Civil Aviation Safety Authority Of Papua New Guinea
PNG MEDICAL MANUAL
VOLUME 5 PART E
Control Copy Number: ……………
PNG MEDICAL MANUAL
PRELIMINARY AUTHORISATION Page III of XIII
AUTHORIZATION
This manual is a Civil Aviation Safety Authority document setting out the procedures for aviation medical practices and forms part of the Civil Aviation Safety Authority Manual Suite. This manual sets out responsibilities; specific procedures and systems applicable to Aviation Medical Standards and Certification.
The main purpose of the PNG Medical Manual is to assist and guide designated aviation medical examiners (DAMEs), medical assessors (MAs) and CASA, in decisions relating to the medical fitness of licence applicants as specified in Annex 1.
The originator or Controlling Authority of this document is the Principal Medical Officer (PMO).
For the purpose of ensuring that the process detailed in this document is standardised, I require all designated aviation medical examiners and relevant staff to use this document in the performance of their duties.
This manual is a living document and I encourage DAMEs, Mas and CASA staff to continually contribute to its improvement taking into account the legislative changes, annex amendments and latest technological changes and experience, and also to your work practices covered by the procedures contained in this document.
This document has been issued under the authority of the Director of the Civil Aviation Safety Authority.
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CONDITION OF USE
The assigned manual holder is responsible for the care and upkeep of the manual, and for its revision, in accordance with any instructions or revision material provided by the Civil Aviation Safety Authority.
Assigned manual holders are to ensure that they familiarise themselves with the content of the manual, including any revision received.
Manual holders with staff management or supervisory responsibilities shall ensure that their subordinate staffs are fully aware of changes to work practices or duties which may occur as a result of revisions to the manual.
The manual holder is encouraged to identify, recommend and submit any request to amend any part of this manual via the Revision Request Form.
Manual holders and users are not permitted to make any alternations, erasures or use marks of emphasis in this manual.
This manual must be returned to the Civil Aviation Safety Authority on cessation of Designated Aviation Medical Examiner Instrument of Approval, or otherwise recalled by the Chief Executive Officer/Director.
In the event a manual is lost, stolen or damaged beyond usability, the following process will apply:
(1) The manual holder is required to provide written report of the details of the loss, theft or damage to the Chief Executive Officer, as soon as practicable.
(2) If the loss of the manual is determined to be caused by any failure of care by the holder, a reimbursement and/ or replacement costs may be applied by the Civil Aviation Safety Authority.
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INTER-RELATION OF CIVIL AVIATION MANUAL SUITE
CORPORATE MANUALS
Volume 5 – Part E:PNG Medical Manual
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RECORD OF REVISIONS
This table is to be completed by the manual holder upon receipt of each authorized revision or amendment.
Amendments and additions are marked with change bars on the right side of the page. Refer to the ‘List of Effective Pages’ which indicates the pages that have changed.
To request a change, or make any recommendations to this manual, complete a Revision Request Form’ contained in the Quality Manual and forward to the manual originator or Controlling Authority.
Rev. Effective Entered Insert Rev. Effective Entered Insert No. Date By Date No. Date By Date 0 01/06/2016 1 30/11/2017
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LIST OF EFFECTIVE PAGES
Page No. Rev. No. Effective Date Page No. Rev. No. Effective Date
Preliminary
I 1 30/11/17
II 1 30/11/17 Part 3
III 1 30/11/17 1-42 1 30/11/17
IV 1 30/11/17
V 1 30/11/17
Vi 1 30/11/17
VII 1 30/11/17
VIII 1 30/11/17
IX 1 30/11/17
X 1 30/11/17
XI 1 30/11/17
XII 1 30/11/17
XIII 1 30/11/17
Part 1
1-4 1 30/11/17
Part 2
1-38 1 30/11/17
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HISTORY OF REVISIONS
Rev. No Reference Areas Subjected To Change Effective Date
0.00 Initial Issue All pages 30/06/2017
0.01 All All pages 30/11/2017
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PRELIMINARY TABLE OF CONTENTS Page XI of XIII
TABLE OF CONTENTS
AUTHORIZATION ...... III
CONDITION OF USE ...... V
INTER-RELATION OF CIVIL AVIATION MANUAL SUITE ...... VII
RECORD OF REVISIONS ...... VIII
LIST OF EFFECTIVE PAGES ...... IX
HISTORY OF REVISIONS ...... X
TABLE OF CONTENTS ...... XI
DISTRIBUTION LIST...... XII
ABBREVIATIONS ...... XIII
SECTION 1: INTRODUCTION ...... 14
SECTION 2: PNG MEDICAL CERTIFICATION SYSTEM ...... 18
SECTION 3: CARDIOLOGY...... 56
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DISTRIBUTION LIST
DOCUMENT NUMBER NAME AND TITLE OF HOLDER
Master LIBRARY
001 DIRECTOR
002 CHIEF OPERATIONS OFFICER
003 EXECUTIVE MANAGER SAFETY REGULATION
004 PRINCIPAL MEDICAL OFFICER (PMO)
005 MANAGER PEL BRANCH
006 SENIOR PEL INSPECTOR
007 FCL INSPECTOR
008 AMEL INSPECTOR
09 ATSL INSPECTOR
010 MANAGER - FLIGHT OPERATIONS
011 MANAGER – AVIATION FACILITIES
Rev. No. 01 Civil Aviation Safety Authority of Papua New Guinea Revision Date: 30/11/2017 PNG MEDICAL MANUAL
PRELIMINARIES ABBREVIATIONS Page 1 of 1
ABBREVIATIONS
Rev. No. 01 Civil Aviation Safety Authority of Papua New Guinea Revision Date: 30/11/2017 PNG Medical Examiners’ - Medical Manual
Part 1 – Introduction Approved By: Principal Medical Officer Revision: 01 Date:30/11/ 2017
Table of Contents
Subsections to Part 1 are identified as: Page
Medical Examiners’ - Medical Manual ...... 1 1.1 About this Manual ...... 2 1.2 Who will use this Manual ...... 2 1.3 Structure of this Manual ...... 2 1.4 Copies of this Medical Manual ...... 3 1.5 Terminology ...... 3 1.6 Definitions ...... 3 1.7 Abbreviations ...... 3 1.1 About this Manual
This Medical Manual aims, in conjunction with the relevant legislation, to provide information, guidance, policy, and requirements relating to medical certification under the Civil Aviation Act 2000(as amended).
This document is to be used in conjunction with:
• The Civil Aviation Act 2000
• The Civil Aviation Rules (CARs) including Rule Part 67; • The General Directions and Emergency Directives issued by the Director of Civil Aviation; • Civil Aviation Authority (CAA) medical certification forms;
• Advice from the CAA Principal Medical Officer-Dr Robin Sios via e-mail [email protected]
Whenever an inconsistency occurs between this document and any legislation, the legislation prevails.
1.2 Who will use this Manual
This Medical Manual is published primarily for Medical Examiners (MEs) to assist them in discharging their civil aviation regulatory responsibilities. It may also provide a useful resource to those who hold or are applying for Papua New Guinea medical certificates.
1.3 Structure of this Manual
This Medical Manual is divided into 5 parts:
Part 1: Introduction
Part 2: The medical certification system
Part 3: Clinical aviation medicine
Part 4: General directions and emergency directives (WIP
Part 5: Appendices
In addition each part may contain annexed supportive documents.
Civil Aviation Safety Authority of Papua New Guinea– November 2017 Part 1 – Introduction 2 1.4 Copies of this Medical Manual
This Medical Manual is intended to be accessed via the CASA website. No printed copies are provided by the CASA. Users who refer to printed copies of this Medical Manual must ensure that they are using the most up-to-date version.
Medical Examiners will be advised, by e-mail, when updated versions of this Medical Manual are available on the CASA website.
1.5 Terminology
Terms used in the civil aviation regulatory environment can be found at Section 3 of the Civil Aviation Act 2000 as well as interpretation sections at the start of some parts and sections of the Civil Aviation Act 2000 (e.g.PART IVA – Medical Certification), in Civil Aviation Rule Part 1 and Part 67.03, and in section 64G-General Directions and Emergency Directives.
1.6 Definitions
Throughout this document:
• The Act means the Civil Aviation Act 2000(as amended);
• The Director means the Director of Civil Aviation;
• The Delegate means a Medical Examiner with delegation to act on behalf of the Director, but only in accordance with the terms of the delegated authority;
• Medical standards mean the medical standards contained within Civil Aviation Rule Part 67;
• Part 67 means Civil Aviation Rule Part 67;
• The Rules mean the Civil Aviation Rules.
1.7 Abbreviations
Throughout this document the abbreviations mean as follows:
AMC Accredited Medical Conclusion
CAA Civil Aviation Authority
CAR Civil Aviation Rule
Civil Aviation Safety Authority of Papua New Guinea– November 2017 Part 1 – Introduction 3 GD General Direction
ME Medical Examiner
ME1 Medical Examiner 1
ME2 Medical Examiner 2
MO CAA Medical Officer
SME Special Medical Examiner
PMO CASA PNG Principal Medical Officer
Civil Aviation Safety Authority of Papua New Guinea - November 2017 Part 1 – Introduction 4 PNG Medical Examiners’ - Medical Manual
Part 2 – The Medical Certification System Approved By: Principal Medical Officer Version: 02 Date: 30/11/2017
Table of Contents
Subsections to Part 2 are identified as: Page
Medical Examiners’ - Medical Manual ...... 1 2.1 Introduction ...... 2 2.2 Legislation ...... 2 2.3 Application for a Medical Certificate ...... 3 2.4 Examination by Medical Examiner ...... 5 2.5 Use of General Directions (GDs) ...... 7 2.6 Assessment by Medical Examiner ...... 11 2.7 Extending a Medical Certificate ...... 19 2.8 Issue of Medical Certificate ...... 21 2.9 Communication ...... 29 2.10 Review of Assessment by CASA ...... 31 2.11 Change in Medical Condition / Suspension Process ...... 32 2.12 Review of Director’s decision by the Convener ...... 36 2.13 Replacement Certificate ...... 37 2.14 Medical Examiner absence ...... 38 2.1 Introduction
This part of the Medical Manual describes the administration procedure(s) that may be relevant when an applicant applies for a medical certificate, or when advising a medical certificate holder.
2.2 Legislation
On May 2016 an amendment to the Civil Aviation Act 2000 (the Act) established a new medical certification system. At the core of this system are Medical Examiners (MEs) who are designated as such by being issued a delegation. This delegation is an Aviation Document, the privileges of which enable the ME to conduct examinations for a specified class of aviation medical certificates as described in the Civil Aviation Rules (the rules).
Medical Examiners may also be delegated certain powers and functions of the Director of Civil Aviation (the Director), such as the power to issue medical certificates. Only the Director has the power to suspend or revoke a medical certificate under section 64I of the Act.
The rules are made by the Minister for Civil Aviation under the Act. The medical standards are prescribed in Civil Aviation Rules (CAR) Part 67.
General Directions (GDs) are issued by the Director under section 64G of the Act. They are items of legislation and as such are mandatory. They provide direction(s) to MEs in relation to the conduct of medical examinations, and other requirements. In that regard they address matters of a clinical nature, refer to subsection 2.5 – Use of General Directions. Links to the GDs are in Part 4 of this Medical Manual.
Civil Aviation Safety Authority of PNG-June 2016 Part 2 – The Medical Certification System 2 2.3 Application for a Medical Certificate
Primary Legislation: Civil Aviation Act s48,49
Secondary Legislation: CAR Part 67.51 to 67.55 Form:
Application for Medical Certificate (CAA form 67/02)
To be completed by: Applicant
For the purpose of certification an “Application for Medical Certificate” form must be completed. It is available on the Civil Aviation Authority (CASA) website. The applicant is responsible for accurately completing the Application for Medical Certificate. This should include explanations of any positive answers in the space provided under question 31, or on a separate sheet if necessary. The application is to be signed in front of the ME prior to the commencement of any examination, investigation, or assessment.
The ME must ensure that the form has been completed in full prior to proceeding further with the examination.
As the application includes a declaration, it is important that the ME does not complete the form on behalf of the applicant or make any changes to the entries made by the applicant. Given that the Application for Medical Certificate is the responsibility of the applicant, the ME should sign only in the final section as a witness to the applicant signing the form. The ME should ensure that the consent on the last page of the application has not been altered by the applicant.
The ME who first receives the completed Application for Medical Certificate must forward a copy of the front page to the CASA within five (5) working days of the application being made (the page may be faxed or emailed to [email protected]). This is important in order to inform the CASA PEL Branch that an application has been made with a particular ME.
Civil Aviation Safety Authority of PNG –Nov 2016 Part 2 – The Medical Certification System 3 Key Points:
Applicant to fill in an application with no omissions.
Applicant to expand on “yes” answers in the space provided, or on a separate sheet as necessary.
Applicant to sign the application in front of the ME.
Medical Examiner to identify the applicant and witness the signature prior to any questioning or examination.
Medical Examiner must not write on the application form except for signing.
The ME must forward to CASA the front page of the application within 5 working days.
Civil Aviation Safety Authority of PNG – Nov 2017 Part 2 – The Medical Certification System 4 2.4 Examination by Medical Examiner
Primary Legislation: Civil Aviation Act s64B(1) refers to “the report of the medical examiner”. Secondary Legislation: CAR 67.57
Form: Medical Examination Report
To be completed by: Medical Examiner
Once a properly completed Application for Medical Certificate has been received, the ME can commence history taking, examination and investigation as necessary.
2.4.1 Medical Examination Report This form is the examining ME’s responsibility and contains the following:
• Confirmation by the ME of the applicant’s identity, refer to subsection 2.4.2 – Identification of applicant;
• Relevant medical history (including follow-up questioning concerning positive responses made in the application and any other matter of clinical relevance);
• Details concerning height and weight, blood pressure and pulse, urinalysis, electrocardiogram and blood lipid evaluations;
• Cardiovascular risk assessment;
• Systems review of the applicant;
• Spirometry;
• Dates of tests conducted;
• Report of any other matters identified;
• Signature, date and stamp of the ME.
If additional space is required the ME should attach additional page(s) to the Medical Examination form.
If the ME has the appropriate delegation(s), that ME can assess the applicant for the issue of a Medical Certificate. Refer to subsection 2.6 – Assessment by Medical Examiner.
If not, the necessary report(s) must be forwarded to a ME who holds the appropriate delegation(s).
Civil Aviation Safety Authority of PNG– Nov 2017 Part 2 – The Medical Certification System 5 2.4.2 Identification of applicant Under rule 67.55(2) an applicant must produce a current PNG Passport, a current PNG Driver Licence, or an equivalent photographic identification that is acceptable to the Director.
Advisory Circular AC 67-1 Original. Lists equivalent forms of photographic identifications that are acceptable to the Director.
The ME should attach a photocopy of the photographic identification produced by the applicant at the time of a first application.
Key Points:
The examining ME is to only write comments on the medical examination report, not on the application form.
The examining ME must complete the examination in full and attach any other relevant documentation.
The examining ME must submit the application and the examination reports without delay to the ME who will be conducting the assessment, if different.
