{"change_dates":[],"dossier":{"amendments":[{"authors":"Urszula Krupa","changes":{},"committee":["ENVI"],"date":"2009-03-02T00:00:00","id":"PE421.189-19","justification":"Unless there is a steady increase in resources for the health system, systemic factors and\norganisational solutions will not change anything.","location":[["Proposal for a recommendation","Recital 3"]],"meps":[28334],"meta":{"created":"2020-01-20T00:06:09"},"new":["(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 limited","financial resources and systemic factors","appearing to account for a majority of","them."],"old":["(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."],"orig_lang":"pl","peid":"PE421.189v01-00","reference":"2009/0003(CNS)","seq":"19","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-421.189+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Amalia Sartori","changes":{},"committee":["ENVI"],"date":"2009-03-02T00:00:00","id":"PE421.189-20","justification":" The impact assessment (SEC(2008)3005) has shown that medical errors and misdiagnosis are\n one of the main causes of adverse events associated with healthcare.","location":[["Proposal for a recommendation","Recital 3"]],"meps":[4423],"meta":{"created":"2020-01-20T00:06:09"},"new":["(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","systemic factors appearing to account for a","majority of them."],"old":["(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."],"orig_lang":"it","peid":"PE421.189v01-00","reference":"2009/0003(CNS)","seq":"20","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-421.189+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Elizabeth Lynne","changes":{},"committee":["ENVI"],"date":"2009-03-02T00:00:00","id":"PE421.189-21","justification":" A 20% reduction needs to be achieved in 3 years, not 6, and a further 20% reduction should\n be the goal for the following 3 years.","location":[[" Proposal for a recommendation","Recital 6 a (new)"]],"meps":[4541],"meta":{"created":"2020-01-20T00:06:09"},"new":["(6a) Among the adverse events associated","with healthcare, healthcare associated","infections are easily avoidable. Member","States should provide the means to enable","the number of persons a year in Europe","affected by adverse events to be reduced","by 20 % by 2012 and by a further 20 % by","2015."],"orig_lang":"en","peid":"PE421.189v01-00","reference":"2009/0003(CNS)","seq":"21","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-421.189+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Urszula Krupa","changes":{},"committee":["ENVI"],"date":"2009-03-02T00:00:00","id":"PE421.189-22","justification":"Healthcare providers' responsibility towards patients needs to be stressed.","location":[[" Proposal for a recommendation","Recital 7"]],"meps":[28334],"meta":{"created":"2020-01-20T00:06:09"},"new":["(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."],"old":["(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."],"orig_lang":"pl","peid":"PE421.189v01-00","reference":"2009/0003(CNS)","seq":"22","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-421.189+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Thomas Ulmer","changes":{},"committee":["ENVI"],"date":"2009-03-02T00:00:00","id":"PE421.189-23","justification":"Support is given to avoiding the duplication of work. Close attention should be paid to WHO\nactivities and the Council of Europe recommendations in the field of patient safety and any\nadditional measures at Community level should be dovetailed to provide synergies. Detailed\nrequirements and guidelines on patient safety issues at European level are, however, rejected\n\n with reference to Article 152.","location":[["Proposal for a recommendation","Recital 7"]],"meps":[28221],"meta":{"created":"2020-01-20T00:06:09"},"new":["(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. In","accordance with Article 152 of the Treaty","establishing the European Community,","however, there must be no encroachment","upon Member States' competences."],"old":["(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."],"orig_lang":"de","peid":"PE421.189v01-00","reference":"2009/0003(CNS)","seq":"23","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-421.189+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Urszula Krupa","changes":{},"committee":["ENVI"],"date":"2009-03-02T00:00:00","id":"PE421.189-24","justification":" Explicit reference should also be made to pharmaceutical companies in connection with the\n provision of information to patients.","location":[[" Proposal for a recommendation","Recital 8"]],"meps":[28334],"meta":{"created":"2020-01-20T00:06:09"},"new":["(8) Patients should be informed and","empowered by involving them in the","patient safety process; they should be","informed of levels of safety, including of","the medicines dispensed and on how they","can find accessible and comprehensible","information on complaints and redress","systems in relation to healthcare","institutions and establishments and","pharmaceutical companies."],"old":["(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."],"orig_lang":"pl","peid":"PE421.189v01-00","reference":"2009/0003(CNS)","seq":"24","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-421.189+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Thomas Ulmer","changes":{},"committee":["ENVI"],"date":"2009-03-02T00:00:00","id":"PE421.189-25","justification":"It is important that citizens who have suffered as a result of healthcare failures receive\nsufficient compensation. The Rome I and Rome II Regulations already determine the\napplicable law for cross-border cases within the EU. There must be no encroachment upon\nMember States' competences.","location":[[" Proposal for a recommendation","Recital 8"]],"meps":[28221],"meta":{"created":"2020-01-20T00:06:09"},"new":["(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 shall, however, be","competent for the type and method of","compensation."],"old":["(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.",""],"orig_lang":"de","peid":"PE421.189v01-00","reference":"2009/0003(CNS)","seq":"25","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-421.189+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Thomas Ulmer","changes":{},"committee":["ENVI"],"date":"2009-03-02T00:00:00","id":"PE421.189-26","justification":"Data protection rules must be followed when collecting these data. There should be no\nmisuse.","location":[["Proposal for a recommendation","Recital 10"]],"meps":[28221],"meta":{"created":"2020-01-20T00:06:09"},"new":["(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","healthcare associated infections. 