Best Practice & Research Clinical Anaesthesiology 25 (2011) 277–290

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Best Practice & Research ClinicalAnaesthesiology

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15

The Helsinki Declaration on Patient Safety inAnaesthesiology: Putting words into practice

David K. Whitaker, FRCA, FFPMRCA, FFICM, Hon FCARCSI, ConsultantAnaesthetist a,*, Guttorm Brattebø, MD, FERC b,Andrew F. Smith, FRCA, Consultant Anaesthetist and Director c,Sven E.A. Staender, MD, DEAA, Head d

aDepartment of Anaesthesia, Manchester Royal Infirmary, Oxford Road, Manchester M13 9WL, UKbDepartment of Anaesthesia, Intensive Care, Haukeland University Hospital, Bergen, Norwayc Lancaster Patient Safety Research Unit, Royal Lancaster Infirmary, Lancaster, UKdDepartment of Anaesthesia and Intensive Care Medicine, Maennedorf, Switzerland

Keywords:safetyanaesthesiologyperioperative careintensive care medicineemergency medicinepain medicine

* Corresponding author. Tel.: þ44 (0) 161 276 45E-mail address: whitaker2000@gmail.com (D.K

1521-6896/$ – see front matter � 2011 Publisheddoi:10.1016/j.bpa.2011.02.001

In June 2010, the European Board of Anaesthesiology (EBA) of theEuropean Union of Medical Specialists (UEMS) and the EuropeanSociety of Anaesthesiology (ESA) signed the Helsinki Declaration forPatient Safety in Anaesthesiology at the Euroanaesthesiameeting inHelsinki. The document had been jointly prepared by these twoprincipal anaesthesiology organisations in Europe who pledged toimprove the safety of patients being cared for by anaesthesiologistsworking in the medical fields of perioperative care, intensive caremedicine, emergency medicine and pain medicine. The declarationstated their current heads of agreement on patient safety and listeda number of principle requirements as thought necessary foranaesthesiologists, anaesthesiology departments and institutionsto introduce to improve patient safety. Good words are only as goodas their implementation and this article explains the rationalebehind them and expands the recommendations practically soanaesthesiologists caring for patients everywhere can follow theHelsinki Declaration and put the words into practice.

� 2011 Published by Elsevier Ltd.

Everyone wants patients to be as safe as possible and to do no harm is one of the guiding ethicalprinciplesofmedicinedatingback to at least the timeofHippocrates. Ever since anaesthesiologystarted to

51/2.. Whitaker).

by Elsevier Ltd.

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develop, the doctors practising it were concerned for a successful outcome for patients in their carebecause the safety margins of drugs available were narrow and human physiology was much less wellunderstood. Some of John Snow’s (1813–1858) anaesthetic records are available and he conductedresearch to improve practice and patient safety.1 Over 150 years later, anaesthesiology encompassesanaesthesia, intensive care medicine, emergency medicine and pain medicine and healthcare itself hasbecome much more complex. For example, the numerous and sophisticated advances in surgery madepossible by parallel advances in anaesthesia have led to much more complicated processes involvingnumerouspiecesof equipment,powerful drugs and large teamsof personnel.Demographic changesmeanthat increasingly older and sicker patients are requiring treatment in the operating theatre and intensivecare units. Changes in society accompanied by political interest and information in themedia have madepatient safety a topic of widespread interest. It is also now accepted amongst the profession that there isa normal and natural tendency for errors to occur but by identifying and critically analysing them, theirroot causes can be addressed and their potential to cause harm to patients reduced. Anaesthesiology hasmade considerable strides being the first specialty to address the subject2,3 but it is not complacent andthat iswhy in2009, its leaders inEuropedecided to take stockofwhatwasalreadyagreeduponand setoutproposals of what might be done to continue improving patient safety in anaesthesiology in the yearsahead. To this end, the European Board of Anaesthesiology (EBA) of the European Union of MedicalSpecialists (UEMS) in cooperationwith theEuropeanSocietyofAnaesthesiology (ESA)drafted adocumenttitled theHelsinki Declaration on Patient Safety inAnaesthesiology.4 Thiswas endorsed by the two bodiestogether with the World Health Organisation (WHO), theWorld Federation of Societies of Anesthesiolo-gists (WFSA) and the European Patients Federation at the Euroanaesthesia meeting in Helsinki in June2010. Goodwords are only as good as their implementation and this article explains the rationale behindthe words of the Helsinki Declaration (shown sequentially in italics) expanding the recommendationspractically so that anesthesiologists everywhere can put the words into practice.

Helsinki Declaration: background

Anaesthesiology shares responsibility for quality and safety in anaesthesia, intensive care, emergencymedicine and pain medicine, including the whole perioperative process and also with many other situationsinside and outside the hospital where patients are at their most vulnerable.

This highlights the fact that anaesthesiologists have knowledge and skills which are applicable fortreating patients across a wide range of healthcare situations. The National Audit Office (NAO) in the UKshowed that anaesthesiologists are involved in the care of 60% of patients in the hospital5 and outside, andthey can be involved in prehospital and emergency care. All these areas have developed with theinvolvement of anaesthesiologists taking on new challenges and applying their experience and skills toprovide safe care for patients in new situations. Intensive care developed with the anaesthesiologiststransferring their techniques out of the operating theatre to deal with critically ill patients. Many of thetechniques suchaspostoperativeventilation,monitoring, forexamplepulmonaryarterycatheters, syringedrivers and currently, transesophageal echocardiography and extracorporeal membrane oxygenation(ECMO) were transferred from cardiac anaesthesia. Surprisingly, continuous waveform capnography isone monitoring modality which, in many European countries, has not been widely adopted in intensivecare6 and this is one area for improving the safety of such patients in the future.7 In addition to beingspecialists in acute medicine, anaesthesiologists play a leading role in the management of patients withpain, both acute and chronic, and some of the long-term conditions associatedwith it. This was originallya natural extension of the skills of anaesthesiologists with needle techniques for local blocks and expe-rience in the use of opiates. Again, however, the treatment of patients with chronic pain has developedenormously now requiring expertise in multiple pharmacology, radiology and psychology.8

Around 230 million patients undergo anaesthesia for major surgery in the world every year. 7 milliondeveloped severe complications associated with the surgical procedures from which 1 million die (200, 000in Europe). All involved should try to reduce this complication rate significantly.9

Around 2008, the WHO started to concern themselves with the burden of harm to patients asa result of mortality and complications following surgery around the world. For the first time, an

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accurate assessment of the number of operations being carried out worldwide was made along withcalculations of themortality and incidence of complications.9 This showed the harm to patients to be inexcess of many of the other things which WHO regards as epidemics, such as malaria, AIDS, etc. Asa result of this the World Alliance for Patient Safety set up the project Safe Surgery Saves Lives (SSSL)led by Atul Gawande to address it. This developed and published the WHO Surgical Checklist, which iscovered in more detail in chapter 5.

