John H. Eichhorn

Prevention of Intraoperative Anesthesia Accidents and Related Severe Injury through Safety Monitoring

Among 1,001,000 ASA Physical Status I and II patients (a subset of the 1,329,000 anesthetics administered from 1976 through mid-1988 in the nine component hospitals of the Harvard Department of Anaesthesia), there were 11 major intraoperative accidents solely attributable to anesthesia (five deaths, four cases of permanent CNS damage, and two cardiac arrests with eventual recovery) among the 70 cases reported to the insurance carrier. Review of these accidents revealed that unrecognized hypoventilation was the most common cause (seven cases). These seven accidents and one other due to discontinuation of inspired oxygen in all likelihood would have been prevented by appropriate response to earlier warnings generated by the safety monitoring principles mandated by the Harvard minimal monitoring standards. Analysis suggests capnography (although not mandated) would be the best monitor of ventilation. An important associated issue was the apparent inadequacy of supervision of residents and C.R.N.A.s. The eight preventable accidents represent 88% of the projected insurance payout. Only one accident occurred after the 1985 adoption of the standards (in the month following their implementation). From that time through mid-1988, there have been 319,000 anesthetics without a major preventable intraoperative injury. Although not statistically significant, the accident rate in the target population of healthy people is reduced more than threefold. This and the case analyses support the contention that nearly all the inevitable mishaps (technical or from errors in judgement) that occur during anesthesia can be identified through safety monitoring early enough to prevent most major patient injuries. This improved clinical outcome should lessen the medical-legal and malpractice insurance burdens of anesthesiologists.

International Standards for a Safe Practice of Anesthesia 2010

These standards1 are recommended for anesthesia professionals throughout the world. They are intended to provide guidance and assistance to anesthesia professionals, their professional societies, hospital and facility administrators, and governments for improving and maintaining the quality and safety of anesthesia care. They were adopted by the World Federation of Societies of Anaesthesiologists on the 13th June 1992, and revisions were ratified on 5th March 2008 and on 19th March 2010. n nFor some anesthesia services, groups, and departments these standards will represent a future goal, while for others they may already have been implemented and be regarded as mandatory. It is recognized that in some settings facing challenges in resources and organization, not even those standards regarded as mandatory are met at present. The provision of anesthesia under such circumstances should be restricted to procedures which are absolutely essential for the urgent or emergency saving of life or limb, and every effort should be made by those responsible for the provision of healthcare in these areas and settings to ensure that the standards are met. Provision of anesthesia care at standards lower than those outlined as mandatory for anesthesia for elective surgical procedures simply cannot be construed as safe acceptable practice. The most important standards relate to individual anesthesia professionals. Monitoring devices play an important part in safe anesthesia as extensions of human senses and clinical skills rather than their replacement. n n nAdopting the standardized language of the World Health Organization, minimum standards that would be expected in all anesthesia care for elective surgical procedures are termed “HIGHLY RECOMMENDED” and these are the functional equivalent of “mandatory” standards. These HIGHLY RECOMMENDED standards, indicated in bold type, are applicable throughout any elective procedure, from patient evaluation until recovery (it is recognized, however, that immediate life-saving measures always take precedence in an emergency). In the judgement of the WFSA, these are the minimum standards for anesthesia for a “necessary” procedure (rather than essential and/or emergency) in settings where resources are extremely limited. This does not imply that these standards on their own are ideal or even acceptable in more adequately resourced settings. These HIGHLY RECOMMENDED (functional equivalent of mandatory) standards and (regarding facilities, equipment, and medications) the parallel prescription for “Level 1” or “basic” infrastructure are relevant to any healthcare environment anywhere in which general or regional anesthetics are administered, but not to a setting where superficial procedures involving local anesthetics only are performed. Additional elements of the anesthesia standards should be implemented as resources, organization, and training permit, yielding this paradigm: n n n nxa0 n n n n nSee Tablexa01 for a detailed outline of the integration of the practice standards with the levels of facilities/infrastructure. The goal always in any setting is to practice to the highest possible standards, specifically exceeding those prescribed if that can be accomplished. In spite of some facilities’ limitations, it may be possible to implement elements of the RECOMMENDED standards even in a “basic” setting and, likewise, to implement elements of the Suggested standards even in an “intermediate” setting. The goal is always the best care possible and ongoing improvement by meeting and exceeding the standards for safe practice of anesthesia, starting with all providers meeting the HIGHLY RECOMMENDED standards and striving to meet as many of the RECOMMENDED and Suggested standards as well. n n n nTablexa01 n nGuide to Infrastructure, Supplies and Anesthesia Standards at Three Levels of Health Care Facility Infrastructure and Supplies n n n nIt is anticipated that these standards and the setting/infrastructure specifications will be revised as practice and technology evolve.

