Introduction

Introduction (Arnal, Preckel)

‘Anaesthesiologists have a unique, cross-speciality opportunity to influence the safety and quality of patient care’.¹ The central role of anaesthesiologists in the acute and surgical patient; the safety improvements in anaesthetic practice, with more than 10-fold decrease of anaesthesia mortality since 1970 and the pioneering interest in the topic have made anaesthesiology the leading medical speciality for addressing patient safety issues.^2–4 In the 1999 Institute of Medicine report ‘To Err is Human’, Anaesthesiology rightly received the recognition it deserved as the original leader in patient safety, and even the source of the term ‘Patient Safety’ itself.⁵ Anaesthesia care has become quite safe: an analysis of national registry data from the United States revealed for the years 1999 to 2005 an estimated rate for anaesthesia-related death of 1.1 per million population per year, and 8.2 per million hospital surgical discharges.⁶ However, huge regional differences exist, and anaesthesia-related mortality is much higher in low-income and middle-income countries.^7,8 This difference becomes even more important if we recognise that availability of surgery is unequally distributed in the world, with the expectation that surgery will increase in the lower income countries during the next decades.⁹

Which risks for patient safety do we face in anaesthesiology? today Previous publications have shown that even in high-income countries, 44 to 54% of peri-operative ‘adverse events’ are preventable. Factors like increased pressure on throughput, along with reduced medical staff, new drugs and devices, sicker patients, as well as more complex procedures all increase the opportunity for errors in our work. Are we now paying the price for the success from previous years? Chantler¹⁰, already in 1999, said that ‘Medicine used to be simple, ineffective and relatively safe. Now it is complex, effective and potentially dangerous’. Surgical and anaesthesia safety was for a long time unrecognised as a public health issue and for numerous safety topics we still lack evidence-based data. For years, medical staff and policy makers failed to use existing safety know-how from industry in healthcare systems.¹¹

Patient safety is an activity to mitigate preventable patient harm that may occur during the delivery of medical care. The European Board of Anaesthesiology (EBA)/European Union of Medical Specialists (UEMS) had previously published safety recommendations on Minimal Monitoring and Postanaesthesia Care, but with the growing public and professional interest it was decided to produce a much more encompassing document.^12,13 The EBA and the European Society of Anaesthesiology (ESA) published a consensus on what needs to be done/achieved for improvement of peri-operative patient safety. During the Euroanaesthesia meeting in 2010, taking place in Helsinki, Finland, this vision was presented to anaesthesiologists, patients, industry and others involved in health care as the ‘Helsinki Declaration on Patient Safety in Anaesthesiology’.¹

This Declaration represents a shared opinion of what currently is worth doing and practical to improve patient safety. There are eight ‘Heads of Agreement’ and seven ‘Principal Requirements’.

Helsinki Declaration on patient safety in anaesthesiology

Background

Anaesthesiology shares responsibility for quality and safety in Anaesthesia, Intensive Care, Emergency Medicine and Pain Medicine, including the whole peri-operative process and also in many other situations inside and outside the hospital where patients are at their most vulnerable.¹

• (1) 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).¹ All involved should try to reduce this complication rate significantly.

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

Heads of agreement

• (1) 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 in improving patient safety peri-operatively. To this end we fully endorse the World Federation of Societies of Anaesthesiologists International Standards for a Safe Practice of Anaesthesia.
• (2) 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.
• (3) The funders of health care have a right to expect that peri-operative anaesthesia care will be delivered safely and therefore they must provide appropriate resources.
• (4) Education has a key role to play in improving patient safety, and we fully support the development, dissemination and delivery of patient safety training.
• (5) 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.
• (6) Our partners in industry have an important role to play in developing, manufacturing and supplying safe drugs and equipment for our patients’ care.
• (7) Anaesthesiology has been a key speciality 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.
• (8) No ethical, legal or regulatory requirement should reduce or eliminate any of the protections for safe care set forth in this Declaration.