In consideration of the data from Europe, which was amongst the most complete in Weiser’s paper,with a population of 560million and 60million operations a year, it is estimated that 1 million patientswill die and 200,000 have severe complications after surgery. Weiser also suggests that these figurescould be halved using the WHO Checklist. Anaesthesia-related mortality and morbidity makes up forpart of this harm to patients but taken on its own, this occurs at a much lower rate. The current figureswere considered in some detail by Mellin Olsen et al. 4 who have suggested that specific anaesthesia-related death occurs in less than 1 per 100,000 patients and severe perioperative complications withpermanent damage occurred in 1 per 170–500 patients. This provides the context in which we areworking and demonstrates that even within anaesthesiology it has made considerable progress sincethe early dayswhenmortality was 1 per 200 (still 1 per 50 for anaesthesia for caesarean section in partsof Africa10) there is still scope for further improvement. Also as part of the perioperative team,anaesthesiologists have an important role to play particularly, with checklists and promoting a safetyculture in order to improve the whole performance of the team within which they work.

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

The goals listed in the declaration relate to anaesthesia, intensive care, emergency medicine and painmedicine and as such, anaesthesiologists are the ones to promote and implement them in these areas ofclinical practice. Many of the goals however are not exclusive to anaesthesiology and through theirpromotionanddevelopment inourareaof clinical practice the specialtycan showleadershipandencouragethem to be applied throughout medicine, further contributing towards the safety of patients in Europe.

Helsinki Declaration: heads of agreement

Patients have a right to expect to be safe and protected from harm during their medical care andanaesthesiology has a key role to play in improving patient safety perioperatively. To this end we fullyendorse theWorld Federation of Societies of Anaesthesiologists International Standards for a Safe Practice ofAnaesthesia.

The doctor–patient relationship is such that every patient being treatedwould reasonably expect allpossible attempts will be made within the context of their care for the risk of harm to be kept toa minimum. As highlighted before, anaesthesiology has an overarching role involving patients’ peri-operative care from pre-assessment through the operating theatre to their recovery and treatment ofany ensuing chronic pain. The World Federation of Societies of Anaesthesiologists (WFSA) produceda set of standards for the safe practice of anaesthesia in all countries around the world taking intoaccount their healthcare system context. These were updated at the World Congress in Cape Town in2008 and minimum standards which should be achievable were set.11 All anaesthesiologists should beaware of these standards and try to work within them on every occasion.

Patients have an important role to play in their safe care which they should be educated about and givenopportunities to provide feedback to further improve the process for others.12,13

Patient-centred health services have become the modern agenda, they always should have been,but maybe now some people are only just appreciating this. Patients need to be informed and given theopportunity to interact with their care providers to assist in making their patient pathway as safe aspossible. They also have responsibility to cooperate appropriately for their own and other patients’benefit. As with all services there should be adequate opportunity for them to give feedback whichshould be respectfully analysed and used to improve future care. Patients should always be listened to

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from the beginning of their medical history through to their experience of often completed treatmentand this can provide a very valuable learning opportunity for other matters as well as patient safety.

The funders of health care have a right to expect that perioperative anaesthesia care will be deliveredsafely and therefore they must provide appropriate resources.

Average healthcare spent in theEU states is 8.3% of gross domestic product (GDP) and ranges from lessthan 6% in Cyprus and Romania to more than 10% in France, Switzerland, Germany and Austria.14

Depending on each country’s arrangements, this will be a variable combination of governmentspending fromdirect taxation, insurance- funded schemes and cashpurchase.Whichever it is, all fundersexpect that the healthcare they are paying for will provide the safest outcomes not least for the reasonthat when taken overall this can provide the most cost-efficient outturn. As a rule of thumb 50% of thetotal cost of caring for any group of surgical patients will ultimately be spent on 10% of the group whodevelop complications.15 Some of these complications may have developed from lapses in safe care andtherefore if number of patients harmed by such complications can be reduced by even a small amount,a considerable dividend will be paid. It is logical therefore that the necessary resources for safe care areappropriately funded, otherwise it is unreasonable to expect the optimum care all parties aim for.

Education has a key role to play in improving patient safety, and we fully support the development, anddissemination of delivery of patient safety training.16

Patient safety training, both theoretical and practical, is now being developed by anaesthesiologiststhroughout Europe. The declaration emphasises the key role in raising awareness of the issues andimproving safety standards. It should of course begin in medical school and a number of trainingpackages for medical students are now available including one from theWHO .17,18 European Society ofanaesthesiology provides Patient Safety Training at its meetings and the EBA/ ESA Patient Safety TaskForce (PSTF) will further stimulate its development.