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."],"old":["(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."],"orig_lang":"de","peid":"PE421.189v01-00","reference":"2009/0003(CNS)","seq":"26","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-421.189+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Kathy Sinnott","changes":{},"committee":["ENVI"],"date":"2009-03-02T00:00:00","id":"PE421.189-27","justification":" Older people are likely to have weaker immune systems and are more likely than younger\n people to pick up infectious diseases if they have hospital care. Research should be conducted\n into their unique needs because older patients should not receive a lower standard of\n healthcare than other citizens, and the aim should be to rehabilitate all citizens.","location":[[" Proposal for a recommendation","Recital 12 a (new)"]],"meps":[28119],"meta":{"created":"2020-01-20T00:06:09"},"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 their needs so as to","promote their rehabilitation and return to","good health."],"orig_lang":"en","peid":"PE421.189v01-00","reference":"2009/0003(CNS)","seq":"27","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-421.189+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Urszula Krupa","changes":{},"committee":["ENVI"],"date":"2009-03-02T00:00:00","id":"PE421.189-28","justification":"Funding levels are extremely important.","location":[[" Proposal for a recommendation","Recital 13"]],"meps":[28334],"meta":{"created":"2020-01-20T00:06:10"},"new":["(13) A national strategy, complementary to","strategies targeted towards the prudent use","of antimicrobial agents, 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 and that the level of","such resources remains constant."],"old":["(13) A national strategy, complementary to","strategies targeted towards the prudent use","of antimicrobial agents, 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."],"orig_lang":"pl","peid":"PE421.189v01-00","reference":"2009/0003(CNS)","seq":"28","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-421.189+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Philip Bushill-Matthews","changes":{},"committee":["ENVI"],"date":"2009-03-02T00:00:00","id":"PE421.189-29","location":[["Proposal for a recommendation","Recital 15 a (new)"]],"meps":[4535],"meta":{"created":"2020-01-20T00:06:10"},"new":["(15a) 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;"],"orig_lang":"en","peid":"PE421.189v01-00","reference":"2009/0003(CNS)","seq":"29","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-421.189+01+DOC+PDF+V0//EN&language=EN"},{"authors":"John Bowis","changes":{},"committee":["ENVI"],"date":"2009-03-02T00:00:00","id":"PE421.189-30","location":[["Proposal for a recommendation","Recital 16 a (new)"]],"meps":[4527],"meta":{"created":"2020-01-20T00:06:10"},"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."],"orig_lang":"en","peid":"PE421.189v01-00","reference":"2009/0003(CNS)","seq":"30","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-421.189+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Linda McAvan","changes":{},"committee":["ENVI"],"date":"2009-03-02T00:00:00","id":"PE421.189-31","location":[[" Proposal for a recommendation","Part I \u2013 Chapter I a (new) \u2013 point 1"]],"meps":[2327],"meta":{"created":"2020-01-20T00:06:10"},"new":["(1) Member States should provide the","means necessary to bring about a","reduction in the number of persons in","Europe affected annually by adverse","events resulting from healthcare, and","should be encouraged to set challenging","local and national targets."],"orig_lang":"en","peid":"PE421.189v01-00","reference":"2009/0003(CNS)","seq":"31","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-421.189+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Elizabeth Lynne","changes":{},"committee":["ENVI"],"date":"2009-03-02T00:00:00","id":"PE421.189-32","justification":" A 20% reduction needs to be achieved in 3 years, not 6, and a further 20% reduction should\n be the goal for the following 3 years.","location":[[" Proposal for a recommendation","Part I \u2013 Chapter I a (new) \u2013 point 1"]],"meps":[4541],"meta":{"created":"2020-01-20T00:06:10"},"new":["(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 2012. A","further 20 % reduction should be","achieved by 2015."],"orig_lang":"en","peid":"PE421.189v01-00","reference":"2009/0003(CNS)","seq":"32","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-421.189+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Linda McAvan","changes":{},"committee":["ENVI"],"date":"2009-03-02T00:00:00","id":"PE421.189-33","justification":"An increased number of healthcare professionals specialising in infection control is needed to\nimprove patient safety standards. However, the specific number of staff required will depend\non the type of treatment being carried out at the hospital and so targets should be set at the\nlocal and national level.","location":[["Proposal for a recommendation","Part I \u2013 Chapter I a (new) \u2013 point 2"]],"meps":[2327],"meta":{"created":"2020-01-20T00:06:10"},"new":["2. In order to achieve a reduction in","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."],"orig_lang":"en","peid":"PE421.189v01-00","reference":"2009/0003(CNS)","seq":"33","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-421.189+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Urszula Krupa","changes":{},"committee":["ENVI"],"date":"2009-03-02T00:00:00","id":"PE421.189-34","justification":"Bodies responsible for coordinating public health measures at regional level do not exist in\nall the Member States (e.g. Poland).","location":[["Proposal for a recommendation","Part I \u2013 Chapter II \u2013 point 1 \u2013 point a"]],"meps":[28334],"meta":{"created":"2020-01-20T00:06:10"},"new":["(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;"],"old":["(a) Designating the competent authority or","authorities responsible for patient safety on","their territory;"],"orig_lang":"pl","peid":"PE421.189v01-00","reference":"2009/0003(CNS)","seq":"34","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-421.189+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Amalia Sartori","changes":{},"committee":["ENVI"],"date":"2009-03-02T00:00:00","id":"PE421.189-35","justification":" The development of systems, processes, and tools should allow for the needs and abilities of\n their users.","location":[[" Proposal for a recommendation","Part I \u2013 Chapter II \u2013 point 1 \u2013 point c"]],"meps":[4423],"meta":{"created":"2020-01-20T00:06:10"},"new":["(c) Supporting the development of safer,","user-friendly systems, processes and tools,","including the use of information and","communication technology."],"old":["(c) Supporting the development of safer","systems, processes and tools, including the","use of information and communication","technology."],"orig_lang":"it","peid":"PE421.189v01-00","reference":"2009/0003(CNS)","seq":"35","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-421.189+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Urszula Krupa","changes":{},"committee":["ENVI"],"date":"2009-03-02T00:00:00","id":"PE421.189-36","justification":" In the new Member States, many people are unaware of their rights and of the remedies they\n can obtain and from whom.","location":[[" Proposal for a recommendation","Part I \u2013 Chapter II \u2013 point 2 \u2013 point b a (new)"]],"meps":[28334],"meta":{"created":"2020-01-20T00:06:10"},"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."],"orig_lang":"pl","peid":"PE421.189v01-00","reference":"2009/0003(CNS)","seq":"36","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-421.189+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Urszula Krupa","changes":{},"committee":["ENVI"],"date":"2009-03-02T00:00:00","id":"PE421.189-37","justification":"Patients must know exactly who is responsible for what.","location":[["Proposal for a recommendation","Part I \u2013 Chapter II \u2013 point 3 \u2013 point a"]],"meps":[28334],"meta":{"created":"2020-01-20T00:06:10"},"new":["(a) Provide adequate information on the","extent, types and causes of errors, adverse","events and near misses and identify those","responsible;"],"old":["(a) Provide adequate information on the","extent, types and causes of errors, adverse","events and near misses;"],"orig_lang":"pl","peid":"PE421.189v01-00","reference":"2009/0003(CNS)","seq":"37","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-421.189+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Thomas Ulmer","changes":{},"committee":["ENVI"],"date":"2009-03-02T00:00:00","id":"PE421.189-38","justification":" The EU-wide and possibly binding introduction of error reporting systems should be rejected.