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Helsinki Declaration for Patient Safety in Anaesthesiology

''This article is about the Helsinki Declaration on Patient Safety in Anaesthesiology. For the Declaration of Helsinki dealing with human research ethics, see Declaration of Helsinki.''

The Helsinki Declaration for Patient Safety in Anaesthesiology is a document prepared jointly by the two principal anaesthesiology organizations in Europe, the European Board of Anaesthesiology (EBA) and the European Society of Anaesthesiology (ESA). It was launched in June 2010 at the Euroanaesthesia meeting in Helsinki. It aims to provide a focus for improvements in the safety of patient care in anaesthesiology and related medical fields of perioperative care, intensive care medicine, pain therapy and emergency medicine throughout Europe. The specialty of anaesthesiology has been at the forefront of the patient safety movement for many years.

Development of the Declaration

Starting in June 2009, the patient safety subcommittee of the EBA consulted widely to set up this document and many individuals and representatives of national societies have been involved in the drafting and development of this Declaration. The ESA scientific programme subcommittees for Evidence-based Practice and Quality Improvement and Patient Safety were involved from the beginning. The first draft was discussed in a meeting in London with representatives from all over Europe in November 2009. Following that it was finalized by involving all EBA representatives as well as the ESA Board of Directors. The Declaration in its present form is the result of a consensus between both the ESA Board of Directors and the EBA.

Principles and aims

The Declaration builds on earlier statements about safety and quality of care. It represents a shared European opinion of what currently is both worth doing and practical to improve patient safety in anaesthesiology in 2010. The Declaration recommends practical steps that all anaesthesiologists who are not already using them should include in their own practice. These are relatively straightforward and where they are currently being used have a track record of improving patient safety. All European anaesthesiology institutions are expected to support the World Health Organisation (WHO) ‘Safe Surgery Saves Lives’ initiative including the “Safe Surgery Checklist”, where anaesthesiology plays an important role and where other safety recommendations are made. The Declaration was endorsed by EBA and ESA. It was officially launched at the Euroanaesthesia congress in Helsinki in June 2010 and was subsequently signed by several representatives of European anaesthesiology and other stakeholders (WHO, World Federation of Societies of Anaesthesiologists (WFSA), European Patients Federation (EPF)). The EBA and ESA have established a Patient Safety Task Force to take forward this work by providing the tools and protocols anaesthesiologists might need to help them fulfil their obligations under the Declaration.

Text of the Declaration

Background

•	Anaesthesiology shares responsibility for quality and safety in Anaesthesia, Intensive Care, Emergency Medicine and Pain Medicine, including the whole perioperative process and also in many other situations inside and outside the hospital where patients are at their most vulnerable.

•	Around 230 million patients undergo anaesthesia for major surgery in the world every year. Seven million develop severe complications associated with these surgical procedures from which one million die (200,000 in Europe). All involved should try to reduce this complication rate significantly.

•	Anaesthesiology is the key specialty in medicine to take up responsibility for achieving the goals listed below which will notably improve Patient Safety in Europe.

Heads of Agreement

We, the leaders of societies representing the medical speciality of anaesthesiology, met in Helsinki on 14 June 2010 and all agree that:

•	Patients have a right to expect to be safe and protected from harm during their medical care and anaesthesiology has a key role to play improving patient safety perioperatively. To this end we fully endorse the World Federation of Societies of Anaesthesiologists International Standards for a Safe Practice of Anaesthesia.

•	Patients have an important role to play in their safe care which they should be educated about and given opportunities to provide feedback to further improve the process for others. The funders of healthcare have a right to expect that perioperative anaesthesia care will be delivered safely and therefore they must provide appropriate resources.

•	Education has a key role to play in improving patient safety, and we fully support the development, dissemination and delivery of patient safety training.

•	Human factors play a large part in the delivery of safe care to patients, and we will work with our surgical, nursing and other clinical partners to reliably provide this. Reason J. Human Error. Cambridge: Cambridge University Press, 1990.

•	Our partners in industry have an important role to play in developing, manufacturing and supplying safe drugs and equipment for our patients’ care.

•	Anaesthesiology has been a key specialty in medicine leading the development of patient safety. We are not complacent and know there are still more areas to improve through research and innovation.

•	 No ethical, legal or regulatory requirement should reduce or eliminate any of the protections for safe care set forth in this Declaration.

Principal requirements

Today we pledge to join with the European Board of Anaesthesiology (EBA) in declaring the following aims for improving Patient Safety in Europe. Close cooperation between European organisations will be required to achieve these goals, for which the input and efforts of the European Society of Anaesthesiology (ESA) will be instrumental:

1. All institutions providing perioperative anaesthesia care to patients (in Europe) should comply with the minimum standards of monitoring recommended by the EBA both in operating theatres and in recovery areas.

2. All such institutions should have protocols  and the necessary facilities for managing the following: o	Preoperative assessment and preparation

o	Checking Equipment and drugs

o	Syringe labelling

o	Difficult/failed intubation

o	Malignant hyperpyrexia

o	Anaphylaxis

o	Local anaesthetic toxicity

o	Massive haemorrhage

o	Infection control

o	Postoperative care including pain relief

3. All institutions providing sedation to patients must comply with anaesthesiology recognised sedation standards for safe practice.

4. All institutions should support the WHO Safe Surgery Saves Lives initiative and Checklist.

5. All departments of anaesthesiology in Europe must be able to produce an annual report of measures taken and results obtained in improving patient safety locally. 6. All institutions providing anaesthesiological care to patients must collect the required data to be able to produce an annual report on patient morbidity and mortality. 7. All institutions providing anaesthesiological care to patients must contribute to the recognised national or other major audits of safe practice and critical incident reporting systems. Resources must be provided to achieve this.

Conclusion

•	This declaration emphasises the key role of anaesthesiology in promoting safe perioperative care.

Continuity

•	We invite anyone involved in healthcare to join us and sign up to this declaration.

•	We will reconvene to annually review our progress to implement this declaration.