Human factors play a large part in the delivery of safe care to patients, and we will work with oursurgical, nursing and other clinical partners to reliably provide this.19,20

The realisation that human factors are involved in 70% of critical incidents in other areas of activitysuggests that it should be similar for incidents in medicine.21 There is an increasing amount of researchabout the role human factors play in anaesthesiologyand a cross-transfer of existing learning fromotherindustries. Human factors are even more complicated when the workplace involves large teams, inparticular those that aremultidisciplinarycoming fromawidevarietyof trainingandbackgrounds.22 It istherefore essential that any consideration of human factors fully involves anaesthesiologists, surgical,nursing and other clinical colleagues together and even more importantly, if possible, the particularindividuals who wework with, day in and day out. Simulation has a part to play but it does not alwaysneed to be at a distance in large-purpose-built facilities. Simply rehearsing scenarios with the regularteam in theatre or intensive care unit can be particularly valuable, especially if properly debriefed,afterwards whenmost of the learning occurs. Communication is better when a shared commonmentalmodel is used like SBAR (Situation, Background, Assessment and Recommendation).23

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

The wider healthcare team includes the whole supply chain and this is particularly important inanaesthesiology because of the considerable amounts of drugs and equipment that our profession uses.The development of safe and effective pharmaceuticals has become a massive undertaking and rand-omised controlled trials that can cost up to £100 million are verging on the prohibitive to new thera-peutic interventions.24 Randomised controlled trials with drugs given in tightly defined circumstancesto a limited number of patients are not ideally suited to ensuring the ultimate safety of the drug. Thesedays it is only through rigorous post marketing surveillance by clinicians that this knowledge can beacquired. Simplifying the clinical trial and research process is one ofmedicine’s current challenges alongwith reducing the time span for new drugs to be introduced into clinical practice.

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Anaesthesiologists are very dependent on having safe and reliable equipment to use. The industrythat provides it has a good track record of responding to clinical requirements and wemust continue tosupport and develop this partnership. The laryngeal mask provides an excellent example of how aninnovative clinician’s idea, pushing the envelope, also required a pioneering manufacturer to have theconfidence to back it and revolutionise one area of anaesthesiologists’ patient care worldwide.25 TheNational Patient Safety Agency in the UK recommends a ‘Purchasing for Safety’ policy.26 If two productsare similar the safest should always be purchased. As well as providing safer equipment at the timelonger term it influences the culture of the market supporting companies who are designing saferproducts and incentivising the others to do the same.

Anaesthesiology has been a key specialty in medicine leading the development of patient safety. We arenot complacent and know there are still more areas to improve through research and innovation.3

Asmentioned above anaesthesia-relatedmortality rateswere formerlymuch higher than at presentbut through a whole series of step changes including the use of safer drugs, better understanding ofhuman physiology, improved equipment, better training and analysis of critical incidents, anaesthesialed the way to improving this significantly. Learning from the continuum of patient safety improve-ments in the past, we know this must continue and a focusing of research and promotion of testedinnovations in this area will translate into further reducing the number of patients who are harmed.

No ethical, legal or regulatory requirement should reduce or eliminate any of the protection for safe careset forth in this Declaration.

The signatories to this document see patient safety as paramount but are well aware of the law ofunintended consequences where changes in other areas such as ethical, legal or regulatory which maywhen seen standing alone appearappropriate butwhen fully implemented canhave knock-oneffectswithdeleterious effects onpatient care.27 A number of targets set by theUK government for theNationalHealthService (NHS) management to carry out were shown to be distorting the clinical priorities by whichpatients are treatedandhavesincebeenwithdrawn.Anaesthesiologists should remainvigilant to thewiderpicture influencing the safety of patients in their care and raise any legitimate concerns they may have.

Helsinki Declaration: Principal Requirements

The heads of agreement mentioned above summarise the current issues thought to be significantfor patient safety in anaesthesiology in Europe. Ensuring they translate into significant improvementsin clinical practice is the even more difficult second stage. This was recognised by all involved whothought that some concrete practical advice should also be specifically put forward to provide guidanceto support anaesthesiologists taking the issue forward.4

It was thought that these principal requirements should be practical, clearly set out, readilyattainable, have plenty of information and examples to follow.28 The list was reached by consensus andrepresents what was considered potentially achievable by anaesthesiologists applicable for the care ofevery patient and by departments and institutions for the anaesthesiology services they provide. In thismanner, the words of the Helsinki Declaration will be put into practice.

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

As a result of this, the EBA and ESA have set up a joint Patient Safety Task Force (PTSF) which willfacilitate the implementation of the Helsinki Declaration taking this work forward and providing accessto the necessary protocols and tools that anaesthesiologists may need to carry it out. In connectionwiththis the task force will set up a patient safety webpage providing background information and links todocuments, templates and other safety resources. One of the templates theywill provide will be for theannual report on patient safety, which the departments of anaesthesiology are encouraged to produce.The PSTF will invite departments who are willing to submit their annual reports and in this way track

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progress and share good practice and lessons learned with other European anaesthesiologists. Simi-larly the task force will act as a clearing house for incident reporting sharing individual incidents ofoutstanding importance and national recommendations arising out of incident reporting systems. Thetask force will also facilitate research and audit related to patient safety and the first project is plannedto be a study on drugs syringe labelling.

1. All such institutions providing perioperative anaesthesia care to patients (in Europe) should complywith the minimum standards of monitoring recommended by the EBA in operating theatres and inrecovery areas.29

Minimal monitoring standards for every anaesthetised patient of non-invasive blood pressuremeasurement, electrocardiography (ECG), pulse oximetry and capnography were first introduced in1984 in the United States in the Harvard group of hospitals.30 In the ensuing years there was a markedreduction in the number of patients with hypoxic brain damage and subsequent reduction in medico-legal premiums for anaesthesiologists. Other countries introduced similar minimal monitoringstandards with similar results and 2007 European Board of Anaesthesiology recommended similar up-to-date standards for both operating theatres and recovery areas.29 Recovery areas have sometimesbeen overlooked in the past and it is particularly important that patients continue to receive highstandards of monitoring and care until they are fully awake and safe to return to the ward. Morestandardisation of monitoring equipment dedicating colours to specific parameter traces, for example,red for arterial pressure and specific tones for particular alarms could further enhance safety.31

2. All institutions should have protocols32 and the necessary facilities for managing the following.

The key to having a high reliability safe organisation is to do the right thing to every patient all of thetime.Having protocols developed byconsensus to saywhat is normally the right thing to do in a particularset of circumstances is oneway to set about doing this. Standardisation of routines, drugs, equipment anddocumentation will also ensure that care can be more reliably and safely given. The Helsinki Declarationsuggests 10 topic areas where protocols are already available and used by some hospitals. Adopting thesedirectly ormodifying themappropriately for local use is a relatively simpleway to provide safe up-to-datepatient care in these 10 significant areas of practice. As well as the protocols, the necessary facilities fordelivering them are required and if they are not all completely in place, the very existence of an acceptedprotocol elsewhere strengthens the case for having them funded and acquired locally.

