm implies impairment of structure or function of the body and/or any deleterious effect which arises from that.

Incident which results in harm to a patient while undergoing medical treatment. Harm implies permanent or temporary impairment of structure or function of the body and/or any deleterious effect which arises from that.

Justification

The definition of adverse events should also cover temporary impairment of a bodily structure or function.

Text proposed by the Commission

Amendment

An institution where healthcare workers provide secondary or tertiary care.

A public, non-public or charitable healthcare institution, where healthcare volunteers or workers provide secondary or tertiary care.

Justification

The definition given in the proposal fails to cover the various types of healthcare organisation existing within the EU and the fact that there are clinics, hospitals and palliative care centres that are run by religious orders, faith-based associations and charitable organisations and foundations.

Text proposed by the Commission

Amendment

Freedom for a patient from unnecessary harm or potential harm associated with healthcare.

Absence of adverse events, where an adverse event is defined as a harmful incident due more to the treatment than to the illness. This adverse event may be avoidable or unavoidable.

Text proposed by the Commission

Amendment

Health professionals working in clinical wards/departments who act as a liaison between their wards/departments and the Infection Prevention and Control Team. Infection control link staff helps promote infection prevention and control in their wards/departments and give feedback to the Infection Prevention and Control Team.

Health professionals working in the corresponding sectors who act as a liaison between their work sector and the Infection Prevention and Control Team. Infection control link staff help promote infection prevention and control in their sectors and give feedback to the Infection Prevention and Control Team.

Justification

Preference should be given here to a more neutral definition in order to highlight the fact that infections can occur not just in hospitals but also in other healthcare sectors, such as doctors’ practices. A high level of patient safety also has to be guaranteed in these sectors so that no further patients are put at risk during subsequent treatment.

Text proposed by the Commission

Amendment

(ba) Accepting and facilitating the use of information and communication technology tools, such as electronic instructions for use, in order to improve the understanding of users of the medical products.

Justification

Enhancing healthcare workers' understanding of the proper functioning and use of medical products reduces the likelihood of misuse and therefore the risks for patients treated with these products. New ICT tools, such as electronic manuals, including pictures or films, could help raise the level of understanding of medical products significantly.

Text proposed by the Commission

Amendment

(ca) Providing adequate education and training for all healthcare workers so that they use medical technology appropriately in accordance with the function and specifications outlined in the instruction manuals in order to prevent health risks and adverse effects, including those arising from unintended reuse of devices.

Justification

Healthcare workers need to have the best possible knowledge about the proper functioning and use of the products they use in treatments. Only this knowledge enables them to minimise the risks of health of patients and themselves which could arise from wrong application of medical devices, for example by reusing devices which are designed and manufactured for one use on one patient only.

Text proposed by the Commission

Amendment

(aa) Encouraging research, for example into medical applications of nanotechnologies and nanomaterials.

Justification

Nanotechnologies have many applications, those in the health field being among the most promising. For example, altering surface nanostructures of hospital building materials so as to make surfaces clean or sterile could be a helpful way to control healthcare-associated infections.

Text proposed by the Commission

Amendment

- Integrating infection prevention and control measures into patient care plans;

- Integrating infection prevention and control measures into patient care plans, including the necessary staff vaccination campaigns;

Justification

Medical and paramedical personnel are not just exposed to the danger of catching diseases and healthcare-associated infections, but are also potential carriers. Member States should therefore seek to guarantee the safety of staff as well as patients. As regards the ways of reducing the incidence of healthcare-associated infections, it would be useful to organise specifically targeted staff vaccination campaigns.