In Belgium, between 2,000 and 4,000 are said to die each year due to an adverse event in a medical setting(1) according to the Belgian Federal Public Health Service (2). Furthermore, these adverse events are responsible for 65.000 extensions of hospital stays and for 32.000 permanent disability of various forms yearly, resulting in more than 400 million euros entra cost for national health services (3).
In about 70% of case, these adverse events are not due to a lack of knowledge or medical skills, but to "human factors", including miscommunication among staff and with patients, and errors in handling evermore complex pieces of equipment. Human factors management techniques adapted to healthcare exist. These errors are largely preventable (4), but medical and nursing staff is still not trained accordingly, even though it is advocated by the Council of Europe in its Recommendation 2009/C 151/01 dated June 9th, 2009.
Human factors management techniques have been developed by the civil aviation jointly with NASA in the 1980s, with unequivocal results. In 2013, in 36.4 million flights, only 81 accidents occurred, causing 210 deaths (5).
Civil aviation is cited as a reference in many medical publications because human factors management tools can be adapted to healthcare. This is precisely what is happening in the US, with results in line with expectations (6).
In addition, in 2009, WHO published a checklist to help avoid errors in the operating room. Results published in the NEJM in 2009 show an infection rate reduction of 45%, a re-admission rate reduction of 25%, and a decrease in patient deaths by 46% (7).
The human factors management techniques have been developed by the airlines industry and NASA in the 80's, with undisputable results. In 2013, on 36,4 millions flights, only 81 accidents happened, killing 210 people (5).
The airlines industry is pointed as the reference in many healthcare publications, because human factors management tools can be adapted the healthcare industry. It is regularly the case in United States, with expected results (6).
On the other hand, the WHO has published in 2009 a check-list aiming to avoid errors in the operating theater, with as a result a decrease of infections by 45%, re-operation by 25% and death by 46% (7).
In 1999, the Institute of Medicine in Washington published its report titled "To Err is Human" (8) in which it estimates that in hospitals in the US, between 44,000 and 96,000 people die each year due an adverse events suites, resulting in direct yearly cost is between 17 and 29 billion USD. The data used for this study dated from 1984.
The estimate of 2,000 to 4,000 deaths per year in Belgium an extrapolation of the figures from the IOM report "To Err is Human".
In 2013, the Journal of Patient Safety has released new estimates based on figures collected between 2008 and 2011 (9). According to this study, more than 400,000 people die each year in US hospitals due to adverse event.
In the United-Kingdom, the cost of extra hospital stays resulting from adverse events was estimated at 2 billion pounds in 2000 (10).
In France in 2009, DREES published the ENEIS survey on serious adverse events in hospitals (11). This study establishes that in 1,000 days of hospitalization, there are 4.2 days during which an event occurs leading to a extension of the hospital stay, and 1.9 days that lead to a disability of some kind. Furthermore, a significant number of hospital admissions are caused by an adverse event.
Turning the tide in the US.
Following the IOM report, several initiatives have emerged in the US, including one in collaboration with the DoD (Department of Defense), to adapt the human factors management techniques developed by civil aviation for use in healthcare. These programs were developed in the many military hospitals across the country, and were offered to civilian institutions as from 2006.
The AHRQ (Agency for Healthcare Research and Quality) has recently published the results of a study designed to measure the positive effects of these programs.
Between 2010 and 2013, the number of "Hospital Acquired Conditions" fell by 17%, resulting in 50,000 lives saved, and in a cost reduction of 12 billion USD in 3 years (12).
Initiatives in Europe
On June 9th, 2009, the European Council issued the recommendation 2009/C 151/01 on patient safety, including the prevention of healthcare associated infections. In its introduction, the Council writes « Each year, 8-12% of hospitalized patients suffer from healthcare-associated complications in hospitals in the European Union (EU). These complications are often related to systemic factors, and generate suffering for patients and their families, as well as important healthcare spendings. To avoid these problems, the European Council advocates for better supervision of patient safety. »
The importance of taking human factors into account is broadly explained.
Le level of compliance with this recommendation varies widely between countries :
• In France, the HAS (Haute Autorité de la Santé) has mandated the use of the Surgical Safety Checklist, and set up the PACT program, Program of Continuous Improvement of Team Work.
• In the United-Kingdom, the Clinical Human Factors Group obtained the signature of the NQB Concordat, in which all healthcare stakeholders undertake to improve the management of human by all necessary means.
• In Denmark, the 2003 « Patient Safety Act » legally requires that practitioners who are responsible for or who witness an adverse event to make a report. Furthermore, human factors management training has been integrated into academic curricula.