Preoperative assessment and preparation

Preoperative assessment of elective patients ensures that they are fit for the intended operation andalso provides time for any comorbidities to be adequately treated and optimised prior to anaesthesiaand surgery. Not only is this cost-effective and avoids unnecessary last-minute cancellations but alsoensures the patient is in the safest of medical conditions to undergo the stress of surgery.33 There is notthe same luxury of time for emergency patients but they can still be preoperatively assessed and forexample, appropriate resuscitation begun prior to anaesthesia and surgery. As well as optimisingcomorbidities, preoperative preparation may involve simple measures such as raising the patient’shaemoglobin levels to the upper end of the normal range prior to blood-losing surgery to provide anextra margin of safety in the perioperative period and avoid unnecessary donor blood transfusion.34

Checking equipment and drugs

Checklists for anaesthetic equipment and machines were one of the earliest safety measuresintroduced by anaesthesiologists to mirror those of preflight checks by airline pilots.35,36 These havebecome more sophisticated as have the anaesthetic machines but one core component remainsa readily available alternative means of ventilating the patient with a self-inflating bag and mask andan independent supply of oxygen from a cylinder. Every anaesthetic venue should have this and all

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relevant staff must be familiar with its location and operation. Checklists for drugs are also used, inparticular, those that are required in emergency situations and cardiac arrests. Keeping drug-filledsyringes on trays in standard positions can reduce errors and omissions.

Syringe labelling

Medication safety is a whole subject in itself and is covered in detail in chapter 4. It is however,probably the next area after minimal monitoring where significant advances can be made. Anaes-thesiologists prepare and give more intravenous drugs than any other doctor and since the intro-duction of plastic disposable syringes and needles more than 50 years ago, very few safetyimprovements have been made. User applied syringe labels following the international colour code37

were recommended by the European Board of Anaesthesiology for use in anaesthesia, intensive care,emergency medicine and pain medicine throughout Europe in 2008. Used correctly, drawing the drugup into the syringe and applying the correct label whilst the syringe is still in the anaesthesiologist’shand before putting it down can reduce drug errors caused by syringe swaps, distraction and otherhuman factors.38 This is seen as a low-cost safety intervention and one of the early pieces of worksupported by the EBA/ESAPSTF will be a Europe-wide survey to look at this.

Difficult/failed intubation

Airway management is a fundamental key skill for anaesthesiologists but a number of patients stillcome to harm from poorly managed difficult or failed intubation situations. Difficult intubationprotocols are nowwidely available and every anaesthetist should be familiar with one and periodicallyrehearse it ideally with the theatre teams they regularly work with.39,40 Various pieces of equipmentfrom gum elastic boogies upwards are nowavailable to help with these difficult situations and again anappropriate selectionwith which local anaesthesiologists have been trained should be readily availablefor all anaesthesia locations.41

Malignant hyperpyrexia

Malignant hyperpyrexia is fortunately a rare condition that can specifically be triggered by somedrugs that the anaesthesiologists use and can lead to patient deaths. For this reason a protocol forrecognising hyperpyrexia, managing it and all the necessary drugs required for treating this shouldagain be readily available for use in all anaesthesia locations.42

Anaphylaxis

Anaphylaxis is a more frequent occurrence which can be caused by almost any drug, some intra-venous fluids, latex and other substances.43 This again causes anaesthetic-related mortality andmorbidity and protocols for its diagnosis and treatment are now widely available.44 The necessarydrugs and resuscitation equipment must be kept at all appropriate clinical locations.

Local anaesthetic toxicity

Local anaesthetic toxicity continues to occur and as techniques involving local anaesthetics increase,its incidence may similarly increase. Preventative measures such as first knowing, then not exceeding,the toxic dose of the local anaesthetic agents are essential but inadvertent intravascular injections canstill occur. Every department of anaesthesiology should have an up-to-date protocol for its diagnosisand treatment including a readily available supply of 10% intralipid.45,46

Massive haemorrhage

Massive haemorrhage is clearly a life-threatening situation which anaesthesiologists should beprepared to deal with and again protocols are available which can be adapted to coordinate and fast-

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track the local supply of blood.47 In the United Kingdom, the highest cause of death associated with theblood transfusion is no longer an administrative or clerical error but the physical non-availability ofblood in a timely manner to patients experiencing massive haemorrhage. There have been 11 deathsand 83 incidents in the last 4 years. Institutions have been recommended to improve their lines ofcommunication and blood delivery when the critical nature of a massive haemorrhage has becomeapparent and unusually large quantities of blood and blood products requested urgently.48 On largesites, additional supplies of O negative blood can be kept in satellite fridges close to clinical areas.

Infection control

The importance of infection control has been emphasised by the appearance of prion-relateddisease and a number of antibiotic-resistant infections. Anaesthesiologists have a particular role to playin the way they practice in the perioperative period and intensive care. Protocols have been devised toguide anaesthesiologists in these situations and it is important that they tie in with other localprotocols that are addressing this issue.49 Many additional pieces of equipment are now available asdisposable items but all-round considerations of patient safety need to be taken into account whenthinking of introducing them.

In the United States, there have been more than 35 outbreaks of viral hepatitis relating to unsafemedication injection practice in the period 1998–2008. Over 100,000 individuals were exposed andhepatitis B virus (HBV) or hepatitis C (HCV) was transmitted to more than 500 patients.50 Many caseswere caused by staff using 50 ml bottles of propofol for more than one patient51,52 and in 2010 the firstof at least 145 patients infected in Nevada was awarded $500million from the pharmaceuticalcompanies who continued to market the 50-ml bottles despite warnings from the earlier episodesyears before. A public health ‘One and Only campaign’ has now been launched to inform patients andstaff about safe injection practices: ONE Needle, ONE Syringe, ONLY ONE time.53 Wherever possible,multidose containers should no longer be used for injections54 and 500-ml saline bags often used forexample, on intensive care units for filling syringes for line flushing and drug preparation, should neverbe used for more than one patient. These are best replaced with separate saline ampoules andcommercial or pharmacy-prepared drugs in prefilled syringes.

