CASA’s policy about aeromedical decision making (ADM) in respect of mature pilots Aviation Medicine Branch Industry Permissions Division CASA Table of contents The context ................................................................................................................................ 3 What is aviation medicine? ....................................................................................................3 Legal Framework for regulatory aviation medicine ...............................................................3 International ..................................................................................................................... 3 Domestic ........................................................................................................................... 4 System of Regulatory Aviation Medicine in Australia ............................................................5 Regulatory Medical Decision Making ............................................................................... 5 Developing policy.............................................................................................................. 8 The Issue raised by this paper ................................................................................................... 9 The Legislation .......................................................................................................................9 The CASA CAA policy development meeting .........................................................................9 Outcomes of the meeting ............................................................................................... 10 Periodicity of testing ....................................................................................................... 11 Implementation .................................................................................................................. 12 Appendix.................................................................................................................................. 13 List of requirements (consolidated) .................................................................................... 13 ADM in Mature pilots – Position paper Civil Aviation Safety Authority Page 2 of 13 The context What is aviation medicine? Aviation medicine is the branch of medicine concerned with the human capacity to safely and effectively perform complex tasks in the potentially hostile aviation working environment. Although clinical aviation medicine largely involves the physical and mental health of aircrew and passengers exposed to a wide range of environmental stresses, aviation medicine is also an applied science which embraces experimental physiology, bio-dynamics, psychology and human factors, the neurosciences and scientific study of the special senses. Regulatory aviation medicine, outside of the military, is the application of aviation medical knowledge and expertise to regulatory aspects of the civil aviation sector. Throughout the world, most of the practice of civil aviation regulatory medicine involves the assessment of professional and non-professional pilots and air traffic controllers against defined medical standards. Some refer to this in relation to flight crew as ‘fit to fly’ or ‘fitness to fly’ determinations. In Australia, aviation medicine is not a recognised discrete medical speciality but is often considered a branch of the preventative or occupational medicine speciality. The main specialist aviation medicine qualifications recognised within Australasia are the postgraduate Diplomas of Aviation Medicine awarded by Otago University or the Royal College of Physicians (UK). In other countries, including the United States, Canada, Great Britain and India, aviation medicine is recognised as a discrete medical speciality and is often referred to as Aerospace medicine. Medical practitioners who have completed a CASA approved course can register with CASA as Designated Aviation Medical Examiners (DAMEs), and are then qualified to medically examine pilots and air traffic controllers to certify their fitness for work. Legal Framework for regulatory aviation medicine International The 1944 Convention on International Civil Aviation ("the Chicago Convention") provides the basis for the unification and standardisation of safety-related civil aviation law. Australia is a signatory to the Chicago Convention. Among other things, the Chicago Convention established the International Civil Aviation Organisation (ICAO), which has as one of its functions the adoption of international standards and practices. Once adopted, these are designated as annexes to the Chicago Convention. These standards and recommended practices and procedures relate to a variety of matters including air navigation, registration of aircraft and the certification of personnel, such as flight crew. Where a Contracting State does not adhere to these Standards it must notify ICAO of the differences to enable the Council to notify all Member States. ADM in Mature pilots – Position paper Civil Aviation Safety Authority Page 3 of 13 The first Annex to the Chicago Convention (“Annex 1”), titled “Personnel Licensing”, states (Note 2 to 1.2.4) that -– “To satisfy the licensing requirements of medical fitness for the issue of various types of licences, the applicant must meet certain appropriate medical requirements which are specified as three classes of Medical Assessment”. The ICAO medical provisions for licensing, including the medical standards, are prescribed in Chapter 6 of Annex 1. Section 6.1.1 of Annex 1 and describe three classes of medical assessment: class 1, class 2, and class 3. These three classes of medical assessment apply to aviation personnel licences as follows: Class 1: Applies to applicants for, and holders of commercial pilot licences, airline transport pilot licences, flight engineer licences, or flight navigator licences. Class 2: Applies to applicants for, and holders of private pilot