\n This is contrary to the principle of healthcare providers being responsible for their own\n actions and the organisational sovereignty of Member States.","location":[["Proposal for a recommendation","Part I \u2013 Chapter II \u2013 point 3"]],"meps":[28221],"meta":{"created":"2020-01-20T00:06:10"},"new":["deleted"],"old":["(3) Member States should establish or","strengthen reporting and learning systems","on adverse events that:","(a) Provide adequate information on the","extent, types and causes of errors, adverse","events and near misses;","(b) Encourage healthcare workers to","actively report through the establishment","of a reporting environment which is open","and fair. This reporting should be","differentiated from Member States'","disciplinary systems and procedures for","healthcare workers, and the legal issues","surrounding the healthcare workers'","liability should be clarified."],"orig_lang":"de","peid":"PE421.189v01-00","reference":"2009/0003(CNS)","seq":"38","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-421.189+01+DOC+PDF+V0//EN&language=EN"},{"authors":" John Bowis","changes":{},"committee":["ENVI"],"date":"2009-03-02T00:00:00","id":"PE421.189-39","location":[[" Proposal for a recommendation","Part I \u2013 Chapter II \u2013 point 3 \u2013 point b a (new)"]],"meps":[4527],"meta":{"created":"2020-01-20T00:06:10"},"new":["(ba) Provide confidential sharing of","information between health authorities in","different Member States on health","professionals who have been found guilty","of negligence or malpractice."],"orig_lang":"en","peid":"PE421.189v01-00","reference":"2009/0003(CNS)","seq":"39","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-421.189+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Christofer Fjellner","changes":{},"committee":["ENVI"],"date":"2009-03-02T00:00:00","id":"PE421.189-40","justification":" Healthcare workers need to have the best possible knowledge about the proper functioning\n\nand use of the products they use in treatments. Only this knowledge enables them to minimise\nthe risks for patients and themselves which could arise from wrong application of medical\ndevices, for example by reusing devices which are designed and manufactured for one use on\none patient only.","location":[[" Proposal for a recommendation","Part I \u2013 Chapter II \u2013 point 4 \u2013 point b a (new)"]],"meps":[28126],"meta":{"created":"2020-01-20T00:06:11"},"new":["ba) Providing adequate education and","training for all healthcare workers to 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."],"orig_lang":"en","peid":"PE421.189v01-00","reference":"2009/0003(CNS)","seq":"40","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-421.189+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Thomas Ulmer","changes":{},"committee":["ENVI"],"date":"2009-03-02T00:00:00","id":"PE421.189-41","justification":"The cooperation sought between Member States and the Commission with respect to\nclassification, codification and data collection should not result in the European Commission\nobtaining the right to draw conclusions from the data collected.","location":[["Proposal for a recommendation","Part I \u2013 Chapter II \u2013 point 5 \u2013 point c"]],"meps":[28221],"meta":{"created":"2020-01-20T00:06:11"},"new":["(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 treatment-related","infections through common learning. It","shall be the responsibility of the Member","States alone to set priorities for possible","follow-up action, as these issues relate to","the organisation of healthcare systems."],"old":["(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."],"orig_lang":"de","peid":"PE421.189v01-00","reference":"2009/0003(CNS)","seq":"41","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-421.189+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Linda McAvan","changes":{},"committee":["ENVI"],"date":"2009-03-02T00:00:00","id":"PE421.189-42","location":[[" Proposal for a recommendation","Part I \u2013 Chapter II \u2013 point 6 \u2013 point b a (new)"]],"meps":[2327],"meta":{"created":"2020-01-20T00:06:11"},"new":["(ba) Promoting opportunities for","cooperation and exchange of experience","and best practice between hospital","managers, clinical teams and patient","groups across the EU on patient safety","initiatives at the local level."],"orig_lang":"en","peid":"PE421.189v01-00","reference":"2009/0003(CNS)","seq":"42","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-421.189+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Elizabeth Lynne","changes":{},"committee":["ENVI"],"date":"2009-03-02T00:00:00","id":"PE421.189-43","justification":" It is vitally important that patients are assessed prior to admission, and that those carrying\n infections, such as MRSA, are quickly diagnosed and treated, to safeguard their health and to\n prevent them passing infections on to other patients and to healthcare staff.","location":[[" Proposal for a recommendation","Part I \u2013 Chapter III\u2013 point 1 \u2013 point -a (new)"]],"meps":[4541],"meta":{"created":"2020-01-20T00:06:11"},"new":["(-a) Provide effective risk assessment","mechanisms, including pre-admission","diagnostic screening of patients, in order","to rapidly identify conditions requiring","additional precautionary measures."],"orig_lang":"en","peid":"PE421.189v01-00","reference":"2009/0003(CNS)","seq":"43","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-421.189+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Elizabeth Lynne","changes":{},"committee":["ENVI"],"date":"2009-03-02T00:00:00","id":"PE421.189-44","justification":"Healthcare staff risk potentially fatal infections every day and can spread infections amongst\npatients and out into the community.","location":[["Proposal for a recommendation","Part I \u2013 Chapter III\u2013 point 1 \u2013 point -a a (new)"]],"meps":[4541],"meta":{"created":"2020-01-20T00:06:11"},"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."],"orig_lang":"en","peid":"PE421.189v01-00","reference":"2009/0003(CNS)","seq":"44","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-421.189+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Elizabeth