Post operative care including pain relief

Protocols for postoperative care and pain relief are available.55–57 Many patients now benefit fromacute pain techniques such as postoperative pain relief from patient-controlled analgesia andcontinuous epidural infusions. Wherever these are used, protocols should be drawn up for their safemanagement and all staff in the post-operative areaswhere such patients are nursed should be familiarwith them and the management of possible complications.

3. All institutions providing sedation to patients must comply with anaesthesiology-related sedationstandards for safe practice.58–62

An increasing range of procedures are being carried out under sedation in areas outside theoperating theatre such as radiology departments, cardiac catheter laboratories and other remote sitesaround the hospital. The same high standards of care should be maintained wherever sedation iscarried out and recognised up-to-date guidelines should be followed paying particular attention tooxygen and recommendations for using capnography.63

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

It is now recognised that surgical mortality is of the same order as in epidemics thatWHO considersas global public health problems.64 In 2008, the WHO World Alliance for Patients Safety took surgicalsafety as its second Global Patient Safety Challenge, the first was the Save Lives Clean Hands campaign(see chapter 5). A large part was the development and promulgation of a three-section checklist with

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‘Sign in’, ‘Time out’ and ‘Sign out’ to be used for every surgical procedure. It is freely available in manylanguages for local and specialty adaptation still following the original key principles. Having fully

Data Collection at a National Level (Surgical Vital Statistics)

� Number of surgical procedures performed in the operating theatre per 100,000 populationper year.

� Number of operating theatres per 100,000 population.� Number of surgeons per 100,000 population.� Number of anaesthesia professionals per 100,000 population.� Day-of-surgery mortality rate.� Postoperative in-hospital mortality rate.

functioning anaesthesia monitoring in the ‘Sign in’ was one of these and the WHO checklist sets pulseoximetry as theminimum standard for every patient about to undergo anaesthesiaworldwide. This hasextended on to a further Global Oximetry project to provide cheap pulse oximeters to hospitals in poorcountries.65,66 Countries where minimal monitoring standards already exceed this should substitutetheir existing standard in their local checklist in its place. Team training in connection with the use ofchecklists, briefing at the start of the list and debriefing at the end can be particularly valuable andreduce mortality.67,68 There is an international lack of data about perioperative activity, so calledSurgical Vital Statistics and the final section of the SSSL project includes data collection which isessential to inform providers and funders about the available resources for surgical patients’ care.

5. All Departments of anaesthesiology in Europe must be able to produce an annual report of measurestaken and results obtained in improving patient safety locally.

One of the ways to raise the topic of patient safety up the agenda of any department of anaes-thesiology’s priorities is to create an opportunity for everyone to reflect on the current situationlocally and how it might be improved in the future. Producing an annual report provides just such anopportunity to focus on this particular aspect and then use it to inform the rest of the department,hospital colleagues and other parties further a field. Some departments may already do this. TheEBA/ESA Patient Safety Task Force has produced a template for any department that wishes to useand also an example of a completed report to inform the process and show what might be possible.These are available on the PSTF website. The suggested departmental patient safety report beginswith a few demographic details about the department to set the context and then providesa checklist to measure progress on the implementation of the principal requirements for havingprotocols available as included in the Helsinki declaration. There is a section for the department tooutline the measures taken and results obtained in improving patient safety locally in the last 12months. Each safety initiative can be outlined in terms of how the safety hazard was officially firstrecognised, what action was taken and what improvements to outcomes had been obtained. It issuggested that departments should be able to cover at least three of these a year and reporting themin this way will be useful if the report is shared with other departments who could then learn fromtheir initiative and experience.

There is a section for the department to identify safety hazards or risks they have recognised butwhich are still waiting attention. Listing the top three may help guide the department’s safety initia-tives over the coming year and again if these are shared with other departments they in turn may beable to offer solutions or improvements they have already made in these areas. The next sectionprovides opportunity to comment and reflect on factors that may have prevented patient safetyinitiatives progressing over the last 12 months, which again, if shared with others may provide anopportunity for potential solutions to overcome these barriers to be imported into the homedepartment.

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In the next section, the department can highlight the important patient safety lessons it has learntover the past 12 months that it would wish to share or promulgate to others. Section 7 of the HelsinkiDeclaration requires participation in appropriate national and other major audits of safe practice andcritical incident reporting and the departmental report can record this here as well.

Section 6 of the Helsinki Declaration requires all institutions providing anaesthesiological care topatients to collect data on patient mortality andmorbidity and there is opportunity to include this datain the departmental report.

As outlined above the value of producing such report occurs at several levels. The first andmaybe most important is the internal reflection within a department about patient safety andhow its actions and processes currently deliver this locally and how it could be improved in thefuture. Such a report could remain an internal document having already provided the depart-ment with the opportunity for it to scrutinise its own performance. If however, it is decided toshare the report with a wider audience even just within the local hospital it will raise awarenessof how their department of anaesthesiology is developing patient safety and encourage otherhospital departments to raise their game. Sharing the report and its data further afield withother departments nationally or internationally will provide a wider opportunity for sharing,learning and exchanging solutions to current safety problems. The EBA/ESA task force plans to bea focus for departments who voluntarily wish to submit their reports and share the lessonslearned.

The first annual report for each department will have a learning curve but repeating the processevery 12months should become easier andmore refined and become built into thework and culture ofthe department.

6. All institutions providing anaesthesiological care to patients must collect the required data to be able toproduce an annual report on patient morbidity and mortality.

Most institutions collect this type of data and there are variable requirements to submit some ofthis to different organisations on a regional or national basis. The WHO SSSL initiative decided thatalmost every healthcare institution in the world should have the capability with even the mostrudimentary of records system to be able to determine the number of patients dying on the samedate as they had their surgery. More sophisticated systems often collect the number of patients dyingwithin 30 days of surgery and even more refined ones can track patients until their deaths areeventually reported to the National death register. The number of patients dying on the day ofsurgery however is a way of picking up say deaths on the table and other catastrophic events whichmay be associated with anaesthesia and therefore all institutions and nations should collect this asrecommended by the WHO. The Helsinki Declaration implies that institutional morbidity andmortality data should be such that it can be related to anaesthesiological care and that the institutionshould provide the resources to gather this. The subgroup of such data in the institution’s annualreport will be able to be used by departments in their own without having to duplicate datacollection.