licences, glider pilot licences, or free balloon pilot licences. Class 3: Applies to applicants for, and holders of air traffic controller licences. The standards contained within Chapter 6 of Annex 1 have generally been implemented in Australian law. Domestic The Australian civil aviation medical certification system is governed by the Civil Aviation Act 1988 (“the Act”), the Civil Aviation Regulations 1988(CAR), and the Civil Aviation Safety Regulations 1998(CASR). The Act, Part 5 of the CAR, and Part 67 of the CASR (Part 67) contain the main legislative requirements in relation to pilot licences and the role of medical certificates in enabling the exercise of the privileges of a pilot licence. Part 5 of the CAR deals with pilot licences and ratings. It requires a current medical certificate for an individual to exercise the privileges of his/her pilot licence. In relation to a medical certificate, “current” means that the holder of the certificate has satisfied the medical requirements and the medical certificate is valid and has not expired or been revoked or suspended. Part 67 of the CASR contains the medical standards. Consistent with the ICAO requirements these medical standards and the medical certificates that are issued, are divided into three classes which relate to the exercise of the privileges of the different types of licences as follows: Class 1 - airline transport pilot licence, commercial pilot licence, or flight engineer licence; Class 2 - private pilot licence or any person who wishes to fly solo; and Class 3 - required to be held by persons wishing to exercise the privileges of an air traffic controller licence. ADM in Mature pilots – Position paper Civil Aviation Safety Authority Page 4 of 13 Medical certificates are subject to differing maximum validity periods prescribed in Subpart 67.205(3) of the CASR. The maximum validity period varies with the class of medical certificate, type of aviation activities, and with the age of the holder of the medical certificate. There are presently over 37,000 pilot and air traffic controller licences on issue from CASA. These licenses are divided between approximately 17,000 private pilot licences, 5700 commercial pilot licences, 7500 airline transport pilot licences, 600 air traffic controller licences, and the rest a combination of student pilot and other licenses. Approximately 23,000 Australian civil aviation medical certificates were issued during the last twelve months and approximately 4500 of these were first-time certifications. The medical practitioners involved directly in the Australian medical certification system include over 700 DAMEs spread throughout Australia and overseas and the medical staff of the CASA Office of Aviation Medical. The CASA medical certification system also utilises the opinions of a wide variety of clinical medical specialists such as psychiatrists, neurologists, and cardiologists. System of Regulatory Aviation Medicine in Australia Regulatory Medical Decision Making The CASA develops and administers medical standards (CASR Pt 67) applicable to licence holders in air transport and general aviation operations as well as for air traffic control operations. As indicated above, in developing regulations, CASA uses the Standards and Recommended Practices for medical fitness for licence holders as stated in Chapter 6 of Annex 1 to the Chicago Convention. CASA also prepares associated guidance material and issues advice in relation to the above matters. In assessing the more complex or difficult cases, the medical officers of CASA apply a philosophy of evidence-based, risk management to regulatory aviation medical considerations. All decisions are a result of a collegial process. Collegial The collegial aspect of the process involves using more than one medical officer in the consideration of complex cases. Those medical officers seek to achieve consensus with respect to the final conclusion. This component of the philosophy is intended to ensure consistent outcomes, provide a degree of internal peer review and focus a high level of aviation medical expertise onto the case. Evidence based The evidence based aspect of the process is directed to ensuring that wherever possible and appropriate the relevant medical and scientific research literature is searched, reviewed and applied to the considerations of the case. In assessing the evidence in support of any decision making, CASA uses the hierarchy of evidence provided by the NHMRC (which largely mirrors the hierarchies of many other august bodies internationally). A diagrammatic representation of this hierarchy is shown below: ADM in Mature pilots – Position paper Civil Aviation Safety Authority Page 5 of 13 By the very nature of the studies, any systematic reviews take time, and therefore will often deal with studies that are a few years old This is recognised in the formation of these hierarchies, as the value of the rigorous review outweighs the recency of the information. Additional medical clinical specialists, or others, may also be consulted to add clinical and other experience and expertise to the pool of information under consideration. In some medical conditions the published material has limited relevance to aviation considerations, and it may be necessary to take recourse to material presented at conferences. Medical evidence is rarely perfect, or does not always exactly relate to the case under consideration. Recognising the imperfection of medical evidence, CASA takes a view that medical evidence should not be ignored because of its imperfection, but that the best available medical evidence should be applied to a case in a reasonable manner. This may sometimes involve generalising or extrapolating findings from the medical literature. Risk Management In an ideal world, there would be no risk associated with air travel such that flying would be perfectly safe. Unfortunately, this is not the case. Air travel involves a complex interplay between machines, people and the environment and each of these