Lynne","changes":{},"committee":["ENVI"],"date":"2009-03-02T00:00:00","id":"PE421.189-45","justification":"It is important that long-term nursing homes are not overlooked. Close living proximity,\nbuilding design, multiple medications, pressure sores and catheter usage all make nursing\nhomes ideal for breeding and spreading MRSA and other infections.","location":[["Proposal for a recommendation","Part I \u2013 Chapter III\u2013 point 1 \u2013 point -a b (new)"]],"meps":[4541],"meta":{"created":"2020-01-20T00:06:11"},"new":["(-ab) Provide effective infection","prevention and control in long-term","nursing and rehabilitation facilities."],"orig_lang":"en","peid":"PE421.189v01-00","reference":"2009/0003(CNS)","seq":"45","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-421.189+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Salvatore Tatarella","changes":{},"committee":["ENVI"],"date":"2009-03-02T00:00:00","id":"PE421.189-46","justification":" Infection is usually spread on the hands of healthcare staff and other people who come into\n contact with infected patients or with environmental surfaces.","location":[[" Proposal for a recommendation","Part I \u2013 Chapter III\u2013 point 1 \u2013 point b \u2013 new indent"]],"meps":[1945],"meta":{"created":"2020-01-20T00:06:11"},"new":["- promote hand hygiene among health","professionals;"],"orig_lang":"en","peid":"PE421.189v01-00","reference":"2009/0003(CNS)","seq":"46","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-421.189+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Amalia Sartori","changes":{},"committee":["ENVI"],"date":"2009-03-02T00:00:00","id":"PE421.189-47","justification":" Medical and paramedical personnel are not just exposed to the danger of catching diseases\n and healthcare-associated infections, but are also potential carriers. Member States should\n therefore seek to guarantee the safety of staff as well as patients. As regards the ways of\n reducing the incidence of healthcare-associated infections, it would be useful to organise\n specifically targeted staff vaccination campaigns.","location":[[" Proposal for a recommendation","Part I \u2013 Chapter III\u2013 point 1 \u2013 point b \u2013 new indent"]],"meps":[4423],"meta":{"created":"2020-01-20T00:06:11"},"new":["- 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;"],"orig_lang":"it","peid":"PE421.189v01-00","reference":"2009/0003(CNS)","seq":"47","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-421.189+01+DOC+PDF+V0//EN&language=EN"},{"authors":"John Bowis","changes":{},"committee":["ENVI"],"date":"2009-03-02T00:00:00","id":"PE421.189-48","location":[["Proposal for a recommendation","Part I \u2013 Chapter III\u2013 point 1 \u2013 point f a (new)"]],"meps":[4527],"meta":{"created":"2020-01-20T00:06:11"},"new":["(fa) Report every healthcare associated","infection outbreak to the European","Centre for Disease Prevention and","Control."],"orig_lang":"en","peid":"PE421.189v01-00","reference":"2009/0003(CNS)","seq":"48","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-421.189+01+DOC+PDF+V0//EN&language=EN"},{"authors":"John Bowis","changes":{},"committee":["ENVI"],"date":"2009-03-02T00:00:00","id":"PE421.189-49","location":[["Proposal for a recommendation","Part I \u2013 Chapter III\u2013 point 1 \u2013 point f b (new)"]],"meps":[4527],"meta":{"created":"2020-01-20T00:06:12"},"new":["(fb) Conduct awareness campaigns for the","public and for healthcare workers with","the aim of reducing practices which lead","to antimicrobial resistance."],"orig_lang":"en","peid":"PE421.189v01-00","reference":"2009/0003(CNS)","seq":"49","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-421.189+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Linda McAvan","changes":{},"committee":["ENVI"],"date":"2009-03-02T00:00:00","id":"PE421.189-50","location":[["Proposal for a recommendation","Part II \u2013 point 1 a (new)"]],"meps":[2327],"meta":{"created":"2020-01-20T00:06:12"},"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 against individuals, and not","just their initial qualifications."],"old":[""],"orig_lang":"en","peid":"PE421.189v01-00","reference":"2009/0003(CNS)","seq":"50","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-421.189+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Hanne Dahl","changes":{},"committee":["ENVI"],"date":"2009-03-02T00:00:00","id":"PE421.189-51","justification":" We believe that this definition is more precise and comprehensive because it covers two\n essential points:\n\n 1. harm which is not attributable to the patient's illness,\n\n 2. an event which could have resulted in harm but was recognised in time. That is\n important so that such an event can be registered and thereby also be avoided in the\n future.","location":[[" Proposal for a recommendation","Annex 1 \u2013 line 1 \u2013 column 2"]],"meps":[40817],"meta":{"created":"2020-01-20T00:06:12"},"new":["Incident which is the result of treatment or","a stay in hospital, and which is not","attributable to the patient's illness, and","which at the same time is either harmful","or could have been harmful, but which","was prevented in advance or otherwise did","not occur owing to other circumstances.","Includes both previously known and","unknown events and errors."],"old":["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."],"orig_lang":"da","peid":"PE421.189v01-00","reference":"2009/0003(CNS)","seq":"51","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-421.189+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Urszula Krupa","changes":{},"committee":["ENVI"],"date":"2009-03-02T00:00:00","id":"PE421.189-52","justification":"The definition given in the proposal fails to cover the various types of healthcare organisation\nexisting within the EU and the fact that there are clinics, hospitals and palliative care centre\nthat are run by religious orders, faith-based associations and charitable organisations and\nfoundations.","location":[["Proposal for a recommendation","Annex 1 \u2013 line 4 \u2013 column 2"]],"meps":[28334],"meta":{"created":"2020-01-20T00:06:12"},"new":["A charitable or public or non-public","healthcare institution where healthcare","volunteers or workers provide secondary","or tertiary care."],"old":["An institution where healthcare workers","provide secondary or tertiary care."],"orig_lang":"pl","peid":"PE421.189v01-00","reference":"2009/0003(CNS)","seq":"52","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-421.189+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Thomas Ulmer","changes":{},"committee":["ENVI"],"date":"2009-03-02T00:00:00","id":"PE421.189-53","location":[["Proposal for a recommendation","Annex 1 \u2013 line 9 \u2013 column 2"]],"meps":[28221],"meta":{"created":"2020-01-20T00:06:12"},"new":["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."],"old":["Freedom for a patient from unnecessary","harm or potential harm associated with","healthcare."],"orig_lang":"de","peid":"PE421.189v01-00","reference":"2009/0003(CNS)","seq":"53","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-421.189+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Thomas Ulmer","changes":{},"committee":["ENVI"],"date":"2009-03-02T00:00:00","id":"PE421.189-54","justification":" Preference