Civil Aviation Safety Authority of PNG– Nov 2017 Part 2 – The Medical Certification System 6 2.5 Use of General Directions (GDs)
Primary Legislation: Civil Aviation Act 64G
Secondary Legislation: CAR 67.57, 67.67, 67.103, 67.105 and 67.107
Form: Not Applicable
Use by: Medical Examiner conducting examination and Medical Examiner conducting the assessment.
The Act states that the Director may issue General Directions in relation to-
• Conducting examinations of applicants and licence holders and reporting the results of those examinations to the Director; and
• providing exceptions for temporary medical conditions to the reporting requirements set in section 64C, refer to subsection 2.11 - Change in Medical Condition / Suspension process; and
• specifying the requirements of examinations or other clinical matters, which must be reasonable, including but not limited to:
- the medical content of examinations;
- the interpretation and analysis of results of examinations;
- the significance of results of examinations for the purpose of determining whether or not an applicant is eligible for a medical certificate under section 64B.
General Directions are items of legislation and as such must be adhered to. A brief description of some of the GDs is offered below:
2.5.1 Timetable for Routine Examinations GD This GD prescribes the timing of routine examinations. An important feature of this GD is the series of tables that detail the examination requirements needed to issue a certificate and includes examples. Here are other examples.
Example 1: A 43 years old applicant presents for a first examination for issue of a Class 2 certificate.
The requirements are those for an initial general medical examination as demonstrated in the first line of the table “Class 2 medical certificate”.
Civil Aviation Safety Authority of PNG– Nov 2017 Part 2 – The Medical Certification System 7 Thus the applicant will need, as per the first medical examination requirements:
12 lead ECG, Cardio-vascular risk estimation – only if note 1 applies, blood lipids estimation and blood sugar estimation, a chest X-ray – only if note 2 applies, Spirometry, Audiometry – refer to note 3, and Colour vision testing.
Part 2 Class 2 medical certificate Timing of 12-lead ECG Cardio- Blood lipids Chest X-ray Spirometry Audiometry Colour routine vascular risk estimation & vision examination estimation Blood sugar screening estimation examin-ation (Ishihara) First general 9 9 medical 9 if note 1 9 if note 2 9 9 see note 3 9 examination applies applies Notes: 1. This examination is required if the applicant is 35 years of age or older.
2. This examination is required only if the applicant’s history indicates a high likelihood of asymptomatic pulmonary disease. An example of such history is if the applicant has had a prolonged stay in an area in which infective pulmonary disease is endemic.
3. Routine periodic audiometry is only required for class 2 applicants who undertake Instrument Flight Rules flights. If audiometry is not undertaken as specified in the schedule then any medical certificate that is issued must be endorsed “Not valid for IFR flight”.
Example 2: The same applicant presents again at age 45 for a subsequent examination for re-issue of his Class 2 medical certificate.
One needs to look at the relevant age. This is the current age of 45 plus the age(s) in between the age of 43 (when he had his last examination) and the current age of 45. In this instance the ‘in between age’ is 44.
Part 2 Class 2 medical certificate Timing of routine 12-lead ECG Cardiovascular Blood liplids Spirometry Audiometry examination risk estimation estimation & Blood sugar estimation Age 43 Age 44 9 9 9 9 see note 3 Age 45 Thus the applicant needs: 12-lead ECG, Cardio-vascular risk estimation, blood lipids estimation and blood sugar estimation and Audiometry – refer to note 3.
Civil Aviation Safety Authority of PNG-Nov 2017 Part 2 – The Medical Certification System 8 Example 3: An applicant aged 65 presents for a subsequent Class 1 examination. His last examination was at age 64. The examinations required under the GD “timetable for routine examinations” are:
Part 1 Class 1 medical certificate Timing of routine 12-lead ECG Cardiovascular Blood lipids Spirometry Audiometry examination risk estimation estimation & Blood sugar estimation Age 63 Age 64 9 9 9 9 Age 65 The examinations required under the current age of 65: Nil.
If the last examination had occurred at age 63, there would be an age in between the current age of 65 and the age at the time of the last examination. The examinations required at age 64 would have to be completed.
2.5.2 Examination Procedures GD This GD prescribes how to conduct, interpret and report a number of examinations as well as their validity periods. MEs should become familiar with this GD, which is by and large self-explanatory.
2.5.3 Clinical GD(s): These GDs prescribe which examination(s) or investigation(s) are to be conducted in relation to specific medical conditions and how to interpret and analyse tests and reports. The Impaired Hearing and Hearing Aids GD is the first clinical GD to be available.
Clinical GDs allow MEs to determine if particular conditions are safety relevant and assist in deciding if an applicant meets the standard prescribed in CAR Part 67.
Medical Examiners having any difficulty with the interpretation of a clinical GD are advised to contact the CASA PNG Principal Medical Officer.
2.5.4 Conditions that do not need reporting GD (Temporary Medical Conditions): This GD (still under development) describes changes in medical condition that do not need reporting to the Director.
Civil Aviation Safety Authority of PNG – Nov 2017 Part 2 – The Medical Certification System 9 Key Points:
The GDs prescribe:
- The timing of routine examinations.
- The content of examinations.
- The interpretation of examination results.
- The reporting of examinations.
The ME:
- Must apply the correct GD to the assessment being performed.
- Must record on the Medical Assessment Report the clinical GD applied to the assessment, if any.
Civil Aviation Safety Authority of PNG – Nov 2017 Part 2 – The Medical Certification System 10 2.6 Assessment by Medical Examiner
Primary Legislation: Civil Aviation Act s64B
Secondary Legislation: CAR 67.59 – 67.61
Form: Medical Assessment Report (CAA form 24067-003)
Conducted by: Medical Examiner with delegation to issue certificates
The Act [s64B(1)] requires the Director to consider the report of the ME for certification assessment purposes. This report consists of:
• Completed and signed Application for a Medical Certificate (CAA form 67/02);
• Completed and signed Medical Examination Report ( CAA form 24067-002);
• Completed and signed Medical Assessment Report (CAA form 24067-003)
• All ancillary results and reports whether required by legislation, or likely to be helpful to the decision.
An ME with delegation to conduct the assessment can require, under section 64B(5), other tests, examinations, re-examinations, or the provision of further medical information as reasonably considered necessary. For instance, to routinely require a PSA in a healthy young male applicant may be unreasonable, but the same requirement in an older male applicant with symptoms suggestive of prostate problems may be reasonable.
Once the Director or ME has received the report he must assess:
• whether the applicant is eligible for certification, or
• the application can be considered using the flexibility process, or
• the issue of a medical certificate should be declined without considering the application of flexibility.
This decision-making process must be documented and reported on the Medical Assessment Report (MAR) (CAA 24067-003).
Completion of the MAR is the assessing ME’s responsibility and contains the following:
• Dates of tests and documents seen;
• Medical conditions that have been considered during the assessment;
• Required surveillance during the validity period of the medical certificate;
• Recommended surveillance at the time of a future application;
Civil Aviation Safety Authority of PNG – Nov 2017 Part 2 – The Medical Certification System 11 • Expiry dates if certification is an eligible decision;
• Decision concerning any restrictions or endorsements that are applied;
• Decision concerning eligibility. The options provided are eligible (for certification), ineligible (for certification), and deferred (assessment);
• Any relevant additional information;
• Signature, date and stamp of assessing ME.
Key Points:
Start the assessment as soon as practicable, considering the complete report and accompanying documentation.
Notify CASA within 5 working days of the commencement of the assessment unless CASA has already been informed of the application taking place, or the assessment can be completed and sent to CASA within 5 working days.
Ensure that any information missing on the Application form or the Medical Examination report is obtained.
Obtain any other test, examination, re-examination or results as necessary.
Assess eligibility for issue of a medical certificate – refer to subsection 2.6.1.
Complete the MAR inclusive of any restrictions or conditions to be imposed on the medical certificate.
2.6.1 Applicant meets the Medical Standards prescribed in CAR Part 67
Primary Legislation: Civil Aviation Act s64B
Secondary Legislation: CAR 67.59 – 67.61
General Directions: As relevant
Conducted by: Medical Examiner with delegation to issue certificates
If an applicant meets the medical standards, having regard to any relevant General Direction(s), the applicant is eligible under 64B(1)for the issue of a Medical Certificate (with conditions, restrictions or endorsements as appropriate). This is unless the applicant has any characteristic that may interfere with the safe exercise of the privileges to which the medical certificate relates. The MAR must be completed accordingly and an appropriate certificate issued.
Under s64B of the Act the Medical Certificate must be issued as soon as practicable but no
Civil Aviation Safety Authority of PNG- Nov 2017 Part 2 – The Medical Certification System 12 later than 30 working days after completing or receiving the reports from the ME. If further reports are needed the time spent waiting for the reports does not form part of the 30 days time limitation.
Key Points – Applicant meets the medical standards:
Medical Examiner to ensure compliance with any relevant GD.
Medical Examiner to issue certificate ASAP but no later than 30 working days after receiving the ME’s report.
Medical Examiner to ensure all required medical reports have not expired at the time of issue.
2.6.2 Applicant does not meet the Medical Standards of CAR Part 67
Primary Legislation: Civil Aviation Act s64B
Secondary Legislation: CAR 67.59 – 67.61
Form: Not Applicable
Conducted by: Medical Examiner with delegation to issue certificates
If, having regard to any relevant General Direction(s), the ME determines that an applicant fails to meet the standards prescribed in CAR Part 67, consideration can be given to the exercise of statutory flexibility as provided for by s64B(2) and (3) of the Act.
The ME should carefully consider the rules and the relevant GDs to determine if the applicant meets the standard. This is to avoid assessing someone as meeting the standards when this is not the case, or conversely following the flexibility pathway and seeking an Accredited Medical Conclusion (AMC) unnecessarily.
Example 1: A Class 1 certificate applicant suffers from well controlled hypertension and the cardiovascular risk assessment is acceptable according to the GD Examination Procedures. The applicant does meet the standard according to CAR 67.105(b), unless another section of the rules or GDs dictates otherwise.
Example 2: A Class 2 applicant has diabetes controlled with Metformin, it is well controlled and the CV risk is acceptable according to the Examination Procedures GD. In that case, according to CAR 67.107 the applicant meets the standard with “on-going medical supervision and control”,
Civil Aviation Safety Authority of Papua New Guinea – Nov 2017 Part 2 – The Medical Certification System 13 unless another section of the rules or GD dictates otherwise. If the applicant was using a Sulphonylurea he may not meet the standard according to CAR 67.107.
Example 3: A Class 3 applicant has amblyopia with a visual acuity in one eye of 6/18. He has been certificated with this impairment for many years and the situation is stable. He does not meet the standard prescribed in CAR 67.109. Thus this applicant can only be certificated via the flexibility pathway. Identification of experts must be sought in order to obtain an Accredited Medical Conclusion (AMC).
If the ME conducting the assessment considers that flexibility should not be exercised, the alternative is to determine that the applicant is “ineligible” for the issue of a Medical Certificate,
The exercise of flexibility, described in s64B(3) of the Act, requires fulfilment of the following three conditions:
• An AMC indicates that in special circumstances the applicant's failure to meet any medical standard prescribed in the rules is such that the exercise of the privileges to which a medical certificate relates is not likely to jeopardise aviation safety; and
• The relevant ability, skill, and experiences of the applicant and operational conditions have been given due consideration; and
• The medical certificate is endorsed with any restrictions, conditions, or endorsements when the safe performance of the applicant's duties is dependent on compliance with those restrictions, conditions, or endorsements.
When an ME assesses that an applicant does not meet the standards but wishes to apply flexibility, the ME should document this step on the MAR by specifying that the applicant is not eligible for a certificate under section 64B(1) and that the ME is considering issuing a certificate under flexibility. The box “deferred” or “ineligible” may be circled with the comment that this applies to s64B(1). This is important in order to clarify the legal process that is being followed. Circling “ineligible” without comment could be confused with ineligible without flexibility being pursued. For this reason circling the box “deferred” is preferable.
Civil Aviation Safety Authority of PNG – Nov 2017 Part 2 – The Medical Certification System 14 Applicant fails to meet CAR Part 67 medical standards
Class 1 – For Ops Class 1 – Single Class of other than single pilot pilot air ops carrying Class 2 Class 3 Certificate air ops carrying passengers passengers
Certificate Expiry Date
Restrictions/ Endorsements Result of Eligible Eligible Eligible Assessment Ineligible Ineligible Ineligible N/A Deferred Deferred Deferred
Additional Information: Ineligible under section 64B(1).
I elect to consider relying on flexibility under s64B(2) and will seek an Accredited Medical Conclusion.
Or, alternatively if flexibility is not considered.
Class 1 – For Ops Class 1 – Single Class of other than single pilot pilot air ops carrying Class 2 Class 3 Certificate air ops carrying passengers passengers
Certificate Expiry Date
Restrictions/ Endorsements Result of Eligible Eligible Eligible Assessment Ineligible Ineligible Ineligible N/A Deferred Deferred Deferred
Additional Information: I do not elect to rely on flexibility, certificate declined
If the ME considers that the applicant does not meet the standards prescribed in CAR Part 67 but wishes to pursue the flexibility route, the applicant needs to be informed accordingly (refer to subsection 2.6.2.1 - Accredited Medical Conclusion).
If the certificate is declined the applicant is to be informed in writing without delay of the ME’s decision. The applicant is also to be informed of the right to seek review of, or appeal against the ME’s decision, refer to subsection 2.12 - Review of Director’s decision by the Convener.
Civil Aviation Safety Authority of PNG– Nov 2017 Part 2 – The Medical Certification System 15 Key Points – Applicant does not meet the medical standards:
Applicant is not eligible under s64B(1) (does not meet the standard) and the application of flexibility may be considered under s64B(2) and (3), or
Applicant is not eligible under s64B(1) (does not meet the standard) the application of flexibility is not considered appropriate by the ME.
Medical Examiner to ensure the applicant is informed in writing of the process and any right of review.
2.6.2.1 Accredited Medical Conclusion
Primary Legislation: Civil Aviation Act s64A(1) - s64B(2)
Secondary Legislation: CAR 67.75
Form: Accredited Medical Conclusion – Request for Identification of Experts (CAA form
24067-300) Conducted by: Expert(s) identified by the Director for the case concerned.
Action by the ME:
The AMC process provides individual case consideration for applicants who do not meet the medical standards. If an applicant fails to fulfil the standards prescribed in CAR Part 67 then an AMC may be sought in order to consider issuing a certificate under the flexibility provisions of the Act. The decision to apply flexibility is entirely discretionary.
To seek an AMC the ME must make an application to the Director for identification of expert(s), via the Principal Medical Officer. A form is provided for this purpose and is available on the CASA website. The ME should state on the application if he/she is willing to be identified as an expert. See below for information that must be provided with the request.
Action by the Director (PMO):
The Director, or delegate, will then identify medical expert(s) acceptable for the purposes of conducting the AMC for the case concerned.
If the ME does not wish to be identified as an expert, all the information in relation to the application should be forwarded with the request to the PMO. Otherwise only the information relating to the specific condition(s) under consideration should be forwarded to the PMO.
In practice, one or more of the following scenario(s) may occur.
