Anaesthesia safety in the 1980 s

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1 Patient safety : Translating safety concepts into practice example of anaesthesia F Clergue Patient safety : the example of anaesthesia outline From the dark years to the first improvements Addressing human s and organisational changes How to adapt safety concepts to the medical environment? the dark years of anaesthesia Geneva, October 23, 2012 Anaesthesia mortality in Finland M Hovi-Viander, Br J Anaesth 1980 intra-op mortality : 2/ anaesthetic deaths : inadequacy in fluid management (n=17) respiratory insufficiency (n=15) cardiac complications (n=12) technical s (n=5) inadequate supervision after surgery (n=5) Anaesthesia mortality in France Analysis of procedures : French Survey Totally anaesthesiarelated Partially anaesthesiarelated Deaths 0.8/ / Deaths + comas 1.3/10' /10'000 ASA 1-2 patients : 1 death / 10,340 53% of totally anaesthesia-related deaths 27% of partially anaesthesia-related deaths Situations at risk : Recovery : 63% of deaths Emergency : 1.3 death per (60% of deaths) Cooper JB et al, Anesthesiology 1984 Instrumental intra-op monitoring : in 57% of anaesthetics : none in 36% of anaesthetics : EKG only Location of recovery ( ) Univ. Hosp Regional Hosp. Private Clinics Operating room 6% 8% 16% Recovery Room 36% 26% 36% ICU 8% 4% 2% Ward 50% 61% 45% Anaesthesia-related mortality : epidemiologic surveys Survey in The Netherlands (Arbous MS et al, Anaesthesia, 2001) 869,483 anaesthetics ( ): 14 deaths / 100,000 (= 1 / 7,100) Anaesthesia sole cause of death : 8 deaths / million (= 1/125,000) Australian survey (Gibbs N, Austr. & NZ College of anaesthetists, 2006) 137 anaesthesia deaths for 7.65 million procedures Mortality totally/partially related to anaesthesia : 18 per million (1 / 56,000) Anaesthesia sole cause of death : 5.5 deaths / million (1/180,000) Australian survey (Gibbs N, Austr. & NZ College of anaesthetists, 2009) 112 anaesthesia deaths for 6 million procedures Mortality totally/partially related to anaesthesia : 19 per million (1 / 53,426) Anaesthesia sole cause of death : 4 deaths / million (1/249,000) French survey 1999 (Lienhart A et al., Anesthesiology, 2006) Mortality totally/partially related to anaesthesia : 47 per million (1 / 21,000) Anaesthesia sole cause of death : 7 deaths / million (1/145,000) Anesthesia-related Mortality in the US, (Li G. et al. Anesthesiology 2009) Anesthesia mortality rate : 8 deaths / million hosp. surg.disch. 1

2 $40'000 Improvements in safety confirmed by Insurance premiums for anaesthetists : USA and France Average premiums for anesthesiologists in the US (values are inflation-adjusted for 2007 dollars) Euros 16'000 14'000 France : evolution of insurance premiums Improvements in safety confirmed by a reduction in malpractice claims Malpractice Risk According to Physician Specialty Jena AB et al. N Engl J Med, 365:629; 2011 Litigation related to anaesthesia: an analysis of claims against the NHS in England T. M. Cook et al. Anaesthesia 2009 Anaesthesia safety : the years the results after 15 years of efforts $35'000 $30'000 34'791 12'000 $25'000 $20'000 17'809 23'708 23'156 22'014 25'394 23'481 10'000 8' $15'000 $10'000 $5'000 $ '000 4'000 2' Surgeons Obstetricians Anaesthetists Sleep quiet, anaesthesia is safe In 20 years, the safety of this procedure has become very reliable 1. Training Evolution of the number of anaesthetists in France What changed safety between 1980 s and 1990 s? Improvements have come through standards in : 2. Equipment / drugs 3. Facilities : PACU The main steps in safety The evolution of safety management in high risk socio-technical activities JP Visser, in Safety Management, Pergamon, 1998 Safety Performance Management focus Human / factor Assurance Safety Management System Patient safety : the example of anaesthesia outline From the dark years to the first improvements Addressing human s and organisational changes How to adapt safety concepts to the medical environment? Expertise / Equipment