Principal requirements

• (1) All institutions providing peri-operative 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:
  • (a) Pre-operative assessment and preparation
  • (b) Checking equipment and drugs
  • (c) Syringe labelling
  • (d) Difficult/failed intubation
  • (e) Malignant hyperpyrexia
  • (f) Anaphylaxis
  • (g) Local anaesthetic toxicity
  • (h) Massive haemorrhage
  • (i) Infection control
  • (j) 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 peri-operative care.

Continuity

We invite anyone involved in health care to join us and sign up to this Declaration.

We will reconvene to review our progress annually to implement this Declaration.

The presidents of EBA/UEMS, ESA and the chairperson of the National Anesthesia Society Committee on behalf of the ESA Member Societies signed the Declaration in Helsinki on 12 June 2010. The Declaration was immediately endorsed by several international and national organisations/societies. Meanwhile, anaesthesia societies all over the world signed the Declaration (https://www.esahq.org/uploads/media/ESA/Files/Downloads/Resources-PatientSafety-MapHelsinkiDeclaration/Resources-PatientSafety-Map%20Helsinki%20Declaration.pdf).

This year, in May/June 2020, ESA and EBA are celebrating the 10th anniversary of the Helsinki Declaration on Patient Safety in Anaesthesiology; a good opportunity to look back and forward evaluating what was achieved in the recent 10 years, and what needs to be done in the upcoming years. Implementation of the Declaration was an objective from the outset and in connection with this in 2011, an issue of the journal Best Practice and Research in Clinical the project consisted of an online survey of ESA members to s.¹⁴ A joint EBA/ESA Task Force was set up to deliver this and produced a number of implementation tools distributed at Euroanaesthesia Congresses and put on the website. A discussion in the Patient Safety and Quality Committee (PSQC) of the ESA has led to engagement in an update of the safety literature, resulting in the present ‘Expert Opinion’. This article will go beyond the topics mentioned in the Helsinki Declaration on Patient Safety in Anaesthesiology, and will elaborate on topics, which 10 years ago were not as prevalent as today in the clinical practice. Of course, the list of safety topics covered by the following chapters is not – and cannot be – exhaustive. The reader will learn that there has been enormous progress and developments regarding safety tools, but it will also be mentioned that in given areas we urgently need more valuable research data. Randomised clinical trials are often difficult to perform in safety topics, and newer strategies might offer opportunities.¹⁵ Methods other than clinical trials can also illuminate safety.¹⁶

As this experts’ opinion compilation emanates from the 10th anniversary of the Helsinki Declaration, we start by presenting the state of its implementation and a reflection on the role that the Declaration has meant in the past and can be foreseen in the future. Following this initial chapter, we present a mixture of a selection of Helsinki Declaration principal requirement updates (pre-operative assessment, incident reporting, medication safety (beyond the syringe labelling), monitoring standards and safe sedation) a collection of chapters related to human factors (speak up, multidisciplinary simulation, handovers and cognitive aids, exhibiting the growth of knowledge and relevance of this Helsinki Declaration ‘head of agreement’ in the last decade); and a compendium of relevant topics to patient safety that have become more relevant since the Declaration was launched and that were not specifically addressed in 2010 but we consider necessary to include in 2020 (Learning from Excellence (LfE), the patient perspective, patient safety teaching, second victim support, failure to rescue and patient blood management (PBM)). Displaying all these chapters in the order just presented would probably send the false message of having old and new topics. We have, therefore, mixed them in a varied and eclectic hierarchy-free distribution.

The experts addressed their specific topic: the reader will find classical reviews, more systematic reviews, political statements, personal opinions and also original data presentation. With this publication we hope to further stimulate implementation of the Helsinki Declaration on Patient Safety in Anaesthesiology in your own hospital, as well as opening the scope of the patient safety strategies to address in the near future.

Please visit the following link to see this article in full on the EJA website