Civil Aviation Safety Authority of PNG – Nov 2017 Part 2 – The Medical Certification System 16 No further information is required by the Director to identify the expert(s):
If the Director is satisfied that he can identify expert(s) on the basis of the information provided, he will do so. The ME will receive a letter providing the name(s) of the expert(s).
Further information is required by the Director to identify the expert(s):
If the Director cannot identify the expert(s) on the basis of the information available he will seek additional information prior to identifying the acceptable expert(s).
Medical Examiner is identified as acceptable expert:
If the ME is identified as the only expert, the ME must conduct and document an AMC. The expert can ask for advice from the CMU, and consult with flight operations or any other appropriate expert as may be necessary.
In some cases the Director may identify the ME as expert together with another expert.
Medical Examiner is not identified as an acceptable expert:
The expert(s), who are often Medical Officers employed by the CASA, may need further information and call upon the ME, acting under delegation, to require further tests. The expert(s) may also approach the applicant directly, and seek to obtain the necessary further information.
2.6.2.2 Communication of Accredited Medical Conclusion Medical Examiners named by the Director as acceptable experts for the case concerned should document their own AMC in writing. This is best done on a separate document from the MAR unless very short. The AMC should identify the condition(s) considered and express the special circumstances that have been identified as such that flight safety will not be compromised.
In the case of AMCs conducted by the PMO, once an AMC is reached, a letter detailing the Accredited Medical Conclusion will be sent to the ME.
Once in possession of an AMC, the ME can continue with the assessment with due consideration to:
• The relevant ability, skill, and experiences of the applicant and the operational conditions; and
• The applicable conditions, restrictions, or endorsements when the safe performance of the applicant's duties is dependent on compliance with those restrictions, conditions, or endorsements.
Civil Aviation Safety Authority of Papua New Guiena – Nov 2017 Part 2 – The Medical Certification System 17 The AMC will generally list these as part of the special circumstances identified. The ME can be more restrictive but cannot be less restrictive than any restrictions or conditions identified by the AMC as constituting special circumstances.
Key Points – Accredited Medical Conclusion:
The assessing ME:
- Must request identification of experts using the form provided on the CASA website; include adequate information on the form.
- Should indicate if willing and available to act as expert for the case concerned.
- Should send to CASA all information relevant to the condition(s) under consideration.
- Should send complete information relating to the application if not wishing to be identified as an expert.
- If identified as experts, MEs should document their own AMC.
- Must complete assessment as soon as practicable once in possession of the AMC.
Civil Aviation Safety Authority of PNG – Nov 2017 Part 2 – The Medical Certification System 18 2.7 Extending a Medical Certificate
Primary Legislation: Civil Aviation Act s64E
Secondary Legislation: CAR 67.63
Form: Not Applicable
Conducted by: Medical Examiner conducting the assessment
Section 64E of the Act states “The Director may, on receiving an application for a medical certificate from a licence holder before the expiry of his or her existing medical certificate, grant an extension of no more than 45 days from the expiry date of the licence holder’s existing medical certificate with any additional conditions, restrictions, or endorsements as the Director considers necessary.”
This is a useful option for an ME who is not yet able to issue a medical certificate for some valid and reasonable reason. To legitimately exercise the extension provision an ME must consider the potential for abuse and must be satisfied that there is no risk to flight safety in exercising this option.
To consider an extension the following conditions will need to be met:
• An application (completed, signed and witnessed, on CAA form 67/02) must have been received;
• The existing Medical Certificate for the Class applied for has not expired;
• The ME is satisfied that there is no aviation safety risk in extending the medical certificate;
• The ME has delegation to extend a medical certificate under s64E of the Act (generally MEs who have delegation to issue certificates also have delegation to extend).
Any extension issued is to be in one of the formats shown in the following examples. A suitable electronic form can also be obtained from the CASA PEL Branch or PMO. Alternatively the third party medical certification software (J. Faris), used by many MEs, also provides a suitable format.
A copy of the certificate extension must be sent to CASA PEL Branch within 5 working days for data entry into the CASA register.
Note: Care must be taken to only extend the non expired dates on the certificate.
Civil Aviation Safety Authority of Papua New Guinea – Nov 2017 Part 2 – The Medical Certification System 19 Example: Reprint of the existing medical certificate and endorse as below.
Conditions, Restrictions, or Endorsements Applicable:
002 Bifocal spectacles must be worn 007 Spare spectacles must be readily available
Certificate Extended until 20 May 2009 Add any additional restriction
Signed Stamp
Alternatively the medical certificate can be modified to show on the front the extended expiry date, the date signed, and the usual stamp and signature, with the back endorsed:
Conditions, Restrictions, or Endorsements Applicable:
002 Bifocal spectacles must be worn 007 Spare spectacles must be readily available
Add any additional restriction
This is an extension of the certificate issued on dd/mm/yyyy
Key Points:
Medical Examiner must be satisfied that he or she is working with a valid application and medical certificate.
Medical Examiner must be satisfied of the absence of any safety issue(s) arising from the extension.
Medical Examiner must ensure that the reason for extending is reasonable.
Medical Examiner may extend the existing medical certificate for up to 45 days from the expiry date; the extension must be clearly recorded and readily apparent on the certificate.
Medical Examiner to send a copy of the extension certificate and the MAR in progress to CASA within 5 working days.
The important point is that the medical certificate must clearly indicate which certificate class was extended, until when, by whom and the date when extended.
Civil Aviation Safety Authority of PNG – Nov 2017 Part 2 – The Medical Certification System 20 2.8 Issue of Medical Certificate
Primary Legislation: Civil Aviation Act s64B
Secondary Legislation: CAR 67.59
Form: Not Applicable
Action by: ME conducting the assessment
2.8.1 Medical Certificate Format The Medical Certificate must be issued in a format acceptable to the Director. A suitable electronic form can be obtained from the PMO.
Example: Medical Certificate
Civil Aviation Safety Authority of Papua New Guinea Medical Certificate Issued pursuant to section 64B of the Civil Aviation Act and in accordance with the Act
Surname Blogg Client No: 12345
Date of Given names: John 17/09/1950 Birth: Expiry Dates Class 1 for single pilot air operations carrying passengers 29/11/2009
Class 1 for operations other than single pilot air operations carrying passengers 29/05/2010
Class 2 29/05/2011 ME Stamp:
29/05/2009 Date signed: Signature of Director or Delegate
Conditions, Restrictions, or Endorsements Applicable:
002 Bifocal spectacles must be worn 007 Spare spectacles must be readily available
2.8.2 Effective Start Date A medical certificate issued under the Act commences on the day when the medical assessment concludes and the certificate is issued. Thus the medical certificate commencement date is not calculated based on the date of the examination.
Civil Aviation Safety Authority of PNG – Nov 2017 Part 2 – The Medical Certification System 21 A medical certificate remains in force until a subsequent or replacement medical certificate is issued, refer to CAR 67.59(d).
2.8.3 Validity period of a Medical Certificate The duration of the Medical Certificate cannot exceed the maximum duration specified in CAR Part 67.61. The delegate is able to decide to issue a certificate of a lesser duration if appropriate for safety considerations.
However, CAR Part 67.61(c) allows for the issue of a slightly longer duration than prescribed in CAR Part 67.61(a) in some circumstances. The new applicable expiry date may be the date that would have applied had the certificate been issued on the expiry date of the current medical certificate if:
• the new certificate is issued during the 30 days prior to the expiry date of the current certificate; and
• the current / existing certificate has not been extended, and
• the ME determines that the applicant is eligible for the maximum period permitted under CAR Part 67.61(a).
The purpose of these provisions is to allow an applicant to obtain a certificate that expires on the same calendar date each year of issue, thus avoiding the so called “creep factor” by which a few days may be lost at each certification.
Example: Applicant for a Class 2 certificate is 45 years old and eligible for a certificate of 2 years duration. Existing Class 2 certificate expiry date: 25 June 2009 Assessment date and issue of certificate: 10 June 2009 New maximum permitted expiry date: 25 June 2011 This option would not be available had the assessment been completed on 22 May 2009, that is over 30 days prior to the expiry date of the existing certificate.
2.8.3.1 Special case pertaining to a Class 2 certificate when an applicant for a Class 1 and 2 certificate is over the age of 40 and less than 43 When the applicant is over the age of 40, a class 2 certificate can be issued for a maximum validity period of 2 years. This means that a new Class 2 certificate may well lapse prior to the date when a previously issued Class 2 certificate, valid for 5 years, would have lapsed.
Civil Aviation Safety Authority of PNG-Nov 2017 Part 2 – The Medical Certification System 22 Example: A 41 year old pilot was issued with a Class 1 and Class 2 medical certificate just before turning 40. The Class 1 certificate is about to expire and the pilot seeks a new certificate. The Class 2 medical certificate issued a year ago is valid for a maximum of 5 years and will lapse just before the pilot turns 45. If a new Class 2 certificate is issued now, the expiry date will be at age 43, which is before the expiry date of the previous Class 2 certificate.
Thus a Class 1 certificate only may be assessed and issued, allowing the existing Class 2 to run its course, if believed to be safe. This problem cannot arise once the pilot turns the age of 43.
2.8.3.2 Class 1 certificate, at age 40 or over The duration of a class 1 certificate, at the age of 40 or over depends on the type of operations that are intended. In practice the Class 1 certificate can be treated as two separate certificates. One with 6 months duration for one scope of operations, and one of 12 months duration for another scope of operations.
For this reason, under rule 67.61, the certificate can be issued with two expiry dates pertaining to the two scopes of operations as follows:
6 month expiry date: for single pilot air operations carrying passengers for operations other than single pilot air operations carrying 12 month expiry date: passengers Operators and pilots are responsible for knowing which date is applicable to their different operations.
Example:
Civil Aviation Safety Authority of Papua New Guinea Medical Certificate Issued pursuant to section 64B of the Civil Aviation Act and in accordance with the Act
Surname Blogg Client No: 12345
Date of Given names: John 17/09/1950 Birth: Expiry Dates Class 1 for single pilot air operations carrying passengers 28/11/2009
Class 1 for operations other than single pilot air operations carrying passengers 28/05/2010
Class 2 28/05/2011 ME Stamp:
28/05/2009 Date signed: Signature of Director or Delegate
Note: Whenever a pilot is less than 40 years old, both Class 1 expiry dates should still be completed, using the same 12 month expiry dates. This is important as filling in only the second
Civil Aviation Safety Authority of PNG – Nov 2017 Part 2 – The Medical Certification System 23 expiry may lead licence holders and operators to believe that the applicant can only fly “for operations other than single pilot air operations carrying passengers”, or alternatively can only fly “single pilot air operations carrying passengers” depending on which expiry date has been completed.
2.8.4 Endorsement(s) on a medical certificate
Primary Legislation: Civil Aviation Act s64B(3) & (4) – 64I
Secondary Legislation: Not Applicable
General Directions: Any existing GD relevant to the condition(s) considered
Action by: Medical Examiner conducting the assessment
Under section 64B(4) of the Act “the Director may impose any conditions, restrictions, or endorsements on a medical certificate issued under this section”.
The purpose of restrictions, conditions, and endorsements is to ensure flight safety. They are a risk management tool. Such conditions, restrictions and endorsements affect the privileges related to the Medical Certificate.
Conditions, restrictions and endorsements:
• Should be clear and concise, using either plain English or aviation terminology defined in legislation;
• Operational restrictions, such as those not allowing the certificate holder to undertake some types of operations, should be on the medical certificate;
• Other restrictions and conditions, such as medical restrictions and conditions of surveillance to be carried out during the validity period of the certificate, may be in a letter referred to on the medical certificate, refer to example 1, 2 and 3.
The use of code numbers is not compulsory. Code numbers assist electronic data acquisition and improve consistency. Their use is encouraged, and when used, the standard wording associated with the code number should preferably be used.
A list of common endorsements is available under Part 5 - Annexes and References (still under development).
Civil Aviation Safety Authority of PNG – Nov 2017 Part 2 – The Medical Certification System 24 Conditions, restrictions and endorsements may:
Example 1: Ensure that the medical standards are met while flying: Distance spectacles must be worn. Requires that distance vision spectacles of the exact type worn when tested must be worn at all times when flying. This is to ensure that the prescribed visual acuity standards are met during flight.
Conditions, Restrictions, or Endorsements Applicable:
001 Spectacles (distance vision) must be worn.
Example 2: Eliminate or reduce a particular risk to flight safety: Not valid for night flying or IFR. Will reduce the risk of losing control of the aircraft when it is thought that the distraction and / or impairment resulting from a medical condition, migraine for instance, is unlikely to result in loss of control by day under Visual Flight Rules (VFR), but may result in such a consequence by night; or under Instrument Flight Rules (IFR).
Conditions, Restrictions, or Endorsements Applicable:
040 Not valid for IFR flights. 085 Not valid for night flying.
Civil Aviation Safety Authority of PNG – Nov 2017 Part 2 – The Medical Certification System 25 Example 3: Mitigate the risk to fight safety: Not valid for single pilot air operations carrying passengers: Will mitigate the risk in case of raised, but still acceptable, likelihood of an episode of incapacitation in these circumstances.
Civil Aviation Safety Authority of Papua New Guinea Medical Certificate Issued pursuant to section 64B of the Civil Aviation Act and in accordance with the Act
Surname Blogg Client No: 12345
Date of Given names: John 17/09/1950 Birth: Expiry Dates Class 1 for single pilot air operations carrying N/A passengers
Class 1 for operations other than single pilot air operations carrying passengers 29/05/2010
Class 2 29/05/2011 ME Stamp:
29/05/2009 Date signed: Signature of Director or Delegate
Conditions, Restrictions, or Endorsements Applicable:
Or
Conditions, Restrictions, or Endorsements Applicable:
132 NOT VALID FOR – carriage of passengers; glider towing; unpressurised flight above 8000 feet; flight over built-up areas (circuit exempt), IFR flying; international air navigation.
Civil Aviation Safety Authority of Papua New Guinea – Nov 2017 Part 2 – The Medical Certification System 26 Example 4: Ensure ongoing stability or control of a particular condition: Subject to medical surveillance in accordance with a letter dated
Conditions, Restrictions, or Endorsements Applicable:
059 Subject to medical surveillance as specified in Examiner’s letter dated – 08- May-2009.
2.8.5 Class 2 IFR Civil Aviation Rule Part 67 does not make special provisions for Class 2 IFR (Instrument Flight Rules) as was the case under the previous rule. A Class 2 medical certificate issued in accordance with CAR CAR Part 67 and the applicable GDs will automatically confer IFR privileges if satisfactory audiometry testing has been carried out in accordance with the GD Timetable for Routine Examinations.
If no audiometry has been carried out, the Class 2 certificate must be endorsed in accordance with this GD with the wording: “Not valid for IFR flights”.
Conditions, Restrictions, or Endorsements Applicable:
040 Not valid for IFR flights.
Civil Aviation Safety Authority of Papua New Guinea – Nov 2017 Part 2 – The Medical Certification System 27 Key Points:
A ME holding delegation should limit restrictions, conditions, and endorsements to those relevant to operational matters, or conditions that must be fulfilled during the validity period of the certificate to maintain certificate currency.
Conditions, restrictions and endorsements should be clear and concise, using either plain English or aviation terminology defined in legislation.
