Development of a Medical
Program for Commercial
Spaceflight
Aerospace Medicine Grand Rounds
May 26, 2015
James M. Vanderploeg, MD, MPH
Aerospace Medicine Program
Disclaimer
Principal Investigator for UTMB and Executive Director of the Center
of Excellence for Commercial Space Transportation
Chief Medical Officer for Virgin Galactic
Aerospace Medicine Program
Objectives
1. Recognize the challenges of enabling a
broad range of individuals to safely
undertake a spaceflight.
2. Describe the components of a commercial
spaceflight medical program.
3. Identify the requirements for emergency
medical response for a human commercial
spaceflight.
Aerospace Medicine Program
Commercial Space Flight Participants
Aerospace Medical Association Space Passenger
Task Force published two reports in ASEM
October 2001
• Considered both sub-orbital and orbital SFPs
• Long list of disqualifying conditions
November 2002
• Considered only sub-orbital flights
• Broad guidelines based on certain
assumptions
Aerospace Medicine Program
AsMA Space Passenger Task Force
Report – II
Summary
“In summary, the 2nd Task Force on Space Travel
offers only broad guidelines, rather than specifics,
for short-duration flights. The application of these
guidelines should be left to the discretion of the
companies, physicians, and passengers. In cases
of passengers with significant illness, sound
medical judgment will be essential.”
Aerospace Medicine Program
FAA Documents
March 2003 – Guidance for Medical Screening of
Commercial Aerospace Passengers
February 2005 – Draft Guidelines for Commercial
Suborbital Reusable Launch Vehicle Operations
with Space Flight Participants
February 2005 – Draft Guidelines for Commercial
Suborbital Reusable Launch Vehicle Operations
with Flight Crew
Aerospace Medicine Program
FAA Documents (cont.)
December 2005 – NPRM: Human Space Flight
Requirements for Crew and Space Flight
Participants; Proposed Rule
January 2006 – Guidance for Medical Screening of
Commercial Aerospace Passengers (DOT/FAA/AM06/1)
December 2006 – Human Space Flight
Requirements for Crew and Space Flight
Participants; Final Rule
Aerospace Medicine Program
FAA Final Rule
Crew Members:
• Those with a safety-critical role must possess and carry
an FAA second-class airman medical certificate
Space Flight Participants must:
• Sign informed consent after education about the risks
• Sign waiver of claims against the U.S. Government
• Have training for emergency situations – smoke, fire,
depressurization, emergency exit
• Meet security requirement – the SFP may not carry on
board any explosives, firearms, knives, or other weapons
Aerospace Medicine Program
FAA Medical Guidance – Jan. 2006
Categorizes passengers into suborbital and orbital,
but the G force definitions associated with each will
put some operators’ passengers into the orbital
category for suborbital flights
Assumptions:
• Cabin pressure <= 8,000 feet
• G level limits: +4 Gz, -2 Gz, +/- 4 Gx, +/- 1 Gy
Recommendations for medical history and pre-flight
physical exam
Aerospace Medicine Program
Recommendations from COE CST
Research Task
• Differentiated by Suborbital
versus Orbital and Spaceflight
Participants versus Pilots.
• Take into account the flight
profile.
• Medical screening questionnaires
and pre-flight medical exams.
• Evaluations by physicians trained
in aerospace medicine.
• Employ risk mitigation strategies.
• Provide appropriate pre-flight
training.
Available on COE CST website at:
http://www.coe-cst.org/core/scripts/wysiwyg/kcfinder/upload/files/2012.08.06%20Task%20183UTMB%20Final%20Report.pdf
Aerospace Medicine Program
What are some of the challenges?
Passengers
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Wide age range (18 to 90’s)
Multiple medical conditions
Located around the globe
Lack of data for making
selection decisions
• Need for appropriate training
High Volume of Passengers
Frequent Flights for Crewmembers
Remote Location of Spaceports
Aerospace Medicine Program
Virgin Galactic Customers
The customers form a diverse pool
World wide representation: from 57 countries to date
Men (80%) & women (20%) (current age restriction: 18 and older)
Some are flying as individuals, some as couples
Some are flying as families
Many different cultures and backgrounds
Many customers are high net worth individuals
Some are celebrities
All have a passion for spaceflight
Aerospace Medicine Program
Where are the customers?
57 Countries
Top 5 are:
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United States: 34%
United Kingdom/Ireland: 15%
Australia/New Zealand: 6%
Canada: 5%
Russia: 5%
Aerospace Medicine Program
Factors Affecting Medical Considerations
Acceleration
• Launch: +3.5 Gx and +3.5 Gz
• Re-entry: +6 Gx
Cabin pressurization
• 5,000 to 8,000 feet
On board medical capability – very limited during
the spaceflight itself
Cardiovascular, Pulmonary, Psychological,
Neurological, Musculoskeletal, and other concerns
Aerospace Medicine Program
Other Considerations
Pregnancy
• How do you (can you) protect the fetus?
Children
• Can parents give “informed consent” for their
children
Aerospace Medicine Program
The Virgin Galactic Medical Program
Each customer flies at their own risk
• US FAA regulations require each SPF to receive and sign an
Informed Consent prior to flight
Safety is at the heart of the VG organization
• Safety through vehicle design
• Safety through operation
• Safety through preparation of our customers
Optimal preparation not only protects their safety but also maximizes the
opportunity for enjoyment of the spaceflight experience
• For the individual customer
• And for the group
Aerospace Medicine Program
Overview of Customer Group
Over 700 Ticket holders
Currently, approximately half have submitted
Medical History Questionnaires
• Some have provided significant amounts of
data
• Medical Records
• Imaging reports
Medical History documentation
• Others have given us only minimal information
Aerospace Medicine Program
What kind of medical problems do they have?