Renal failure following enflurane anesthesia.

Enflurane (2-chloro-1, 1,2-trifluoroethyl-difluoromethyl ether: Ethrane, Ohio Medical Products) has rapidly become very popular, and is the inhalation agent most frequently used at this hospital. Enflurane is biotransformed in part to inorganic fluorid ion.1 Fluoride ion-induced nephrotoxicity has been established as a cause of the vasopressin-resistant polyuric renal failure occasionally seen following exposure ot significant doses of methoxyflurane.2 Postanesthetic renal failure in a patient who received enflurane led to measurement of serum fluoride in a search for a possible etiologic factor.

Extending the WHO ‘Safe Surgery Saves Lives’ project through Global Oximetry

Pulse oximetry is widely accepted as essential during anaesthesia and its use is considered mandatory in the UK, Canada and the USA, Australia and New Zealand, much of Europe and South America, and many other countries around the world. At present, however, there are still places where oximeters are simply not available [1, 2]. At the World Congress of Anaesthesiologists in Paris in 2004, the Quality and Safety of Practice Committee of the World Federation of Societies of Anaesthesiologists (WFSA) identified the provision of pulse oximeters for use on every patient undergoing anaesthesia in the world as a priority for patient safety. From this grew the Global Oximetry (GO) initiative [3, 4]. Pilot projects have been underway in regions of Uganda, Vietnam, the Philippines and India. The World Health Organization (WHO) has now adopted this mission as a significant component of its Second Global Patient Safety Challenge. This challenge, Safe Surgery Saves Lives (SSSL) [5], launched in 2007, recognised the rising importance of surgery to public health. With increasing urbanisation and longevity, diseases characteristic of industrialised nations are becoming more prevalent even in resource-challenged low income nations and access to safe and effective surgery is increasingly essential for the health of populations worldwide. In 2008, Weiser et al. estimated the number of operations performed annually around the world as in the order of 230 million – double the number of births [6]. Global distribution is uneven: only 3.5% of surgery is undertaken in the poorest third of the world’s population, and this inadequacy of surgical services in many countries leads to the loss of 164 million disability-adjusted life years annually [7]. Even in industrialised countries, where there is generally good access to surgical services, major complication rates (estimated between 3% and 17%) are unacceptably high. Some of these complications are attributable to anaesthesia; many of them are avoidable. Safe surgery depends on (amongst other things) safe anaesthesia. The WHO SSSL initiative intends to improve safety in surgery and anaesthesia on a global scale. Anaesthesia today is typically very safe in high-income countries, where mortality solely attributable to anaesthetic complications has fallen to rates between 1 in 50 000 and 1 in 200 000 [8]. Unfortunately, there are still places where the anaesthesia mortality rate is probably 1000 times higher than this [9]; in such areas most anaesthesia providers tend to have little training and appallingly inadequate resources [10]. Furthermore, these colleagues are often very disempowered, and poorly placed to address the serious deficiencies in the services they are asked to provide for the large numbers of patients in need of surgery. If adequate access to surgery is important for a nation’s health, then so is adequate access to anaesthesia. However, surgery (and particularly elective surgery) is only worthwhile at acceptable limits of safety. No surgeon would attempt to provide an elective surgical service without a basic set of sterile instruments and sutures; safe anaesthesia is just as important and, in the same way, safety requires trained anaesthesia providers in adequate numbers with access to essential equipment and drugs. In the Safe Surgery Saves Lives project [5], the WHO brought together experts in surgery, anaesthesia, perioperative nursing and related disciplines. The task was to develop a strategy for safer surgery globally. The participants met face to face on several occasions during 2007 and 2008, corresponded between meetings, reviewed the relevant evidence, and iteratively developed consensus guidelines, captured in a substantial technical document. A key output was the WHO Surgical Safety Checklist [11]. As part of the development of this work, the International Standards for a Safe Practice of Anaesthesia, developed in the early 1990s, were revised to reflect advances in anaesthesia over the intervening years [12]. A key revision was the recommendation that pulse oximetry should be used in all anaesthetics worldwide. On the basis of this recommendation, oximetry was included as an essential item on the ‘Sign-In’ of the WHO surgical safety checklist. For some, this endorsement of oximetry by the WHO may seem controversial. In this era of evidence-based medicine (EBM), the fact is that hard evidence to support the routine use of pulse oximetry is limited. In fact, a 2002 Cochrane review concluded: ‘... we have found no evidence that pulse oximetry affects the outcome of anaesthesia. The conflicting subjective and objective results of the studies, despite an intense, methodical collection of data from a relatively large population, indicate that the value of peri-operative monitoring with pulse oximetry is questionable in relation to improved reliable outcomes, effectiveness and efficiency.’ [13] It is tempting to ignore this review or, as with the value of parachute use [14], simply to discount it as flying in the face of the obvious. However, a close analysis of this Cochrane review is quite illuminating. The starting point of such an analysis must be an appreciation that ‘evidence’ does not only come from randomised controlled trials. Sackett has defined EBM as ‘the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients. The practice of EBM means integrating individual clinical expertise with the best available external clinical evidence from systematic research’ [15]. We think the 2002 Cochrane review of Pedersen et al. fails Anaesthesia, 2009, 64, pages 1045–1050 .....................................................................................................................................................................................................................