If using code numbers, consider using the standard wording associated with them.
Operational restrictions should be on the medical certificate.
If imposing non operational restrictions or conditions of use not otherwise listed in the standard list of endorsements, use preferably the endorsement code and wording: “020 restricted in accordance with letter dated
If imposing a condition of surveillance use preferably the code 059 and the wording: “059 subject to medical surveillance in accordance with a letter dated
Civil Aviation Safety Authority of Papua New Guinea – Nov 2017 Part 2 – The Medical Certification System 28 2.9 Communication
Primary Legislation: Not Applicable
Secondary Legislation: CAR 67.163 – 67.59(2) -
Form: Not Applicable
Action by: Medical Examiner conducting the examination
2.9.1 Communication with applicant The following documentation should be forwarded to the applicant immediately once the assessment has been completed:
• The laminated medical certificate;
• The original of the MAR;
• A letter or information sheet detailing the applicant’s obligations and responsibilities;
• If applicable a letter explaining any conditions, restrictions or endorsements, in particular those pertaining to new restrictions or surveillance requirements (this can be on the same letter as above, and should be current).
It is essential to carefully word any letter for maximum clarity. This is particularly important for letters that are referred to on the certificate detailing restrictions, or conditions of surveillance imposed on the certificate.
2.9.2 Communication with CASA Medical Examiners are encouraged to liaise closely with the CASA PEL Branch (email: [email protected] / [email protected]) or PMO (email: [email protected]) during any medical certification activities if unsure of any aspect of the process or any decision. Within five working days of receiving an Application for a Medical Certificate the ME should forward a copy of the front page of the application, to the CAA PEL Branch, unless the assessment can be completed and dispatched within that five working day period. This is critical to inform the CASA that a medical certificate application has been made with a particular ME. It also alerts the CASA when multiple applications are made by an individual. Within five working days of having assessed that an applicant is either eligible or ineligible for a medical certificate, a ME must forward the following details to the CASA: • Copy of any certificate(s) issued and any supporting documentation;
• Copy of the MAR;
• Copy of any letter to the applicant;
Civil Aviation Safety Authority of Papua New Guinea – JNov 2017 Part 2 – The Medical Certification System 29 • Original Application for a Medical Certificate;
• Original Medical History and Examination report;
• Copy of any investigations, results, reports, or consultations undertaken as part of the examination and assessment processes;
Any AMC, unless issued by CASA, and other consideration, discussion, or documentation felt to be relevant to the assessment decision.
Any correspondence to the CASA seeking advice should be placed on top of the paperwork to avoid being overlooked.
The ME should also send a copy of the MAR, certificate and letter to the applicant and to any SME who undertook the applicant’s medical examination.
The use of a document checklist is recommended to reduce the chance of omission.
Key Points:
Send the assessment and certification documentation within 5 working days (in practice a weekly mailing will achieve this), in the following order from top to bottom:
Copy of certificate, stamped, dated and signed, where applicable;
Copy of the MAR, stamped, dated and signed;
Copy of any letter to the applicant;
Original application and examination forms, stamped, dated and signed;
Copy of any documented AMC if conducted by the ME;
Original or good copy or of any ECG tracing;
Original or copy of any other reports;
Note: Any correspondence to CASA should be placed on top of this paper work to avoid being overlooked by CASA staff.
Civil Aviation Safety Authority of Papua New Guinea – Nov 2017 Part 2 – The Medical Certification System 30 2.10 Review of Assessment by CASA
Primary Legislation: Civil Aviation Act s64H(2) and s64I
Secondary Legislation: Not Applicable
Form: Not Applicable
Action by: PMO
The PMO performs a review of a selection of assessments. This review allows for the detection of errors and irregularities requiring further action by the delegated ME.
In particular s64H(2) of the Act provides the CASA with a Medical Certificate “claw back” option that can be exercised within 60 working days of certificate issue. Under this clause the Director may withdraw a medical certificate if he requires further information.
The Director does not need to have reasonable grounds to believe that a licence holder may be unable to exercise safely the privileges to which the certificate relates to exercise this option. It is a useful clause that enables the Director to obtain missing information.
One of the reasons for MEs being asked to forward assessments promptly is to allow the Director to exercise this “claw back” option, if necessary.
The Act (s64I) also provides the Director with a variety of powers for amendment, suspension, disqualification or even revocation of a Medical Certificate when he has reasonable grounds to believe that a licence holder may be unable to exercise safely the privileges to which the certificate relates, refer to subsection 2.11, or the Director has reasonable grounds to believe that a certificate has been issued other than in accordance with the legislation or the MEs delegated authority.
Key Points:
Early receipt of report by CASA is vital to enable the assessment review process by PMO to take place well within 60 days, and allow the Director to exercise his powers under section 64H of the Act.
Civil Aviation Safety Authority of Papua NewGuinea – Nov 2017 Part 2 – The Medical Certification System 31 2.11 Change in Medical Condition / Suspension Process
Primary Legislation: Civil Aviation Act s64C & s64I
Secondary Legislation: Not Applicable
Forms: Suspension Letter
Action by: Licence holder and Medical Examiner who is first informed of the Change in Medical Condition
2.11.1 Change in Medical Condition Licence holders, MEs, aviation operators and registered medical practitioners all have an obligation to report to the Director if they are aware of, or have reasonable grounds to suspect, any change in medical condition of a licence holder that may interfere with the safe exercise of the privileges to which the licence holder’s medical certificate relate.
2.11.2 Action by Licence Holder Section 64C of the Act stipulates a licence holder’s obligations in the case of a change in medical condition such as defined above:
• The licence holder must advise the Director as soon as practicable. In practice this will be by contacting the licence holder’s ME, or the PMO.
• The licence holder may not exercise the privileges to which the licence holder’s medical certificate relates.
It should be noted that changes in medication may at times constitute a change in medical condition such as defined above, and may need to be reported.
Temporary Medical Conditions are medical conditions as described in the relevant General Direction (still under development) that do not need to be reported.
Civil Aviation Safety Authority of Papua New Guinea –Nov 2017 Part 2 – The Medical Certification System 32 2.11.3 Action by Medical Examiner Medical Examiners need to be familiar with the powers they hold under their delegations, as this determines how information about changes in medical conditions are to be handled. Medical Examiner’s usually hold the relevant delegations appropriate to the class of certificate for which they can examine.
Thus a ME who does not have delegated powers in relation to the class of medical certificate affected, must report the change of medical condition to the Director who will then take appropriate action.
Where the Licence Holder IS unable to exercise safely …
“If the Director (or ME acting under delegation) has reasonable grounds to believe that an licence holder is unable to exercise safely the privileges to which the medical certificate relate the Director must . . .” - refer to s64I(2) of the Act for action referred to.
Where the Licence Holder MAY be unable to exercise safely …
“If the Director (or ME acting under delegation) has reasonable grounds to believe that the licence holder may be unable to exercise safely the privileges to which the medical certificate relates the Director may . . .” - refer to s64I(1) of the Act for action referred to.
Medical Examiners with delegation to issue certificates are generally able to impose conditions, place restrictions or endorsements on certificates of a class that they are able to issue. Such actions are limited to 10 working days with the possibility to extend for a further 10 working days. All such action must be notified to PMO as soon as practicable by sending a copy of all documents or information available. If no action is taken, this must also be documented.
If in doubt the ME should forward the information to, and seek advice from, PMO.
2.11.4 Process for suspension of certificate or imposition of conditions, restrictions or endorsements For the suspension or imposition of conditions, restrictions or endorsements of a medical certificate, the ME should liaise with PMO who will provide a brief report to the Director recommending enforcement actions. The Director will take the necessary action.
Civil Aviation Safety Authority of Papua New Guinea– Nov 2017 Part 2 – The Medical Certification System 33 2.11.5 Surrender of the medical certificate Section 64I(9) of the Act requires a licence holder to surrender a suspended, revoked, withdrawn or disqualified medical certificate to the Director, a person authorised by the Director, or a member of the police. This is not optional and is not left to the discretion of the ME. The Director may also require surrender of the certificate under section 24(3)(a) of the Act. Failure to comply is an offence under section 50A of the Act.
During any period of suspension it is appropriate for the ME, in his/her role as Director’s delegate, to act as safe keeper of the certificate, particularly if it is likely that the suspension may be cancelled soon. In such a case the ME should also inform the PMO that he/she is holding the medical certificate.
Civil Aviation Safety Authority of Papua New Guinea – Nov 2017 Part 2 – The Medical Certification System 34 If a notice of conditions, restrictions or endorsements has been issued the licence holder may hold on to the certificate until an amended certificate has been received.
Once an amended certificate has been received the original certificate must be surrendered to CASA.
Key Points:
In case of a change in medical condition that may interfere with the safe exercise of the privileges to which the licence holder’s medical certificate relate:
Licence holder may not exercise the privileges to which the medical certificate relates
Licence holder must advise the ME / Director ASAP, except for those temporary conditions listed in the GD – temporary medical conditions (still under development)
Director may or must suspend as appropriate
Suspension is for a maximum of 10 working days
Suspension can be extended for a further 10 working days
Suspension should be cancelled only by the ME who issued suspension, or by the Director
Director to discuss action taken with PMO ASAP, with any available documentation
The Director only can take action under s64I(7)(a), (c) or (d).
The Director will then take further action as appropriate.
Civil Aviation Safety Authority of Papua New Guinea – Nov 2017 Part 2 – The Medical Certification System 35 2.12 Review of Director’s decision by the Convener
Primary Legislation: Civil Aviation Act s64L
Secondary Legislation: Not Applicable
Form: Application for Review of Medical Certification Decision
Action by: Applicant and Medical Examiner conducting assessment
The Act (s64L) provides an applicant with the ability to seek a review by the convener of a decision made in relation to a Medical Certificate. Those decisions which can be reviewed by the Convener are specified in the Act (s64L).
To initiate a review the applicant must apply directly to the Convener, within 20 working days of the decision to be reviewed, in writing. For this reason the ME should promptly forward their decision to the applicant.
A form Application for Review of Medical Certification Decision is available on the CASA website. This application must be sent to the address below and not to the CASA. PNG
PNG CONVENER - PNG will engage the services of the NZ CONVENER as required
The ME should inform the applicant of this right of review when declining to issue a Medical Certificate or imposing significant conditions or restrictions. Natural justice requires this communication to be done promptly to allow the applicant to lodge an application within the time limitation.
Civil Aviation Safety Authority of Papua New Guinea – Nov 2017 Part 2 – The Medical Certification System 36 2.13 Replacement Certificate
Primary Legislation: Not Applicable
Secondary Legislation: CAR 67.77
Form: Letter to the Director Requesting a replacement certificate
Action by: Applicant
The holder of a medical certificate may apply in writing to the Director for a replacement certificate if the certificate is lost, stolen or destroyed or so damaged that the details on the certificate are no longer clearly legible.
In order to obtain a replacement certificate the holder must submit to the Director the appropriate application form with payment of the appropriate fee.
• If the certificate has been lost, stolen or destroyed the statutory declaration must be completed on the application form.
• If the certificate has been damaged no statutory declaration is required but the damaged certificate must be enclosed with the application.
A form Application for replacement of Medical Certificate CAA form 24067-407 is available on the CASA website.
Replacement certificates are issued only by CASA staff because of their access to any relevant information that may have come to light since the issue of the certificate.
Civil Aviation Safety Authority of Papua New Guinea – Nov 2017 Part 2 – The Medical Certification System 37 2.14 Medical Examiner absence
Medical Examiner absences of more than 5 working days should be notified to CASA (email is acceptable), to assist in case of an inquiry to CASA by an applicant.
In all cases of absence of any duration it is the responsibility of the ME to ensure that any applicant under consideration will not be disadvantaged by any delays resulting from the absence, for instance an applicant’s inability to work.
If such a situation may occur it is better to pass on the assessment to another ME prior to departure.
Whenever the CASA is advised of an ME absence and is made aware that an AMC is expected back by a certain date, CMU tries to provide the AMC in time, if all necessary information is available to do so.
Key Points: In case of absence by ME of more than 5 working days:
Notify the CASA of the absence
Notify the CASA of the applications being processed
Notify the CASA of the name of the ME(s) assessing the applications during your absence.
