A Regulator’s View (1). (Dr David Salisbury).ppt

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ICAO Medical Briefing 2014 Dr. David Salisbury Director Medicine Civil Aviation

Transcript of A Regulator’s View (1). (Dr David Salisbury).ppt

  • ICAO Medical Briefing 2014Dr. David SalisburyDirector MedicineCivil Aviation

  • Disclosure Information85th AsMA Annual Scientific Dr. David SalisburyI have the following financial relationships to disclose:

    Employee of: Transport Canada

    I will not discuss off-label use and/or investigational use in my presentation

    Facts are facts. Opinions are mine and not the official position of TC or the Government of Canada

  • Further DisclosuresIm a Canadian

    Board certified in Aerospace Medicine by Am. Brd. Of Preventive Medicine

    FRCPC in Public Health and Preventive Medicine

    28 years in the CF as a flight surgeon, 5 years in Public Health as a Medical Officer of Health, 6 years at TC as Director

    Non-smoker, normotensive, minimal drinker who exercises hard 3 times a week and always wears his seatbelt. Immunized against most vaccine preventable diseases and all my first degree relatives have lived to 80+

  • Aerospace MedicineBranch of Preventive Medicine that deals with the clinical and preventive medical requirements of man in atmospheric flight and space

  • Approach to Aerospace MedicineAEROSPACENormal PhysiologyAbnormal environmentCLASSICALAbnormal PhysiologyNormal environment

  • Aerospace and Regulatory MedicineAbnormal PhysiologyAbnormal environment

  • Source: http://my.americanheart.org/professional/ScienceNews/Foundational-Factors-for-Cardiovascular-Disease-Behavior-Change-as-a-First-Line_UCM_457215_Article.jsp

  • Aviation Regulatory Medicine

  • WW IMost Canadians flew with the Royal Flying Corps or The Royal Naval Air Service. Over 22,000 served. Canadian Air Force formed at end of war. RCAF given Royal designation 1924.Medical Standards applied by RFC Canada:Perfect VisionUnder 25Hear a whisper at 20 Ft.All MOs from RAMC (Army)

  • Civil Aviation in Canada & the WorldConvention onInternationalCivil AviationChicago 1944Establishment ofICAO 1947Standards &RecommendedPractices (SARP)Annex 1Personnel LicensingMedical StandardsCanada OriginalContracting StateCanadian AviationRegulations(CARs)CARs 404 & 424(Medical Standards)

  • ICAO Annex 1 Annex 1Chapter 1Medical FitnessAll ICAO Contracting States must be in complianceHow they achieve compliance may differNew Manual of Civil Aviation Medicine 2012

  • TC Civil Aviation Medicine Established by Order in Council 1946" To provide medical advice & assistance in setting up physical standards for civil aviation personnel; To advise on all problems connected with the health of travelers by air".Civil AviationMedicineTransport CanadaDeputy MinisterSafety & SecurityADMCivil AviationDirector GeneralMinister of Transport

  • Principal function - medical certification of aviation personnel

    Medical advisors to the Minister of Transport

    Custodians of confidential medical information

    Civil Aviation Medicine

  • Concern :The risk ofincapacitationSuddenSubtleDuring the validity period of the Medical CertificateFitness Criteria

  • CAR 424.05ICAO Annex 1 1.2.4.8

    Accredited medical conclusionUsed for medical certification cases which are technically outside the standardsbut are not deemed to be a threat toaviation safetyFlexibility

  • 1% RuleEvans ADB, Rainford DJ. Medical Standards for Aircrew in Aviation Medicine III Edition. 1999Goal is 1 in 107 for all cause fatal accidentsCrew failure should contribute no more than 10% of riskMedical Incapacitation should contribute no more than 10% of crew failure riskTherefore Pilot Incapacitation should cause an accident no more often than one in 1000 million flying hours

  • 1% Rule ContinuedCVD Mortality of 1 in 109 or annual rate of 1:100,000 is not achievable at any age, hence need for two pilotsSimulator Studies (Chapman 1984) indicate successful takeover rate 1:100Critical Area of flight (T/O and Landing) only 10% of timeIncapacitation occurs randomlyThis gives a protection fact of 1000 soooooIncapacitation Rate of 1 in 106 or annual rate of 1% is acceptable