Review article: Practical current issues in perioperative patient safety

PurposeThis brief review provides an overview and, importantly, a context perspective of relevant current practical issues in perioperative patient safety.Principal findingsThe dramatic improvement in anesthesia patient safety over the last 30xa0years was not initiated by electronic monitors but, rather, largely by a set of behaviours known as “safety monitoring” that were then made decidedly more effective by extending the human senses through electronic monitoring, for example, capnography and pulse oximetry. In the highly developed world, this current success is threatened by complacency and production pressure. In some areas of the developing/underdeveloped world, the challenge is implementing the components of anesthesia practice that will bring safety improvements to parallel the overall current success, for instance, applying the World Federation of Societies of Anaesthesiologists (WFSA) “International Standards for A Safe Practice of Anaesthesia”. Generally, expanding the current success in safety involves many practical issues. System issues involve research, effective reporting mechanisms and analysis/broadcasting of results, perioperative communication (including “speaking up to power”), and checklists. Monitoring issues involve enforcing existing published monitoring standards and also recognizing the risk of danger to the patient from hypoventilation during procedural sedation and from postoperative intravenous pain medications. Issues of clinical care include medication errors in the operating room, cerebral hypoperfusion (especially in the head-up position), dangers of airway management, postoperative residual weakness from muscle relaxants, operating room fires, and risks specific in obstetric anesthesia.ConclusionsRecognition of the issues outlined here and empowerment of all anesthesia professionals, from the most senior professors and administrators to the newest practitioners, should help maintain, solidify, and expand the improvements in anesthesia and perioperative patient safety.RésuméObjectifCet article de synthèse court fournit une vue d’ensemble et surtout, une mise en contexte des problèmes pratiques actuels pertinents ayant trait à la sécurité périopératoire des patients.Constatations principalesL’impressionnante amélioration de la sécurité de l’anesthésie au cours des 30xa0dernières années n’a pas été déclenchée par les moniteurs électroniques, mais plutôt dans une large proportion, par un ensemble de comportements regroupés sous le termexa0«xa0monitorage de la sécuritéxa0»; ceux-ci ont été rendus nettement plus efficaces en élargissant la capacité sensorielle des humains grâce au monitorage électronique; la capnographie et l’oxymétrie de pouls en sont des exemples. Dans les pays hautement développés, ce succès actuel est menacé par un excès de confiance et la pression de la productivité. Dans quelques régions du monde en développement, le défi consiste à mettre en œuvre les éléments d’une pratique de l’anesthésie qui apporteront des améliorations en termes de sécurité pour parvenir au même niveau que dans le reste du monde en appliquant, par exemple, lesxa0«xa0Normes internationales pour une pratique sécuritaire de l’anesthésiexa0»xa0de la Fédération internationale des sociétés d’anesthésiologistes, la WFSA (World Federation of Societies of Anaesthesiologists). D’une manière générale, l’extension du succès actuel en matière de sécurité implique de nombreux problèmes pratiques. Les difficultés liées au système impliquent de la recherche, des mécanismes efficaces de signalement des problèmes et une analyse/diffusion des résultats, une communication périopératoire (y compris unxa0«xa0dialogue avec les autoritésxa0»xa0et des listes de contrôle. La question du monitorage implique l’application stricte des normes de monitorage existantes et publiées, ainsi que l’identification du risque de danger pour le patient lié à une hypoventilation au cours d’une sédation pour une intervention et aux médicaments antalgiques intraveineux administrés en postopératoire. Les problèmes liés aux soins médicaux incluent les erreurs de médicaments en salle d’opération, l’hypoperfusion cérébrale (en particulier quand le patient est dans une position avec la tête élevée), les dangers de la prise en charge des voies aériennes, la faiblesse musculaire résiduelle provoquée par les curares, les incendies en salle d’opération et les risques spécifiques à l’anesthésie obstétricale.ConclusionsL’identification des problèmes soulignés ici et le renforcement de l’autonomie de tous les professionnels de l’anesthésie, des professeurs et administrateurs les plus chevronnés jusqu’aux praticiens débutants, doivent aider à maintenir, renforcer et étendre les progrès de la sécurité des patients sous anesthésie et en période périopératoire.

