Addressing the challenge of healthcare associated infections (HCAIs) in Europe

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1 POSITION PAPER 05 January 2011 Addressing the challenge of healthcare associated infections (HCAIs) in Europe A Call for Action Page 1 of 8

2 A holistic approach to combating HCAIs in Europe We must rise to the challenge of creating efficient and effective health systems, and maintain their operation at the highest level of quality and safety John Dalli, European Commissioner for Health and Consumer Policy at Eucomed MedTech Forum, October 2011 Healthcare associated infections (HCAIs) represent a critical challenge for the healthcare sector in Europe. They severely impact the health of people, lengthen hospital stay of patients and generate significant healthcare costs. Tackling the problem of healthcare associated infections across Europe requires a coherent and holistic approach, which covers the whole patient pathway. Such an approach includes screening patients and their visitors, hand and environmental hygiene measures, appropriate antibiotic control policies, and the establishment of robust surveillance and monitoring systems. The medical technology industry is able and willing to play its role in tackling healthcare associated infections. Medical technology can help detect, prevent and manage healthcare associated infections, but barriers exist to the adoption of these innovative technologies. The medical technology industry supports education of healthcare personnel, including developing e-learning tools for best practice use of innovative technologies. Reducing and better managing healthcare associated infections and ensuring adequate safety Standards demand a coherent and holistic approach along the whole patient pathway. Eucomed believes such an approach would need to embrace the following four STEPs : S- Staff: Ensuring that all staff in healthcare establishments are involved and appropriately trained and educated in infection control practices in addition to the appointment of appropriate specialist staff such as infection control officers. T- Technology: Ensuring the adoption of cost-effective innovative technologies that reduce HCAIs and thereby reducing overall healthcare costs. E-Environment: Controlling environmental risks for HCAIs through cleaning of facilities and equipment with appropriate disinfectants, good hand-hygiene, and isolation or segregation of infected patients. P- Processes: Ensuring comprehensive risk prevention and management of HCAIs throughout the whole patient pathway, starting with screening patients prior to admission to identify, decontaminate, isolate or treat those carrying or infected by HCAIs, implementing strict antibiotic control policies and surveillance systems and embracing information technology where appropriate. Page 2 of 8

3 HCAIs A significant burden for society Healthcare associated infections (HCAIs), also known as nosocomial infections, are diseases or pathologies related to the presence of an infectious agent acquired in hospitals and other healthcare settings as a result of interventions i. The European Centre for Disease Prevention and Control (ECDC) estimates that HCAIs in the EU affect 1 in 20hospitalized patients, or 4.1 million patients a year, resulting in 37,000 deaths ii, which is around the same level as road traffic accident deaths in Europe iii. However, there is a growing view that this is an underestimation of the scale of the problem due to underreporting. HCAIs generate significant healthcare costs as well as having a negative impact on the health of infected individuals. The consequences of HCAIs include longer hospital stays and infections that are more difficult and costly to treat. A conservative estimate by the European Union suggests that HCAIs generate 5.48 billion in healthcare costs each year, excluding productivity loss iv. Through a combination of prevention, detection and management of HCAIs, healthcare systems can significantly decrease the human and economic cost. Spread and transmission of HCAIs Healthcare associated infections (HCAIs) are spread and transmitted in a number of ways, the four principle routes of infection being: Person to person contact with an infected or colonized person v prior to admission to hospital or during a hospital stay; Contact with pathogens from infected individuals; Contact with pathogens from the environment such as soft furnishings (e.g. bedding) and surfaces e.g. trolleys, operating tables, door handles; Surgical or medical instruments and equipment (intravenous lines, catheters, stethoscopes, blood pressure cuffs etc.). Cross-contamination can also occur between different routes of infection. For example, a contaminated surface could transfer a pathogen to a healthcare professional s hand, which could infect a patient, or a contaminated instrument could infect an individual who then becomes a reservoir for infection. The possibility of cross-contamination highlights the importance of following personal hygiene measures such as hand disinfection and using barriers such as gloves, gowns, wound coverings, as well as environmental hygiene measures such as disinfecting surgical and intensive care equipment, operating tables and floors. Antimicrobial resistance is a public health concern worldwide. Infections caused by resistant microorganisms such as Methicillin (or Meticillin )-resistant Staphylococcus aureus (MRSA) Vancomycin-resistant Enterococci (VRE) as well as ESBL producing gram-negative organisms, often fail to respond to conventional treatment, resulting in prolonged illness and greater risk of death. Different reasons are put forward to explain the increase of the so-called superbugs including more intensive hospital bed usage and greater mobility of patients. Appropriate antibiotic control policies are not the only solution to tackle these organisms; innovative medical technologies should also be part of policies to prevent bacterial infections in healthcare settings. Page 3 of 8