  • 1% Rule Summary

    Desirable Accident Rate

    1:107

    Personnel Causes 10%

    1:108

    Pilot Incapacitation due to Medical Reasons 10%

    1:109

    Dual Pilot System gives 1:99 Protection

    1:107

    Critical Time in Flight 10%

    1:106

    Number of hours in a year 104

    = 1% p.a. occurrence

  • Human Rights Issues

    CHRC is a quasi-judicial body empowered under the Canadian Human Right Act

    CHRC investigates and tries to settle complaints of discrimination in employment and in the provision of services within federal jurisdiction

    CHRC is also empowered under the Employment Equity Act to ensure that federally regulated employers provide equal opportunities for four designated groups: women, Aboriginal people, the disabled and visible minorities

    CHRC acts as an advocate for human rights and issues, reports on various aspects of discrimination as well as educational materials designed to promote human rights and inform employers and the general public about human rights regulations

  • Human Rights IIProhibited Grounds of DiscriminationRaceColourNational or ethnic originSex (includes pregnancy)Marital status Family statusAge Religion Sexual OrientationPardoned ConvictionDisability (physical or mental, including drug or alcohol dependence)

  • Human Rights IIIThere is a Duty to Accommodate : it is the LAW The right to accommodation of needs is statutorySupreme Court of Canada: accommodation of needs is necessary to ensure equality under the Charter and statutory human rights legislation (Meiorin + Grismer)

    Accomodation can be denied if The rule, standard or practice is based on a bona fide occupational requirement (BFOR) or bona fide justification (BFJ),It is made in good faith (bona fide), andPutting aside the BFOR to accommodate would cause undue hardship to the provider, considering health, safety and cost To establish BFOR: Meiorin- 3 stage test

  • Latest Framingham CVD Prediction Tool PerformanceThe top sex-specific quintiles of predicted CVD risk identified 48% of men and 58% of women who experienced a first CVD event on follow-up (sensitivity). Proportions of men and women without events who were not in the top quintile of risk were 85% and 83%, respectively (specificity). Source: http://circ.ahajournals.org/content/117/6/743.full

  • Prev. 10%An Event+-FRS+48135-527651009001000

    Sensitivity.48Specificity.85+PV.26-PV.94

  • Source: http://my.americanheart.org/professional/ScienceNews/Foundational-Factors-for-Cardiovascular-Disease-Behavior-Change-as-a-First-Line_UCM_457215_Article.jsp

  • http://my.americanheart.org/professional/ScienceNews/Foundational-Factors-for-Cardiovascular-Disease-Behavior-Change-as-a-First-Line_UCM_457215_Article.jsp

  • ConclusionsAerospace Medicine is Preventive Medicine

    Prevention is effective

    Regulatory Medicine will need more than a paradigm shift to effectively practice primordial prevention

    There are legal, human rights and logistical barriers to practicing prevention in a regulatory framework

  • How can you help?Accurate and complete MERsGood understanding of requirementsThorough history takingSynthesis of issues

  • Some Other PointsIf one of your pilots has received a letter with special conditions or investigation requirements you can make their application much more efficient if you order the extra tests. Cardiovascular screening. If there are other risk factors please get a lipid profile.

  • *Issue is the application of preventive medicine practices in regulatory/aviation medicine.*Traditional definition from Aerospace Medical Association.**333Traditionally we have also stressed the issue that we are often dealing with normal physiology but in an abnormal or changed environment from what we as humans have adapted to and what our classical medical research base has investigated.Now due to an increasing movement of accommodation and rights we are having to deal more and more with abnormal physiology in the abnormal environment.*Figure 2. The evolutionary CVD pyramid. Unhealthy lifestyle practices lead to risk factors, the progression of CVD, and, ultimately, adverse outcomes or clinical endpoints. Prevention can be divided into 3 types: primordial (prevention of risk factors); primary (treatment of risk factors); and secondary (prevention of recurrent cardiovascular events), which can be modulated by environmental (e.g., air pollution) and psychosocial stressors, lifestyle change, and cardioprotective medications, if appropriate. The first-line strategy to prevent initial or recurrent cardiac events is to favorably modify unhealthy lifestyle habits or practices, including poor dietary habits, physical inactivity, and cigarette smoking. CVD signifies cardiovascular disease; MI indicates myocardial infarction; CHF, congestive heart failure; and PAD, peripheral arterial disease. Sources: Mozaffarian et al and Franklin et al.13,14**ICAO sets rules and regulations for its 188 Contracting States. These are published as Standards and Recommended Practices (SARPs) for international civil aviation. The SARPs concerning medical provisions are contained in Annex 1 to the Convention on International Civil Aviation. ICAO SARPs are minimum requirements that Contracting States have to abide to. A State, however, may set higher or stricter national standards. In the context of regulatory civil aviation medicine, Aviation Medicine Section deals with the medical requirements for licensing of flight crew and air traffic controllers and others. To keep abreast with new technological developments and innovations and advances in medical knowledge, the SARPs in Annex 1 to the Convention on International Civil Aviation have to be revised and updated regularly. *responsibilities of the Aviation Medicine Section are: monitoring the developments within the field of aviation medicine worldwide; keeping the medical provisions of Annex 1 - Personnel Licensing up to date, reviewing and maintaining current the Manual of Civil Aviation Medicine (Doc 8984) and the Manual on Prevention of Problematic Use of Substances in the Aviation Workplace (Doc 9654); providing guidance to licensing authorities in Contracting States on medical problems associated with flight operating conditions and flight crew performances and licensing standard, air traffic control staff performance, licensing standards and conditions of work; biological and psychological problems relating to passengers and crew; equipment, first aid and survival, and the medical aspects of accident investigation and prevention; and conducting regional civil aviation seminars and ICAO sessions at international aviation medicine congresses, scientific meetings, etc. + WHO AsMA IAASM - civil aviation authorities Medical Directors of airline companies

