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ALC-955: AirVenture 2022 The Office of Aerospace Medicine and You
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Review

Office of Aerospace Medicine
Aeromedical Assessment  Updates

AIR

AIR Transformation

5 Pre-CSP Activities

  • Implement AIR Integrated Oversight Philosophy, applying one approach to both domestic and international
  • Implement Certification Process Guide (CPG), and initiate national Applicant Showing Only strategy for standard certification and ODA certification implementation
  • Stand up the AIR-600 Innovation Center
  • Foundational – Invest in our people
  • Refine AIR-900, using multiple phases

AFS

Future of Flight Standards

Maturing the SMS relationship with industry

Compliance Philosophy – continue to develop and implement

AOV

Remote Tower Air Traffic Services:

-              Emerging new entrant into NAS

-              Evaluating service capabilities

-              Determining sufficiency of safety controls

UAS Air Traffic Management:

-              Emerging new entrant into NAS

-              Evaluating concept of operations

-              Determining licensing/certification implications 

Commercial Space Acceptable Level of Risk:

-              Increasing tempo of operations in NAS

-              Codifying alternative means of cross line of business risk profiling

-              Determining international implications

ARM

OST-OMB Coordination to implement the new Executive Orders

Revamping internal FAA rulemaking processes (governance, Prioritization Implementation Plan)

Enhancing Committees process (e.g. FACA) – ARAC and ARC

AUS

Stakeholders (multiple initiatives)

Data (multiple initiatives)

Strategy for enabling creative solutions and greater shared responsibility

AAM

Improve ATCS and Airman medical certification metrics

Leverage IT/Human Capital in AAM to efficiently manage AAM’s business processes

Define/Develop a coherent succession plan for AAM

AQS

ISO certification Registration – CAR process

FY18/19 Budget

Hiring Restrictions

AVP

Outward-facing activities (CAST, GAJSC, INFOSHARE) – expanding/new operations

Ongoing NTSB relationship

Budget & resources, esp FY19

 

 

Aerospace Medicine Programs

Aeromedical Standards

Airman Medical Certification

ATCS Medical Clearance

Substance Abuse/Dependence

Aeromedical Education

 

Aerospace Medicine Programs

Research

Protection and survival of aircraft occupants

Medical accident investigation

Toxicology and the effects of drugs on human performance

               

Aerospace Medicine Programs

Research (continued)

Impact of Disease and Disability on human performance

Human factors of flight crews, air traffic controllers, mechanics, and others involved in the operation and maintenance of aircraft and air traffic control equipment

PILOTS BILL OF RIGHTS
Public Law 112-153 112th Congress
(August 2012)

Notice to Airmen – incorporated in MedXPress

Letter to Airmen – with every communication

Appeal rights to US District Court

Section 4 of law called for GAO review of Medical Certification

 

Myth:  Denial Is a Common Event

  • 356,677 Applications submitted CY 2020  34,728 Special Issuances  (10.3%)
  •     6,651 Initial denials  (1.8%)
  •     6,085 failed to pursue (1.7%)
  •     572 provided required follow-up but denial sustained (0.16%)
  •   34,728 Special Issuance Certificates granted.

 

Special Issuances Categories in 2018

Diagnosis

Total

Cardiovascular

9,258

Diabetes

                 5,270 (448)

Sleep Disorders

6,969

Cancer

1,481

Psychiatric

1,367

Substance use

1,273

SSRI

421

Neurologic

557

Transplants

139

Federal Aviation Administration
Aeromedical Certification Summit Follow-Up

 

Leadership Objective

1. The ultimate goal of the summit is to achieve reliable, consistent, quality aeromedical decisions within 60 days from when an airman presents to an Aviation Medical Examiner.

2. Omnidirectional communication

Themes We Heard From You

  • Improve communication and responsiveness between the airmen, AME, and FAA
  • Modernize aeromedical certification process and systems
  • Consider approving more conditions for CACIs

Fundamentals of AAM Compliance Philosophy

Education

Transparency

Open Communication

Efficiency

List of Achievements

  • Improved internal and external communications
    • Established open door policy with new Federal Air Surgeon and Deputy Federal Air Surgeon for trade association partners
    • Conducting routine communication with external partners, including other Chief Medical Officers
    • Revised “hostile” letters
  • Reduced the scanning backlog for airmen records
  • Began process for creating electronic medical records
  • Provided tools to support efficiency of medical certification work
  • Created new Behavioral Health Panel
  • Approved SGLT-2 Inhibitors
  • Expanded Cardiac AASI to 1st and 2nd class
  • Eliminated backlog for airmen with insulin treated diabetes