Civil Aviation Safety Authority of Papua New Guinea – Nov 2017 Part 2 – The Medical Certification System 38 Medical Examiners’ – Medical Manual
Part 3 - Clinical Aviation Medicine
3.1 Cardiovascular System
Table of Contents
Part 3 - Clinical Aviation Medicine ...... 1 3.1 Cardiovascular System ...... 1 3.1.1 General Considerations ...... 4 3.1.2 Hypertension: ...... 5 3.1.2.1 Considerations ...... 5 3.1.2.2 Information to be provided ...... 7 3.1.2.3 Disposition ...... 7 3.1.3 Cardiovascular Risk Assessment ...... 8 3.1.3.1 Considerations ...... 8 3.1.3.2 Information to be provided...... 10 3.1.3.3 Disposition ...... 10 3.1.4 Coronary Heart Disease: ...... 11 3.1.4.1 Considerations ...... 11 3.1.4.2 Information to be provided ...... 11 3.1.4.3 Disposition ...... 12 3.1.5 Mitral valve disease ...... 13 3.1.5.1 Considerations ...... 13 3.1.5.2 Information to be provided ...... 13 3.1.5.3 Disposition ...... 14 3.1.6 Aortic valve disease ...... 15 3.1.6.1 Considerations ...... 15 3.1.6.2 Information to be provided ...... 16 3.1.6.3 Disposition ...... 16 3.1.7 Tricuspid and Pulmonary valve disease ...... 17 3.1.7.1 Considerations ...... 17 3.1.7.2 Information to be provided ...... 17 3.1.7.3 Disposition ...... 17 3.1.8 Valve replacement or repair ...... 18 3.1.8.1 Considerations ...... 18 3.1.8.2 Information to be provided ...... 18 3.1.8.3 Disposition ...... 18 3.1 Cardiovascular System
3.1.9 Atrial Fibrillation (AF) and Atrial Flutter ...... 19 3.1.9.1 Considerations ...... 19 3.1.9.2 Information to be provided ...... 19 3.1.9.3 Disposition ...... 20 3.1.1 Atrial and ventricular premature beats ...... 21 3.1.1.1 Consideration ...... 21 3.1.1.2 Information to be provided ...... 21 3.1.1.3 Disposition ...... 21 3.1.2 Sinus node arrest and sinoatrial block ...... 22 3.1.2.1 Consideration ...... 22 3.1.2.2 Information to be provided ...... 22 3.1.2.3 Disposition ...... 22 3.1.3 Ventricular pre-excitation ...... 23 3.1.3.1 Considerations ...... 23 3.1.3.2 Information to be provided ...... 23 3.1.3.3 Disposition ...... 23 3.1.4 Atrio-Ventricular block (AV block) ...... 24 3.1.4.1 Considerations ...... 24 3.1.4.2 Information to be provided ...... 24 3.1.4.3 Disposition ...... 24 3.1.5 Left Bundle Branch Block (LBBB) ...... 25 3.1.5.1 Consideration ...... 25 3.1.5.2 Information to be provided ...... 25 3.1.5.3 Disposition ...... 25 3.1.6 Right Bundle Branch Block ...... 26 3.1.6.1 Consideration ...... 26 3.1.6.2 Information to be provided ...... 26 3.1.6.3 Disposition ...... 26 3.1.7 Left anterior and Left posterior Hemi-Block ...... 27 3.1.7.1 Consideration ...... 27 3.1.7.2 Information to be provided ...... 27 3.1.7.3 Disposition ...... 27 3.1.8 QT Prolongation ...... 28 3.1.8.1 Considerations ...... 28 3.1.8.2 Information to be provided ...... 28 3.1.8.3 Disposition ...... 28 3.1.9 Brugada syndrome ...... 29 3.1.9.1 Considerations ...... 29 3.1.9.2 Information to be provided ...... 29 3.1.9.3 Disposition ...... 29 3.1.10 Implantable Devices - Pacemaker ...... 30
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3.1.10.1 Considerations ...... 30 3.1.10.2 Information to be provided ...... 30 3.1.10.3 Disposition ...... 30 3.1.11 Cardiomyopathy ...... 32 3.1.11.1 Considerations ...... 32 3.1.11.2 Information to be provided ...... 32 3.1.11.3 Disposition ...... 32 3.1.12 Pericarditis ...... 33 3.1.12.1 Considerations ...... 33 3.1.12.2 Information to be provided ...... 33 3.1.12.3 Disposition ...... 33 3.1.13 Aortic Aneurysm ...... 34 3.1.13.1 Consideration ...... 34 3.1.13.2 Information to be provided ...... 34 3.1.13.3 Disposition ...... 34 3.1.14 Peripheral Vascular Disease...... 36 3.1.14.1 Considerations ...... 36 3.1.14.2 Information to be provided ...... 36 3.1.14.3 Disposition ...... 36 3.1.15 Venous Thrombo-Embolism and Anticoagulation ...... 37 3.1.15.1 Considerations ...... 37 3.1.15.2 Information to be provided ...... 38 3.1.15.3 Disposition ...... 38 3.1.16 Congenital Heart Disease ...... 39 3.1.16.1 Considerations ...... 39 3.1.16.2 Information to be provided ...... 39 3.1.16.3 Disposition ...... 39 3.1.17 Marfan’s Syndrome ...... 40 3.1.17.1 Considerations ...... 40 3.1.17.2 Information to be provided ...... 40 3.1.17.3 Disposition ...... 40 3.1.18 Use of Warfarin ...... 41 3.1.18.1 Considerations ...... 41 3.1.18.2 Information to be provided ...... 41 3.1.18.3 Disposition ...... 41 3.1.19 Use of novel anticoagulants (NOACs) ...... 42 3.1.19.1 Considerations ...... 42 3.1.19.2 Information to be provided ...... 42 3.1.19.3 Disposition ...... 42
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3.1.1 General Considerations
• ICAO Annex 1: 6.3.4, 6.4.4, 6.5.4 • Civil Aviation Act: s64B • CAR Part 67: 67.103, 67.105, 67.107, 67.109 • GD: Timing of Routine Examinations & Examination Procedures • ICAO medical Manual: Chapter 1
This chapter gives guidance for the assessment of applicants’ cardiovascular system.
The aim of the examination is to ensure that the applicant does not suffer from any cardiovascular condition likely to cause aeromedically significant impairment of the cardiovascular function or an unacceptable risk of incapacitation.
The cardiovascular examination may also identify applicants who are more likely to develop cardiovascular disease in the future, and allows giving preventative advice. This may reduce future aeromedical risk and assist those applicants in retaining their medical certificate for longer, thus keeping experienced pilots and controllers in the work force.
These applicants should be given advice or preferably be referred to their GP to seek such advice. While not part of the Director’s regulatory function, this approach is consistent with sound risk management, medical ethics and most recent ICAO recommendations.
The assessment should consider that an unrestricted medical certificate permits to exercise all the privileges that are granted under the licence held. These may include aerobatics, high altitude operations with reduced O2 partial pressure, long period of immobility etc. When appropriate, relevant operational restrictions may be imposed.
This chapter of the manual lists a number of frequently encountered cardiovascular conditions relevant to flight safety. The list is not exhaustive. The CAA Aviation Medical Team can be consulted as necessary.
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3.1.2 Hypertension:
3.1.2.1 Considerations Hypertension represents a long term risk factor for cardiovascular, cerebrovascular and peripheral vascular disease. Isolated mild to moderate hypertension seldom represents an immediate risk of incapacitation but has to be considered when conducting the cardiovascular risk assessment in accordance with the General Direction “Examination Procedures”.
Difficult to control Blood Pressure or need for multiple antihypertensive agents should alert the ME of the possibility of medical causes that require excluding.
Treatment of hypertension should be compatible with flying activities. ACE inhibitors, Beta-blockers, Calcium antagonist and mild Diuretics are generally compatible. A period of grounding should be observed when initiating treatment, lasting from a few days to one month depending on the agent. Dose increments should be more cautious than for the general population to ensure absence of side effects, including electrolytes imbalance, hypotension and decrease in G tolerance.
Clonidine and Methyldopa and other centrally acting agent are not acceptable. Loop diuretics are generally not acceptable. Sympatholytics such as Guanethidine are not acceptable except that low dose Alpha-blockers may be used with caution.
Alpha-blockers should be avoided by pilots doing aerobatics. They generally require a longer, up to one month, ground trial. BP determination lying and standing to observe for postural drop should be recorded on several occasions prior to authorising a return to flying.
Particular care must be taken in assessing applicants working in a hot environment, with possible resulting dehydration, and / or to high G loads (i.e. agricultural pilots, aerobatic pilots).
Measurement of Blood Pressure: The blood pressure is measured in the sitting position. If the BP is outside the range 100- 140 systolic, lying and standing BP readings must also be taken.
If initial two readings are below 140 systolic and 85 diastolic no further action is required.
If levels are 140/90 or higher two further readings at several minutes’ intervals should be taken together with pulse rate.
The same apply to people on antihypertensive medication. Standing and lying readings should also be taken for those on medication to assess for postural drop.
If three blood pressure readings exceed 140/90, hypertension is likely and further readings over several days should be taken. This can be done by the applicant’s own GP or their nursing staff. Persistently elevated blood pressure should not be dismissed as due to “white coat”. If hypertension is suspected a fundus examination should be done.
Pre-existing records from the GP, community readings or ambulatory monitoring can assist in confirming if an individual suffers from unacceptable hypertension. They should be obtained whenever in doubt.
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In doubt a 24 h blood pressure recording should be obtained. The applicant should be referred to their treating physician if hypertension is confirmed.
The mean Blood Pressure can be estimated with the following formula: [D+(S-D)/3]. The normal mean blood pressure range is 70 – 110 mmHg;
A fast pulse rate may mean that the applicant is particularly anxious; a slow pulse may reveal good cardiovascular conditioning or undeclared use of beta blockers.
Medication and Hypertension:
Beta-blockers: Hydrophilic drugs are Only a few days grounding are necessary preferred (i.e. Atenolol, Metoprolol) Observe for any bronchospasm and fatigue.
ACE inhibitors: Long acting ACE inhibitors are preferred; 1 to 3 weeks period off duty are recommended; Observe for postural hypotension and electrolytes imbalance. Do several lying and standing BP measurements.
Angiotensin Receptor Blocker Permitted, see ACE inhibitors, excellent first (ARB): line.
Calcium channel antagonists: Long acting permitted, i.e. Amlodipine permitted, Nifedipine not permitted, unless it is a controlled release preparation, taken once daily. A one week period off flying duty is recommended.
Thiazide diuretics & Low dose diuretics only, avoid in people with a history of gout. Watch for hyponatremia, Spironolactone: hypokalaemia / hyperkalaemia. Only a few days off flying are necessary unless introduced as second line.
α-Blockers Observe for postural hypotension. Do several lying and standing BP measurements. Avoid in aerobatic pilots. 3 to 4 weeks period off duty are recommended. Slow increase in dosage. Selective alpha blockers should be used i.e. Tamsulozin rather Prazocin.
Loop diuretics: Generally not permitted – Of aeromedical significance.
Centrally acting medication: Not permitted.
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3.1.2.2 Information to be provided
• A Blood Pressure Examination Report (form 24067-214) • ECG in accordance with the General Directions, or as clinically indicated; • Fasting glucose or HbA1c and blood lipids in accordance with the GD “Timing of examination” and at other times as indicated; • Creatinine, e-GFR on the fits occasion that hypertension is diagnosed, then as indicated; • Echocardiogram, if clinically indicated, i.e. suspected ventricular hypertrophy; • Investigations to exclude secondary hypertension as clinically indicated, or • Investigations as clinically indicated in the presence of co-existing cardiac, vascular renal disease or other significant pathology.
3.1.2.3 Disposition
Applicants with untreated hypertension should be referred back to their GP for review and treatment as appropriate. Controlled or mild hypertension is generally allowable at all levels of medical certification.
An applicant with hypertension may be considered as having a condition that is not of aeromedical significance if:
• The systolic blood pressure is <160 mmHg; • The diastolic blood pressure is < 95 mmHg; • The cardiovascular risk assessment is less than 10% at five years, unless ischaemia has been excluded in accordance with any relevant General Direction; • The ECG is normal; • There is no evidence of ventricular hypertrophy; • There is no evidence of end-organ damage; • There is no evidence of peripheral vascular disease; • The medication is acceptable; • There are no adverse drug side effects that are of aeromedical significance; • There is no known or suspected unresolved cause of hypertension such as: alcoholism, reno-vascular disease, endocrine disorder, obstructive sleep apnoea, etc.
In general the certificate duration should be reduced to twelve months unless the Blood Pressure is well within normal on simple mono-therapy.
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3.1.3 Cardiovascular Risk Assessment
3.1.3.1 Considerations Cardiovascular events may lead to sudden incapacitation. Thus an estimation of the probability of an applicant suffering a cardiovascular (CV) event is an essential part of the assessment.
The General Direction “Timetable for Routine Examinations” prescribes when a formal cardiovascular risk assessment should be performed.
The General Direction “Examinations Procedures” prescribes how a formal cardiovascular risk assessment should be performed.
The General Direction “Examination Procedures” prescribes that a 5-year CV risk estimate of 10% or above requires exclusion of cardiac ischaemia.
The information sheet “Cardiovascular risk” provides explanations for applicants. MEs may find the information useful.
Note: An applicant with a history of peripheral vascular disease, cerebrovascular accident or cardiovascular disease automatically falls in a high 5-year risk category, i.e. well above 10%.
Stress ECG (or ETT): In general a symptom limited, unequivocally negative, stress ECG at a good level of exercise is acceptable evidence of absence of ischaemia.
When required, such test should be repeated:
• Annually in the case of a Class 1 applicant; • Every two years in the case of a Class 2 or Class 3 applicant.
The Part 5 of this manual provides CAA protocols for the various tests and their reporting.
The relevant protocol should be printed and given to the applicant to pass on to the practitioner conducting the test. This is to ensure that the test is performed to CAA requirements.
Calcium Scoring: CT Coronary Artery Calcium Scoring (CT Calcium Scoring) is a relatively inexpensive test and published research confirms the powerful prognostic value of a zero Agatston score.
For the purpose of the cardiovascular risk assessment, a Calcium Score of zero will allow to reassess the cardiovascular risk as being lower than suggested by the method prescribed in the GD “Examination procedures”.
Currently, until changes are made to several documents, this policy can only be implemented via the statutory process provided by sections 27B(2) and (3) of the Civil Aviation Act flexibility (Accredited Medical Conclusion). A Calcium score of zero can be relied upon for several years.
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At this point of time CAA will accept a zero Agatston score of zero for a period of five years.
So, for the time being:
1. If an applicant returns an elevated 5-year Cardiovascular Risk Estimation (10% or greater) then a CT Calcium Score may be undertaken instead of an Exercise Stress ECG;
2. If the CT Calcium Score is zero then the application may be progressed via the statutory flexibility process, by applying for the identification of AMC experts;
3. If the CT Calcium Score is non-zero then the usual workup, to exclude reversible myocardial ischaemia, would be required.
This process is also shown here in diagram form.
Other cardiac tests: In some cases a stress ECG is not sufficient to exclude ischaemia because of an insufficient level of exercise, a non-unequivocally negative or a positive tracing.
A stress echocardiogram or myocardial perfusion scan can be undertaken to more reliably exclude ischaemia. Other reasons to undertake such investigations may be the applicant’s cardiovascular history or a previous equivocal stress ECG. In doubt MEs should contact CAA.
The role modern investigative modalities, other than Calcium Scoring, have not been clearly established in the context of aeromedical certification. MEs should consult with CAA whenever an applicant presents to their ME having undergone any such other investigations, including angiography.
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3.1.3.2 Information to be provided.
• ECG, blood lipids and blood glucose or HbA1c, in accordance with the GD “Timing for Routine Examinations”; • Cardiovascular risk assessment in accordance with the GDs “Timing of Routine Assessments” and “Examination Procedures”; • In the case of a Class 1 applicant: Annual stress ECG (or test of higher sensitivity / specificity as appropriate) when ischaemia needs excluding under the GD “Examination Procedure” - Full tracing and report to be provided to CAA; • In the case of a Class 2 or Class 3 applicant: Two yearly stress ECG (or test of higher sensitivity / specificity as appropriate) when ischaemia needs excluding under the GD “Examination Procedure” - Full tracing and report to be provided to CAA; • Tests and reports as may have been advised by CAA in the case of an applicant with a history of cardiovascular disease. Such applicants often require annual specialist review and exercise testing of some kind.
3.1.3.3 Disposition
• An applicant with an estimated 5-year CV risk below 10 % may be assessed as having a condition that is not of aeromedical significance.
• An applicant with an estimated 5-year CV risk of 10 % or above, who has provided an unequivocally negative stress ECG at a good level of exercise i.e. at least end of stage 3 of the Bruce protocol, 85% of maximum predicted heart rate or 10 METS, may be assessed as having a condition that is not of aeromedical significance.
• An applicant who has undergone Calcium Scoring, with a zero score may be considered under the flexibility process as possibly having a cardiovascular risk of less than 10% at five years.
• An applicant with a history of cardiac ischaemia, cerebrovascular or peripheral vascular disease should be assessed as having a condition that is of aeromedical significance and considered under the flexibility process.
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3.1.4 Coronary Heart Disease:
3.1.4.1 Considerations In this subchapter we will refer to ischaemic heart disease (IHD) when ischaemia is present and coronary artery disease (CAD) when there is coronary artery disease but ischaemia is absent or has resolved.
Ischaemia may be diagnosed following an acute coronary syndrome, the development of angina or arrhythmia, or through routine screening for elevated CV risk.
An applicant with a history of cardiac ischaemia should be considered a ‘cardiopath’ with an elevated cardiovascular, even if revascularisation has taken place. Recurrent demonstration of absence of ischaemia will be necessary together with adequate control of risk factors, in particular:
• Smoking cessation if the applicant is a smoker; and
• Use of antithrombotic agents: Aspirin lifelong and another agent (i.e: Clopidogrel, Tigegatrol) for twelve months post event; and
• Use of a Statin for plaque stabilisation and blood lipids profile improvement; and
• Use of a beta-blocker or other cardio-protective medication if advised by the treating cardiologist.