• In Germany, the Coalition for Patient Safety has integrated human factors management training in medical academic curricula.
• Spain has implemented a Master in Patient Safety and Quality of Care.
• In Sweden, the government estimates that medical errors are responsible for 3,000 deaths and 100,000 complications per year for an annual cost of 550 million euros. They spent 275 million euros on the current term of office to work towards improving the situation.(13)
• In Switzerland (outside EU), Hôpitaux Universitaires de Genève are pioneers in human factors management, and the pilot program "progress! " aims to increase the adherence to the Surgical Safety Checklist and improve patient safety in 12 hospitals.
The press release of December 1st, 2014 dealing with the compliance to the Council recommendation 2009/C 151/01 draws to the following conclusions:
• Advances in the field of patient safety are encouraging.
• Initiatives aiming to implement elements of safety culture in the medical academic curricula are insufficient.
• Incident reporting systems, which will improve the quality of care and patient safety by sharing experience, are almost nonexistent.
• Efforts to limit infections during hospital stays are insufficient.
It must be noted that today, Europe seems to rely on the goodwill of the various players in healthcare for the situation to improve. The Pasq project (www.pasq.eu), although an interesting initiative, is a good example thereof.
And in Belgium...
Today in Belgium, apart from a few isolated initiatives, there is no human factors management training in healthcare, both during the academic curriculum and as part of recurrent professional training .
In 2013, the Belgian Federal Public Health Service has launched its second Five Year Plan on "Patient Safety". Its aim is to improve coordination of and patient safety and of quality of care, by encouraging hospitals to implement tools such as checklist and organize training courses on communication and teamwork. This also aims to help them prepare for the accreditation of their services, which is already compulsory in countries like France and the US and is being introduced in Belgium.
The previous five-year plan (2007-2012), allowed the hospitals to set up an incident reporting voluntary system. The number of reports obtained remains well below expectations (5-10% of the estimated total adverse events are the subject of a report). Furthermore, lessons learned from the analysis of these incidents are not shared between hospitals(14). Improvement in national patient safety remains marginal.
(1) Definition WHO: Adverse event: « An injury related to medical management, in contrast to complications of disease. Medical management includes all aspects of care, including diagnosis and treatment, failure to diagnose or treat, and the systems and equipment used to deliver care. Adverse events may be preventable or non-preventable. »
(2) « Note stratégique sur la sécurité des patients » written by « Groupe de travail Sécurité des Patients de la Commission Nationale d’accompagnement pour la Performance hospitalière » in 2007.
(3) No specific survey has taken place in Belgium. The figure of 400 million euros is a careful extrapolation done with data published in other industrialized countries such as the USA, France, United-Kingdom, New-Zealand, Australia and Sweden. In these countries, thorough studies have been made concerning adverse events in healthcare and their consequences.
(4) James Reason. A Life in Error : From Little Slips to Big Disasters ; 2013
(5) IATA. IATA Safety Fact Sheet – Results as of 31 December 2013 ; 2014
(6) Weaver et al ; Team-training in healthcare: a narrative synthesis of the literature ; BMJ Qual Saf. May 2014; 23(5): 359–372
(7) Haynes et al ; A Surgical Safety Checklist to Reduce Morbidity and Mortality in a Global Population ; N Engl J Med 2009; 360:491-499
(8) Kohn et al; To Err is Human: Building a Safer Health System. Institute of Medicine. Washington D.C. 1999
(9) John T. James; A New, Evidence-based Estimate of Patient Harms Associated with Hospital Care ; J Patient Saf 2013;9: pp. 122-128
(10) Department of Health. An organization with a memory : report of an expert group on learning from adverse events in the NHS ; 2008
(11) Direction de la Recherche, des Études de l'Évaluation et des Statistiques. L’enquête nationale sur les événements indésirables liés aux soins (ENEIS); 2010
(12) AHRQ ; Interim Update on 2013 Annual Hospital-Acquired Condition Rate and Estimates of Cost Savings and Deaths Averted From 2010 to 2013 ; http://www.ahrq.gov/professionals/quality-patient-safety/pfp/interimhacrate2013.pdf
(13) Soop et al ; The incidence of adverse events in Swedish hospitals: a retrospective medical record review study 2009; International Journal for Quality in Health Care Volume 21, Number 4: 285–291
(14) Decoster et al; Qualité et sécurité des patients dans les hôpitaux belges 2007-2012; SPF Santé Publique 2014