7. All institutions providing anaesthesiological care to patients must contribute to the recognised nationalor other major audits of safe practice and critical incident reporting systems. Resources must beprovided to achieve this.

There are now a number of recognised national and major audits of safe practice that doctors cancontribute to, for example, National Confidential Enquiry into Patient Outcome and Death (NCEPO-D)69in the UK and all clinicians should see it as part of their practice and responsibility to take part.Similarly a number of critical incident-reporting systems have been developed and again good practicewould dictate that all appropriate incidents are reported, for example, The Swiss Anaesthesia CriticalIncident Reporting System (CIRS)70 and the UK Anaesthesia reporting system ‘e-form’.71 Because of theimportance of this activity all institutions should recognise it and provide the necessary time andresources for their clinicians to fully take part.

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Helsinki Declaration: Conclusion

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

As stated at the outset of the Helsinki Declaration, anaesthesiology encompassing anaesthesia,intensive care medicine, emergency medicine and pain medicine is intimately involved with patientsthroughout the whole of their perioperative pathway and everything anaesthesiologists do can havea direct effect on their safety. Because anaesthesiologists recognised this from the early days of thespecialty and started to put measures in place to reduce anaesthetic-related mortality and harm topatients, a track record and culture of safety-related behaviour has developed which confers a key roleon them to lead further such developments in the future. The declaration sets down agreement as tohow far the specialty is along this road today and provides pointers for what are widely considered thenext areaswhere effort should be directed by individual clinicians, departments of anaesthesiology andtheir related institutions. This article tries to put these words into practice by explaining their back-ground and purpose and outlining some of the actions that all three groups can now take to implementthem.

Helsinki Declaration: Continuity

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

Practice points

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

2. All such institutions should have protocols and the necessary facilities for managing thefollowing:� Preoperative assessment and preparation.� Checking equipment and drugs.� Syringe labelling.� Difficult/failed intubation.� Malignant hyperpyrexia.� Anaphylaxis.� Local anaesthetic toxicity.� Massive haemorrhage.� Infection control.� Postoperative care including pain relief.

3. All institutions providing sedation to patients must comply with anaesthesiology-recognisedsedation 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 recog-

nised national or other major audits of safe practice and critical incident reporting systems.Resources must be provided to achieve this.

Research agenda

� Medication safety is high on anaesthesiologists’ research agenda and studies are required tolook at the labelling of syringes, the prefilling of syringes, the methods of checking syringesimmediately prior to administration and infection control.

� Research is required into the standardisation of concentrations of intravenous drugs used byanaesthesiologists in operating theatres and intensive care for their provision in prefilledsyringes.

� Research is required into the value of standardising procedures, equipment, documents andthe perioperative environment.

� Evidence needs to be gathered to the extent of the role human factors play in medical inci-dents and lessons learned from other industries that can appropriately transferred tomedicine.

� There is an urgent need to conduct a study of the practicality and value of simulation exer-cises in the workplace.

� Studies need to be carried out to evaluate the most effective ways of communicating withpatients about safety in anaesthesiology and educating them about the different levels of risk.

D.K. Whitaker et al. / Best Practice & Research Clinical Anaesthesiology 25 (2011) 277–290288

This declarationwas primarily a European initiative and to get consensus from a professional groupcaring for a population of around 560 million is no mean achievement and that in itself reinforces theconfidence that it represents the current core of thinking. Healthcare today is increasingly basedaround teams and this document was always intended to be inclusive; therefore, the signatories wouldlike to invite anyone else involved in healthcare to join them and sign it. The initial signatories wereDr. Jannicke Mellin-Olsen, President, European Board of Anaesthesiology/UEMS, Prof. Paolo Pelosi,President, European Society of Anaesthesiology and Prof. Hugo Van Aken, Chairperson, NationalAnaesthesia Societies Committee on behalf of the ESAMember Societies. Theywere closely followed byDr. Angela Enright, President, World Federation of Societies of Anaesthesiologists, and Susanna Pal-konen, Vice President of the European Patients Forum. European Patients Federation. By 2011 it hadreceived over 50 further signatories representing many other national societies of anaesthesiologistsand other professional groups from around the world.

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

Good words are only as good as their implementation and right from the start it was agreed thatthey should be kept under annual review. Patient safety in anaesthesiology is a dynamic and contin-ually developing process and as progress is made in one area new hazards become apparent in anotherand so the emphasis of the Helsinki Declaration will need to take these into account. The EBA and ESAhave set up a joint Patient Safety Task Force (PSTF) to take this effort forward and provide and coor-dinate the tools and protocols that anaesthesiologists, departments and institutions may need toimplement the declaration. For the time being the Helsinki foundation has been laid, the patient safetyprinciples set out, and it just remains for each and every anaesthesiologist not to hesitate a momentlonger and start to carry out the hard work of putting these words into practice.

Conflict of interest

The authors were all involved in drawing up the Helsinki Declaration and are members of the EBA/ESA PSTF.

References

1. Shephard DA. John Snow and research. Canadian Journal of Anaesthesia 1989 Mar; 36(2): 224–241.2. The Association of Anaesthetists of Great Britain and Ireland 1932-1992 and the Development of the Specialty of Anaesthesia,

Sixty Years of Progress and Achievement in the Context of Scientific, Political and Social Change. London, UK: The Associationof Anaesthetists of Great Britain and Ireland, 1999.

D.K. Whitaker et al. / Best Practice & Research Clinical Anaesthesiology 25 (2011) 277–290 289

3. Gaba DM. Anaesthesiology as a model for patient safety in health care. British Medical Journal 2000 Mar 18; 320(7237):785–788.

*4. Mellin-Olsen J, Staender S, Whitaker DK et al. The Helsinki Declaration on Patient Safety in Anaesthesiology. EuropeanJournal of Anaesthesiology 2010 Jul; 27(7): 592–597.