should be given here to a more neutral definition in order to highlight the fact that\n infections can occur not just in hospitals but also in other healthcare sectors, such as doctors\u2019\n practices. A high level of patient safety also has to be guaranteed in these sectors so that no\n further patients are put at risk during subsequent treatment.","location":[[" Proposal for a recommendation","Annex 1 \u2013 line 7 \u2013 column 2"]],"meps":[28221],"meta":{"created":"2020-01-20T00:06:12"},"new":["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."],"old":["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 help promote","infection prevention and control in their","wards/departments and give feedback to","the Infection Prevention and Control Team."],"orig_lang":"de","peid":"PE421.189v01-00","reference":"2009/0003(CNS)","seq":"54","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-421.189+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Thomas Ulmer","changes":{},"committee":["ENVI"],"date":"2009-03-02T00:00:00","id":"PE421.189-55","justification":"Enhancing healthcare workers' understanding of the proper functioning and use of medical\nproducts reduces the likelihood of misuse and therefore the risks for patients treated with\nthese products. New ICT tools, such as electronic manuals, including pictures or films, could\nhelp raise the level of understanding of medical products significantly.","location":[[" Proposal for a recommendation","Annex 2 \u2013 Chapter 1 \u2013 point 1 \u2013 point b a (new)"]],"meps":[28221],"meta":{"created":"2020-01-20T00:06:12"},"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."],"orig_lang":"en","peid":"PE421.189v01-00","reference":"2009/0003(CNS)","seq":"55","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-421.189+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Urszula Krupa","changes":{},"committee":["ENVI"],"date":"2009-03-02T00:00:00","id":"PE421.189-56","justification":"To help patients or their families to obtain redress.","location":[["Proposal for a recommendation","Annex 2 \u2013 Chapter 1 \u2013 point 2 \u2013 point a"]],"meps":[28334],"meta":{"created":"2020-01-20T00:06:12"},"new":["(a) Disseminating information to patients","on complaints procedures and available","remedies and redress, if they are harmed by","healthcare or a treatment, and on the terms","and conditions applicable as well as the","possibility of obtaining redress from","public or private bodies;"],"old":["(a) Disseminating information to patients","on complaints procedures and available","remedies and redress, if they are harmed by","healthcare, and on the terms and conditions","applicable;"],"orig_lang":"pl","peid":"PE421.189v01-00","reference":"2009/0003(CNS)","seq":"56","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-421.189+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Christofer Fjellner","changes":{},"committee":["ENVI"],"date":"2009-03-02T00:00:00","id":"PE421.189-57","justification":" Healthcare workers need to have the best possible knowledge about the proper functioning\n and use of the products they use in treatments. Only this knowledge enables them to minimise\n the risks of health of patients and themselves which could arise from wrong application of\n medical devices, for example by reusing devices which are designed and manufactured for\n one use on one patient only.","location":[["Proposal for a recommendation","Annex 2 \u2013 Chapter 1 \u2013 point 4 \u2013 point c a (new)"]],"meps":[28126],"meta":{"created":"2020-01-20T00:06:12"},"new":["(ca) Providing adequate education and","training for all healthcare workers to 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."],"old":[""],"orig_lang":"en","peid":"PE421.189v01-00","reference":"2009/0003(CNS)","seq":"57","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-421.189+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Amalia Sartori","changes":{},"committee":["ENVI"],"date":"2009-03-02T00:00:00","id":"PE421.189-58","justification":" Medical and paramedical personnel are not just exposed to the danger of catching diseases\n and healthcare-associated infections, but are also potential carriers. Member States should\n therefore seek to guarantee the safety of staff as well as patients. As regards the ways of\n reducing the incidence of healthcare-associated infections, it would be useful to organise\n specifically targeted staff vaccination campaigns.","location":[[" Proposal for a recommendation","Annex 2 \u2013 Chapter 2 \u2013 point 1 \u2013 point a \u2013 indent 2"]],"meps":[4423],"meta":{"created":"2020-01-20T00:06:12"},"new":["\u2013 Integrating infection prevention and","control measures into patient care plans,","including the necessary staff vaccination","campaigns;"],"old":["\u2013 Integrating infection prevention and","control measures into patient care plans;"],"orig_lang":"it","peid":"PE421.189v01-00","reference":"2009/0003(CNS)","seq":"58","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-421.189+01+DOC+PDF+V0//EN&language=EN"}],"changes":{"2014-11-10T00:26:13":[{"data":[{"body":"EC","commission":[],"date":"2008-12-15T00:00:00","docs":[{"celexid":"CELEX:52008PC0837:EN","text":["
PURPOSE:\n proposal on general patient safety issues as well as on the prevention and\n control of healthcare associated infections.
PROPOSED ACT:\n Council Recommendation.
BACKGROUND: it is estimated that between 8% and 12% of patients\n admitted to hospitals in the EU suffer from adverse events whilst receiving\n healthcare. The Commission, through the 7th Framework\n Programme for Research and Development, supports research in health systems. The\n White\n Paper \"Together for Health: A Strategic Approach for the EU\n 2008-2013\"identifies patient safety as an area for action.
CONTENT: this\n proposal sets out recommendations for specific actions that Member States can\n take, either individually, collectively or with the Commission, to improve\n the safety of patients.
With regard to\n general patient safety issues, Member States should:
With regard to\n the prevention and control of healthcare associated infections, Member\n States should implement a national strategy for the prevention and control of\n healthcare associated infections, pursuing certain specified objectives.\n These include: implementing prevention and control measures to support the\n containment of healthcare associated infections; enhancing infection\n prevention and control at the level of the healthcare institutions; and\n supporting research.
Lastly, the\n Recommendation states that Member States should consider the establishment of\n an inter-sectoral mechanism for the coordinated implementation of the\n national strategy as well as for the purposes of information exchange and\n coordination with the Commission, the ECDC and the other Member States.
\nThe Committee\n on the Environment, Public Health and Food Safety adopted the report drawn up\n by Amalia SARTORI (EPP-ED, IT) amending, under the consultation procedure,\n the proposal for a Council recommendation on patient safety, including the\n prevention and control of healthcare associated infections.