Risk mitigation operational restrictions are generally imposed on medical certificates Class 1 and occasionally on medical certificates Class 2 and 3.
3.1.4.2 Information to be provided On the first occasion that an applicant presents with a history of acute coronary syndrome or coronary artery disease, with or without revascularisation.
• Copy of all discharge summaries; • Copy of all specialists reports; • Copy of any angiography report and images, including an electronic copy; • Copy of any echocardiogram report and images;; • Copy of all stress ECGs complete tracings and reports; • Copy of any other investigation report, for instance myocardial perfusion scan or stress echocardiography; • Copy of any Holter monitoring tracing and report, • Blood lipids, glucose or HbA1c and renal function.
On subsequent occasions that an applicant presents with a history of acute coronary syndrome or a history of coronary artery disease:
• Recent cardiologist report; • Copy of any interim investigation report;
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• Demonstration of absence of ischaemia by stress ECG or stress echography or as advised by CAA; • Blood lipids, glucose or HbA1c, and renal function.
Note: Applicants applying six monthly, should provide the information annually unless there has been a change in condition or treatment, or as required otherwise by CAA of the ME.
3.1.4.3 Disposition
• An applicant with a history acute coronary syndrome should be considered as having a condition that is of aeromedical significance.
A majority of applicants with a history of ischaemic cardiac disease are able to be certificated. CAA generally requires the following medical evidence:
• 6 months have lapsed since the acute coronary event and any re-vascularisation procedure; • Satisfactory cardiac vascularisation; • Satisfactory cardiac function: LVEF 50 % or above; • Absence of ischaemia, demonstrated at 6 months post event and then annually. Note that the acceptable tests to demonstrate absence of ischaemia may vary on a case by case basis; • Control of risk factors: Non-smoking, favourable blood lipid profile; • Compliance with optimum medication.
It may be possible for an applicant who has undergone stenting to be considered for certification earlier than 6 months post re-vascularisation, provided that:
• There has been no myocardial infarction; • Three months have lapsed since stenting; • The cardiac function is normal; • There is single vessel disease, not affecting the proximal LAD; • Absence of ischaemia is demonstrated at three months post stenting. Another test is likely to be required at 6 months post stenting and then annually; • There is control of risk factors: Non-smoking, favourable blood lipid profile; • There is compliance with optimum medication.
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3.1.5 Mitral valve disease
3.1.5.1 Considerations Auscultation remains the main screening test for valvular heart disease. Systolic murmurs in the young and slim are very common and are generally benign and of non- consequence. The cause of a murmur should however be ascertained, particularly when dealing with an applicant planning to do a career in aviation or in older pilots first presenting with a heart murmur. An innocent murmur is systolic, soft and musical, and heard at the upper left sternal border. There is no anamnestic or clinical suggestion of any heart disease.
Rheumatic heart disease is fortunately uncommon in a population of applicants to a medical certificate. One needs to remember however that NZ has a relatively high incidence of rheumatic fever.
Lesions that produce volume overload are better tolerated that those producing pressure overloads.
Rheumatic mitral stenosis and / or regurgitation can lead to atrial fibrillation and cerebral embolism, particularly if associated with atrial dilatation. Fast AF poses a risk of syncope, particularly if associated with mitral stenosis. There is an elevated risk of endocarditis.
The mitral annulus may be calcified, usually in the elderly, or dilated. Leaflets may be affected by rheumatic fever, endocarditis, myxomatous degeneration or redundant tissue, causing prolapse. There may be rupture of the chordae tendinae or papillary muscle rupture or dysfunction from endocarditis of ischaemia.
Mitral valve prolapse is relatively common, being found in 5-8% of the general population. Mild mitral prolapse and regurgitation, not associated with ventricular or atrial dilatation, is acceptable. More than mild mitral regurgitation, ventricular dilation [>6cm diastolic or >4.1cm systolic dimension] and atrial dilatation of 4.5 cm or more are of concerns to flight safety.
The ECG may show signs of LA enlargement, LVH, or AF. Cardiac echography is the most useful and often the only test needed. It allows to evaluate chambers size and function, identify any anatomical abnormalities, estimate the severity of any regurgitation and establish a base line for follow-up.
3.1.5.2 Information to be provided
• Cardiologist report on the first occasion that an applicant presents with a history of rheumatic fever or that a murmur is heard, other than a faint typical flow murmur;; • An Echocardiogram; • Other test such as stress ECG, as recommend by the investigating cardiologist or advised by CAA. • Subsequent recurrent reports and investigations as advised by the investigating cardiologist or CAA.
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3.1.5.3 Disposition
Mitral regurgitation An applicant with no more than mild mitral prolapse and / or regurgitation may be assessed has having a condition that is not of aeromedical significance provided:
• The applicant is asymptomatic; and • There is no history of any tachyarrhythmia or AF; • There is no history of cardiac ischaemia; and • The ventricular dimensions and ejection fraction are normal; and • The left atrium is less than 4.5 cm in diameter; and • The mitral valve is not myxomatous; • Any regurgitation is classified as mild by the investigating cardiologist; • Any regurgitation is not due to ruptured chordae of LV wall dysfunction; • The applicant undergoes a cardiologist review and echocardiogram every two years or more frequently if so advised by the treating cardiologist or CAA. • Trivial to mild MR in the absence of any valve or LV abnormality does not need any further follow up.
An applicant, who does not meet the conditions outlined here, should be considered as having a condition that is of aeromedical significance.
Mitral Stenosis An applicant with mitral stenosis should be considered as having a condition that is of aeromedical significance, unless:
• The applicant is in sinus rhythm; • The valve area is over 2 cm2; • The pressure gradient across the valve is < 5 mmHg.
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3.1.6 Aortic valve disease
3.1.6.1 Considerations Auscultation remains the main screening test for valvular heart disease. Systolic murmurs in the young and slim are very common and are generally benign and of non- consequence. The cause of a murmur should however be ascertained, particularly when dealing with an applicant planning to do a career in aviation or in older pilots first presenting with a heart murmur. An innocent murmur is systolic, usually soft and musical, and heard at the upper left sternal border. There is no anamnestic or clinical suggestion of any heart disease.
Bicuspid aortic valve affects around 1% of the population. It increases the risk of endocarditis, and may lead to aortic stenosis, regurgitation and aortic dilatation. Haemodynamic changes occur slowly and problems generally only occur in the fifth decade or later. Bicuspid aortic valve requires surveillance but is seldom a cause to decline medical certification. A flow velocity across the valve of 2 m/sec or less and an ascending aortic dimension of less than 4.0 cm should generally not affect eligibility.
Aortic regurgitation, if acute, may be caused by endocarditis, dissecting aneurysm and trauma. Chronic aortic regurgitation may be caused by bicuspid aortic valve, rheumatic heart disease, myxomatous degeneration, aneurysm of the ascending aorta, annulo-aortic ectasia, Marfan syndrome and similar. Other possible causes are Syphilis and ankylosing spondylitis.
Aortic regurgitation is generally well tolerated for prolonged period until left ventricular failure, pulmonary oedema, palpitations or angina develop. Clinical signs are wide systo- diastolic blood pressure gradients, bounding pulses (water hammer pulse), bifid pulse.
The ECG may show signs of LA enlargement or LVH. The chest X-ray may show a dilated aortic root of a large heart. Cardiac echography is the most useful and often the only test needed. It allows to evaluate chambers size and function, identify any anatomical abnormalities, estimate the severity of any regurgitation and establish a base line for follow-up.
Even moderate aortic regurgitation may be acceptable as long as there is good exercise tolerance and no evidence of diastolic dilatation.
Aortic stenosis may result in the inability to maintain cardiac output and blood pressure if faced with increased output demand or vasodilation, resulting in the inability to provide adequate cardiac perfusion to a hypertrophied myocardium.
The stenosis may be congenital, secondary to a bicuspid aortic valve, degenerative, or secondary to rheumatic heart disease. It is generally marked by a long asymptomatic phase during which the pressure gradient across the valve increases at a rate of around 7 mmHg / year and the valve area decreases by around 0.15 cm2 / year. These figures are however highly variable.
When a patient becomes symptomatic the clinical progression may be rapid with a high mortality incidence, the five year survival being less than 50%. There is a high risk of syncope or sudden death. Symptoms are poor exercise tolerance, light headiness, syncope and angina.
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Aortic stenosis ECG changes consist in signs of left ventricular hypertrophy and left atrial enlargement seen in around 80 % of patients.
Aortic Stenosis Severity Criteria:
Mean gradient Aortic valve area mmHg cm2
Mild < 25 > 1.5
Moderate 25 – 50 1.0 – 1.5
Severe > 50 < 1.0
Critical > 80 < 0.7
3.1.6.2 Information to be provided
• Cardiologist report on the first occasion that an applicant presents with a history of aortic stenosis, or a murmur, other than a faint flow murmur; • Echocardiogram; • Other test such as stress ECG, as recommended by the investigating cardiologist or CAA; • Subsequent recurrent reports and investigations as advised by the investigating cardiologist or CAA.
3.1.6.3 Disposition
An applicant with aortic stenosis or bicuspid aortic valve should be considered as having a condition that is of aeromedical significance unless:
• The applicant is asymptomatic; • Exercise tolerance is normal; • There are not arrhythmia detected; • There is no ventricular enlargement or hypertrophy; and • The ascending aorta diameter is less than 4 cm; and • The velocity across the valve is less than 3 m/sec or the mean pressure gradient is less than 25 mmHg; • The valve area is 1.5 cm2 or more; and • The applicant undergoes a cardiologist review and echocardiogram every two years, or more frequently if so advised by the treating cardiologist or CAA.
In doubt the MEs should contact CAA for advice.
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3.1.7 Tricuspid and Pulmonary valve disease
3.1.7.1 Considerations
Tricuspid stenosis is most commonly associated with rheumatic fever but may be caused by other conditions. In the case of rheumatic fever it is invariably associated with involvement of the left sided valves. Tricuspid stenosis results in right atrial hypertension and elevated systemic venous pressure with associated pulsations in the neck veins and peripheral oedema. It may be protective of the pulmonary vascular bed by co-existing mitral stenosis. The diastolic heart murmur, best heard along the left low sternal border, increases with inspiration. The ECG may show tall, tented shape, P waves.
Tricuspid Regurgitation is most commonly secondary to right ventricular dilatation and hypertrophy. The jugular veins will display large waves. The murmur is holosystolic and best heard over the left sternal edge, during inspiration. AF is often present with little else showing on the ECG. Tricuspid regurgitation results in hepatic congestion and peripheral oedema.
Pulmonary valve stenosis is most commonly the result of congenital heart disease. See subchapter 3.1.26.
Pulmonary valve regurgitation is commonly caused by pulmonary hypertension, itself secondary to mitral stenosis, pulmonary thrombus or chronic lung disease. The murmur is diastolic and high pitched and best heard along the left sternal border.
3.1.7.2 Information to be provided
• Information relating to any associated cardiac condition as outlined in this chapter; • Cardiologist report on the first occasion that an applicant presents with a murmur, other than a faint flow murmur, or with a history pulmonary or tricuspid valve disease; • Echocardiogram; • Other test such as stress ECG, as recommended by the investigating cardiologist or CAA; • Subsequent recurrent reports and investigations as advised by the investigating cardiologist or CAA.
3.1.7.3 Disposition
An applicant with a history of Tricuspid or Pulmonary valve disease should generally be considered as having a condition that is of aeromedical significance.
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3.1.8 Valve replacement or repair
3.1.8.1 Considerations Valve replacement usually means that severe valve disease has existed, often accompanied by atrial dilatation, ventricular hypertrophy or dilatation, possible aortic dilatation and other cardiac functional impairment, including arrhythmia.
Mechanical valves result in an elevated thrombo-embolic stroke risk necessitating the use of anticoagulation with Warfarin. The target INR for aortic valve replacement is 2.0 – 3.0. The target INR for mitral valve replacement is 2.5-3.5, but these targets may be individualised depending on the patient and the type of prosthesis (See use of Warfarin at the end of this chapter).
Novel Oral Anticoagulants (NOACs) such as Dabigatran, Rivaroxaban and similar are not appropriate prophylaxis in the case of mechanical valve replacement.
Bio-valves are safer in regard to the thrombo-embolic risk and generally do not require anticoagulation by Warfarin, Aspirin treatment being sufficient. They may not provide for ideal valve sizing and can result in less than optimal valvular function.
A heart that has undergone any form of surgery should be regarded as being compromised.
Valvular surgery is not cognitively benign. Cerebral impairment is a known complication following open heart surgery. Mood disorders, loss of confidence and anxiety are common post-operative features.
3.1.8.2 Information to be provided
• Copy of all pre and post-operative cardiologist consultations reports; • Copy of the operating report; • Copy of all investigations complete reports, to include images and full tracing of any stress ECG or Holter monitoring; • Copy of GP notes for the past 12 months.
3.1.8.3 Disposition
An applicant with a history of valvular replacement or repair should be considered as having a condition that is of aeromedical significance.
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3.1.9 Atrial Fibrillation (AF) and Atrial Flutter
3.1.9.1 Considerations Atrial fibrillation is the commonest rhythm disorder, affecting 1% of the general population and 10 % of people over age 80. AF is commonly seen at a younger age in Maori and Pacific Island population, according the NZ Ministry of Health. Its incidence is increasing.
It may be associated with structural heart disease, ischaemia, hyperthyroidism, high alcohol intake or an acute respiratory tract infection. The list is not exhaustive.
The term ‘Lone Atrial Fibrillation’ was coined in 1954. It is no longer relevant as our understanding of the condition has increased and there is no consistent definition of lone AF. A review published in the Journal of the American college of Cardiology in 2014 reads: “This working group proposes that the category of lone (idiopathic) AF no longer has either mechanistic or clinical utility, causes confusion in the literature because of tremendous variability in its definitions, and should therefore be avoided”.
A cause for AF must be sought but often cannot be identified.
AF may be acceptable for certification provided that:
• Any underlying condition causing AF is acceptable; • Any episode of AF remains asymptomatic or any symptoms are not likely to interfere with flight safety; • The AF risk of recurrence is low or adequately minimised; • The AF, when occurring, is at a heart rate unlikely to cause haemodynamic compromise, (i.e. maximum rate 90 bpm at rest, 200 bpm on exercise); • The AF, if chronic, is asymptomatic and at a heart rate unlikely to cause haemodynamic compromised, even under effort, i.e. (90 bpm at rest, 200 bpm on exercise); • Medication is acceptable and well tolerated; • The thromboembolic risk is acceptably low; • The bleeding risk is acceptably low if anticoagulants are used. (See use of Novel Oral Anticoagulants (NOACs and Warfarin at the end of this chapter).
3.1.9.2 Information to be provided
On the first occasion that an applicant presents with a history of AF:
• Copy of any discharge summary; • Copy of all specialists’ reports; • Copy of all investigations reports, to include all laboratory results, full tracing of all ECGs, stress ECGs and Holter recordings, and all cardiac imaging; • If Warfarin is used, a copy of all INR results for at least the past 6 months; • If Flecainide is used, a recent through level determination result.