5. Audit Commission Anaesthesia Under Examination. London, UK: Audit Commission, 1997.6. Georgiou AP, Gouldson S & Amphlett AM. The use of capnography and the availability of airway equipment on Intensive

Care Units in the UK and the Republic of Ireland. Anaesthesia 2010 May; 65(5): 462–467.*7. Thomas AN & McGrath BA. Patient safety incidents associated with airway devices in critical care: a review of reports to

the UK National Patient Safety Agency. Anaesthesia 2009 Apr; 64(4): 358–365.8. Fishman SMB, Jane C & Rathmell James P (eds.). Bonica’s Management of Pain. 4th ed. Lippincott Williams & Wilkins

(LWW), 2009.9. Weiser TG, Regenbogen SE, Thompson KD et al. An estimation of the global volume of surgery: a modelling strategy based

on available data. Lancet 2008 Jul 12; 372(9633): 139–144.10. Clyburn P, Morris S & Hall J. Anaesthesia and safe motherhood. Anaesthesia 2007 Dec; 62(Suppl. 1): 21–25.*11. World Federation of Societies of Anaesthesiologists. International Standards for a Safe Practice of Anaesthesia. 2008 [cited 2010

25/01/2010]; Available from: http://www.anaesthesiologists.org/guidelines/practice/2008-international-standards-for-a-safe-practice-of-anaesthesia.

12. Peat M, Entwistle V, Hall J et al. Scoping review and approach to appraisal of interventions intended to involve patients inpatient safety. Journal of Health Services Research & Policy 2010 Jan; 15(Suppl. 1): 17–25.

13. Davis RE, Jacklin R, Sevdalis N et al. Patient involvement in patient safety: what factors influence patient participation andengagement? Health Expect 2007 Sep; 10(3): 259–267.

14. Health at a Glance: Europe 2010: OECD2010.15. Health Committee – Fourth Report, Session 2005-06, Independent Sector Treatment Centres. Health Committee Publications

2006.16. Staender SE. Patient safety in anesthesia. Minerva Anestesiologica 2010 Jan; 76(1): 45–50.17. Walton M, Woodward H, Van Staalduinen S et al. The WHO patient safety curriculum guide for medical schools. Quality

and Safety in Health Care 2010 Dec; 19(6): 542–546.*18. WHO Patient Safety Curriculum Guide for Medical Schools. World Health Organisation (WHO); Available from: http://

www.who.int/patientsafety/activities/technical/medical_curriculum_download/en/index.html.19. Reason J, Manstead A, Stradling S et al. Errors and violations on the roads: a real distinction? Ergonomics 1990 Oct Nov;

33(10–11): 1315–1332.20. Reason J. Human error. Cambridge: Cambridge University Press, 1990.21. Health Committee – Sixth Report, Session 2008-09. Patient Safety Health Committee Publications 2009.22. First PS. Implementing Human Factors in healthcare, how to guide. NHS Institute for Innovation and Improvement, 25 01

2010. Available from: http://www.patientsafetyfirst.nhs.uk/ashx/Asset.ashx?path¼/Intervention-support/Human%2520Factors%2520How-to%2520Guide%2520v1.2.pdf.

*23. Haig KM, Sutton S & Whittington J. SBAR: a shared mental model for improving communication between clinicians. JointCommission Journal on Quality and Patient Safety 2006 Mar; 32(3): 167–175.

24. Rawlins M. De Testimonio: on the evidence for decisions about the use of therapeutic interventions. Clinical Medicine 2008Dec; 8(6): 579–588.

25. Brain AI, McGhee TD, McAteer EJ et al. The Laryngeal Mask Airway. Development and preliminary trials of a new type ofairway. Anaesthesia 1985 Apr; 40(4): 356–361.

26. Agency NPS. Promoting safer use of injectable medicines. 20th ed. NHS National Patient Safety Agency, 2007. p. 4.27. Freeman JV, Croft S, Cross S et al. The impact of the 4 h target on patient care and outcomes in the Emergency Department:

an analysis of hospital incidence data. Emergency Medicine Journal 2010 Dec; 27(12): 921–927.28. Publications. European Board and Section of Anaesthesiology (EBA) of the European Union of Medical Specialists (UEMS);

Available from: http://www.eba-uems.eu/html/publications.html.29. Mellin-Olsen J, O’Sullivan E, Balogh D et al. Guidelines for safety and quality in anaesthesia practice in the European Union.

European Journal of Anaesthesiology 2007 Jun; 24(6): 479–482.30. Eichhorn JH, Cooper JB, Cullen DJ et al. Standards for patient monitoring during anesthesia at Harvard Medical School.

Journal of the American Medical Association 1986 Aug 22 29; 256(8): 1017–1020.31. Hagenouw RR. Should we be alarmed by our alarms? Current Opinion in Anaesthesiology 2007 Dec; 20(6): 590–594.32. Vimlati L, Gilsanz F & Goldik Z. Quality and Safety Guidelines of Postanaesthesia Care: working party on post anaesthesia

care (approved by the European Board and Section of Anaesthesiology, Union Europeenne des Medecins Specialistes).European Journal of Anaesthesiology 2009 Sep; 26(9): 715–721.

33. Pre-operative assessment and patient preparation - the role of the anaesthetist: Association of Anaesthetists of GreatBritain and Ireland. 2010 [25/01/2011]. Available from: http://www.aagbi.org/publications/guidelines/docs/preop2010.pdf.

34. Whitaker DK. Transfusion strategy. European Journal of Anaesthesiology 2001 Aug; 18(8): 493–494.35. Checklist for Anaesthetic Equipment 2004 Association of Anaesthetists of Great Britain and Ireland. Available from 2004,

http://www.aagbi.org/publications/guidelines/docs/checklista404.pdf.36. Checking Anaesthetic Equipment Association of Anaesthetists of Great Britain and Ireland 2004. Available from: http://www.

aagbi.org/publications/guidelines/docs/checking04.pdf.37. Syringe labelling in critical care areas 2004. Available from: http://www.aagbi.org/publications/guidelines/docs/

syringelabels(june)04.pdf.*38. National recommendations for user-applied labelling of injectable medicines, fluids and lines 1. Australian Commission on

Safety and Quality in Health Care, 2010. Available from: http://www.health.gov.au/internet/safety/publishing.nsf/Content/B01BD32760E99ACBCA25778300050FD6/$File/37746-Recommendations.PDF.