The main\n amendments are as follows;
Scale: Members point out that the numbers affected range from 6.7\n million to 15 million hospital in-patients, along with more than 37 million\n primary care patients. It is estimated that, on average,\n healthcare-associated infections (HCAIs) occur in one patient in twenty, that\n is to say, 4.1 million patients a year in the EU, and that about 37 000\n deaths are caused every year by the after-effects of such infections.
Reduction\n targets: Member States should provide the means\n necessary to bring about a 20% reduction in the number of persons in the\n European Union affected annually by adverse events resulting from healthcare,\n the target thus being to reduce such events by 900 000 cases a year by 2015.
Informing\n patients: patients should be informed about\n treatment risks and Member States should introduce legal mechanisms to\n facilitate the lodging of claims for damage to health, including against\n pharmaceutical companies. They must also identify those responsible for\n errors.
Education\n and training of healthcare workers: the report\n adds that Member States should provide adequate education and training for\n all healthcare workers so that they use medical technology appropriately in\n accordance with the function and specifications outlined in the instruction\n manuals in order to prevent health risks and adverse effects, including those\n arising from unintended reuse of devices.
Cooperation\n with the Commission: the scale and cost of the\n data collection, and use of the data collected, should not be\n disproportionate to the expected benefits. The data should only be collected\n in order to achieve the objective of reducing HCAIs through common learning.
Best\n practice: Members States should promote\n opportunities for cooperation and exchange of experience and best practice\n between hospital managers, clinical teams and patient groups across the\n European Union on patient safety initiatives at the local level.
Prevention\n and control of healthcare associated infections:\n the committee stressed the need to provide: (a) effective risk assessment\n mechanisms, including pre-admission diagnostic screening of patients; (b)\n adequate protection for healthcare staff, through vaccination, post-exposure\n prophylaxis, routine diagnostic screening, provision of personal protective\n equipment and the use of medical technology that reduces exposure to\n blood-borne infections; effective infection prevention and control in\n long-term nursing and rehabilitation facilities.
It also\n stressed that, to prevent nosocomial infections, all equipment with\n which patients come into contact has to meet the highest possible standards\n of cleanliness, hygiene, and, where necessary, asepsis.
Member States\n should therefore seek to guarantee the safety of staff as well as patients.\n As regards the ways of reducing the incidence of healthcare-associated\n infections, it would be useful to organise specifically targeted staff\n vaccination campaigns. Education and training of healthcare and\n paramedical workers at Member State level and at the level of healthcare\n institutions should focus in particular on nosocomial infections and viral\n antibiotic resistance.
Member States\n should also report every healthcare-associated infection outbreak affecting a\n significant number of patients to the European Centre for Disease Prevention\n and Control. They should Conduct awareness campaigns for the public and for\n healthcare workers with the aim of reducing practices which lead to\n antimicrobial resistance.
Actions by\n the Commission: the Commission should consider\n where existing Community legislation could be strengthened to improve patient\n safety, for example by ensuring that, when healthcare professionals cross\n borders within Europe, the professional regulators share information about\n any disciplinary procedures concluded or pending against individuals, and not\n just their initial qualifications.
Using the\n practical guide drawn up by the World Health Organisation in 2002, entitled\n ‘Prevention of hospital-acquired infections’, the Commission is invited to\n produce a document aimed at patients on the prevention of nosocomial\n infections.
\nThe European\n Parliament adopted by 521 votes to 6, with 5 abstentions, a legislative\n resolution amending, under the consultation procedure, the proposal for a\n Council recommendation on patient safety, including the prevention and\n control of healthcare associated infections.
The main\n amendments are as follows:
Scale: Members point out that the numbers affected range from 6.7\n million to 15 million hospital in-patients, along with more than 37 million\n primary care patients. It is estimated that, on average,\n healthcare-associated infections (HCAIs) occur in one patient in twenty, that\n is to say, 4.1 million patients a year in the EU, and that about 37 000\n deaths are caused every year by the after-effects of such infections.
Reduction\n targets: Member States should provide the means\n necessary to bring about a 20% reduction in the number of persons in the\n European Union affected annually by adverse events resulting from healthcare,\n the target thus being to reduce such events by 900 000 cases a year by\n 2015. They should also set local and national targets for recruitment of\n health professionals specialising in infection control, taking into account\n the recommended target ratio of one nurse for every 250 hospital beds by\n 2015.
Informing\n patients: patients should be informed about\n treatment risks and Member States should introduce legal mechanisms to\n facilitate the lodging of claims for damage to health, including against\n pharmaceutical companies. There should also be confidential sharing of\n information between health authorities in different Member States on health\n professionals who have been found guilty of negligence or malpractice.
Education\n and training of healthcare workers: Member States\n should provide adequate education and training for all healthcare workers so\n that they use medical technology appropriately in accordance with the\n function and specifications outlined in the instruction manuals in order to\n prevent health risks and adverse effects, including those arising from\n unintended reuse of devices.
Cooperation\n with the Commission: the scale and cost of the\n data collection, and use of the data collected, should not be\n disproportionate to the expected benefits. The data should only be collected\n in order to achieve the objective of reducing HCAIs through common learning.
Best\n practice: Members States should promote\n opportunities for cooperation and exchange of experience and best practice\n between hospital managers, clinical teams and patient groups across the\n European Union on patient safety initiatives at the local level.
Prevention: the Parliament stressed the need to provide: (a) effective risk\n assessment mechanisms, including pre-admission diagnostic screening of\n patients; (b) adequate protection for healthcare staff, through vaccination,\n post-exposure prophylaxis, routine diagnostic screening, provision of\n personal protective equipment and the use of medical technology that reduces\n exposure to blood-borne infections; (c) effective infection prevention and\n control in long-term nursing and rehabilitation facilities.
It is also\n necessary to enhance infection prevention and control at the level of the\n healthcare institutions and ensure the highest standards of cleanliness,\n hygiene, and, where necessary, asepsis as regards medical equipment and patient\n care facilities.
In order to\n reduce nosocomial infections, it is also important to: (i) promote hand\n hygiene among health professionals; (ii) implement necessary staff\n vaccination campaigns; (iii) foster education and training of healthcare and\n paramedical, focusing in particular on nosocomial infections and viral\n antibiotic resistance; (iv) support research, for instance into potential\n medical applications of nanotechnologies and nanomaterials.