4 Medical Technology as an enabler to combatting HCAIs Medical technology can play a vital role within a coherent and holistic approach to combatting healthcare associated infections. Innovation in medical technology has led to the development of technologies to detect, prevent and manage HCAIs along the entire patient pathway. Detecting HCAIs: Testing and screening technologies as an integral part of a proactive infection prevention program, for example, MRSA screening using rapid molecular technology have led to very significant falls in MRSA bloodstream infections vi. Preventing HCAIs: Surgical instruments that allow a minimally invasive approach though reducing the risk of wound infections; Antimicrobial coatings on invasive devices; Closed catheterization systems; Sterile indication sets, e.g. for wound care or catheterization, which reduce the risk of infections by driving a strong adherence of professional staff to a determined sequence of treatment steps; Area decontamination using technologies like hydrogen peroxide effectively reduces pathogen burden on contaminated surfaces; High quality single-use devices or devices that are designed for safe and easy reprocessing; Dressings which provide a barrier over wounds and insertion sites to prevent bacteria entering (or migrating from) a break in the skin; Fecal management systems designed to minimize exposure to infectious bodily waste Contactless operation of devices; Automatic hand disinfectant dispensers; Diagnostic and therapeutical devices that are designed to be easily and safely disinfected; Software and other management solutions for Antibiotic Stewardship and infection control; Single use surgical barrier materials (surgical gloves, gowns, drapes, masks) to prevent transfer of micro-organisms; State of the art cleaning, disinfection and sterilization technologies which eliminate all forms of viable micro-organisms on multiple use medical equipment. These are important steps to ensure that pathogens are not transmitted to a patient from a medical device vii. Managing HCAIs: Product solutions to isolate and sanitize infected patients; Decolonization of carriers of multi resistant organisms (MRO); Specialized wound care products such as anti-microbial barrier dressings that significantly reduce the bacterial load in wounds. Barriers to adoption of effective solutions Page 4 of 8

5 Investment in medical technologies to detect, prevent and manage HCAIs is one strand of a coherent and holistic approach to reducing the burden of HCAIs on healthcare systems and individuals. However, some barriers exist that inhibit the wide-scale adoption of helpful technologies, including: Lack of funding, e.g. insufficient links to procurement or reimbursement practices; Lack of awareness of hospital managers on the burden of the problem; Lack of financial incentives, e.g. within a hospital, to reduce HCAI; Lack of awareness of long-term cost savings, instead focus on unit cost reduction; Lack of involvement and training of healthcare workers; Lack of transparency on the prevalence, sources and burden of HCAI; Lack of clinical and economical evidence for some medical products developed for preventing of reducing HCAI. Call for Action at European level In 2009 the Council of the European Union published recommendations to Member States on detection, prevention and management of HCAIs, which lead to a number of national initiatives. However, despite progress having been made in some countries, there is still significant room for improvement. Eucomed therefore calls on the European Commission and Member States to build on these Council Recommendations to strengthen and further improve the European response to healthcare associated infections and proposes the following measures: 1. Establishment of robust surveillance and reporting systems on HCAIs Due to varying success in tackling healthcare associated infections across Europe, there is a need to better co-ordinate Member States efforts including showcasing best practice viii. Standardized surveillance and reporting systems should exist across Europe and where practicable data should be publicly available. To facilitate mutual learning and make data more comparable, a common terminology for patient safety and common surveillance indicators need to be developed ix.eu Member States should be obliged to report HCAI levels to the ECDC on a regular basis. 2. Setting HCAI reduction targets Significant progress has been made where policymakers have established measurable HCAI reduction targets that are to be achieved over a defined period of time: Baseline HCAI rates should be established in each healthcare institution and compared to European reference data; Realistic reduction targets should be set; Progress in reducing HCAIs should be measured and lessons learned should be shared to ensure change and improvement. Page 5 of 8