is subject to either failure or unpredictability. It is not possible for aviation to be perfectly safe and without risk, so most countries aim for some reasonable degree of safety. Medical factors represent only one of a number of factors that can contribute to the risk associated with air travel. Medical risk is usually managed so that a balance is achieved where medical factors are neither the weak-link in aviation safety nor so restrictive that virtually no-one is able to fly. Every aviation medical certification system that allows people to fly aircraft involves the acceptance of some amount of medical risk. If striking this medical balance is unsuccessful, in either direction, then the community will be exposed to increased cost either through aircraft accidents with preventable medical causes or through increased costs of compliance, increased rejection of pilots on medical grounds and increased injury and death of pilots due to regimens of medical testing. ADM in Mature pilots – Position paper Civil Aviation Safety Authority Page 6 of 13 In making a medical certification decision, CASA Medical Officers consider the overall risk that the applicant’s medical condition presents to aviation safety and the utility and reliability of risk mitigation efforts. This includes a consideration of the individual’s age, experience, type of flying, currency, extent of flying, the medical condition, the treatment, possible side effects of treatment and a range of other similar and interrelated issues. The process is somewhat simplistically separated into six steps for ease of understanding, though in practice the steps all merge into each other. This flow chart helps to highlight the multiplicity of factors which apply in the making of these decisions. It also helps to clarify the role of the clinical consultant, as being that of providing one of the many components in this decision. Looking at in terms of the legislation, the clinical specialist helps to identify whether the condition is safety relevant and then contributes to the store of information about prognostic probabilities. This information is vital in the next step of the process, but making the certification decision requires a different set of information and expertise and a different skill set. The flowchart on the next page shows the method that we use in making aeromedical decisions. ADM in Mature pilots – Position paper Civil Aviation Safety Authority Page 7 of 13 Regulatory Aeromedical Decision Making Diagnosis or sign/ symptom complex Population bias Referral bias Incidence and prevalence data Determine adequacy of functional capacity 1 Determine likelihood of medical incapacitation 2 Characteristics of symptom/ sign Aeromedical stressors Determine likelihood of unacceptable outcome in-flight 3 4 Flight factors Acceptable level of risk Risk acceptable? Yes No Determine Risk after likelihood modification 5 Legend Process Risk acceptable after likelihood No modification? Yes Decision Manage Consequences 6 Stored Data End of process Risk acceptable after consequence modification Eligible to fly Yes No Ineligible to fly Developing policy The development of policy in complex conditions is based on evidence-based risk management. The Civil Aviation Safety Authority (CASA) generally makes policy changes in connection with medical matters on the basis of relevant medical evidence. CASA convenes meetings at least once every year to discuss an area which is of importance to aviation and on which policies are in need of revision. The day long meetings are attended by expert consultants, CASA doctors, often representatives of the Civil Aviation Authorities of New Zealand and sometimes other jurisdictions, members of the unions, and industry bodies. The purpose of meetings of this kind is to enable all issues to be canvassed and discussed in an open and transparent manner, so that CASA’s policy makers have the benefit of the expert information shared at these events, while at the same time enabling interested members of the wider Australian aviation community to raise questions and come better to understand the issues. The products of this exercise are intended to inform appropriate and ADM in Mature pilots – Position paper Civil Aviation Safety Authority Page 8 of 13 implementable policy, and can shape CASA's policies in medical certification of pilots and air traffic personnel. The Issue raised by this paper The topic for this meeting was the management of the aeromedical risks particular to maturer pilots. This risk assessment is difficult because the onset of different clinical conditions is extremely variable, and so chronological age is not a dependable indicator of performance in all the different domains. Mirroring the risk assessment approach common to all other clinical conditions, the approach was centred on requiring applicants to demonstrate adequate performance of critical systems (eg, cardiovascular, cognition, etc) where the statistical risks become significant. The Legislation CASR Part 67 does not have a standard that is related to age. What is required is (emphasis added): 67.180 Medical certificates — issue and refusal (1) Subject to this regulation, on receiving an application under regulation 67.175, CASA must issue a medical certificate to the applicant only if: (a) the applicant meets the requirements of subregulation (2); or (b) if subregulation (3) applies to the applicant — CASA is satisfied that issuing the medical certificate to the applicant will not adversely affect the safety of air navigation. (2) For paragraph (1) (a), the requirements are: (a) the applicant has undergone any relevant examinations that, in the opinion of CASA, are necessary in the particular case; and The CASA CAA policy development meeting The meeting was held at in Melbourne in November 2011. The meeting was attended by all CASA doctors, a DAME who attended as a member of AOPA, a DAME who attended as a member of ASAM, a member of GAPAN, representatives from Virgin Australia and Qantas, Regulatory