TEXT PROPOSED BY THE COMMISSION AMENDMENT

Amendment 1

Proposal for a recommendation Recital 2

(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 .

Amendment 2

Proposal for a recommendation Recital 2 a (new)

(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.

Amendment 3

Proposal for a recommendation Recital 3

(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.

Amendment 4

Proposal for a recommendation Recital 6 a (new)

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

Amendment 5

Proposal for a recommendation Recital 7

(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.

Amendment 6

Proposal for a recommendation Recital 8

(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.

Amendment 7

Proposal for a recommendation Recital 10

(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.

Amendment 8

Proposal for a recommendation Recital 11

(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 systems (1) .

Amendment 9

Proposal for a recommendation Recital 12 a (new)

(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.

Amendment 10

Proposal for a recommendation Recital 15

(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.

Amendment 11

Proposal for a recommendation Recital 15 a (new)

(15a) Member States need to be able 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.

Amendment 12

Proposal for a recommendation Recital 15 b (new)

(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.

Amendment 13

Proposal for a recommendation Recital 15 c (new)

(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.

Amendment 14

Proposal for a recommendation Recital 16 a (new)

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

Amendment 15

Proposal for a recommendation Part I – Chapter I a (new) – title

Amendment 16

Proposal for a recommendation Part I – Chapter I a (new) – point 1

(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.

Amendment 17

Proposal for a recommendation Part I – Chapter II – point 1 – point a

(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;

Amendment 18

Proposal for a recommendation Part I – Chapter II – point 1 – point c

(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.

Amendment 19

Proposal for a recommendation Part I – Chapter II – point 2 – point b a (new)

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

Amendment 20

Proposal for a recommendation Part I – Chapter II – point 3 – point a

(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 ;

Amendment 21

Proposal for a recommendation Part I – Chapter II – point 3 – point b a (new)

(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.

Amendment 22

Proposal for a recommendation Part I – Chapter II – point 4 – point b a (new)

(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.

Amendment 23

Proposal for a recommendation Part I – Chapter II – point 5 – point c

(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.

Amendment 24

Proposal for a recommendation Part I – Chapter II – point 6 – point b a (new)

(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.

Amendment 25

Proposal for a recommendation Part I – Chapter III – point 1 – point -a (new)

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

Amendment 26

Proposal for a recommendation Part I – Chapter III – point 1 – point -a a (new)

(-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;

Amendment 27

Proposal for a recommendation Part I – Chapter III – point 1 – point -a b (new)

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

Amendment 28

Proposal for a recommendation Part I – Chapter III – point 1 – point b

(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 ;

Amendment 29

Proposal for a recommendation Part I – Chapter III – point 1 – point b a (new)

(ba) Promote hand hygiene among health professionals;

Amendment 30

Proposal for a recommendation Part I – Chapter III – point 1 – point b b (new)

(bb) 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;

Amendment 31

Proposal for a recommendation Part I – Chapter III – point 1 – point d

(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 ;

Amendment 32

Proposal for a recommendation Part I – Chapter III – point 1 – point e

(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 ;

Amendment 33

Proposal for a recommendation Part I – Chapter III – point 1 – point f

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

Amendment 34

Proposal for a recommendation Part I – Chapter III – point 1 – point f a (new)

(fa) Report every HCAI outbreak affecting a significant number of patients to the European Centre for Disease Prevention and Control;

Amendment 35

Proposal for a recommendation Part I – Chapter III – point 1 – point f b (new)

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

Amendment 36

Proposal for a recommendation Part II — Title

Amendment 37

Proposal for a recommendation Part II – point 1 a (new)

(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.

Amendment 38

Proposal for a recommendation Part II – point 1 b (new)

(1b) Using the practical guide drawn up by the World Health Organisation in 2002, entitled ‘Prevention of hospital-acquired infections’ (2), the Commission is invited to produce a document aimed at patients on the prevention of nosocomial infections.

Amendment 39

Proposal for a recommendation Annex 1 – Definitions – ‘Adverse event’ – column 2

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.

Amendment 40

Proposal for a recommendation Annex 1 – Definitions – ‘Healthcare institution’ – column 2

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

Amendment 41

Proposal for a recommendation Annex 1 – Definitions – ‘Patient safety’ - column 2

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.

Amendment 42

Proposal for a recommendation Annex 1 – Definitions – ‘Infection control link staff’ - column 2

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.

Amendment 43

Proposal for a recommendation Annex 2 – Chapter I – point 1 – point ba (new)

(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.

Amendment 44

Proposal for a recommendation Annex 2 – Chapter I – point 4 – point ca (new)

(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.

Amendment 45

Proposal for a recommendation Annex 2 – Chapter 1 – point 7 – point aa (new)

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

Amendment 46

Proposal for a recommendation Annex 2 – Chapter 2 – point 1 – point a – indent 2