6 3. Addressing barriers to innovative solutions The importance of innovation is fully recognised by the Council of the EU x, which has invited the Commission and the Member States to promote measures that make use of valuable innovative solutions with proven benefit as key to address current and future healthcare challenges xi. As a next step healthcare providers should be encouraged to adopt innovative medical technologies that help detect, prevent or manage HCAIs and can contribute to cost savings for example by reducing length of hospital stay or lowering antibiotic use. This could be accelerated on a European level by: Collecting and disseminating best practice on cost-effective solutions reducing the burden of HCAIs; Defining minimum safety standards for HCAI and ensuring EU wide adoption; Examining appropriate funding mechanisms at national, regional or local level to ensure that cost pressures do not impede the use of proven cost-effective solutions; Developing best practice guidelines for HCAIs, which cover the whole patient pathway and the role of healthcare professionals and patients. 4. Providing EU funding for HCAI prevention and control measures To support effective national programmes, EU funding should be made available to assist with the implementation of measures to prevent, detect and manage HCAIs at the Member State level; e.g. within the European Structural Funds or the EU Framework programme for Research. This funding could be used for national projects on HCAIs such as the education and training of healthcare staff, patient education, support for research, and the pilot implementation of innovative solutions. Page 6 of 8

7 Conclusions To effectively combat HCAI a coherent and holistic approach is needed that applies appropriate measures along the whole patient pathway and embraces four key STEPs : Staff, Technology, Environment and Processes. Eucomed calls for EU action on healthcare associated infections through a coherent and holistic approach that builds on, strengthens and further improves the EU Council recommendations of 2009 on the detection, prevention and management of HCAIs. Eucomed believes such action will require: 1) Setting HCAI reduction targets 2) Installing robust surveillance and reporting systems on HCAIs 3) Addressing barriers to innovative solutions 4) Providing EU funding for HCAI prevention, control and education measures Page 7 of 8

8 ABOUT EUCOMED Eucomed represents the medical technology industry in Europe. Our mission is to make modern, innovative and reliable medical technology available to more people. Eucomed members include both national and pan-european trade and product associations as well as medical technology manufacturers. We represent designers, manufacturers and suppliers of medical technology used in the diagnosis, prevention, treatment and amelioration of disease and disability. The industry we represent employs more than 500,000 highly skilled workers, turns over 95 billion per year, invests some 7.5 billion in R&D and encompasses of approximately 500,000 different medical technologies from sticking plasters and wheel chairs through to pacemakers and replacement joints. Eucomed promotes a balanced policy environment that enables the medical technology industry to meet the growing healthcare needs and expectations of society. For more information visit Or contact Tanja Valentin Senior Manager Public Affairs tanja.valentin@eucomed.org Tel.: +32 (0) i As per the definition of HCAIs in the Council recommendations of 9 June 2009 on Patient Safety, Including the Prevention and Control of Healthcare Associated Infections. ii European Commission (2011), Questions and Answers on Patient Safety, Including the Prevention and Control of Healthcare Associated Infections. iii European Road Safety Observatory. Traffic Safety Basic Facts Main figures. iv Harbarth S, Sax H, and Gastmeier P (2003), The preventable proportion of nosocomial infections: an overview of published reports, Journal of Hospital Infections,54(4), pp v A colonised person is a carrier on an infection, for example has a bacterium on their skin, but has not been infected (harmed) by it, i.e. it is possible to be a carrier of MRSA without being infected by it. vi AchyutGuleri, Aidan Kehoe, Julian Hartley, Barrie Lunt, Nick Harper, Ruth Palmer, Joe Lickiss, Sharon Mawdsley and Annie Jones (2011), The Costs and Benefits of hospital MRSA Screening; British Journal of Healthcare Management Volume 17, No 2. vii Rutala WA (2008) Guideline for Disinfection and Sterilization in Healthcare Facilities, Centres for Disease Control and Prevention. viii Council Recommendation of 9 June 2009 on patient safety, including the prevention and control of healthcare associated infections. ix Idem. x Council of the European Union, Council Conclusions on Innovation in the Medical Device Sector, June xi Idem. Page 8 of 8