Contamination of Medical Gas and Water Pipelines in a New Hospital Building

Medical gases and water were sampled and tested for purity prior to the opening of a 176-bed addition to a 450-bed general hospital. Contamination was found. In delivered oxygen, compressed air, and nitrous oxide, this consisted of a volatile hydrocarbon at an initial concentration of 10 parts per million and a dust of fine gray particulate matter. In water from new taps bacterial contamination with as many as 400,000 organisms per 100 ml was present. All these contaminants were considered potential hazards to patient safety. Studies were done to help delineate the nature and origin of these contaminants. Each contaminant was eventually largely eliminated by purging the respective pipeline systems with continuous flows. Planners, builders, and responsible medical personnel must be aware of the potential for such hazards in a new hospital building.

A burning issue: preventing patient fires in the operating room.

749 October 2013 W can you say to a patient having a skin lesion excised under monitored anesthesia care (MAC) who suffers severe burns to the neck and face from a surgical-site fire caused by unnecessary supplemental nasal cannula oxygen leaking under drapes and towels into the surgical field where electrocautery was used? “Oops!” is clearly insufficient. Although “I’m sorry” and then an outline of exactly what happened may be a start, there is often a significant difference between an explanation and an excuse. With the recent widespread emphasis on the risk of surgical-site fires and new knowledge about the flammability of surgical drapes and materials, there can be no excuse. In this issue of the journal, Culp et al.1 squarely address this emphasis on the risk of surgical-site fires that was echoed very recently in the report of the American Society of Anesthesiologists Closed Claims Study analysis of operating room fires.2 Culp et al. demonstrated the flammability of the drapes and towels used to create surgical fields and the sponges used during surgery. Furthermore, particularly, the authors showed huge (and dangerous) increases in flammability of these materials in oxygen-enriched environments. Some anesthesia professionals may think that this is intuitively obvious from basic chemistry, but it is the time measurements using stop-action video at 30 frames a second that provide their dramatic results. The authors used a standardized test method used for garment fabric and used a common match as an ignition source, which burns at 200°C less than the temperature of the spark from a monopolar electrocautery that burns tissue to stop bleeding. For a cotton surgical sponge, the ignition times were 0.9 s in 21% oxygen (room air), 0.3 s in 50% oxygen, and less than 0.1 s in 100% oxygen. Times for the standard-sized samples to burn completely were 27, 2, and 0.8 s, respectively. For the routine blue cotton towel that forms the edges of so many surgical sites, ignition was 1.6 s in room air and 0.1 s in 100% oxygen. Towel samples burned up completely within 22 s in room air and 0.9 s in 100% oxygen. These results showing increased flammability are both remarkable and consistent with the concept that most oxygenenhanced surgical-site fires occur so rapidly that even the quickest response from the operating team cannot prevent patient burns. The “paper drapes” commonly used to cover patients on the operating table (including the patient’s head and face during many procedures on the upper torso, neck, and head), which are mostly made of the organic polymer polypropylene, ignite and burn much faster in 100% oxygen (note that the surgical drapes burned in 81% of MAC case fires reported to the American Society of Anesthesiologists Closed Claims Study3 and that supplemental oxygen was being administered in 100% of those cases.) Even surgical gowns, which are almost entirely made of polypropylene and which do not ignite in room air, ignite and burn almost instantly in 100% oxygen. These findings show truly dramatic oxygen-enriched facilitation of flammability of the materials comprising a surgical field. They must serve as a warning to those anesthesia professionals who apparently still do not appreciate the great risks caused by open supplemental oxygen, usually from nasal cannulae covered by a drape over the head, leaking into a surgical site where electrocautery will be used. These practitioners still place nasal cannulae or even a perforated plastic face mask (preferred by some in order to keep the surgical drape off the patient’s face) and administer 2 or 3 l/min of oxygen for every single MAC case, including for perfectly healthy patients. This is done allegedly out of concern that IV “sedation” with benzodiazepines, narcotics, and hypnotics such as propofol will cause hypoxemia manifest as hemoglobin desaturation A Burning Issue