High blood pressure
Neck, back, and extremity problems
Heart disease
• Bypass surgery
• Stents
• Implanted pacemakers
Pulmonary disease
Diabetes (w insulin pump)
High cholesterol
Cancer
Psychiatric or psychological problems
Aerospace Medicine Program
Medical Decision Making
How do we identify concerning medical conditions?
• Novel field, most of these diseases have
NEVER flown before…
• Concerns:
• How to screen/train/monitor
• Medical problem arising during dynamic phases of flight
• Space environment exacerbating medical condition
Aerospace Medicine Program
Initial Studies
Initial data collected 2007-2008 during Virgin Galactic Founders
training centrifuge runs
• NASTAR centrifuge, Southampton, PA
77 participants, voluntarily offered data for analysis
• Pre/post-spin BP
• Continuous HR
• 16 subjects with PO2
Aerospace Medicine Program
NASTAR Center
Aerospace Medicine Program
Results
Aerospace Medicine Program
Results
SFPs successfully completed centrifuge training with little
difficulty
• Additional medical testing or records:
• Did not preclude anyone from participating
• Not predictive of participant performance
• Past medical history NOT associated with difference in
tolerance
No significant cardiac, cerebrovascular, respiratory events
Cardiovascular response attenuated in older participants
• NOT associated with change in tolerance
Most individuals likely able to tolerate…?
Aerospace Medicine Program
University Research Studies
(conducted by UTMB at the NASTAR Center)
Purpose:
• To evaluate subjects with defined disease states under
the G-loads expected during commercial spaceflight
using centrifuge-induced acceleration
• Disease cohorts:
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Cardiovascular disease
Hypertension
Diabetes
Pulmonary Disease
Spinal Disease or Injury
Aerospace Medicine Program
Methods
Seven centrifuge runs over 2 days:
• Day 1:
• Two +Gz runs (Peak +3.5Gz, Run 2)
• Two +Gx runs (Peak +6Gx, Run 2)
• Day 2: 3 runs approximating suborbital spaceflight
profiles
• Combined +Gx and +Gz
• Peak +6.0Gx/+4.0Gz/R+6.1G
Aerospace Medicine Program
NASTAR Center Training Profiles
Aerospace Medicine Program
NASTAR Center Training Profiles
Aerospace Medicine Program
Methods
Data collected included:
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Blood Pressure
Electrocardiogram
Pulse oximetry
Neurovestibular exams
Post-run questionnaires regarding:
• Motion sickness, disorientation, greyout, anxiety,
other symptoms
Aerospace Medicine Program
Conclusions
Overall:
• The majority of individuals with WELL
CONTROLLED medical conditions appear to
be able to tolerate the acceleration profiles of
launch/landing of commercial spaceflight
• Anxiety may be an issue
• Mitigation strategies for common problems
(anxiety, ineffective AGSM) should be
considered
Aerospace Medicine Program
How do our customers impact operations?
Training
Care and feeding
Seat design and fit
Restraint design
Egress – nominal & emergency
Speed of response
Language barriers
Aerospace Medicine Program
Components of Medical Program
Online Medical
Questionnaire
Review
Risk
estimate
Additional
Information
Review
Risk
estimate
AME Exam
Review
Acceptance for
Flight
Mitigation of
Risk
Acceptance of Risk
Additional Testing
Classification of
Risk
Ongoing review
and updates
Preflight
Training
Space Flight
Aerospace Medicine Program
Post-flight Medical Debrief
Virgin Galactic Medical Program
• Electronic Health
Record System
• Involve aerospace
medicine specialists
around the world
• Basic medical
evaluation with
augmentation as
indicated
Aerospace Medicine Program
Detailed Medical Questionnaire
Aerospace Medicine Program
Evaluating Medical Risk
Initial risk assessment
• Subjectively identified as low-medium-high
• Given “green, yellow, red” coding
• Reevaluated with further information:
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Cardiovascular
Blood pressure
Musculoskeletal
Exercise
Diabetes
Pulmonary
Overall
Aerospace Medicine Program
Evaluating Medical Risks
- Graded by two evaluators – green, yellow, red
per category
- Cumulative score given on a 1-10 scale
• 1-4 Green (could fly without trouble)
• 5-7 Yellow (need more evaluation before flight)
• 8-10 Red (would have difficulty tolerating flight)
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Aerospace Medicine Program
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Medical Screening Flow
Online Medical
Questionnaire
Review
Risk
estimate
Additional
Information
Review
Risk
estimate
AME Exam
Review
Acceptance for
Flight
Mitigation of
Risk
Acceptance of Risk
Additional Testing
Classification of
Risk
Ongoing review
and updates
Preflight
Training
Space Flight
Aerospace Medicine Program
Post-flight Medical Debrief
Emergency Medical Response
• Highly trained on
scene medical team
• Emergency medical
transport
Aerospace Medicine Program
Spaceport America
• Remote location
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Rough terrain
• Limited access
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Air medevac will be
necessary
• Definitive medical
care is a long way
away
Aerospace Medicine Program
Emergency Medical Response
In-house capabilities for planning and oversight roles
Coordinate with Spaceport fire/crash/rescue capabilities
Establish air and ground medevac capabilities
Engage local and regional medical communities
Augment on-site capabilities with additional EMS and
emergency medicine trained physicians on flight days
Practice, practice, practice …….
Plan for the worst / expect the best
Aerospace Medicine Program
Questions?
Aerospace Medicine Program