Member States\n should also: (i) report every healthcare-associated infection outbreak\n affecting a significant number of patients to the European Centre for Disease\n Prevention and Control; (ii) conduct awareness campaigns for the public and\n for healthcare workers with the aim of reducing practices which lead to\n antimicrobial resistance.
Actions by\n the Commission: the Commission should consider\n where existing Community legislation could be strengthened to improve patient\n safety, for example by ensuring that, when healthcare professionals cross\n borders within Europe, the professional regulators share information about\n any disciplinary procedures concluded or pending against individuals, and not\n just their initial qualifications.
Using the\n practical guide drawn up by the World Health Organisation in 2002, entitled\n ‘Prevention of hospital-acquired infections’, the Commission is invited to\n produce a document aimed at patients on the prevention of nosocomial\n infections. It is also called upon to bring forward proposals to prevent the\n circulation of counterfeit drugs and harm to patients and health workers from\n needlestick injuries.
\nPURPOSE: to\n encourage Member States to take measures to improve patient safety, including\n the prevention and control of healthcare-associated infections.
ACT: Council\n Recommendation on patient safety, including the prevention and control of\n healthcare associated infections.
CONTENT: it is\n estimated that in Member States between 8 % and 12 % of patients admitted to\n hospital suffer from adverse events whilst receiving healthcare. The European\n Centre for Disease Prevention and Control (ECDC) has estimated that, on\n average, healthcare associated infections occur in one hospitalised patient\n in 20, that is to say 4.1 million patients a year in the EU, and that 37 000\n deaths are caused every year as a result of such infections.
The Community,\n through the seventh framework programme for research and development,\n supports research in the quality of healthcare provision. The Commission, in\n its White\n Paper ‘Together for Health: A Strategic Approach for the EU 2008-2013’,\n identifies patient safety as an area for action.
This\n Recommendation lists the measures that Member States can take - alone,\n collectively or together with the Commission - in order to improve patient\n safety.
In terms of patient\n safety, Member States are called upon to:
In terms of the\n prevention and control of healthcare associated infections, Member\n States should:
The Commission\n is called upon to produce, by 9 June 2012, an implementation report to the Council\n assessing the impact of this Recommendation, on the basis of the information that\n Member States must provide by 9 June 2011.
\nPURPOSE:\n proposal on general patient safety issues as well as on the prevention and\n control of healthcare associated infections.
PROPOSED ACT:\n Council Recommendation.
BACKGROUND: it is estimated that between 8% and 12% of patients\n admitted to hospitals in the EU suffer from adverse events whilst receiving\n healthcare. The Commission, through the 7th Framework\n Programme for Research and Development, supports research in health systems. The\n White\n Paper \"Together for Health: A Strategic Approach for the EU\n 2008-2013\"identifies patient safety as an area for action.
CONTENT: this\n proposal sets out recommendations for specific actions that Member States can\n take, either individually, collectively or with the Commission, to improve\n the safety of patients.
With regard to\n general patient safety issues, Member States should:
With regard to\n the prevention and control of healthcare associated infections, Member\n States should implement a national strategy for the prevention and control of\n healthcare associated infections, pursuing certain specified objectives.\n These include: implementing prevention and control measures to support the\n containment of healthcare associated infections; enhancing infection\n prevention and control at the level of the healthcare institutions; and\n supporting research.
Lastly, the\n Recommendation states that Member States should consider the establishment of\n an inter-sectoral mechanism for the coordinated implementation of the\n national strategy as well as for the purposes of information exchange and\n coordination with the Commission, the ECDC and the other Member States.
\nThe Committee\n on the Environment, Public Health and Food Safety adopted the report drawn up\n by Amalia SARTORI (EPP-ED, IT) amending, under the consultation procedure,\n the proposal for a Council recommendation on patient safety, including the\n prevention and control of healthcare associated infections.
The main\n amendments are as follows;
Scale: Members point out that the numbers affected range from 6.7\n million to 15 million hospital in-patients, along with more than 37 million\n primary care patients. It is estimated that, on average,\n healthcare-associated infections (HCAIs) occur in one patient in twenty, that\n is to say, 4.1 million patients a year in the EU, and that about 37 000\n deaths are caused every year by the after-effects of such infections.
Reduction\n targets: Member States should provide the means\n necessary to bring about a 20% reduction in the number of persons in the\n European Union affected annually by adverse events resulting from healthcare,\n the target thus being to reduce such events by 900 000 cases a year by 2015.
Informing\n patients: patients should be informed about\n treatment risks and Member States should introduce legal mechanisms to\n facilitate the lodging of claims for damage to health, including against\n pharmaceutical companies. They must also identify those responsible for\n errors.
Education\n and training of healthcare workers: the report\n adds that Member States should provide adequate education and training for\n all healthcare workers so that they use medical technology appropriately in\n accordance with the function and specifications outlined in the instruction\n manuals in order to prevent health risks and adverse effects, including those\n arising from unintended reuse of devices.
Cooperation\n with the Commission: the scale and cost of the\n data collection, and use of the data collected, should not be\n disproportionate to the expected benefits. The data should only be collected\n in order to achieve the objective of reducing HCAIs through common learning.
Best\n practice: Members States should promote\n opportunities for cooperation and exchange of experience and best practice\n between hospital managers, clinical teams and patient groups across the\n European Union on patient safety initiatives at the local level.
Prevention\n and control of healthcare associated infections:\n the committee stressed the need to provide: (a) effective risk assessment\n mechanisms, including pre-admission diagnostic screening of patients; (b)\n adequate protection for healthcare staff, through vaccination, post-exposure\n prophylaxis, routine diagnostic screening, provision of personal protective\n equipment and the use of medical technology that reduces exposure to\n blood-borne infections; effective infection prevention and control in\n long-term nursing and rehabilitation facilities.
It also\n stressed that, to prevent nosocomial infections, all equipment with\n which patients come into contact has to meet the highest possible standards\n of cleanliness, hygiene, and, where necessary, asepsis.