    *PRIVY Council:, CANADACertified to be a true copy of a Minute of a Meeting of the Treasury Board, approved by His Excellency the Governor General in Council, on the 30th Oct., 1946.NATIONAL HEALTH AND WELFAREThe Board had under consideration the following memorandum from the Honourable the Acting Minister of National Health and Welfare:-"The undersigned, on the advice of the Deputy Minister of National Health, has the honour to report.THAT the Department of Transport hat requested the Department of National Health and Welfare to provide medical advice and assistance in setting up physical standards for civil aviation personnel; to advice on all problens connected vith the health of travellers by air;THAT there are no present facilities in the Department of National Health and Welfare to render such services and a Division of Civil Aviation Medicine of the Department of National Health and Welfare should be established, to be headed by a Chief of Division vith such other officers, clerks, and employees as Bay be necessary therefore, to provide services in the foregoing connection;NOW, THEREFORE, the uadarsigned, on the recommendation of the Deputy Minister of National Health, has the honour to reconnend to Your Excellency in Council that a Division of Civil Aviation Medicine of the Department of National Health and Welfare be established to be headed by a Chief of Division, with such other officers, darks, End employees as may be necessary, therefore, to provide services as aforesaid." *Hx -after World War I - International Commission on Air Navigation (ICAN) - established following the Paris Air Convention of 1919. This organization was set up to establish rules and regulations for the safe conduct of civil aviation. ICAN established a medical sub-commission which set about producing the first ever medical standards for civil aircrew which were extremely strict. In 1944, towards the end of World War II, the International Civil Aviation Organization (ICAO), an agency of the United Nations, was formed to carry on the work of ICAN, which had ceased to exist during World War II.

    **Figure 2. The evolutionary CVD pyramid. Unhealthy lifestyle practices lead to risk factors, the progression of CVD, and, ultimately, adverse outcomes or clinical endpoints. Prevention can be divided into 3 types: primordial (prevention of risk factors); primary (treatment of risk factors); and secondary (prevention of recurrent cardiovascular events), which can be modulated by environmental (e.g., air pollution) and psychosocial stressors, lifestyle change, and cardioprotective medications, if appropriate. The first-line strategy to prevent initial or recurrent cardiac events is to favorably modify unhealthy lifestyle habits or practices, including poor dietary habits, physical inactivity, and cigarette smoking. CVD signifies cardiovascular disease; MI indicates myocardial infarction; CHF, congestive heart failure; and PAD, peripheral arterial disease. Sources: Mozaffarian et al and Franklin et al.13,14*Figure 3. The 5 As to facilitate effective health behavior change counseling during a medical visit. Although more providers now perform the first 2 As, that is, assess the risk behavior and advise behavior change, it is the latter, less frequently performed 3 As (shaded) that have the greatest impact on healthful behavior change. Effective clinician behavior change strategies include using motivational interviewing along with rewards or incentives, asking patients to self-monitor behaviors, enhancing patients self-efficacy (confidence), accessing social support from family and friends, and scheduling regular follow-up communications/meetings to assess progress. Sources: Chase et al and Alexander et al.77,78.****