What’s Next On Deck

Mid-Term Goals:

  • Continue efforts to reduce the number of EIRs
  • Decrease wait times
  • Revalidate future information system requirements
  • Continue to improve AME education
  • Expand CACI Conditions. Conditions being considered:
    • PAP treated Sleep Apnea
    • Accutane
    • Cardiac conditions not specifically DQ
    • Hemochromatosis
  • Med Flight Test
  • Revise Quotas
  • Pilot Minute

Long-term Goals:

  • Utilize common ICD Path coding
  • Consolidate all certification guidance into one Guide

ITDM Continuous Glucose Monitoring (GCM) Protocol for All Classes

  • Initial evaluation requirements
    • 6 months stability on insulin.
    • Initial battery of reports and testing
    • Consider for 12 month Special Issuance
  • Recertification
    • See endocrinologist every 3 months
    • Compile CGM data
    • Submit to AME every 6 months
  • All cases worked at FAS office

CGM protocol---uses CGM date to verify trends in glucose and stability of control. Also uses CGM data to predict a change and identify trends in glucose and be able to make an intervention before glucose gets too high or too low for aeromedical safety. 

Non-CGM protocol is the current 3rd class protocol  that requires the airman to check finger sticks before, during and after flight.  It also requires we tell them how much glucose to take per abnormal FSBS reading.  This is not feasible from an operational point.

MedXPress
https://medexpress.faa.gov

Application Status Update: New Release 4-13-2023

The Details

When:  Release targeted for Wednesday,  April 13, 2023

Who: Updates impact pilots only (no ATCs)

What: Updates provide a way for pilots to check their certification status (are they
issued or denied) as well as a way to see the current status of a deferred application.

Why: Improve communication by providing clear, concise, accurate information. 
This project was a result of the Medical Certification Summit

MedX: Submitted Status

Pilots will see a new Application Status tab in MedXPress.  This tab will show the status of their most recent application and will update as the application moves through the process.  Here the pilot’s application is in the Submitted status.  This screen will display when the pilot has submitted their MedXPress application and the AME has not yet imported. 

MedX: Imported Status

Once the AME imports the application into AMCS, MedXPress will display the application status as Imported.  Notice, the pilot will be given the MID number, the application submission date, and the date the AME imported.  It also notifies the pilot that the AME has 14 days to transmit.

MedX: Transmitted Status

This is where the behavior will change.  The Transmitted screen will only display when an AME defers an application.  Unissued pilots will be able to log in to MedXPress to see more detail.  They’ll be given an estimate on when initial review will be completed.  This estimate will be based on recent activity in AAM and will calculate the time it is taking between an exam being transmitted and the first piece of correspondence being sent.  Notice this screen also displays a list of any attached documents.  NOTE: pilots will not be able to open documents as MedXPress is not authorized to release Personally Identifiable Information and Protected Health Information.  Let’s take a closer look at the text displayed on this screen.

MedX: Unissued Exam,

No Activity for 60 Days

                Please call the Aerospace Medical Certification Division at 405-954-4821

MedX: In Review Status

Once the Review process starts on an unissued exam, the MedX Application Status screen will show an In Review status.  This status will display once a particular action is taken in DIWS.  We’ll get to that in a few moments.  Once the pilot reaches the In Review status, a list of FAA Correspondence, if any, will display.  Correspondence will not display until it is in the Printed Correspondence status in DIWS, meaning the package has been generated and it has been sent to print.

MedX: Action Required Status

If we determine more information is required, the In Review status changes to Action Required.  The information text on this screen will vary based upon the selection made in DIWS by the Reviewer.

MedX: Documentation Lists

Here is a closer look at the information available under the Documentation Lists.  Pilots will be able to see a list of document attached to their exam, both scanned/imported documents and correspondence.

Certification Decision

The third variation for the Certification Decision screen is the final review stage.  This is an interim step in the processing of an deferred exam.  This screen captures the time between when the Reviewer has updated the class issued code but the case is not yet sent to file.  This status alerts the pilot that the decision is imminent. 

MedX: Certification Decision

The final status is Certification Decision.  This screen will display in one of three ways: 1.  Issued (the most common) in the case of an issued exam, the medical certificate information is displayed; so, for the 95% of airman who walk out of the AME’s office with a medical certificate, they will pop right to this status from the Imported status. 2. in the case of a denial or disqualification ……

MedX: Certification Decision

…….in the case of a denial or disqualification, the Certification Decision screen will show a STOP sign along with information text.  In either case, the text lets the pilot know more details will be coming to them via mail.