doctors from CASA and CAA New Zealand, and the following specialists: An occupational physician with experience of and expertise in managing age related medical exams in other sectors A Geriatrician A neurologist specialising in geriatrics ADM in Mature pilots – Position paper Civil Aviation Safety Authority Page 9 of 13 A neurophysiologist A cardiologist A Designated Eye Examiner All attendees had been provided with a copy of the results of a review of the scientific literature around the subject, and many had done their own further subject reviews. The meeting was conducted in an open and collaborative manner with all parties able to make comments or pose questions to the specialists. Outcomes of the meeting The meeting formed the following views: That chronological age was not a dependable indicator of performance as the onset of the many problems of age was variable and not well predicted in an individual case. However, there was supporting evidence to link the onset of the following conditions to age: o Cognitive decrement o Atrial fibrillation o Coronary artery disease o Glaucoma and visual field defects o Hearing defects It was agreed that the statistical risk of these conditions increased after the late 50s and increased steeply thereafter. There was considerable discussion about the methods by which cognitive decrement should be assessed. The options discussed were Cogscreen or other psychometric testing Review by a neuropsychologist Mini Mental state exam The Montreal Cognitive Assessment (MOCA) Flight tests CASA’s doctors have long supported the use of the flight test as being a good test of cognitive function, and it is in use by CASA and CAA of NZ as a means of returning young people with risk of cognitive defects following illness or injury. The specialist geriatricians and the neurologist with expertise in cognitive testing pointed out that this testing by itself was inadequate, because subtle changes missed in the flight tests could be picked up by cognitive testing. They recommended that the assessment should consist of a test ADM in Mature pilots – Position paper Civil Aviation Safety Authority Page 10 of 13 administered by the DAME, a flight test, and an overall assessment of the individual (during the entire process of the medical examination), by the DAME. There was discussion about the specific test to be used. Many good tests are available, and were discussed. CASA was interested in having a valid and dependable test that was accessible and available, effective, and cost as little as possible. The consensus of the consultants was that the MOCA was a well validated test, did not take long (about 10 minutes), and had a high sensitivity and specificity. It also had the advantage of being available freely at no cost. The accepted process for assessment of cognition was decided to be a combination of: MOCA Flight test DAME judgment The process for assessment of visual field defects was decided to be a combination of: Confrontation test at each medical examination Periodic automated perimetry A general eye examination The process for assessment of Atrial fibrillation and coronary artery disease was decided to be a combination of: Resting ECG Cardiac risk index scoring Appropriate follow up in cases of abnormality Hearing already has a standard in Part 67, and the assessment methodologies are already clear, so this subject was not discussed in any great detail. While it was clearly understood by all parties that CASA would form a policy view based on the outcomes of the meeting, there were opinions expressed by the various experts to suggest that a periodicity of 5 years between 60 and 70 years of age was the safe maximum, with closer scrutiny after 70 years of age. Periodicity of testing Following the meeting, CASA formulated a table listing the details of the ages at which different assessments are needed. There is already an existing table that has been formulated based on risk, and the additional assessments recommended by the panel at the meeting have been incorporated. In devising this periodicity of assessment, it is noted that a feature of increasing ages is that functional reserve is diminished, and therefore de-compensation can occur quickly. This ADM in Mature pilots – Position paper Civil Aviation Safety Authority Page 11 of 13 necessitates increased scrutiny, as the individual can decline rapidly following the assessment The dates of consolidated table have been rationalised so as to “clump” most assessments in specific years. The schedule of tests is placed at Appendix to this document. Implementation The planned assessment schedule is offered for consultation. After any changes are made following consultation, implementation is intended to be complete by the end of the first quarter of 2013. ADM in Mature pilots – Position paper Civil Aviation Safety Authority Page 12 of 13 Appendix List of requirements (consolidated) Special Reports and Tests Age (Yrs) Ser., Lips & BI.GI Audio Eye ECG CVD Risk Score INITIAL ISSUE All 1, 3 1, 3 1, 3 1, 3 1, 3 All 2 No additional tests required unless clinically indicated RENEWALS 25 1, 3 1, 3 1, 3 1, 3 30 1, 3 1, 3 1, 3 1, 3 32 1, 3 34 1, 3 35 1, 3 1, 3 1, 3 36 1, 3 38 1, 3 40 1, 3 1, 3 An ECG is 1, 3 45 1, 3 1, 3 required yearly 1, 3 50 1, 3 1, 3 from age 40 1, 3 55 1, 3 1, 3 for Class 1 1, 3 60 To be done 1, 3 1, 3 and every 2 Calculate each 62 every year over 1, 3 years for Class year over 65 64 60 years 1, 3 3 for Class 1 & 3 65 1, 3 From age 66 66 2 as well 1, 2, 3 every 2 yrs 2 as well 68 1, 3 for Class 2 70 2 as well 1, 3 1, 2, 3 2 as well 72 1, 3 74 1, 3 75 2 as well 1, 3 1, 2, 3 2 as well 76 1, 3 78 1, 3 80+ Additional requirements advised individually 2 as well No additional tests required unless clinically indicated 1= Class 1 Medical certificate 3= Class 3 Medical certificate 2= Class 2 Medical certificate *Functional Checks ADM in Mature pilots – Position paper Civil Aviation Safety Authority Page 13 of 13 MOCA + Flight Test 1, 2, 3* 1, 2, 3* 1, 2, 3* Annually