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On subsequent occasions:
• Copy of any interim cardiologist and investigations reports; • A recent cardiologist report as recommended by the treating cardiologist or CAA.
3.1.9.3 Disposition
• An applicant with a history of Atrial Fibrillation should be considered as having a condition that is of aeromedical significance. • An applicant with a history of Atrial Flutter should be considered as having a condition that is of aeromedical significance.
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3.1.1 Atrial and ventricular premature beats
3.1.1.1 Consideration Atrial and premature ventricular, or ectopic beats, are common findings on routine ECG. Frequently benign, their presence may however suggest the possibility of aeromedically significant arrhythmia or underlying cardiomyopathy.
The finding of no more than one atrial premature beat or one ventricular premature beat on a routine ECG is acceptable without further investigations.
Atrial ectopic beats are common and mostly harmless unless very frequent, or sustained. Holter monitoring will usually permit to detect bouts of concerning tachycardia or sino- atrial disease.
Ventricular premature beats are also usually harmless if infrequent, unifocal and the heart is anatomically normal. Couplets, multifocal ectopics and bouts of tachycardia not exceeding 120 bpm may still be acceptable following specialist assessment.
3.1.1.2 Information to be provided
• On the first occasion that symptomatic or frequent ectopy is diagnosed, a 24h Holter monitor; • A cardiologist report if the Holter is abnormal, or reveals more than 2 % of ectopic beats over the 24h period, or if the applicant is symptomatic; • On subsequent occasions a cardiologist report if there is an increase in the frequency of premature beats, the applicant has become symptomatic, or such review has been advised.
3.1.1.3 Disposition
• An applicant with a history of relevant symptoms (distraction, dizziness, fainting), couplets, multifocal premature beats, abnormal heart anatomy, or abnormal 24h Holter, should be considered as having a condition that is of aeromedical significance. • An applicant with more than one premature beat on the ECG but no more than 2% premature beats on a 24h Holter, may be assessed as having a condition that is not of aeromedical significance, is there is not suspicion of underlying heart disease. • An applicant previously investigated for premature beats that were considered not aeromedically significant, may be considered as having a condition that is not of aeromedical significant if there has been no suspected change in condition; • An applicant with no more than one premature beat on the ECG may be considered as having a condition that is not of aeromedical significance.
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3.1.2 Sinus node arrest and sinoatrial block
3.1.2.1 Consideration Sinus pauses may at time be seen in athletes with high vagal tones. Sinus node dysfunction can lead to pauses or tachyarrhythmia. The condition usually progresses slowly with no complications for sustained periods, but will eventually become problematic, requiring a pacemaker.
Asymptomatic applicants found to have sinoatrial dysfunction at routine ECG can often be certificated following investigations, with ongoing surveillance.
3.1.2.2 Information to be provided On the first occasion that an applicant present with an abnormal ECG suggesting sinoatrial disease:
• A cardiologist report; • 24h Holter monitor; • Other tests as suggested by the cardiologist or CAA. This may include Electro- Physiology study.
3.1.2.3 Disposition
• An applicant with evidence of sinoatrial disease should be considered as having a condition that is of aeromedical significance.
A certificate is likely to be issued if the applicant is asymptomatic, there are no pauses longer than 2.5 sec, no complex or sustained rhythm disturbance, and no other unacceptable characteristic have been identified.
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3.1.3 Ventricular pre-excitation
3.1.3.1 Considerations This spectrum of ventricular pre-excitation syndromes include Wolf-Parkinson-White pattern, Lown-Ganong-Levine and other similar conditions related to an accessory pathway.
They also include atrioventricular and atrioventricular nodal re-entrant tachycardia, (AVRT and AVNRT respectively). These can lead to rapid tachycardia and cardiovascular compromise, and even syncope. This is more likely to occur if AF develops.
WPW may be compatible with flying with demonstration of a long by-pass tract refractory period.
3.1.3.2 Information to be provided On the first occasion that a suggestive abnormal ECG is identified or that a history of tachy-arrhythmia or cardiovascular compromise exists:
• A cardiologist report; • A 24h Holter monitor; • Electrophysiology study will often be required; Other tests as may be suggested by the cardiologist or CAA during an AMC process.
On subsequent occasions that an applicant presents following initial certification of the certificate sought:
• ECG; • 24-Holter or other tests as may have been suggested a cardiologist or CAA.
3.1.3.3 Disposition
• An applicant with a history of ventricular pre-excitation should be considered as having a condition that is of aeromedical significance; • An applicant with a history of ventricular pre-excitation treated by radioablation should be considered as having a condition that is of aeromedical significance; • An applicant with a history of accessory pathway successfully treated by radio- ablation may be considered as having a condition that is not of aeromedical significance if a previous AMC has deemed the condition to be no longer of aeromedical significance, in the absence of new ECG changes or symptoms – This may take several years.
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3.1.4 Atrio-Ventricular block (AV block)
3.1.4.1 Considerations First degree heart blocks are very common and often the result of high vagal tone. In this situation, increasing the heart rate to a higher level, i.e. 100 bpm or more, by doing some exercise, and repeating the ECG, should see a normalisation of the PR interval. A conduction defect must be suspected if the PR interval does not normalise, or if the PR interval increases over time.
The PR interval can occasionally be found to be very prolonged. If normalising with exercise, this is likely to be due to a very high vagal tone in a healthy individual.
The combination of AV block and a bundle branch block however suggests the existence of a conduction tissue disorder.
Mobitz I (Wenkebach) AV block may be seen in normal individuals during sleep. However, the presence of second degree requires investigation as those can rarely progress to complete block.
Mobitz II AV block and complete heart blocks are generally not acceptable.
3.1.4.2 Information to be provided
• ECG following exercise to raise the heart rate, on the first occasion that the PR interval is abnormal, i.e. measures 210 ms or more, or if the PR interval has increased since last investigated; • A cardiologist report in the case that a Mobitz I (Wenkebach) AV block has been identified), this should generally include a Holter monitoring.
3.1.4.3 Disposition
• An applicant presenting with a first degree AV block that normalises [<200 ms] during exercise may be considered as having a condition that is not of aeromedical significance. • An applicant presenting with second degree AV block, Mobitz I type, should be considered as having a condition that is of aeromedical significance, unless a previous AMC has considered the condition to be no longer of aeromedical significance; • An applicant with a second degree AV block, Mobitz II, or third degree AV block, should be considered as having a condition that is of aeromedical significance.
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3.1.5 Left Bundle Branch Block (LBBB)
3.1.5.1 Consideration Left Bundle Branch Block results from ischaemic heart disease in over a quarter of cases. This is particular true for applicants presenting over the age of 45 with a new LBBB. The risk of sudden death in this group is about 10 times that of a control group. An LBBB may manifests as an intermittent rate related phenomenon or be constant.
The discovery of a LBBB requires investigations to exclude ischaemia. Stress ECG alone is unable to achieve that and stress echography or myocardial perfusion scan are necessary. The stress echo can be difficult to interpret as the LBBB will affect septal motion.
3.1.5.2 Information to be provided
• On the first occasion that an applicant presents with LBBB, a cardiologist report and investigations reports to include at least a stress echocardiogram. The applicant should not be exercising their privileges while investigations are carried out. • Other tests as may be required during the flexibility process; • On subsequent occasions, reports and tests as advised by the CAA.
3.1.5.3 Disposition
• An applicant with LBBB must be considered as having a condition that is of aeromedical significance; unless • A previous AMC has concluded that the condition may be considered to be no longer of aeromedical significance.
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3.1.6 Right Bundle Branch Block
3.1.6.1 Consideration Incomplete RBBB is common, being seen in 2-3 % of routine ECGs. It has no negative prognostic features. It is considered to be a normal variant of no aeromedical significance.
Complete RBBB is seen ten times less frequently. It has a good prognosis provided that ischaemia has been excluded and there is no associated cardiac abnormality or atrioventricular block.
3.1.6.2 Information to be provided
• On the first occasion that an applicant presents with an RBBB, a cardiologist report to include: • The result of an echocardiogram; • A stress ECG if the applicant is aged 45 or above; • On subsequent occasions if no change to the ECG has occurred, routine investigations as prescribed by the General Directions.
3.1.6.3 Disposition On the first occasion that an applicant presents with an RBBB, that applicant may be considered has having a condition that is not of aeromedical significance if:
• No myocardium anatomy abnormality has been identified; • There is no AV block; • Ischaemia has been excluded by stress testing if the applicant is 45 years old or more, or if required under the General Directions.
On subsequent occasions that an applicant presented with an RBBB, that applicant may be considered as having a condition that is not of aeromedical significance if:
• The ECG has not changed; • The applicant cardiovascular risk has been assessed in accordance with the General Directions and remains acceptable.
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3.1.7 Left anterior and Left posterior Hemi-Block
3.1.7.1 Consideration
This ECG abnormality can be found in 1-2 % of healthy individuals.
If recently acquired, left anterior hemiblock raises the possibility of ischaemia or progressive conduction defect. The same applies to left posterior hemiblock, though the latter is ten times less frequent and probably of little significance.
3.1.7.2 Information to be provided
• On the first occasion that an applicant presents with left anterior or posterior hemiblock, a cardiologist report to include: • The result of an echocardiogram; • A stress ECG if the applicant is aged 45 years old or more; • On subsequent occasions, if no change to the ECG has occurred, routine investigations as prescribed by the General Directions.
3.1.7.3 Disposition On the first occasion that an applicant presents with a left anterior or posterior hemiblock, that applicant may be considered has having a condition that is not of aeromedical significance if:
• No myocardium anatomy abnormality has been identified; • Ischaemia has been excluded by stress testing if the applicant aged 45 or older, or if required under the General Directions.
On subsequent occasions that an applicant presented with a left anterior or posterior hemiblock, that applicant may be considered as having a condition that is not of aeromedical significance if:
• The ECG has not changed; • The applicant cardiovascular risk has been assessed in accordance with the General Directions and remains acceptable.
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3.1.8 QT Prolongation
3.1.8.1 Considerations Long QT syndrome is transmitted as an autosomal recessive condition when associated with deafness or as an autosomal dominant condition without this association. The syndrome may be marked by sudden loss of consciousness due to tachyarrhythmia and possibly death due to torsade de pointe. The QT should be corrected by dividing its value by the RR2 interval to obtain the QTc. The longer the QTc, the greater the risk of an acute event. The QT may be influenced by medication so that moderately prolonged QT intervals may become symptomatic in some circumstances.
3.1.8.2 Information to be provided
• ECG tracing(s) and cardiologist interpretation; • Detailed of any applicant’s’ fainting or near fainting episode; • Detailed of any family member fainting episode or sudden cardiac event.
3.1.8.3 Disposition
• An applicant presenting with a prolonged QTc > 440 ms for males and >460 ms for females should be considered as having a condition that is of aeromedical significance.
Note: An ME who is unsure if the QTc is prolonged should send the ECG to a cardiologist for interpretation, as prescribed in the GD ‘Examination Procedures’.
If a prolonged QTc is confirmed or if the ME is still uncertain about the tracing characteristics, the ME may seek a further ECG review by CAA prior to deciding whether to proceed via the section 27B(2) the flexibility pathway. Alternatively the ME may consider outright to assess the application under section 27(B2).
The ME should also consider any medication capable of affecting the QT and QTc duration.
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3.1.9 Brugada syndrome
3.1.9.1 Considerations This condition is named after three cardiologists, the Brugada brothers, who have described this syndrome. The syndrome is characterised by the possibility of sudden death in people who present with a particular ECG pattern.
The Brugada brothers have published a long term follow up study (Circulation 2002;105:73-78). They studied three groups of patients with Brugada pattern ECGs, some of whom have had cardiac arrests, some of whom had presented with syncope and some who were asymptomatic. Of the symptomatic group more than 70% had a family history of sudden cardiac death. The paper states that they would not diagnose Brugada syndrome in an individual with a “saddle-like” ECG without inducing a coved type ECG on pharmacological testing. The ECG pattern may vary from time to time, making the diagnosis difficult. It is also difficult to predict its aeromedical significance.
3.1.9.2 Information to be provided An applicant presenting with a history of Brugada syndrome or showing a Brugada pattern of their ECG should provide:
• Copy of all previous ECG tracings unless already submitted to CAA; • Copy of any cardiologist report or cardiac investigation that may have been carried out unless already submitted to CAA; • ECG at each application unless stated otherwise by CAA; • For a first application, a copy of the GP notes for the past five years; • Detailed of any family member fainting episode or sudden cardiac event.
3.1.9.3 Disposition
• An applicant with an ECG pattern suggestive of, or a diagnosis of Brugada syndrome should be considered as having a condition that is of aeromedical significance.
The likely outcomes following an AMC are:
Diagnostic Features Certification Disposal
Definite Brugada pattern, and syncope or family history of Ineligible sudden death
Definite Brugada pattern; but no syncope, and no family history Class 1: No Single Pilot Air Operations of sudden death, and asymptomatic. carrying passengers
Brugada pattern not definite Class 1 & 2: Unrestricted
However, every conclusion is made on a case by case consideration and may differ from this advice.
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3.1.10 Implantable Devices - Pacemaker
3.1.10.1 Considerations Pacemakers have a failure rate of well below 1% per annum. The leads have a higher risk of failure, of around 1% per annum. Regular pacemaker checks will often detect failing leads in good time.
Modern pacemakers will also record episodes of arrhythmia that can be identified by downloading the data during checks.
Unipolar pacemakers may interfere with aircraft systems and are usually not acceptable. Bipolar pacemakers are much less affected. Bipolar devices are generally acceptable.
Implanted Cardiac Defibrillators of any kind (ICD) are generally not acceptable unless deactivated and no longer necessary.
3.1.10.2 Information to be provided
• On the first occasion that an applicant presents with a history of pacemaker implantation, a copy of all cardiologist consultation notes; and • Copy of all investigations reports; • Copy of all pacemakers check reports; • On subsequent occasions, a copy of all interim pacemaker check reports; • Copy of any subsequent cardiologist consultation report; • Report of investigations as recommended by the consultant cardiologist or requested by CAA.
3.1.10.3 Disposition
• An applicant with an implanted cardiac defibrillator (ICD ) should be considered as having a condition that is of aeromedical significance. A certificate is unlikely to be issued.
An applicant with a Pacemaker may be considered as having a condition that is not of aeromedical significance if:
• An earlier AMC allowed for an unrestricted medical certificate in regard to the implanted device; • There has been no change of condition; • There is no associated cardiac condition that is of aeromedical significance; • The device is fitted with bipolar leads; • The applicant is not pacemaker dependant; • The applicant undergoes pacemaker checks as recommended by the treating physician, but at least 6 monthly;
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• A recent pacemaker check was normal and did not reveal concerning arrhythmia.
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3.1.11 Cardiomyopathy
3.1.11.1 Considerations In this subchapter we consider cardiomyopathy as a myocardial disorder not caused by hypertension, valvular disease or ischaemia. It is characterised by systolic and, or diastolic dysfunction. The cardiomyopathy may be dilated or hypertrophic. Cardiomyopathy can be due to alcohol, viral infection, or infiltration by amyloid or sarcoid granuloma. This list is not exhaustive. There might be fibrosis or eosinophilic heart disease. Infiltrative disease commonly leads to arrhythmia and mays cause sudden death.