Member States\n should therefore seek to guarantee the safety of staff as well as patients.\n As regards the ways of reducing the incidence of healthcare-associated\n infections, it would be useful to organise specifically targeted staff\n vaccination campaigns. Education and training of healthcare and\n paramedical workers at Member State level and at the level of healthcare\n institutions should focus in particular on nosocomial infections and viral\n antibiotic resistance.
Member States\n should also report every healthcare-associated infection outbreak affecting a\n significant number of patients to the European Centre for Disease Prevention\n and Control. They should Conduct awareness campaigns for the public and for\n healthcare workers with the aim of reducing practices which lead to\n antimicrobial resistance.
Actions by\n the Commission: the Commission should consider\n where existing Community legislation could be strengthened to improve patient\n safety, for example by ensuring that, when healthcare professionals cross\n borders within Europe, the professional regulators share information about\n any disciplinary procedures concluded or pending against individuals, and not\n just their initial qualifications.
Using the\n practical guide drawn up by the World Health Organisation in 2002, entitled\n ‘Prevention of hospital-acquired infections’, the Commission is invited to\n produce a document aimed at patients on the prevention of nosocomial\n infections.
\nThe European\n Parliament adopted by 521 votes to 6, with 5 abstentions, a legislative\n resolution amending, under the consultation procedure, the proposal for a\n Council recommendation on patient safety, including the prevention and\n control of healthcare associated infections.
The main\n amendments are as follows:
Scale: Members point out that the numbers affected range from 6.7\n million to 15 million hospital in-patients, along with more than 37 million\n primary care patients. It is estimated that, on average,\n healthcare-associated infections (HCAIs) occur in one patient in twenty, that\n is to say, 4.1 million patients a year in the EU, and that about 37 000\n deaths are caused every year by the after-effects of such infections.
Reduction\n targets: Member States should provide the means\n necessary to bring about a 20% reduction in the number of persons in the\n European Union affected annually by adverse events resulting from healthcare,\n the target thus being to reduce such events by 900 000 cases a year by\n 2015. They should also set local and national targets for recruitment of\n health professionals specialising in infection control, taking into account\n the recommended target ratio of one nurse for every 250 hospital beds by\n 2015.
Informing\n patients: patients should be informed about\n treatment risks and Member States should introduce legal mechanisms to\n facilitate the lodging of claims for damage to health, including against\n pharmaceutical companies. There should also be confidential sharing of\n information between health authorities in different Member States on health\n professionals who have been found guilty of negligence or malpractice.
Education\n and training of healthcare workers: Member States\n should provide adequate education and training for all healthcare workers so\n that they use medical technology appropriately in accordance with the\n function and specifications outlined in the instruction manuals in order to\n prevent health risks and adverse effects, including those arising from\n unintended reuse of devices.
Cooperation\n with the Commission: the scale and cost of the\n data collection, and use of the data collected, should not be\n disproportionate to the expected benefits. The data should only be collected\n in order to achieve the objective of reducing HCAIs through common learning.
Best\n practice: Members States should promote\n opportunities for cooperation and exchange of experience and best practice\n between hospital managers, clinical teams and patient groups across the\n European Union on patient safety initiatives at the local level.
Prevention: the Parliament stressed the need to provide: (a) effective risk\n assessment mechanisms, including pre-admission diagnostic screening of\n patients; (b) adequate protection for healthcare staff, through vaccination,\n post-exposure prophylaxis, routine diagnostic screening, provision of\n personal protective equipment and the use of medical technology that reduces\n exposure to blood-borne infections; (c) effective infection prevention and\n control in long-term nursing and rehabilitation facilities.
It is also\n necessary to enhance infection prevention and control at the level of the\n healthcare institutions and ensure the highest standards of cleanliness,\n hygiene, and, where necessary, asepsis as regards medical equipment and patient\n care facilities.
In order to\n reduce nosocomial infections, it is also important to: (i) promote hand\n hygiene among health professionals; (ii) implement necessary staff\n vaccination campaigns; (iii) foster education and training of healthcare and\n paramedical, focusing in particular on nosocomial infections and viral\n antibiotic resistance; (iv) support research, for instance into potential\n medical applications of nanotechnologies and nanomaterials.
Member States\n should also: (i) report every healthcare-associated infection outbreak\n affecting a significant number of patients to the European Centre for Disease\n Prevention and Control; (ii) conduct awareness campaigns for the public and\n for healthcare workers with the aim of reducing practices which lead to\n antimicrobial resistance.
Actions by\n the Commission: the Commission should consider\n where existing Community legislation could be strengthened to improve patient\n safety, for example by ensuring that, when healthcare professionals cross\n borders within Europe, the professional regulators share information about\n any disciplinary procedures concluded or pending against individuals, and not\n just their initial qualifications.
Using the\n practical guide drawn up by the World Health Organisation in 2002, entitled\n ‘Prevention of hospital-acquired infections’, the Commission is invited to\n produce a document aimed at patients on the prevention of nosocomial\n infections. It is also called upon to bring forward proposals to prevent the\n circulation of counterfeit drugs and harm to patients and health workers from\n needlestick injuries.
\nPURPOSE: to\n encourage Member States to take measures to improve patient safety, including\n the prevention and control of healthcare-associated infections.
ACT: Council\n Recommendation on patient safety, including the prevention and control of\n healthcare associated infections.
CONTENT: it is\n estimated that in Member States between 8 % and 12 % of patients admitted to\n hospital suffer from adverse events whilst receiving healthcare. The European\n Centre for Disease Prevention and Control (ECDC) has estimated that, on\n average, healthcare associated infections occur in one hospitalised patient\n in 20, that is to say 4.1 million patients a year in the EU, and that 37 000\n deaths are caused every year as a result of such infections.
The Community,\n through the seventh framework programme for research and development,\n supports research in the quality of healthcare provision. The Commission, in\n its White\n Paper ‘Together for Health: A Strategic Approach for the EU 2008-2013’,\n identifies patient safety as an area for action.
This\n Recommendation lists the measures that Member States can take - alone,\n collectively or together with the Commission - in order to improve patient\n safety.
In terms of patient\n safety, Member States are called upon to:
In terms of the\n prevention and control of healthcare associated infections, Member\n States should:
The Commission\n is called upon to produce, by 9 June 2012, an implementation report to the Council\n assessing the impact of this Recommendation, on the basis of the information that\n Member States must provide by 9 June 2011.
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