3 proportion of operators Hammurabi s code and medical responsibility Medical s : where do we come from? Two attitudes : responsibility or denial If a doctor operates a man for a severe wound and causes his death or opens an abscess on an eye and destroys the eye, his fingers will be cut" An eye for an eye, a tooth for a tooth «Accidents : the price to pay to take advantage of the inestimable benefits of diagnostic and therapeutic progress» Hazards of modern diagnosis and therapy the price we pay. D.P. Barr, JAMA 1956 A good professional doesn t make s! The classical model of medicine without s Principle of the perfectible model (D Blumenthal, JAMA 1994 the ideal physician : great knowledge and infallibility training respect of good practices if an weakness and/or negligence punishment, re-training total Nurses 3.0% [CI: 2.3%- Anaesthetists Errors in drug administration : identify the s 3.7%] 6.5% [CI: 4.7%- 8.7%] omission s 0.6% [CI: 0.3%- 1.0%] 0% [CI: 0%- 0.6%] selection 2.0% [CI: 1.5%- 2.6%] 1.8% [CI: 0.9%- 3.2%] commission s count / volume 0.2% [CI: 0.05%- 0.4%] 1.3% [CI: 0.6%-2.5%] dilution repartition NA 0.2% 3.4% [CI: 2.1%- 5.2%] [CI: 0.07%- 0.5%] NA Drug s in selection and labelling : a simulation study P. Garnerin et al, Anaesthesia 2007 Make the system more robust to the occurrence of human s The Swiss cheese model of Reason Staffing / activity, team, adaptation of Competent-vigilant, legislation, safety facilities and distracted, tired, culture equipment dangerous 3

4 What is meant by organisation? W. Van Vuuren; Safety Science, 1999 Organisational culture : an example for the timeout procedure What is associated with a good organisation? Coordination of tasks Structure of the organisation Configuration Hierarchical lines Task definition Responsibilities Work procedures Supervision Culture of the organisation Strategy Internal policy Priorities Interpersonal relations Environment (external) of the organisation Pressures, influences, Financial policy Planning Organisation for what is «predictable» Anticipated planning of tasks and roles prescription sheet, procedures manual, operative program, Indirect communication Mutual adjustment Adaptation for what is «unpredictable» Non formalized mechanism based on exchanges of informations in real time interactions between care providers, handoffs oral communication Direct communication From H. Mintzberg Structure in fives: designing effective organisations. Englewood Cliffs, N.J. Prentice-Hall, Beyond technical aids, two models of safety in high-risk industries : what applicability in heath care? Present concept : «Errors are unavoidable» 2 ways to reduce their occurrence The SURgical PAtient Safety System (SURPASS) checklist de Vries E et al. Qual Saf Health Care 2009 Effect of a Comprehensive Surgical Safety System on Patient Outcomes de Vries E et al. New Engl J Med, Nov hospitals in the Netherlands : rate of complications measured during 3 months before (3760 patients) and after (3820 patients) implementation of the checklist Similar data were collected from a control group of 5 hospitals Price to pay - autonomy of actors - Track deviant practices - May limit activities Normative Respect of guidelines Adhesion of actors Ultra-safe systems Adaptive (auto-guidance) Autonomy for decision Flexibility : distribution of decisions Reinforce team cohesion Bring aids to adapt decisions HRO (High Reliability Org) Resilient systems Price to pay - Teamwork : monitoring, training in simulators Adapted from J Pariès Infection : Reduction from 4.8% to 3.3% in the intervention hospitals (p=0.006), vs 6.8% to 6.3% in the control hospitals (ns) Death : Reduction from 1.5% to 0.8% in the intervention hospitals (p=0.003), vs 1.2% to 1.1% in the control hospitals (ns) 4

5 Causes of accidents in surgery A Gawande et al, Surgery 2003 Boston, interview of 38 surgeons : 146 accidents, 13% of deaths, 33% of permanent disability Combined team training coordination versus competition Human factor team training DM Gaba, Br J Anaesth 2010 Seminars-based methods, combining : didactic training on teamwork principles Exercises such as role-playing, discussion of trigger videos of team performance Simulation sessions Can be outsourced or developed in-house? Do these techniques improve patient care and patient outcome? No evidence Aviation itself lacks such data Remaining challenges : What mix of modalities of teaching : verbal simulation, role-playing, standardized patient actors, manikin-simulation What frequency? one shot is not enough Association Between Implementation of a Medical Team Training Program and Surgical Mortality J Neily et al, JAMA 2010 Postop mortality was by 18% Dose-response relationship for additional quarters of the training program : every ¼ of the program : by 0.5 deaths per 1000 procedures (95% CI : ; p=0.001) Anaesthesia safety : CONCLUSION Anaesthesia safety : from a critical situation, we gained an experience of improvement Safety improved step by step : Knowledge-expertise / equipment Addressing human s Improving organisation : tasks/roles, culture The next steps in anaesthesia safety : a system more mature Ready to adapt the safety concepts to the specificities medical care (rather than copying high-risk industries) Mixing proceduralization and reinforcement of teamwork, according to the complexity of care? 5

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