39. Petrini F, Accorsi A, Adrario E et al. Recommendations for airway control and difficult airway management. MinervaAnestesiologica 2005 Nov; 71(11): 617–657.

40. Society DA. Difficult Airway Society Guidelines. Available from: http://www.das.uk.com/guidelines/guidelineshome.html.

D.K. Whitaker et al. / Best Practice & Research Clinical Anaesthesiology 25 (2011) 277–290290

41. Scott DA & Merry AF. Development of an ’Equipment to manage a difficult airway during anaesthesia’ professionaldocument using a new evidence-based approach. Anaesth Intensive Care 2010 Jan; 38(1): 11–12.

42. Guidelines for the Management of a Malignant Hyperthermia Crisis 2007. Available from: http://www.aagbi.org/publications/guidelines/docs/malignanthyp07amended.pdf.

43. Harper NJ, Dixon T, Dugue P et al. Suspected anaphylactic reactions associated with anaesthesia. Anaesthesia 2009 Feb;64(2): 199–211.

44. Management of a patient with suspected anaphylaxis during anaesthesia safety drill 2009. Available from: http://www.aagbi.org/publications/guidelines/docs/ana_laminate_2009.pdf.

*45. AAGBI Safety Guideline, Management of Severe Local Anaesthetic Toxicity 2010. Available from: http://www.aagbi.org/publications/guidelines/docs/la_toxicity_2010.pdf.

46. AAGBI Safety Guideline, Management of Severe Local Anaesthetic Toxicity, Accompanying Notes 2010. Available from: http://www.aagbi.org/publications/guidelines/docs/la_toxicity_notes_2010.pdf.

47. Thomas D, Wee M, Clyburn P et al. Blood transfusion and the anaesthetist: management of massive haemorrhage.Anaesthesia 2010 Nov; 65(11): 1153–1161.

48. Agency NPS. The transfusion of blood and blood components in an emergency 2010. Available from: http://www.nrls.npsa.nhs.uk/resources/type/alerts/?entryid45¼83659.

49. Infection control in anaesthesia. Anaesthesia 2008 Sep; 63(9): 1027–1036.50. Dolan SA, Felizardo G, Barnes S et al. APIC position paper: safe injection, infusion, and medication vial practices in health

care. American Journal of Infection Control 2010 Apr; 38(3): 167–172.*51. Gutelius B, Perz JF, Parker MM et al. Multiple clusters of hepatitis virus infections associated with anesthesia for outpatient

endoscopy procedures. Gastroenterology 2010 Jul; 139(1): 163–170.52. Fischer GE, Schaefer MK, Labus BJ et al. Hepatitis C virus infections from unsafe injection practices at an endoscopy clinic

in Las Vegas, Nevada, 2007–2008. Clinical Infectious Diseases 2010 Aug 1; 51(3): 267–273.53. The One and Only Campaign, about the safe injection practices (25/01/2011): 2010. Available from: http://www.

oneandonlycampaign.org/default.aspx.54. Feinmann J. Doctors call for ban on multidose vials after hepatitis C outbreak in US. British Medical Journal 2010; 341:

c4057.55. Enhanced recovery programme. NHS Institute for innovation and improvement, 2008. Available from: http://www.institute.

nhs.uk/quality_and_service_improvement_tools/quality_and_service_improvement_tools/enhanced_recovery_programme.html.

56. British Pain Society publications British Pain Society; Available from: http://www.britishpainsociety.org/pub_professional.htm.

57. Acute Pain Management: Scientific Evidence Australian and New Zealand College of Anaesthetists and Faculty of Pain Medicine2010. Available from: http://www.anzca.edu.au/resources/books-and-publications/acutepain.pdf.

58. Practice guidelines for sedation and analgesia by non-anesthesiologists. Anesthesiology 2002 Apr; 96(4): 1004–1017.59. Gisvold SE, Raeder J, Jyssum T et al. Guidelines for the practice of anesthesia in Norway. Acta Anaesthesiologica Scandi-

navica 2002 Sep; 46(8): 942–946.60. Recommendations for anesthesia and sedation in nonoperating room locations. Minerva Anestesiologica 2005 Jan-Feb;

71(1–2): 11–20.61. Cote CJ & Wilson S. Guidelines for monitoring and management of pediatric patients during and after sedation for

diagnostic and therapeutic procedures: an update. Paediatric Anaesthesia 2008 Jan; 18(1): 9–10.62. Knape JT. The impact of the European guidelines for sedation by non-anaesthesiologists for gastroenterology practice.

Journal of Gastrointestinal Liver Disease 2007 Dec; 16(4): 429–430.*63. Capnography outside the operating theatre. Available from: Association of Anaesthetists of Great Britain and Ireland, 2009,

http://www.aagbi.org/aboutaagbi/pressoffice/statements/aagbi_safety_statement_capnography_jan09.htm.64. Wilson IH & Walker IA. Theatre checklists and patient safety. Anaesthesia 2008 Sep; 63(9): 921–923.65. Merry AF, Eichhorn JH & Wilson IH. Extending the WHO ’Safe Surgery Saves Lives’ project through global oximetry.

Anaesthesia 2009 Oct; 64(10): 1045–1048.66. Walker IA, Merry AF, Wilson IH et al. Global oximetry: an international anaesthesia quality improvement project.

Anaesthesia 2009 Oct; 64(10): 1051–1060.*67. Schlack WS & Boermeester MA. Patient safety during anaesthesia: incorporation of the WHO safe surgery guidelines into

clinical practice. Current Opinion in Anaesthesiology 2010 Dec; 23(6): 754–758.68. de Vries EN, Prins HA, Crolla RM et al. Effect of a comprehensive surgical safety system on patient outcomes. New England

Journal of Medicine 2010 Nov 11; 363(20): 1928–1937.69. National Confidential Enquiry into Patient Outcome and Death (NCEPOD). Available from: http://www.ncepod.org.uk/.70. The anaesthesia critical incident reporting system (CIRS�); Available from: http://www.anaesthesie.ch/cirs/.71. Patient Safety incident report form: Anaesthesia team. NHS National Patient Safety Agency (NPSA); Available from:

https://www.eforms.npsa.nhs.uk/asbreport/.