A call for standards on perioperative CO2 regulation Reply

To The Editor, The Journal recently published the International Standards to the Practice of Anesthesia. These Standards mandate the use of capnography, but they fail to provide guidelines for carbon dioxide management. Except under rare circumstances, carbon dioxide is inert, odourless, tasteless, invisible, and remarkably benign and beneficial. It is heavier than other atmospheric gases, so it accumulates in dependent locations, such as mines, where air circulation is lacking. Under these conditions, it displaces oxygen and causes death by drowning. Since this phenomenon was attributed to toxicity in earlier times and early gas research confused CO2 effects with carbon monoxide toxicity, carbon dioxide remains widely but mistakenly feared as toxic and narcotic. All vertebrate cells produce CO2 continuously. It saturates body tissues and fluids, and it equilibrates with the external environment. Carotid and aortic respiratory chemoreceptors gradually adapt to and maintain this equilibrium. Synergistic combinations of hypercarbia and hypoxemia exponentially increase chemoreceptor activity and respiratory drive. Hyperventilation is unnatural and abnormal in all circumstances. It confers no tangible benefits, and it may cause serious adverse events, including ‘‘shallow water blackout syndrome’’, brain damage in mountain climbers, and increased morbidity and mortality in otherwise healthy polio victims. Nowadays, its traditional use to counteract brain swelling is discouraged. Mechanical hyperventilation rapidly depletes CO2 tissue reserves, which obtunds chemoreceptors and undermines respiratory drive. Mechanical hyperventilation during anesthesia originated before pulse oximetry and capnography were available. In that bygone era, carbon dioxide was assumed to be a ‘‘toxic waste gas’’ that must be rid from the body rather than an essential element of normal physiology that is rapidly depleted by mechanical hyperventilation and requires careful conservation. It was not understood that hyperventilation damages lung tissues, impairs tissue perfusion and oxygenation, inhibits opioid clearance, traps opioids in brain tissues, and depletes CO2 reserves necessary for normal respiratory chemoreceptor activity. Moreover, it was not understood that mild hypoventilation reduces blood viscosity beneficially, increases cardiac output, promotes tissue perfusion and oxygenation, protects lung tissues, preserves tissue reserves of carbon dioxide, offsets the respiratory depressant effects of opioids, and prevents opioid ‘‘trapping’’ in brain tissues. During that past era, evidence was often misinterpreted or overlooked in favour of pre-existing beliefs about carbon dioxide toxicity. For example, Boniface and Brown mistakenly concluded that CO2 causes toxic depression of cardiac contractility, even though their study documented beneficial decreases in systemic vascular resistance that offered a simpler explanation for decreased cardiac work. Unfortunately, anesthesia hyperventilation remains entrenched, even though critical care experts have embraced the safety of permissive hypercapnia. The practice is reinforced by the routine observation that hyperventilated patients usually breathe adequately upon anesthetic emergence, provided that opioid dosage has been carefully constrained. This is because conscious awareness sustains breathing despite the absence of chemoreceptor activity, particularly in the presence of pain. L. S. Coleman, MD (&) Fresno Dental Surgery Center, 888 E. Divisadero St. #209, Fresno, CA 93721, USA e-mail: lewis_coleman@yahoo.com