CAMI Pilot Minute

Microlearning Video Series produced by CAMI Featuring Dr. Susan Northrup

CGM protocol---uses CGM date to verify trends in glucose and stability of control. 

Also uses CGM data to predict a change, identify trends in glucose, and make an intervention before glucose gets too high or too low for aeromedical safety. 

Non-CGM protocol is the current 3rd class protocol  that requires the airman to check finger sticks before, during and after flight.  It also requires we tell them how much glucose to take per abnormal FSBS reading.  This is not feasible from an operational point.

Subscribe to the Federal Air Surgeon's Medical Bulletin!

www.faa.gov/go/ame

FAA Mental Health Initiatives
Update

Changing the Narrative

The Myth: 

Anyone with a mental health condition will be grounded forever.

Aviator recognized performance-impairing mental status, but won’t take action.  “I’ll look weak” or “I’ll have to tell the FAA.”

Aviator recognized performance-impairing mental status, takes action, but does not report.  “I know it’s illegal, but maybe they won’t catch me.”

Aviator does not recognize performance-impairing mental status.  “I’m just fine.”

Cultural problem vs disease symptom

The Message:

Mental status is a performance issue and a safety issue

Naming it facilitates communication

Communication facilitates recognition

Recognition decreases fear

Decreased fear enables action

Early intervention is critical (and easier to ultimately certify)

The magnitude of Mental Illness

Estimated 50% of general population will experience mental illness during their lifetime.

12-month prevalence of any DSM-IV mental disorder is 26%

COVID-19 World

  • Stresses

Family dynamics

Financial

Deaths

Isolation

Infection and long-COVID effects

Uncertainty

Mental Health Continuum

Healthy____Reacting____Injured____Ill

FAA Philosophy

In a pilot, with a mental health diagnosis… return him/her to flying…as soon as it is safe to do so.

Conditions of Aeromedical Significance

Sudden incapacitation

Sudden/unpredictable onset

Subtle incapacitation

Progresses unpredictably 

Difficult to monitor/recognize

Subtle impairment

Cognitive, motor, sensory

The Regs:
Title 14, CFR Part 67-Standards-
Mental

“No established medical history or clinical diagnosis of …”

Bipolar Disorder

Psychosis

Personality Disorder manifested by repeated overt acts

Psychiatric Special Issuances All Classes (CY 2020)

SSRI Program History

General observation that pilots on antidepressants were doing well

General awareness that mild/moderate depression is very common

Publication in Federal Register April 5, 2010

4 approved medications chosen for most favorable side effect profile

Diagnoses Treated with SSRI’s

  • Depression                                       61%
  • Anxiety                                             39%
  • Major depression                             12%
  • Obsessive/compulsive                       0.05%
  • PTSD                                                 0.02%
  • Dysthymia                                          0.02%

       

What Else Is FAA doing?

  • Expanded Mental Health content in AME seminars
  • Champion Pilot Peer Support Programs
  • Improved Decision Grids in AME Guide
  • Emphasis on the least information necessary to make a good decision
  • Exploring new medications for approval
  • Education efforts

What Can You Do?

  • Be informed – don’t perpetuate myths
  • Take care of yourself – there is an overwhelming need out there
  • Be alert – not every opportunity will come via phone call
  • Encourage action – wide range of options
  • Take action early!

Aviation Multilayered Disease Defense Strategy

Individual Responsibilities                                          Shared Responsibilities

Risk Assessment                              Harmonized Processes and Procedures

Physical Distancing                          Communication, Education and Training

Masks                                               Technological and Engineering Factors

General Hygiene                              Disinfection/Cleaning

Health Declaration                            Passenger Education and Compliance Monitoring

Testing                                              Border Control and Health Screening

                                                          Public Health Measures

Each intervention(Layer) has imperfections (holes)

Medical Standards

For the Evolving Global Aircraft Operational Environment

What medical standards are necessary to ensure an acceptable level of public safety across the range of aircraft operations, from full automation to direct human control? Acceptable medical risk in most commercial transport operations today is based on the presence of two pilots on board the aircraft. Advances in technology are changing the risk equation and challenging the applicability of current medical standards in all crewed scenarios, regardless of pilot location. It is important to consider what risk tolerance is acceptable in this evolving system—a global system that must accommodate both legacy aircraft operations and operations dependent on rapidly advancing technologies. Pilot incapacitation continues to pose a safety risk in the global aerospace system, whether the pilot is located on the ground or at altitude. We must balance ensuring safety with the rights of individuals and the potential benefits of these emerging technologies.