Cardiac sarcoidosis for instance may result in atrioventricular block or ventricular rhythm disturbance. Cardiac sarcoidosis has a high sudden death rate (see also the respiratory chapter).
Dilated cardiomyopathy This type of cardiomyopathy may result from myocarditis, alcohol abuse, be idiopathic or even congenital. Medication such as Adriamycin and radiotherapy delivered to the left chest are possible cause of dilated cardiomyopathy. Symptoms are those of exercise intolerance, fatigue and breathlessness. The condition may remain stable for prolonged period or be progressive despite optimal management. Medication usually includes an ACE inhibitor or Angiotensin II Receptor Blocker (ARB). Dilated cardiomyopathy can lead to sudden death.
There is a high risk of atrial or ventricular arrhythmia and embolism. Right ventricular cardiomyopathy is frequently arrhythmogenic.
Hypertrophic Obstructive Cardiomyopathy (HOC) This is hypertrophic cardiomyopathy not due to hypertension or outflow obstruction such as exists in aortic stenosis. It has a genetic etiology with multiple genes identified. It is often asymmetrical. Obstruction may result and this will be made worth by volume depletion or catecholamines release. Ventricular arrhythmias are common. Beta-blockers are useful in limiting the risk of obstruction.
3.1.11.2 Information to be provided
• All cardiologist consultations reports; • All investigations reports, to include images and full tracing of any stress ECG or Holter monitoring; • Copy of GP notes for the past 12 months.
3.1.11.3 Disposition
• An applicant with a history of cardiomyopathy should be considered as having a condition that is of aeromedical significance.
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3.1.12 Pericarditis
3.1.12.1 Considerations Pericarditis may be caused by bacterial of viral infection, ischaemic heart disease, collagen disease, metabolic abnormality, medication, cancer etc.
Pericarditis may be recurrent and there is evidence that Colchicine can reduce the likelihood of relapse. It is sometimes prescribed.
Acute non-infective or viral pericarditis usually, but not always, follows a benign course and resolves within weeks. Full resolution usually allows a return to flying within months.
3.1.12.2 Information to be provided
• A recent ECG; • Copy of all cardiologist consultation reports; • Copy of any discharge summary; • Copy of all investigations reports and images, to include echocardiogram and full tracing of any stress ECG or Holter monitoring; • Copy of GP notes for the past 6 months.
3.1.12.3 Disposition
An applicant who has suffered an episode of pericarditis may be considered has having a condition that is not of aeromedical significance if:
• The pericarditis has occurred more than two years ago; • The ECG and the cardiac function, as demonstrated by cardiac imaging, are normal; • There is no history of arrhythmia; • The pericarditis was acute non-infective or viral; • The applicant has been free of relapse during that period.
In doubt the ME should consult with CAA.
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3.1.13 Aortic Aneurysm
3.1.13.1 Consideration The incidence of aortic aneurysm increases with age. There is evidence that this condition is becoming more frequent. Aortic aneurysm has the potential to result in sudden and complete incapacitation.
Coming out of the heart, the thoracic aorta has a maximum dimension of 4 cm at the root. < 3.5-3.8 cm by the time it becomes the ascending aorta and 3 cm at the arch. The descending aorta's diameter should not exceed 2.5 cm. The normal size for the aorta depends on body surface area.
Aortic dilatation may remain static for long periods, particularly if causal factors such as hypertension have been well addressed. On average however, if aortic dilatation is present, the diameter increases by 1 mm per year for the ascending aorta, 3 mm for the descending thoracic aorta and 1.2 mm for the abdominal aorta. These figures are variable. However one cannot confidently determine the ascending aorta diameter better than within a 3 mm margin of error. This is true for echography, MRI or CT as the measurement is technically difficult. This makes the assessment of diameter stability difficult.
For asymptomatic thoracic aneurysms, and those with bicuspid aortic valve, an ascending aorta diameter of 55 mm is an indication for intervention as the risk of the procedure becomes less than the risk of doing nothing. The threshold is 5.0 cm for patients with Marfan syndrome, and those with a family history of aortic dissection, but recent recommendations suggest a threshold of 5.5 cm for these patients also. Dissection may happen at smaller size also and the risk of this occurring is not negligible.
3.1.13.2 Information to be provided
• A cardiologist report; • A recent echocardiogram, cardiac MRI or CT.
3.1.13.3 Disposition
• An applicant with a dilated ascending aorta of 40 mm or more, or with a history of symptomatic aortic disease, or aortic surgery should be considered as having a condition that is of aeromedical significance.
An applicant with a dilated ascending aorta diameter of less than 40 mm may be considered as having a condition that is not of aeromedical significance if:
• The applicant does not have Marfan syndrome, bicuspid aortic valve or a family history of aortic dissection; • The applicant has well controlled blood pressure; and
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• The applicant undergoes a cardiologist review, to include an echocardiogram or MRI, at least every two years, or more frequently as may be advised by the cardiologist or CAA.
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3.1.14 Peripheral Vascular Disease
3.1.14.1 Considerations Peripheral vascular disease refers in this subchapter to vascular disease other than coronary artery disease. It relates to lower limbs arterial disease, carotid vessels, cerebral vessels disease, mesenteric ischaemia and renal artery disease.
The implication of a diagnosis of peripheral vascular disease is an elevated cardiovascular risk. For instance, an applicant with femoral artery stenosis, successfully stented, should be considered as having an elevated 5-year cardiovascular risk of over 10% and possibly suffering from myocardial ischaemia or carotid artery disease unless proven otherwise.
In the case of cerebral ischaemia the probability of recurrence of stroke is of aeromedical significance. An information sheet “Strokes and Transient Ischaemic Attacks” is available on the CAA website. Please refer also to the neurology chapter of this manual.
3.1.14.2 Information to be provided
• All specialists’ reports relating to any peripheral vascular disease manifestation, to include any imaging reports and operating notes; • A cardiologist report, to include evidence of absence of cardiac ischaemia; • Up to date specialists’ reports and investigations results are likely to be requested by CAA.
3.1.14.3 Disposition
• A history of peripheral vascular disease should be assessed as being of aeromedical significance.
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3.1.15 Venous Thrombo-Embolism and Anticoagulation
3.1.15.1 Considerations Venous thromboembolism disease includes deep vein thrombosis and pulmonary embolism. The incidence is 0.1 to 0.2% per annum in the general population. The risk increases with age. A pulmonary embolism may result in subtle or sudden incapacitation, including death and is likely to affect flight safety.
Thrombo-embolic disease has a high risk or recurrence or 5-7% per year following a first episode, or about 50 times the risk of someone who has not suffered an episode of DVT. The risk is much higher following a recurrent episode. The risk decreases over time.
Since anticoagulation has its own risk, an episode of treated VTE implies an increased risk to flight safety.
A provoked VTE episode means an occurrence in the presence of a transient risk factor, for instance pregnancy, surgery, trauma or prolonged immobilisation. It can also be in the presence of a persistent risk factor such as a malignancy or congenital coagulopathy.
An unprovoked or idiopathic VTE episode means an occurrence where no clinical risk factor can be identified
Treatment is by anticoagulants. The American College of Chest Physicians (ACCP) Guidelines recommend the following duration, taking into account the risk versus benefit of treatment.
Provoked distal DVT • 3 months
Unprovoked isolated distal DVT • 3 months, then evaluation of risk- benefit of extended therapy
Provoked proximal DVT • 3 months
Unprovoked proximal DVT • At least 3 months, then evaluation of risk-benefit of extended therapy
o High risk of bleeding: 3 months o Low/moderate risk: extended anticoagulation
Second provoked DVT • Low risk of bleeding: extended anticoagulation
• Moderate risk of bleeding: extended anticoagulation
DVT and active cancer • Low, moderate and high risk of bleeding: extended anticoagulation
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The following parameters need considering since they do increase the risk of recurrence (J Fahrni and al; Assessing the risk of recurrent venous thromboembolism – a practical approach; Vascular Health and Risk Management 2015:11 451-459). The relative risk (RR) is between 1.5 and 2.8 depending on the parameter considered. These are:
Unprovoked proximal DVT, Obesity, Male sex, positive D-dimer test, residual thrombosis, hereditary thrombophilia, inflammatory bowel disease and antiphospholipid antibody.
Male sex and positive D-dimer test following anticoagulation have the highest relative risk, 2.8 and 2.6 respectively while Asian and Pacific Islander ethnicity decreases the risk, with a RR = 0.7
3.1.15.2 Information to be provided Following an episode of VTE:
• Complete medical notes relating to the thrombo-embolic episode; • A recent D-dimer test if anticoagulants have been discontinued within the past 12 months; • A recent Ultra-Sound of the affected limb may be required; • A haematologist report may be required; • Result of a thrombophilia screen in the case of an unprovoked VTE episode.
3.1.15.3 Disposition
• An applicant who has suffered from a recent thromboembolic episode, currently treated with anticoagulants should be considered as having a condition that is of aeromedical significance.
An applicant who has suffered a thromboembolic episode more than 6 months ago and who is no longer requiring anticoagulants or is only requiring an anti-coagulant for prophylactic reasons may be considered as having a condition that is not of aeromedical significance if: Currently in discussion with specialist
• A thrombophilia screen, completed at least one month after cessation of anticoagulants is normal, or Discuss this with Huib • A haematologist has opined on a risk of recurrence that is acceptable to CAA • If taking prophylactic treatment with Warfarin, is assessed by following the guidelines “use of Warfarin”, in subchapter 3.1.18 of this manual; • If taking prophylactic treatment with a novel oral anticoagulant (NOAC), is assessed by following the guidelines “use of NOACs”, in subchapter 3.1.19 of this manual.
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3.1.16 Congenital Heart Disease
3.1.16.1 Considerations Surgical progress is now allowing many subjects to lead a reasonably normal life following successful surgical treatment.
Some conditions do not require surgery because of small defects only. However some may pose a risk to aviation safety due to an elevated risk of symptomatic conduction defect abnormality.
Congenital heart diseases often leave subjects with functional cardiac impairment, including risk of arrhythmia, that are of aeromedical significance. Congenital heart disease may be part of a syndrome encompassing other abnormalities.
3.1.16.2 Information to be provided On the first occasion that an applicant presents with a history of congenital heart disease
• A recent cardiologist report; • Copy of all cardiologist consultations reports; • Copy of any operating reports; • Copy of most recent investigations reports, to include echocardiogram or MRI images and full tracing of any stress ECG or Holter monitoring; • Copy of GP notes for the past two years.
3.1.16.3 Disposition An applicant with a history of congenital heart disease should be considered as having a condition that is of aeromedical significance; unless:
• A previous Accredited Medical Conclusion has concluded that the condition is no longer of aeromedical significance; • There is no evidence or suspicion of change in the applicant’s condition.
An applicant with a history of closed patent ductus arteriosus may be considered as having a condition that is not of aeromedical significance if:
• A cardiologist report indicates normal cardiac function; and • Absence of pulmonary hypertension.
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3.1.17 Marfan’s Syndrome
3.1.17.1 Considerations Marfan’s syndrome is usually transmitted via an autosomal dominant gene with variable expression.
The condition may lead to progressive aortic and mitral valve regurgitation and aortic aneurysm. For those reasons the condition is of aeromedical significance and the ability to maintain a medical certificate is likely to be compromised in the long term, assuming that a certificate can be issued.
3.1.17.2 Information to be provided
• A cardiologist report; • An echocardiogram report; • Copy of all previous specialists and investigations reports.
3.1.17.3 Disposition
• An applicant with Marfan syndrome should be considered as having a condition that is of aeromedical significance.
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3.1.18 Use of Warfarin
3.1.18.1 Considerations In recent years CAA has authorised the use of Warfarin by Air Crew and Air traffic Controllers. This has paved the way for the acceptance of conditions that would otherwise carry an excessive risk of incapacitation without antithrombotic prophylaxis.
The use of Warfarin however does carry risks. Too low an INR and the risk posed by the condition being treated becomes excessive. Too high an INR and the risk inherent to Warfarin becomes excessive. This is illustrated in the following graph in the case of AF.
Thus it is critical, when certifying anyone on Warfarin, to ensure perfect compliance with:
• dosage, and • INR testing, and • any condition or restriction imposed on the Medical Certificate.
3.1.18.2 Information to be provided
• INR results, dates of determination and doses for the past 6 months; at least the last 6 results should be provided; • Confirmation of absence of any complication relating to the use of Warfarin or the condition being treated; • All information relating to the condition being treated, in accordance with any relevant guidelines outlined in other parts of this manual.
3.1.18.3 Disposition An applicant taking Warfarin should be considered as having a condition that is of aeromedical significance, unless:
• The condition being treated is not of aeromedical significance while being treated, in accordance with any relevant guidelines outlined in other parts of this manual; • The have been no episode of spontaneous or major bleeding; • A condition of surveillance requiring regular INR determinations to be undertaken [specify interval] and a diary kept, to be presented on demand; • Four out of the last five INR determination results are within the therapeutic range for the condition being treated (i.e.: 2.0 – 3.0 or 2.5 – 3.5 as appropriate); • A restriction preventing the privileges from being exercised unless four out of the last five INR results are within the therapeutic range for the condition being treated; • A restriction “not valid for single pilot air operations carrying passengers” is imposed in the case of a Class 1 medical certificate.
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3.1.19 Use of novel anticoagulants (NOACs)
3.1.19.1 Considerations NOACs such as Dabigatran, Rivaroxaban, Apixoban and others have rapidly taken over from the use of Warfarin when anticoagulation is recommended. The exception is mechanical valve replacement for which Warfarin should be used.
NOACs have been showed be as effective as Warfarin, and to have a lesser risk of bleeding generally. While the gastrointestinal risk of bleeding is a little higher than for Warfarin, there is lower risk of intracranial haemorrhage.
The NOACs have however a number of characteristics which are of aeromedical concern.
• Compliance cannot be reliably ascertained;
• Their biological effect in a particular individual is not known;
• Overdose may occur, for instance in there is decreased renal function or small body frame for the dose prescribed;
• Long haul pilots flying through multiple time zones may have difficulties taking their medication at the appropriate time. This is not unique;
• Their effect t is not rapidly reversible.
3.1.19.2 Information to be provided
• Medication generic name and dose; • Renal function; • Confirmation of absence of any complication relating to the use of NOACs or the condition being treated; • All information relating to the condition being treated, in accordance with any relevant guidelines outlined in other parts of this manual.
3.1.19.3 Disposition An applicant taking NOACs should be considered as having a condition that is of aeromedical significance, unless:
• The condition being treated is not of aeromedical significance while being treated, i.e. a past history of DVT requiring long term prophylaxis (cardiac conditions requiring Warfarin should be considered as being of aeromedical significance); • The renal function is not significantly impaired: i.e. eGFR ≥60 ml/min/1.73m2; • The dose is appropriate of the body size; • There have been no episode of spontaneous or major bleeding; • A restriction “not valid for single pilot air operations carrying passengers” is imposed in the case of a Class 1 medical certificate. For Discussion
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