Multiple Paths – A Common Destination

                UAS- Highly automated / autonomous systems with:

No onboard pilot

Optional onboard pilot

Monitored onboard pilot with automation backup

How do medical standards improve safety

at this destination?

The Weak Link is the Human Being

Reduced Crew & Single Pilot Operations

  • For commercial transport
    • Initially, the relaxation of rules would be for less-critical elements of flights (cruise)
    • A more significant relaxation of the rules allowing single-pilot operations for the entire flight could just be a “little further away”
  • If the flight were to be single-piloted for the entire flight –
    • Advanced autonomous systems would need to be in place to “fly the aircraft without a pilot being in command”,
    • In case of incapacitation of the pilot

Pilot Physiological Monitoring in Civil Aviation

  • Regulatory Concerns
    • What are industry’s concepts of operations?
    • Isolated on pilot vs. coupled to autopilot
    • What technologies are likely coming?
    • What are the certification standards?
    • How to calculate system-level risk for conditional aeromedical certification based on aircraft technology
    • Opportunities
    • Routine or periodic monitoring between aeromedical exams as basis for earlier return to flying duties

Biomedical Applications of Radar Technology

  • Vital Signs Monitoring
  • Human Posture Recognition
  • Human Motion Detection & Tracking
  • Human Occupancy Monitoring
  • Human Fall Detection
  • Biofeedback-Based Rehabilitation (Respiratory, Cardiovascular, Occupational Therapy)
  • Prosthetics Control
  • Operation of Wheelchair Driving Systems
  • Radar Vision for the Visually Impaired
  • Human Brain Stroke Detection
  • Blood Glucose Level Monitoring
  • Sleep Monitoring
  • Voice/Speech/Swallowing Detection (lips, tongue, glottis, trachea, vocal cords)
  • Medical Imaging (Cardiology, Pneumology, Obstetrics, ENT)

Beyond Biomedical Monitoring

Human-Machine interaction goes beyond biomedical monitoring

https://defenseinnovationmarketplace.dtic.mil/

RPAS Operations - a Human-In-The-Loop Perspective

  • Pilots/Operators are Required.
  • Pilots/Operators are NOT Required.

UAS “Pilot” Medical Standard?

Where are the Safety Risks?

  • Physiological/Psychological Hazards to UAS Pilots
  • Occupational Hazards to UAS Pilots
  • Physical Hazards to UAS Pilots and 3rd Parties
  • Human Factors of UAS Air Traffic Control

Physiological/Psychological Hazards

Operator Fatigue

  • Fatigue research is needed to improve specific understanding of UAS issues associated with scheduling, duty time, shift work (and rotations), workload, and other Human Factors concerns.
  • Goals: to minimize risk, maximize safety, and improve operator performance during actual UAS operations.

Workstation-Related Ergonomic Issues

  • Control stations are similar to office workstations
  • User ergonomic injuries are also similar:
    • repetitive motion disorders
    • carpal tunnel syndrome

 

Human Factors of UAS Air Traffic Control

Potential research questions include:

Visibility from ATCT

  • Tower controller ability to de-conflict aircraft and UAS due to UAS:
    • Integration into towered airport environments,
    • Deviation from a designated corridor, or
    • Operated with malintent
  • Identification of impacts to:
    • Controller workload and task flow of UAS integration into controlled airspace
    • Traffic flow management workload and task flow of UAS operations in En Route and Terminal airspace
    • Communication pathways and their effectiveness

Medical Standards for AAM Pilots?

Applicability of Current Medical Standards Challenged

  • Onboard (optional) pilots - What is the impact of simplification or elimination of traditional aircraft control tasks?
  • Evolution of pilot to remote operator/monitor
    • What is the safety threat of remote operator incapacitation or degraded performance?
    • How does the availability of other remote operators in facility/on network mitigate incapacitation risk?
  • Medically monitored remote operator
    • What are the monitoring and automated control performance requirements?
    • Enroute/cruise
    • In terminal operations

Where do we go from here?

  • More questions than answers.
  • Operators on the ground, like Air Traffic Controllers, are not immune from medical incapacitation.

Risk of medical incapacitation for safety-critical employees must be considered.

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